Registration Dossier
Registration Dossier
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EC number: 606-541-4 | CAS number: 2037-95-8
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- Limited material and methods but results usable
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1,3-benzoxazine-2,4-dione
- Cas Number:
- 2037-95-8
- IUPAC Name:
- 1,3-benzoxazine-2,4-dione
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- SPF-quality
- Details on test animals or test system and environmental conditions:
- no details provided
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 gram of v184844 was applied to the intact skin of a shaved area on a flank of an albino rabbit.
- Duration of treatment / exposure:
- four hours
- Observation period:
- 72 hours
- Number of animals:
- 1
- Details on study design:
- The patch was fixed with a dressing, which was wrapped around the abdomen and secured with an elastic bandage. The application should be regarded as a semi-occlusive application. Four hours after the application, the dressing was removed and the remaining test substance removed using a tissue moistened with tap-water and subsequently dry tissue.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Four hours exposure to 0.5 grams of V184844 (CH02586) resulted in no skin irritation. V184844 (CH02586) resulted in a primary irritation index of 0 (non-irritating) when applied to the intact rabbit skin.
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