Registration Dossier
Registration Dossier
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EC number: 240-702-6 | CAS number: 16652-76-9
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10.11.1995 - 17.11.1995
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study with acceptable restrictions due to usage of an occlusive dressing.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- an occlusive dressing was used
- GLP compliance:
- yes
Test material
- Reference substance name:
- O-benzyl-L-valine toluene-p-sulphonate
- EC Number:
- 240-702-6
- EC Name:
- O-benzyl-L-valine toluene-p-sulphonate
- Cas Number:
- 16652-76-9
- Molecular formula:
- C12H17NO2.C7H8O3S
- IUPAC Name:
- O-benzyl-L-valine toluene-p-sulphonate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Chbb:HM (SPF)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: not required, the untreated skin sites of each animal served as control
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 72 h
reading time points: 1, 24, 48 and 72 h - Number of animals:
- 3
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- over all 3 animals
- Time point:
- other: mean over 24, 48 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- over all 3 animal
- Time point:
- other: mean over 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: reversibility: not applicable
Any other information on results incl. tables
Clinical Signs: No clinical signs were induced.
Skin Examinations: No skin reactions were observed.
Body Weight: No influence on the body weight was noted.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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