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EC number: 700-585-9 | CAS number: 35786-94-8
Skin irritation / corrosion
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: Non GLP Study, but well documented
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
Test material
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- water
Results and discussion
Any other information on results incl. tables
No dermal irritation was observed in three rabbits throughout the study. The remaining three
rabbits exhibited slight or mild erythema at one hour after test substance removal. One rabbit
also exhibited slight edema. At 24 hours, slight or mild erythema was observed in two rabbits,
and no dermal irritation was observed in four rabbits. No dermal irritation was observed at 48 or
72 hours. No clinical signs were observed, and no body weight loss occurred during the study.
A summary of skin responses is presented in the following table.
SUMMARY OF SKIN RESPONSES HOURS AFTER TEST SUBSTANCE REMOVAL
ERYTHEMA EDEMA
RESPONSE 1 24 48 72 1 24 48 72
No Response 3/6 4/6 6/6 6/6 5/6 6/6 6/6 6/6
Slight 1/6 1/6 0/6 0/6 1/6 0/6 0/6 0/6
Mild 2/6 1/6 0/6 0/6 0/6 0/6 0/6 0/6
Moderate 0/6 0/6 0/6 0/6 0/6 0/6 0/6 0/6
Severe 0/6 0/6 0/6 0/6 0/6 0/6 0/6 0/6
Under the conditions of this study, the test item was a mild skin irritant.
If these test scores are to be used for EEC/OECD classification, according to the guide to the
labeling of dangerous substances published in the Official Journal of European Communities
(67/548/EEC), the test item probably should not be classified as irritant unless additional data proves
otherwise.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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