Registration Dossier
Registration Dossier
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EC number: 203-305-9 | CAS number: 105-53-3
Endpoint summary
Administrative data
Description of key information
A human maximisation test was conducted with 23 volunteers. 4% of the test substance in petrolatum produced no sensitization reactions.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- GLP compliance:
- not specified
- Type of study:
- other: human maximisation test
- Justification for non-LLNA method:
- not available
- Species:
- human
- Concentration / amount:
- 4%
- Concentration / amount:
- 4%
- No. of animals per dose:
- 23
- Positive control results:
- A maximisation test according to Kligman, 1966 and Kligman and Eppstein, 1975 was reported in 23 volunteers. 4% of the test substance in petrolatum produced no sensitization reactions.
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 4%
- No. with + reactions:
- 0
- Total no. in group:
- 23
- Remarks on result:
- other: Reading: 1st reading. Group: test group. Dose level: 4%. No with. + reactions: 0.0. Total no. in groups: 23.0.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A human maximisation test was conducted with 23 volunteers. 4% of the test substance in petrolatum produced no sensitization reactions.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
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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