Registration Dossier

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:

In a dermal sensitisation study (RCC Ltd, 1993) with the test item in propylene glycol or vaseline young Himalayan guinea pigs (20 females) were tested using the guinea pig maximisation test of Magnusson and Kligman (induction exposure: 5 % intracutaneous and 50 % epicutaneous; challenge exposure: 50 %, 25 %, 10 % epicutaneous). Concurrent negative control animals (10 females) were treated similarly, except that during the induction phase the test item was omitted. In this study only 2 of 20 animals treated with the test item showed a response (score 1) after challenge. Thus, under the conditions of this study, the test item was no dermal sensitizer.


Migrated from Short description of key information:
In a GLP-compliant skin sensitisation study according to OECD Guideline 406 only 10 % (2/20) of the animals treated with the test item showed a weak response after challenge at the 48h reading.

Respiratory sensitisation

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

Justification for classification or non-classification

Based on the results obtained in the skin sensitisation study and taking into account the provisions laid down in Directive 67/548/EEC and Regulation 1272/2008/EC, a classification has not to be done with respect to skin sensitisation.