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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
Reference
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%
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.