(+)-neomenthol

Skin irritation / corrosion

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

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

Test material information

Constituent 1

Reference substance name:

Oils, peppermint (Mentha piperita)

EC Number:

616-900-7

Cas Number:

8006-90-4

IUPAC Name:

Oils, peppermint (Mentha piperita)

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.