Registration Dossier
Registration Dossier
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EC number: 226-403-3 | CAS number: 5394-63-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1981-06-23 to 1981-06-30
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: No test Guideline is mentioned. Acceptable for reliability but not in detail documented.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 981
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Principles of method if other than guideline:
- DOT method
- GLP compliance:
- no
Test material
- Reference substance name:
- Diketen-Acetone-Adduct
- IUPAC Name:
- Diketen-Acetone-Adduct
- Test material form:
- other: liquid
- Details on test material:
- light yellow liquid
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 24 hrs, 72 hrs and 7 days
- Number of animals:
- 6 male and female
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hours
- Score:
- 0.8
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 72 hours
- Score:
- 0.2
- Max. score:
- 1
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24 hours, 72 hours
- Score:
- 0
- Max. score:
- 0
- Other effects:
- No other effects reported.
Any other information on results incl. tables
After the 24 -hr exposure, the cuff and the patch were removed and the application site gently wiped with paper towel. All animals were subsequently observed preening the application site.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance is considered to be not irritating to the rabbit skin.
- Executive summary:
The skin irritation study was performed in year 1981. 6 male and female New Zealand White rabbits were used for the test. The test substance is considered to be not irritating to the rabbit skin.
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