Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication/ study report which meets basic scientific principles
Remarks:
The detailed protocole description for the Open Application Test was inserted into the study report by mistake. The correct protocole, based on a concurrent study report, is attachede to this endpoint study record for information.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Covered patch test in Rabbit (see attached protocole)
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Sample No.: 11.549T1/1B

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Age at study initiation: 9 - 12 weeks
- Housing:individually

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: clipped
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
0.5 ml of neat substance
Duration of treatment / exposure:
4 hours
Observation period:
4, 24, 48, and 72 hours
(grading for erythema, edema, cracking and scaling)
Number of animals:
8
Details on study design:
- standard controls: geraniol, cyclamen aldehyde, and diethyl phthalate
- statistics: Wilcoxon Matched-Pairs Signed Rank Test

Results and discussion

In vivo

Results
Irritation parameter:
overall irritation score
Basis:
mean
Time point:
other: 24, 48, 72 h
Score:
177
Reversibility:
not fully reversible within: 72 h

Any other information on results incl. tables

Under the conditions of this study, the test substance caused moderate irritation to rabbit skin.

At 4 hours, produced marginal to distinct erythema and edema in most rabbits;

at 24 hours, the intensity of erythema and edema increased with 5/8 animals also showing marginal cracking;

at 48 hours, the intensity of erythema and edema stabilized and 6/8 animals had marginal to slight cracking with 1/8 animals having marginal scaling and

at 72 hours, 1/8 rabbits showed no erythema or edema; 7/8 had marginal to distinct erythema and edema; 7/8 had marginal to slight cracking and 5/8 had marginal scaling.

The overall irritation score was 177, mean score per site was 22.13, and mean score per site per day was 5.53.

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria
Conclusions:
Under the conditions of this study, the test substance caused only moderate irritation to rabbit skin.
However, due to the described irritation effects and choosing a conservative approach, methylionone is regarded as irritant to rabbit skin.