Registration Dossier
Registration Dossier
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EC number: 231-494-8 | CAS number: 7585-41-3
Endpoint summary
Administrative data
Description of key information
No reliable data regarding skin sensitization is available for Pigment Red 48:1(Ba). Based on studies performed with members of the same category it can be concluded that Pigment Red 48:1(Ba) is not sensitizing to skin.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Justification for type of information:
- Please see the category read-across justification in the category object.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Parameter:
- SI
- Value:
- >= 0.7 - <= 2.06
- Test group / Remarks:
- 2.5% - 25%
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Four valid and reliable studies were performed with commercial products of analogue substances of the same category. Pigment Red 57:1(Ca) did not cause skin sensitization in the Buehler test in guinea pigs (ETAD 1995) and in the local lymph node assay in mice (Clariant 2008). Pigment Red 48:2(Ca) and Pigment Red 48:4(Mn) were found to be non-sensitizing in a valid local lymph node assay in mice (Clariant 2007 and Harlan 2012, respectively).
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is not considered to be classified for skin sensitization according to Classification, Labelling, and Packaging 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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