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Diss Factsheets

Toxicological information

Skin irritation / corrosion

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Administrative data

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
Cross-reference
Reason / purpose for cross-reference:
reference to same study
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
Study performed equivalent or similar to OECD 402, but pre-GLP.
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 402 (Acute Dermal Toxicity)
Deviations:
no
GLP compliance:
no
Remarks:
pre-GLP
Test type:
standard acute method
Limit test:
yes
Specific details on test material used for the study:
TSCA-CAS No.: 8008-79-5
Species:
rabbit
Strain:
not specified
Sex:
not specified
Details on test animals or test system and environmental conditions:
No data available
Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
No data available
Duration of exposure:
No data
Doses:
5000 mg/kg bw
No. of animals per sex per dose:
10 (one dose, unspecified sex)
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days
- Other examinations performed: clinical signs and skin irritation
Statistics:
Not relevant
Key result
Sex:
not specified
Dose descriptor:
LD50
Effect level:
> 5 000 mg/kg bw
Based on:
test mat.
Remarks on result:
other: 3/10 animals died at 5000 mg/kg bw
Mortality:
Mortality was seen in 3 out of 10 animals. The animals died on day 2,4 and 6.
Clinical signs:
other: Hypothermia and ataxia was observed in 2 out of 3 rabbits that died. Moderate redness and edema was seen in all test animals.
Gross pathology:
No data available
Other findings:
No data available
Interpretation of results:
other: Not classified
Remarks:
Based on CLP criteria
Conclusions:
Under the conditions of this test, an LD50 greater than 5000 mg/kg bw was found. Based on this result, the test substance does not need to be classified for acute dermal toxicity in accordance with the criteria outlined in Annex I of 1272/2008/EC (CLP).
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.

Three out of 10 animals died during the observation period on day 2, 4 and 6. Hypothermia and ataxia was observed in 2/3 animals which died. Moderate redness and edema was observed in all animals.

In conclusion, an LD50 of >5000 mg/kg bw was established and therefore the test substance does not need to be classified for acute dermal toxicity in accordance to the criteria outlined in Annex I of 1272/2008/EC (CLP).

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report date:
1976

Materials and methods

Test guideline
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

Test material

1
Reference substance name:
Essential oil of Spearmint obtained from the aerial part of Mentha spicata and/or Mentha cardiaca (Lamiaceae) obtained by distillation
EC Number:
946-253-9
Molecular formula:
Not applicable
IUPAC Name:
Essential oil of Spearmint obtained from the aerial part of Mentha spicata and/or Mentha cardiaca (Lamiaceae) obtained by distillation
Details on test material:
- Name of test material (as cited in study report): Spearmint oil
- Physical state: liquid
- Purity: no data
- Lot/batch No.: Confidential information

Test animals

Species:
rabbit
Strain:
not specified
Details on test animals or test system and environmental conditions:
No data available

Test system

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

Results and discussion

In vivo

Results
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.

Applicant's summary and conclusion

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).