Registration Dossier
Registration Dossier
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EC number: 200-908-9 | CAS number: 75-85-4
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation
- Remarks:
- in vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: only secondary literature (handbook)
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Sensitization test according to Maguire (modified)
- GLP compliance:
- not specified
- Type of study:
- other: Maguire method
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- not specified
- Vehicle:
- no data
- Concentration / amount:
- undiluted
- Vehicle:
- no data
- Concentration / amount:
- undiluted
- No. of animals per dose:
- 10 animals
- Positive control substance(s):
- yes
- Remarks:
- Positive control group
- Positive control results:
- All 10 animals showed sensitizing effects
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of the present study the test item is not a skin sensitiser.
- Executive summary:
The skin sensitizing potential of the test item was determined. A group of 10 guinea pigs was tested with undiluted test substance. No sensitizing effects were observed. All 10 animals in the positive group showed sensitizing effects.
Reference
When a group of 10 animals was tested with undiluted test substance none was sensitized (whereas all 10 of positive control group were sensitized).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitizing potential of the test item was determined. A group of 10 guinea pigs was tested with undiluted test substance. No sensitizing effects were observed. All 10 animals in the positive group showed sensitizing effects.
Migrated from Short description of key information:
The skin sensitizing potential of the test item was determined on guinea pigs according to the Maguire method. No sensitizing potential was determined.
Justification for selection of skin sensitisation endpoint:
Only study available
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
Self-Classification, Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data is reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. Based on the results the substance is not considered to be classified as skin sensitizing under Regulation (EC) No 1272/2008.
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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