Registration Dossier
Registration Dossier
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EC number: 424-060-6 | CAS number: 6364-17-6
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: Meets the criteria for classification as Reliable with restriction according to Klimisch et al (1997)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: See comments
- Principles of method if other than guideline:
- The study uses a method with a longer exposure time than that required in Annex V guidelines. Although it was not conducted to GLP, on the grounds of animal welfare and considering the clearly negative results, the UK c.a. have accepted this study. The method used was Guidelines of the Consumer Product Safety Commission, Title 16, Chapter II Part 1500.
- GLP compliance:
- no
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Vehicle:
- other: 0.9% Sodium chloride solution
- Amount / concentration applied:
- 500 mg
- Duration of treatment / exposure:
- 24 h
- Number of animals:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- other: 24 hrs and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: 0
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: 24hrs and 72 hrs
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- other: Max. duration: d; Max. value at end of observation period: 0
- Other effects:
- None
Any other information on results incl. tables
The study uses a method with a longer exposure time than
that required in Annex V guidelines. Although it was not
conducted to GLP, on the grounds of animal welfare and
considering the clearly negative results, the UK c.a. have
accepted this study. The method used was Guidelines of the
Consumer Product Safety Commission, Title 16, Chapter II
Part 1500.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information not classified Criteria used for interpretation of results: EU
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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