Registration Dossier
Registration Dossier
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EC number: 827-162-2 | CAS number: 2218502-12-4
Endpoint summary
Administrative data
Description of key information
To assess the skin sensitisation potential of the substance with CAS 2218502-12-4 (Direct Black 168 NaLi salts), an in vivo study conducted on the similar substance (read-across) with CAS 93281-13-1(Direct Black 168 Na salt) has been chosen.
The results of the study, conducted according to OECD 406, support that the substance is not a skin sensitiser. No studies are available for respiratory sensitisation.
Both substances CAS 218502-12-4 (Direct Black 168 NaLi salt) and CAS 93281-13-1 (Direct Black 168 Na salt) have the same organic anionic structure. The differences are considered to be not able to impact the study outcome, thus the read-across can be considered as reliable and appropriate to evaluate the endpoint. Details on read-across approach are given in the section 13 of IUCLID file.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Justification for type of information:
- See the report for the analogue approach in section 13 "Other reports"
- Reason / purpose for cross-reference:
- read-across source
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 25%
- No. with + reactions:
- 0
- Total no. in group:
- 20
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- negative control
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- no indication of skin sensitisation
- Reading:
- rechallenge
- Hours after challenge:
- 48
- Group:
- positive control
- Dose level:
- 15%
- No. with + reactions:
- 7
- Total no. in group:
- 10
- Remarks on result:
- positive indication of skin sensitisation
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
- Additional information:
This endpoint is not an information requirement of Annex VIII of REACH Regulation.
Justification for classification or non-classification
Based on the above stated assessments of the skin sensitisation potential, the substance is classified as non-sensitising according to CLP (Regulation (EC) No 1272/2008 of the European Parliament and of the Council) as implementation of UN-GHS in the 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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
