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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

The skin sensitising potential of the test substance was investigated in the Buehler test with Dunkin-Hartley guinea pigs according to OECD TG 406 and GLP. The experimental group consisted of 20 animals and 10 animals were used as a control group. The animals were subjected to nine epicutaneous occlusive induction exposures with the test substance as a 50% (w/w) suspension in 1 % methyl cellulose and milli-RO water. The control animals were treated with the vehicle alone. Ten days after the last induction treatment, all animals were challenged with the test substance at a concentration of 50% (w/w) in the same vehicle. A positive control (formaldehyde solution) tested in a separate test showed significant positive results in the same test system. Following challenge application, no dermal reactions were seen in any of the test or control animals. No death occurred during the study, no systemic symptoms were observed and body weight gain of all animals was not affected by the treatment. All scores were 0 in the negative control group and in the test group 24 and 48 hours after patch application. Consequently the test substance was considered as non sensitising.

Migrated from Short description of key information:
The test substance has no skin sensitising potential when tested in guinea pigs (OECD 406, GLP).

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

Based on the results of the skin sensitising study, the test substance is not subject to classification and labelling according to Directive 67/548/EEC and Regulation 1272/2008/EC.