Registration Dossier
Registration Dossier
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EC number: 228-532-0 | CAS number: 6290-03-5
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- other:
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
- Justification for type of information:
- No in vivo data is available for the target substance. However, adequate in vitro data is available for the target substance and therefore, in vivo data is not required. This endpoint study record is additional supporting in vivo data for the source substance.
- Qualifier:
- according to guideline
- Guideline:
- other: Official French methods for cosmetics, Annex I
- Deviations:
- no
- GLP compliance:
- not specified
- Specific details on test material used for the study:
- purity not stated, but "specifications of test material ... corresponding to those regularly employed in industry"
- Species:
- rabbit
- Strain:
- not specified
- Type of coverage:
- occlusive
- Preparation of test site:
- other: shaved, tested at intact or abraded skin in parallel
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 100% (undiluted)
- Details on study design:
- The test procedure is described in the Journal Officiel de la République Française Annexe I, with the following additions or modifications:
Use of occlusive patches "Neodermotest". Fixing of the patches using absorbent gauze held in place by adhesive tape. Housing in individual cages. Modification of the evaluation scoring - non irritant: less than 0.5, and slightly irritant: 0.5 - 2.0.
The results were deemed satisfactory if the index was less than 0.5, but it is still acceptable if it is not greater than 1, taking into account experimental practice. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Score:
- 0.08
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The primary skin irritation index of undiluted test substance was 0.08 (not irritating)
- Executive summary:
Rabbits were exposed dermally to single doses of undiluted test substance. No irritation was observed.
Data source
Materials and methods
Results and discussion
Applicant's summary and conclusion
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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