Registration Dossier
Registration Dossier
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EC number: 606-524-1 | CAS number: 203313-47-7
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March 20 - May 21, 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- 2002-04-24
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- methyl cis-1-{[(2,5-dimethylphenyl)acetyl]amino}-4-methoxycyclohexanecarboxylate
- EC Number:
- 606-524-1
- Cas Number:
- 203313-47-7
- Molecular formula:
- C19H27NO4
- IUPAC Name:
- methyl cis-1-{[(2,5-dimethylphenyl)acetyl]amino}-4-methoxycyclohexanecarboxylate
- Test material form:
- solid: bulk
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Controls:
- yes, concurrent no treatment
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
- Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test item did not cause local skin irritation.
- Executive summary:
The irritant / corrosive potential of of the test item was studied on the skin of rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 404 -" Acute Dermal Irritation/Corrosion"; adopted: 24th April 2002; EEC Directive 67/548 Annex V - Method B.4. (1967) in its current version, and the principles of the EPA Health Effects Test Guidelines (OPPTS 870.2500), United States, EPA 712-C-98-196 (1998).
According to classification criteria the test item is not an irritant to the skin.
There were no systemic intolerance reactions.
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