Registration Dossier

Administrative data

Description of key information

No reliable data regarding skin sensitization is available for Pigment Red 52(Sr). Based on studies performed with members of the same category it can be concluded that Pigment Red 52(Sr) is not sensitizing to skin.

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation, other
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).

Experimental data on the calcium and manganese analogues is taken into account for assessment of skin sensitization because strontium is abundant in the environment and has not been associated with sensitization (UNEP 2010).

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.