Essential oil of Spearmint obtained from the aerial part of Mentha spicata and/or Mentha cardiaca (Lamiaceae) obtained by distillation

Endpoint summary

Description of key information

Skin irritation:

- Acute dermal toxicity study (similar to OECD TG 402 / pre-GLP): irritating

- Six GPMT studies (similar to OECD TG 406 / pre-GLP): irritating (25% solution)

Eye irritation (OECD TG 405 / GLP): not irritating

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Reference 1

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

no

Principles of method if other than guideline:

A dermal toxicity test was performed on 10 rabbits according to a method similar to OECD402. A single dose of 5000 mg/kg bw was used. Mortality, clinical signs and skin irritation were observed for 14 days.

GLP compliance:

no

Remarks:

pre-GLP

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

No data available

Type of coverage:

not specified

Preparation of test site:

not specified

Vehicle:

not specified

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): not specified
- Concentration (if solution): 5000 mg/kg bw undiluted test substance

Duration of treatment / exposure:

not specified

Observation period:

14 days

Number of animals:

10

Details on study design:

TEST SITE
- Area of exposure: not specified
- % coverage: not specified
- Type of wrap if used: not specified

REMOVAL OF TEST SUBSTANCE
- Washing (if done): not specified
- Time after start of exposure: not specified

OBSERVATION TIME POINTS
Mortality, clinical signs and skin irritation were observed for 14 days.

SCORING SYSTEM:
- Method of calculation: not specified

Irritation parameter:

other: Redness and edema

Basis:

other: All 10 animals

Time point:

other: Not specified

Remarks on result:

other: moderate redness and edema were observed in all animals

Irritant / corrosive response data:

Moderate redness and edema were observed in all animals.

Other effects:

Mortality was seen in 3 out of 10 animals. The animals died on day 2,4 and 6. Hypothermia and ataxia was observed in 2 out of 3 rabbits that died.

Interpretation of results:

other: Category 2 (irritant)

Remarks:

Based on CLP criteria

Conclusions:

Under the conditions of the test, undiluted Spearmint oil is considered to cause skin irritation in rabbits. Based on this, the substance should be classified for skin irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

A dermal toxicity test was performed on 10 rabbits according to a method similar to OECD402. A single dose of 5000 mg/kg bw was used. Mortality, clinical signs and skin irritation were observed for 14 days.

Moderate redness and edema was observed in all animals. Under the conditions of the test, undiluted Spearmint oil  is considered to cause skin irritation in rabbits. Based on this, the substance should be classified for skin irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Reference 2

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

05-01-1983 to 24-02-1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Principles of method if other than guideline:

This Guinea Pig Maximization Test (equivalent to OECD 406) was performed to determine the skin sensitising potential of Spearmint Oil Mentha Spicata in guinea pigs. Prior to the main sensitization test, intradermal and topical preliminary irritation tests were performed in order to determine suitable concentration for the sensitization test.

GLP compliance:

no

Remarks:

Pre-GLP

Species:

guinea pig

Strain:

Dunkin-Hartley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Environmental Safety Division of the Unilever Research Laboratory
- Diet (e.g. ad libitum): Ad libitum (RGP pellets, had and cabbage)
- Water (e.g. ad libitum): Ad libitum
- Weight: approximately 450 g

ENVIRONMENTAL CONDITIONS
no data available

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: Acetone/ PEG

Controls:

not specified

Amount / concentration applied:

5%, 10%, and 25% test substance.

Duration of treatment / exposure:

24 hours

Observation period:

48 hours

Number of animals:

4 females

Details on study design:

TEST SITE
- Area of exposure: Eight millimeter diameter paper patches in 11 mm aluminium patch test cups saturated with the test substance in a suitable solvent were applied to the flanks.
- Type of wrap if used: Adhesive plaster wound around the trunck.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
24h and 48 h after patch removal.

SCORING SYSTEM:
Reaction are scored on a scale from 0 - 3.
0 = no reaction
0.5 = very faint erythema (usually non-confluent)
1 = faint erythema (usually confluent)
2 = moderate erythema
3 = marked erythema (with or without oedema)
n = necrosis
sp = small spots of erythema

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #4

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #4

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal: #1

Time point:

24/48 h

Score:

0.25

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #1

Time point:

24/48 h

Score:

0.5

Max. score:

3

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0.5

Max. score:

3

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #4

Time point:

24/48 h

Score:

0.5

Max. score:

3

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Irritant / corrosive response data:

25%: suitable irritant concentration.
5%: was a suitable non-irritant for the challenge.
None of the applied concentrations caused corrosion.

Irritation results preliminary test 24 and 48 hours after patch removal:

Guinea pigs	Concentrations
Females	5%		10%		25%
	24 h	48 h	24 h	48 h	24 h	48 h
5135 (#1)	0	0	0.5	0	0.5 -1	0.5
5162 (#2)	0	0	0	0	0.5	0.5
5261 (#3)	0	0	0	0	0	0
4962 (#4)	0	0	0	0	0.5	0.5

0 = no reaction

0.5 = very faint erythema (usually non-confluent)

1 = faint erythema (usually confluent)

2 = moderate erythema

3 = marked erythema (with or without oedema)

n = necrosis

sp = small spots of erythema

Interpretation of results:

other: Category 2 (irritant)

Remarks:

based on CLP criteria

Conclusions:

Under the conditions of this test, topical application of 25% Spearmint Oil Mentha Spicata in guinea pigs is considered to cause skin irritation. Based on this, the substance should be classified for skin irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

This Guinea Pig Maximization Test (equivalent to OECD 406) was performed to determine the skin sensitising potential of Spearmint Oil Mentha Spicata in guinea pigs. Prior to the main sensitization test, a topical preliminary irritation tests was performed in order to determine suitable concentration for the sensitization test. 5% Spearmint Oil Mentha Spicata was a non-irritant concentration. Under the conditions of this test, topical application of 25% Spearmint Oil Mentha Spicata in guinea pigs is considered to cause skin irritation. Based on this, the substance should be classified for skin irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Reference 3

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

05-01-1983 to 24-02-1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Principles of method if other than guideline:

This Guinea Pig Maximization Test (equivalent to OECD 406) was performed to determine the skin sensitising potential of Spearmint Oil Mentha Spicata in guinea pigs. Prior to the main sensitization test, intradermal and topical preliminary irritation tests were performed in order to determine suitable concentration for the sensitization test.

GLP compliance:

no

Remarks:

Pre-GLP

Species:

guinea pig

Strain:

Dunkin-Hartley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Environmental Safety Division of the Unilever Research Laboratory
- Diet (e.g. ad libitum): Ad libitum (RGP pellets, had and cabbage)
- Water (e.g. ad libitum): Ad libitum
- Weight: approximately 450 g

ENVIRONMENTAL CONDITIONS
no data available

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: Acetone/ PEG

Controls:

not specified

Amount / concentration applied:

5%, 10%, and 25% test substance.

Duration of treatment / exposure:

24 hours

Observation period:

48 hours

Number of animals:

4 females

Details on study design:

TEST SITE
- Area of exposure: Eight millimeter diameter paper patches in 11 mm aluminium patch test cups saturated with the test substance in a suitable solvent were applied to the flanks.
- Type of wrap if used: Adhesive plaster wound around the trunck.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
24h and 48 h after patch removal.

SCORING SYSTEM:
Reaction are scored on a scale from 0 - 3.
0 = no reaction
0.5 = very faint erythema (usually non-confluent)
1 = faint erythema (usually confluent)
2 = moderate erythema
3 = marked erythema (with or without oedema)
n = necrosis
sp = small spots of erythema

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #4

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

other: animal #3 showed small spots of erythema

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal: #4

Time point:

24/48 h

Score:

0.25

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal: #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal: #3

Time point:

24/48 h

Score:

0.25

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #1

Time point:

24/48 h

Score:

0.5

Max. score:

3

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #4

Time point:

24/48 h

Score:

0.5

Max. score:

3

Irritant / corrosive response data:

25%: suitable irritant concentration.
5%: was a suitable non-irritant for the challenge.
None of the applied concentrations caused corrosion.

Irritation results preliminary test 24 and 48 hours after patch removal:

Guinea pigs	Concentrations
Females	5%		10%		25%
	24 h	48 h	24 h	48 h	24 h	48 h
5431 (#1)	0	0	0	0	0.5	0.5
5517 (#2)	0	0	SP	0	0	0
5436 (#3)	0	0	0	0	0.5	0
5223 (#4)	0	0	0.5	0	0.5-1	0.5

0 = no reaction

0.5 = very faint erythema (usually non-confluent)

1 = faint erythema (usually confluent)

2 = moderate erythema

3 = marked erythema (with or without oedema)

n = necrosis

sp = small spots of erythema

Interpretation of results:

other: Category 2 (irritant)

Remarks:

based on CLP criteria

Conclusions:

Under the conditions of this test, topical application of 25% Spearmint Oil Mentha Spicata in guinea pigs is considered to cause skin irritation. Based on this, the substance should be classified for skin irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

This Guinea Pig Maximization Test (equivalent to OECD 406) was performed to determine the skin sensitising potential of Spearmint Oil Mentha Spicata in guinea pigs. Prior to the main sensitization test, a topical preliminary irritation tests was performed in order to determine suitable concentration for the sensitization test. 5% Spearmint Oil Mentha Spicata was a non-irritant concentration. Under the conditions of this test, topical application of 25% Spearmint Oil Mentha Spicata in guinea pigs is considered to cause skin irritation. Based on this, the substance should be classified for skin irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Reference 4

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

05-01-1983 to 24-02-1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Principles of method if other than guideline:

This Guinea Pig Maximization Test (equivalent to OECD 406) was performed to determine the skin sensitising potential of Spearmint Oil Mentha Spicata in guinea pigs. Prior to the main sensitization test, intradermal and topical preliminary irritation tests were performed in order to determine suitable concentration for the sensitization test.

GLP compliance:

no

Remarks:

Pre-GLP

Species:

guinea pig

Strain:

Dunkin-Hartley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Environmental Safety Division of the Unilever Research Laboratory
- Diet (e.g. ad libitum): Ad libitum (RGP pellets, had and cabbage)
- Water (e.g. ad libitum): Ad libitum
- Weight: approximately 450 g

ENVIRONMENTAL CONDITIONS
no data available

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: Acetone/ PEG

Controls:

not specified

Amount / concentration applied:

5%, 10%, and 25% test substance.

Duration of treatment / exposure:

24 hours

Observation period:

24 and 48 hours after patch removal.

Number of animals:

4 females

Details on study design:

TEST SITE
- Area of exposure: Eight millimeter diameter paper patches in 11 mm aluminium patch test cups saturated with the test substance in a suitable solvent were applied to the flanks.
- Type of wrap if used: Adhesive plaster wound around the trunck.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
24h and 48 h after patch removal.

SCORING SYSTEM:
Reaction are scored on a scale from 0 - 3.
0 = no reaction
0.5 = very faint erythema (usually non-confluent)
1 = faint erythema (usually confluent)
2 = moderate erythema
3 = marked erythema (with or without oedema)
n = necrosis
sp = small spots of erythema

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #4

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #4

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal: #3

Time point:

24/48 h

Score:

0.25

Max. score:

3

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal: #1

Time point:

24/48 h

Score:

0.25

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0.5

Max. score:

3

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #4

Time point:

24/48 h

Score:

0.5

Max. score:

3

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #3

Time point:

24/48 h

Score:

1

Max. score:

3

Irritant / corrosive response data:

25%: suitable irritant concentration.
5%: was a suitable non-irritant for the challenge.
None of the applied concentrations caused corrosion.

Irritation results preliminary test 24 and 48 hours after patch removal:

Guinea pigs	Concentrations
Females	5%		10%		25%
	24 h	48 h	24 h	48 h	24 h	48 h
5023 (#1)	0	0	0	0	0.5	0
5259 (#2)	0	0	0	0	0.5-1	0.5
5619 (#3)	0	0	0	0.5	1	1
4954 (#4)	0	0	0	0	0.5	0.5

0 = no reaction

0.5 = very faint erythema (usually non-confluent)

1 = faint erythema (usually confluent)

2 = moderate erythema

3 = marked erythema (with or without oedema)

n = necrosis

sp = small spots of erythema

Interpretation of results:

other: Category 2 (irritant)

Remarks:

Based on CLP criteria

Conclusions:

Under the conditions of this test, topical application of 25% Spearmint Oil Mentha Spicata in guinea pigs is considered to cause skin irritation. Based on this, the substance should be classified for skin irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

This Guinea Pig Maximization Test (equivalent to OECD 406) was performed to determine the skin sensitising potential of Spearmint Oil Mentha Spicata in guinea pigs. Prior to the main sensitization test, a topical preliminary irritation tests was performed in order to determine suitable concentration for the sensitization test. 5% Spearmint Oil Mentha Spicata was a non-irritant concentration. Under the conditions of this test, topical application of 25% Spearmint Oil Mentha Spicata in guinea pigs is considered to cause skin irritation. Based on this, the substance should be classified for skin irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Reference 5

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

05-01-1983 to 25-02-1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Principles of method if other than guideline:

This Guinea Pig Maximization Test (equivalent to OECD 406) was performed to determine the skin sensitising potential of Spearmint Oil Mentha Spicata in guinea pigs. Prior to the main sensitization test, intradermal and topical preliminary irritation tests were performed in order to determine suitable concentration for the sensitization test.

GLP compliance:

no

Remarks:

Pre-GLP

Species:

guinea pig

Strain:

Dunkin-Hartley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Environmental Safety Division of the Unilever Research Laboratory
- Diet (e.g. ad libitum): Ad libitum (RGP pellets, had and cabbage)
- Water (e.g. ad libitum): Ad libitum
- Weight: approximately 450 g

ENVIRONMENTAL CONDITIONS
no data available

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: Acetone/ PEG

Controls:

not specified

Amount / concentration applied:

5%, 10%, and 25% test substance.

Duration of treatment / exposure:

24 hours

Observation period:

48 hours

Number of animals:

4 females

Details on study design:

TEST SITE
- Area of exposure: Eight millimeter diameter paper patches in 11 mm aluminium patch test cups saturated with the test substance in a suitable solvent were applied to the flanks.
- Type of wrap if used: Adhesive plaster wound around the trunck.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
24h and 48 h after patch removal.

SCORING SYSTEM:
Reaction are scored on a scale from 0 - 3.
0 = no reaction
0.5 = very faint erythema (usually non-confluent)
1 = faint erythema (usually confluent)
2 = moderate erythema
3 = marked erythema (with or without oedema)
n = necrosis
sp = small spots of erythema

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #4

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal: #4

Time point:

24/48 h

Score:

0.25

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0.25

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #4

Time point:

24/48 h

Score:

0.25

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

25%: suitable irritant concentration.
5%: was a suitable non-irritant for the challenge.
None of the applied concentrations caused corrosion.

Irritation results preliminary test 24 and 48 hours after patch removal:

Guinea pigs	Concentrations
Females	5%		10%		25%
	24 h	48 h	24 h	48 h	24 h	48 h
5208 (#1)	0	0	0	0	0	0
5252 (#2)	0	0	0	0	0.5	0
5607 (#3)	0	0	0	0	0	0
5360 (#4)	0	0	0	0.5	0.5	0

0 = no reaction

0.5 = very faint erythema (usually non-confluent)

1 = faint erythema (usually confluent)

2 = moderate erythema

3 = marked erythema (with or without oedema)

n = necrosis

sp = small spots of erythema

Interpretation of results:

other: Category 2 (irritant)

Remarks:

Based on CLP criteria

Conclusions:

Under the conditions of this test, topical application of 25% Spearmint Oil Mentha Spicata in guinea pigs is considered to cause skin irritation. Based on this, the substance should be classified for skin irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

This Guinea Pig Maximization Test (equivalent to OECD 406) was performed to determine the skin sensitising potential of Spearmint Oil Mentha Spicata in guinea pigs. Prior to the main sensitization test, a topical preliminary irritation tests was performed in order to determine suitable concentration for the sensitization test. 5% Spearmint Oil Mentha Spicata was a non-irritant concentration. Under the conditions of this test, topical application of 25% Spearmint Oil Mentha Spicata in guinea pigs is considered to cause skin irritation. Based on this, the substance should be classified for skin irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Reference 6

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

05-01-1983 to 03-03-1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Principles of method if other than guideline:

This Guinea Pig Maximization Test (equivalent to OECD 406) was performed to determine the skin sensitising potential of Spearmint Oil Mentha Spicata in guinea pigs. Prior to the main sensitization test, intradermal and topical preliminary irritation tests were performed in order to determine suitable concentration for the sensitization test.

GLP compliance:

no

Remarks:

Pre-GLP

Specific details on test material used for the study:

spearmint oil
Spearmint, ext. (Mentha spicata L.)
EC 283-656-2
CAS 84696-51-5
Oil of spearmint - Native type
Oil of spearmint - Indian type

Species:

guinea pig

Strain:

Dunkin-Hartley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Environmental Safety Division of the Unilever Research Laboratory
- Diet (e.g. ad libitum): Ad libitum (RGP pellets, had and cabbage)
- Water (e.g. ad libitum): Ad libitum
- Weight: approximately 450 g

ENVIRONMENTAL CONDITIONS
no data available

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: Acetone/ PEG

Controls:

not specified

Amount / concentration applied:

5%, 10%, and 25% test substance.

Duration of treatment / exposure:

24 hours

Observation period:

48 hours

Number of animals:

4 males & 4 females

Details on study design:

TEST SITE
- Area of exposure: Eight millimeter diameter paper patches in 11 mm aluminium patch test cups saturated with the test substance in a suitable solvent were applied to the flanks.
- Type of wrap if used: Adhesive plaster wound around the trunck.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
24h and 48 h after patch removal.

SCORING SYSTEM:
Reaction are scored on a scale from 0 - 3.
0 = no reaction
0.5 = very faint erythema (usually non-confluent)
1 = faint erythema (usually confluent)
2 = moderate erythema
3 = marked erythema (with or without oedema)
n = necrosis
sp = small spots of erythema

Irritation parameter:

erythema score

Remarks:

5%

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5%

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5%

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5%

Basis:

animal #4

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5%

Basis:

animal #5

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5%

Basis:

animal #6

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5%

Basis:

animal: #7

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5%

Basis:

animal: #8

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #4

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #5

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #6

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal: #8

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal: #7

Time point:

24/48 h

Score:

0.25

Max. score:

3

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #1

Time point:

24/48 h

Score:

1

Max. score:

3

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal: #7

Time point:

24/48 h

Score:

1

Max. score:

3

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #4

Time point:

24/48 h

Score:

0.25

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #5

Time point:

24/48 h

Score:

0.25

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #6

Time point:

24/48 h

Score:

0.5

Max. score:

3

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal: #8

Time point:

24/48 h

Score:

0.5

Max. score:

3

Irritant / corrosive response data:

10%: highest non-irritant concentration, challenge application.
25%: suitable irritant for induction application.
None of the applied concentrations caused corrosion.

Irritation results preliminary test 24 and 48 hours after patch removal:

Guinea pigs	Concentrations
Males	5%		10%		25%
	24 h	48 h	24 h	48 h	24 h	48 h
6273 (#1)	0	0	0	0	1	1
6365 (#2)	0	0	0	0	0	0
6364 (#3)	0	0	0	0	0	0
6546 (#4)	0	0	0	0	0.5	0

Guinea pigs	Concentrations
Females	5%		10%		25%
	24 h	48 h	24 h	48 h	24 h	48 h
5023 (#5)	0	0	0	0	0.5	0
5259 (#6)	0	0	0	0	0.5-1	0.5
5619 (#7)	0	0	0	0.5	1	1
4954 (#8)	0	0	0	0	0.5	0.5

0 = no reaction

0.5 = very faint erythema (usually non-confluent)

1 = faint erythema (usually confluent)

2 = moderate erythema

3 = marked erythema (with or without oedema)

n = necrosis

sp = small spots of erythema

Interpretation of results:

other: Category 2 (irritant)

Remarks:

Based on CLP criteria

Conclusions:

Under the conditions of this test, topical application of 25% Spearmint Oil Mentha Spicata in guinea pigs is considered to cause skin irritation. Based on this, the substance should be classified for skin irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

This Guinea Pig Maximization Test (equivalent to OECD 406) was performed to determine the skin sensitising potential of Spearmint Oil Mentha Spicata in guinea pigs. Prior to the main sensitization test, a topical preliminary irritation tests was performed in order to determine suitable concentration for the sensitization test. 5 and 10% Spearmint Oil Mentha Spicata were non-irritant concentrations. Under the conditions of this test, topical application of 25% Spearmint Oil Mentha Spicata in guinea pigs is considered to cause skin irritation. Based on this, the substance should be classified for skin irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Reference 7

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

06-01-1983 to 03-03-1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Reason / purpose for cross-reference:

reference to same study

Qualifier:

equivalent or similar to guideline

Guideline:

other: OECD Guideline 406 (Skin Sensitisation)

Deviations:

no

Principles of method if other than guideline:

This Guinea Pig Maximization Test (equivalent to OECD 406) was performed to determine the skin sensitising potential of Spearmint Oil Mentha Spicata in guinea pigs. Prior to the main sensitization test, intradermal and topical preliminary irritation tests were performed in order to determine suitable concentration for the sensitization test.

GLP compliance:

no

Remarks:

Pre-GLP

Species:

guinea pig

Strain:

Dunkin-Hartley

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Environmental Safety Division of the Unilever Research Laboratory
- Diet (e.g. ad libitum): Ad libitum (RGP pellets, had and cabbage)
- Water (e.g. ad libitum): Ad libitum
- Weight: approximately 450 g

ENVIRONMENTAL CONDITIONS
no data available

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: Acetone/ PEG

Controls:

not specified

Amount / concentration applied:

5%, 10%, and 25% test substance.

Duration of treatment / exposure:

24 hours

Observation period:

48 hours

Number of animals:

4 males & 4 females

Details on study design:

TEST SITE
- Area of exposure: Eight millimeter diameter paper patches in 11 mm aluminium patch test cups saturated with the test substance in a suitable solvent were applied to the flanks.
- Type of wrap if used: Adhesive plaster wound around the trunck.

REMOVAL OF TEST SUBSTANCE
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
24h and 48 h after patch removal.

SCORING SYSTEM:
Reaction are scored on a scale from 0 - 3.
0 = no reaction
0.5 = very faint erythema (usually non-confluent)
1 = faint erythema (usually confluent)
2 = moderate erythema
3 = marked erythema (with or without oedema)
n = necrosis
sp = small spots of erythema

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #4

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal #5

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5%

Basis:

animal #6

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5%

Basis:

animal: #7

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

5% test substance

Basis:

animal: #8

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #1

Time point:

24/48 h

Score:

0.5

Max. score:

3

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #4

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #5

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal #6

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal: #8

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

10% test substance

Basis:

animal: #7

Time point:

24/48 h

Score:

0.25

Max. score:

3

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #1

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #3

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #4

Time point:

24/48 h

Score:

0

Max. score:

3

Remarks on result:

no indication of irritation

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #2

Time point:

24/48 h

Score:

0.5

Max. score:

3

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #6

Time point:

24/48 h

Score:

0.5

Max. score:

3

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal: #8

Time point:

24/48 h

Score:

0.5

Max. score:

3

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal #5

Time point:

24/48 h

Score:

0.25

Max. score:

3

Reversibility:

fully reversible within: 48 h

Irritation parameter:

erythema score

Remarks:

25% test substance

Basis:

animal: #7

Time point:

24/48 h

Score:

1

Max. score:

3

Irritant / corrosive response data:

25%: 50% test substance was selected as 25% was insufficiently irritant for the induction application (see also Any other information on results incl. tables).
10%: was a suitable non-irritant for the challenge.
None of the applied concentrations caused corrosion.

Irritation results preliminary test 24 and 48 hours after patch removal:

Guinea pigs	Concentrations
Males	5%		10%		25%
	24 h	48 h	24 h	48 h	24 h	48 h
6478 (#1)	0	0	0.5	0.5	0	0
6041 (#2)	0	0	0	0	0.5	0.5
5846 (#3)	0	0	0	0	0	0
5654 (#4)	0	0	0	0	0	0

Guinea pigs	Concentrations
Females	5%		10%		25%
	24 h	48 h	24 h	48 h	24 h	48 h
5023 (#5)	0	0	0	0	0.5	0
5259 (#6)	0	0	0	0	0.5-1	0.5
5619 (#7)	0	0	0	0.5	1	1
4954 (#8)	0	0	0	0	0.5	0.5

0 = no reaction

0.5 = very faint erythema (usually non-confluent)

1 = faint erythema (usually confluent)

2 = moderate erythema

3 = marked erythema (with or without oedema)

n = necrosis

sp = small spots of erythema

Interpretation of results:

other: Category 2 (irritant)

Remarks:

Based on CLP criteria

Conclusions:

Under the conditions of this test, topical application of 25% Spearmint Oil Mentha Spicata in guinea pigs is considered to cause skin irritation. Based on this, the substance should be classified for skin irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Executive summary:

This Guinea Pig Maximization Test (equivalent to OECD 406) was performed to determine the skin sensitising potential of Spearmint Oil Mentha Spicata in guinea pigs. Prior to the main sensitization test, a topical preliminary irritation tests was performed in order to determine suitable concentration for the sensitization test. 5 and 10% Spearmint Oil Mentha Spicata were non-irritant concentrations. Under the conditions of this test, topical application of 25% Spearmint Oil Mentha Spicata in guinea pigs is considered to cause skin irritation. Based on this, the substance should be classified for skin irritation in accordance with the criteria outlined in Annex I of the CLP Regulation (1272/2008/EC).

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

2015-10-19 to 2016-03-14

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study is performed according to OECD Guideline 405 (2012), and under GLP.

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.2400 (Acute Eye Irritation)

Qualifier:

according to guideline

Guideline:

other: JMAFF Guidelines (2000), including the most recent revisions

GLP compliance:

yes (incl. QA statement)

Specific details on test material used for the study:

spearmint oil
Spearmint, ext. (Mentha spicata L.)
EC 283-656-2
CAS 84696-51-5
Oil of spearmint - Native type
Oil of spearmint - Indian type

Species:

rabbit

Strain:

New Zealand White

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: Charles River France, L'Arbresle Cedex, France
- Age at study initiation: between 12 and 24 weeks old
- Weight at study initiation: at least 1.5 kg
- Housing: animals were individually housed in labeled cages with perforated floors and shelters.
- Diet (e.g. ad libitum): pellet diet for rabbits (approximately 100 grams per day) and wooden sticks
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before start of treatment under laboratory conditions

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 24 °C
- Humidity (%): 40-70%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL of the test item
- Concentration (if solution): n.a.

VEHICLE
The testitem was instilled undiluted, as delivered by the sponsor.

Duration of treatment / exposure:

The animals were treated by instillation of the test item, and subsequently exposed (e.g. the eyes were not washed) to the test item for 72 hours (two test animals) or 7 days (sentinel).

Observation period (in vivo):

The sentinel animal was observed 1 hour after installation, and 24, 48 and 72 hours after (in total for 7 days). 2.5 weeks later the two other animals were observed in a similar way, but for 72 hours in total.

Number of animals or in vitro replicates:

Three in total.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): No data
- Time after start of exposure: No data

SCORING SYSTEM:
The numerical scorings recorded were made in compliance with OECD guideline 405 (2012).

TOOL USED TO ASSESS SCORE:
If standard lighting was not considered to be enough, an ophthalmic examination lamp was used to examine the eyes.

Irritation parameter:

cornea opacity score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: not applicable

Irritation parameter:

cornea opacity score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

fully reversible within: three days

Irritation parameter:

iris score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: Not applicable

Irritation parameter:

iris score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: Not applicable

Irritation parameter:

iris score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: Not applicable

Irritation parameter:

conjunctivae score

Remarks:

(Redness)

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 1

Max. score:

1

Reversibility:

fully reversible within: 4 days

Irritation parameter:

conjunctivae score

Remarks:

(Redness)

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0.3

Max. score:

1

Reversibility:

fully reversible within: 48 hours

Irritation parameter:

conjunctivae score

Remarks:

(Redness)

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0.7

Max. score:

1

Reversibility:

fully reversible within: 72 hours

Irritation parameter:

chemosis score

Basis:

animal #1

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: Not applicable

Irritation parameter:

chemosis score

Basis:

animal #2

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: Not applicable

Irritation parameter:

chemosis score

Basis:

animal #3

Time point:

24/48/72 h

Score:

ca. 0

Max. score:

0

Reversibility:

other: Not applicable

Irritant / corrosive response data:

All animals showed irritation of the conjunctivae; e.g. all animals showed discharge 1 hour after dosing the test substance. This was not observed after 24 hours for animal 1 and 2, and the discharge effect for the sentinel was reversible after 48 hours. In addition the sentinel suffered from redness for 72 hours. The redness observed for animals 1 and 2 was no longer observed after 24 and 48 hours respectively. All animals suffered from chemosis, but for all three this effect was only observed 1 hour after dosing. Treatment of the eyes with 2% fluorescein 24 hours after test item instillation revealed no corneal epithelial damage.

Other effects:

There were no signs of systemic toxicity, nor mortality, observed during the test period. The bodyweight of the animals was not reduced. There was no evidence of ocular corrosion.

Interpretation of results:

other: Not classified

Remarks:

Based on CLP criteria

Conclusions:

Under the conditions of this test, Spearmint Essential Oil, ex Mentha spicata does not need to be classified as eye irritant, in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).

Executive summary:

To investigate the potential eye irritating effects of Spearmint Essential Oil, ex Mentha spicata, a study was conducted according to OECD 405. The test item was applied by instillation of 0.1 ml of the testsubstance into one eye of in total three New Zealand White rabbits. The ocular reactions observed included irritation of the conjunctivae (redness, chemosis and discharge). These effects were fully reversible within 4 days, 72 hours or 48 hours. No iridial irritation or corneal opacity were observed. Based on the results of this test it was concluded that Spearmint Essential Oil, ex Mentha spicata does not need to be classified as eye irritant, in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Skin irritation

Information regarding the irritating properties of spearmint oil was obtained from the available acute dermal toxicity studies and 6 Guinea Pig Maximisation Tests.

A dermal toxicity test was performed on 10 rabbits according to a method similar to OECD402. A single dose of 5000 mg/kg bw Spearmint oil was used. Mortality, clinical signs and skin irritation were observed for 14 days. Moderate redness and edema was observed in all animals. Undiluted Spearmint Oil caused skin irritation in all rabbits. Skin Irritation was also observed in six Guinea Pig Maximization Tests (equivalent to OECD 406). Prior to the main sensitization tests, topical preliminary irritation tests were performed in order to determine suitable concentration for the sensitization test. Filter paper patches in aluminium patch test cups were saturated with a range of concentrations of test substance in a suitable solvent (Acetone/PEG) and were applied to the shaved flanks of 4 guinea pigs of the same sex and weighing approximately 450 g. The patches were removed 24 h after application and the treated sites were examined 24 and 48 hours after removal of the patch. 5% Spearmint Oil Mentha Spicata was a non-irritant concentration in all tests. The topical application of 25% Spearmint Oil Mentha Spicata in guinea pigs caused skin irritation in all tests.

In the dermal toxicity as well as the Guinea Pig Maximization Tests irritant effects were observed and no corrosive effects were reported. Based on these results it can be concluded that spearmint oil is a skin irritant. This conclusion is supported by the irritating properties of the constituents L-Limonene (CAS 5989-54-8) and β-myrcene (CAS 123-35-3). These are present respectively at a typical concentration of 14% and 4% in spearmint oil and are currently classified as H315 (Skin Irrit. 2) and their presence is well above the CLP mixture classification limit for skin irritation (10%). Based on the available information regarding the irritating properties of spearmint oil and considering the irritating properties of its constituents L-Limonene (CAS 5989-54-8) and β-myrcene (CAS 123-35-3) , Spearmint oil is considered to be classified as H315 (Skin Irrit. 2) and therefore further testing is deemed not required.

Eye irritation

To investigate the potential eye irritating effects of Spearmint Essential Oil, ex Mentha spicata, a study was conducted according to OECD 405. The test item was applied by instillation of 0.1 ml of the testsubstance into one eye of in total three New Zealand White rabbits. The ocular reactions observed included irritation of the conjunctivae (redness, chemosis and discharge). These effects were fully reversible within 4 days, 72 hours or 48 hours. No iridial irritation or corneal opacity were observed. This is not fully supported by the available in vitro eye irritation test (BCOP) performed for Spearmint oil, as this turned our to be inconclusive. As in vivo data is considered to be more reliable than in vitro data, it was concluded that Spearmint Essential Oil, ex Mentha spicata does not need to be classified as eye irritant, in accordance with the criteria outlined in Annex I of CLP (1272/2008/EC).

Justification for classification or non-classification

Spearmint oil is considered to be classified as Skin Irrit. 2, H315 according to Regulation 1272/2008/EC (CLP).