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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Skin sensitisation: not a skin sensitiser based on testing similar to OECD TG 406.

Key value for chemical safety assessment

Skin sensitisation

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

GPMT study

A Guinea pig maximisation test was performed similar to OECD TG 406. Fifteen test and fifteen control animals were used. Induction consisted of two stages, intradermal injection followed one week later by a 48 hour occluded patch application. Based on the results of a preliminary study dose levels selected were as follows. A total of 6 intradermal injections were administered: 2 injections of 0.1 mL of 50 % Freund's Complete Adjuvant, 2 injections of 0.1 mL of a 10 % solution of the test material in liquid paraffin and 2 injections of 0.1 mL of a 10 % suspension of the test material in Freund's Complete Adjuvant and liquid paraffin (1:1). The topical induction concentration was 100 %. In the challenge phase, the substance was applied topically at 10 and 20 % (v/v) in liquid paraffin. Erythema and oedema were scored 24, 48 and 72 hours after the challenge. The sensitising potential of the substance was classified according to the grading of Magnusson and Kligman. None of the animals had a positive reaction to the test substance. The substance is, therefore, not a skin sensitiser.

HRIPT studies

HRIPT studies are available for the test substance, showing lack of sensitisationat 5%in 43 and 50 individuals(IFF, 1977baal and IFF, baak, respectively) and at 25% in 44 and 45 individuals (IFF, 1977baam and IFF, baan, respectively). This information does not lead to a different C&L.

Similar reaction mass as Rosamusk with EC no: 949-569-5

In this ECHA dossier with different composition of two substances was negative in the DPRA and Keratinosens.

Justification for classification or non-classification

The substance does not need to be classified for skin sensitisation according to EU CLP (EC No. 1272/2008 and its amendments).