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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
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
data from handbook or collection of data
Justification for type of information:
data is from peer reviewed journals

Data source

Reference
Reference Type:
publication
Title:
Final report on the Safety Assessment of the components of Mentha Piperita Plant
Author:
Cosmetic Ingredient Review Expert Panel
Year:
2001
Bibliographic source:
International Journal of Toxicology, 2001

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: as mentioned below
Principles of method if other than guideline:
To assess the dermal irritation potential of test chemical in rabbits
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid: volatile
Details on test material:
- Name of test material (as cited in study report):Peppermint oil- Substance Type: organic- Physical State: Liquid

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
open
Preparation of test site:
other: hairless
Vehicle:
unchanged (no vehicle)
Controls:
not specified
Amount / concentration applied:
0.05 ml
Duration of treatment / exposure:
The dosing was repeated between 5 and 10 times
Observation period:
24,48 hours and at 1,2 weeks sometimes till 1month
Number of animals:
5
Details on study design:
TEST SITE- Area of exposure: hairless sites

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: not mentioned
Reversibility:
not specified
Remarks on result:
positive indication of irritation
Irritant / corrosive response data:
Moderate reactions characterized by polymorphonucelar leukocytes, and plasma cells(without necrosis) were noted in 3 rabbits. Severe reactions as well as necrosis were noted in the other 2 rabbits.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Moderate reactions characterized by polymorphonucelar leukocytes, and plasma cells(without necrosis) were noted in 3 rabbits. Severe reactions as well as necrosis were noted in the other 2 rabbits.Hence, the test chemical can be considered to be a skin irritant.
Executive summary:

The dermal irritation potential of the test chemical was assessed in rabbits.

Hairless sites on the skin of 5 White rabbits were intradermally injected with 0.05ml of the test chemical. The dosing was repeated between 5 and 10 times. Gross examinations were made at 24 and 48 hours, at 1 and 2 weeks and in some cases 1 month following dosing. Microscopic examination of the skin was performed after the gross examination.

Moderate reactions characterized by polymorphonucelar leukocytes, and plasma cells(without necrosis) were noted in 3 rabbits. Severe reactions as well as necrosis were noted in the other 2 rabbits.

Hence,the test chemical can be considered to be a skin irritant.