Hexanamide, N-(2-ethylhexyl)-3,5,5-trimethyl-

Endpoint summary

Description of key information

The skin irritation potential of the registration substance was evaluated according to OECD TG 404 protocol in 3 New Zealand albino rabbits. Following a 4 hour exposure period only slight, fully reversible erythema reactions in 2 animals but no edema reactions were observed. Based on the results, the registration substance is therefore classified as non-irritant in accordance with UN GHS and EU CLP as "no category".

The eye irritation potential of the registration substance was evaluated according to OECD TG 405 protocol in 3 New Zealand rabbits. Following a 24 hour exposure period only slight, but fully reversible conjunctival reddening was observed. No other ocilar effect occurred. Based on the results, the registration substance is therefore classified as non-irritant in accordance with UN GHS and EU CLP as "no category".

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Reference

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SPF breeding, Thomae GmbH, Biberach, Germany
- Age at study initiation: approximately 3 - 5 month
- Weight at study initiation: 2.1 - 2.5 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): approximately 15
- Photoperiod (hrs dark / hrs light): 12 hours periodically

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): undiluted

Duration of treatment / exposure:

4 hour exposure

Observation period:

7 days

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 100%
- Type of wrap if used: surgical tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize

Irritation parameter:

erythema score

Remarks:

all animals

Basis:

mean

Remarks:

overall

Time point:

24/48/72 h

Score:

0.4

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

erythema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

erythema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

1

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

edema score

Remarks:

all animals

Basis:

mean

Remarks:

overall

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

edema score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Only slight erythema but no edema reactions. No corrosive effects.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The registration substance was not irritating to rabbit skin and is not subject for labelling requirements.

Executive summary:

The primary skin irritation potential of the registration substance was evaluated according to OECD test guideline 404 using three New Zealand albino rabbits. Only animals with intact skin were used. Each animal was treated with 0.5 mL of undiluted test material.The test item was applied over the whole surface of a 2.5 x 2.5 cm cellulose patch on a piece of surgical plaster. The plaster was fixed to the prepared skin area and then covered with a semi-occlusive bandage. The exposure period was 4 hours. After the exposure all remnants of the test material were carefully removed from the skin with warm tap water. Examinations of the skin took place after 30-60 minutes, 24, 48 and 72 hours as well as 7 days after removal of the patches. Erythema and oedema were evaluated numerically according to the score of DRAIZE. From 1 hour up to 72 hours after removal of the patches, only slight erythema were observed in 2 animals. Edema reactions were not observed in any animal at any time point. 7 days p.a. all signs of irritation were reversible. Based on the study results, the registration substance is not subject to labelling requirements with regard to skin irritating effects.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Reference

Endpoint:

eye irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study according to GLP

Qualifier:

according to guideline

Guideline:

OECD Guideline 405 (Acute Eye Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes

Species:

rabbit

Strain:

Wistar

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: SPF breeding, Thomae GmbH, Biberach, Germany
- Age at study initiation: approximately 3 - 5 month
- Weight at study initiation: 2.9 - 3.9 kg
- Housing: individually in stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: approximately 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +/- 3 °C
- Humidity (%): 50 +/- 20 %
- Air changes (per hr): approxiamtely 15
- Photoperiod (hrs dark / hrs light): 12 hours periodically

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.1 mL per eye

Duration of treatment / exposure:

24 hours

Observation period (in vivo):

72 hours

Number of animals or in vitro replicates:

3

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes
- Time after start of exposure: 24 hours p.a.

SCORING SYSTEM: Draize

TOOL USED TO ASSESS SCORE: hand-slit lamp / fluorescein

Irritation parameter:

cornea opacity score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

cornea opacity score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

iris score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

conjunctivae score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0.2

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0.3

Max. score:

1

Reversibility:

fully reversible

Irritation parameter:

conjunctivae score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Remarks:

overall

Basis:

mean

Remarks:

all animals

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #1

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #2

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritation parameter:

chemosis score

Basis:

animal #3

Remarks:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

Only slight reddenings of the conjunctivae noted in 2 animals. All signs of irritation were reversible within 48 hours p.a.

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test item exhibited only minor reddenings of the conjunctivae which were reversible within 48 hours. Thus the registration substance is considered to be not irritating to the rabbit eye and is not subject for labelling requirements.

Executive summary:

The primary eye irritation potential of the registration substance was evaluated in the New Zealand albino rabbit according to OECD test guideline 405. Only animals without ocular abnormalities were used for the study. o.1 mL of undiluted test material was applied once to the conjunctival sac of the left eye of three rabbits. The untreated eyes served in each case as a control. The exposure period was 24 hours. 24 hours after instillation and at all the designated examination times at which a corneal examination with fluorescein sodium solution took place, the treated eyes were washed out thoroughly with isotonic saline at approx. 37°C. The eyes were examined 1, 24, 48 and 72 hours after application of the test substance. At 24 and 72 hours the eyes were also examined for corneal lesions under UV light after instillation of one drop of 0.01% fluorescein-sodium solution. From one hour up to 24 hours after administration the conjunctivae of 2 animals showed some blood vessels definitely injected. The effects were accompanied by aqueous eye discharge. 48 hours after application all signs of irritation were reversible. Accordingly, the registration substance is not considered to be an eye irritant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Justification for classification or non-classification

Based on the results of a guideline and GLP compliant OECD TG 404 study, no classification of the registration substance with regard to skin irritation/corrosion is warranted according to the criteria of the EU Classification, Labelling and Packaging Regulation 1272/2008/EC (CLP).

Based on the results of a guideline and GLP compliant OECD TG 405 study, no classification of the registration substance with regard to eye irritation/corrosion is warranted according to the criteria of the EU Classification, Labelling and Packaging Regulation 1272/2008/EC (CLP).