Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Potential for skin sensitisation has been investigated for five stilbene fluorescent whitening agents. Guinea pig maximisation assays according to or equivalent to OECD TG 406 have been performed with stilbene fluorescent whitening agents with the CAS numbers: 16090 -02 -1, 4193 -55 -9, 27344 -06 -5, 16470 -24 -9, and 41098 -56 -0. All test results were consistently negative. No toxic symptoms were evident in the guinea pigs of the control or test group. No deaths occurred. From the results described no allergenic potency of the test articles were concluded. This result is supported by a study with CAS 16090 -02 -1 which was tested using a Maurer optimisation test (Ciba-Geigy Ltd 1975). In another study done for CAS 27344 -06 -5 (Sandoz Chemical Corp. 1989a) the photosensitising potential of the test substance was investigated. During epicutaneous induction animals were exposed with UVA and UVB light. As in the first study the sensitisation rate of the test animals after challenge were each 0%. As found in this study the test substance is classified as a non-photosensitiser when tested at a concentration of 5% in DAE.

Therefore, it is concluded that Stilbene fluorescent whitening agents and then, reading across, also the substance CAS 371756 -75 -1, are not sensitising to skin and have not to be classified for skin sensitisation.


Migrated from Short description of key information:
Category assessment used to read across:
Not sensitising to skin as assessed in guina pig maximization assays (OECD 406) with several category members

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No experimental data is available regarding respiratory sensitization.

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the category members are not considered to be classified for skin sensitisation under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/EC.

 

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the category members are not considered to be classified for skin sensitisation under Regulation (EC) No. 1272/2008.