Registration Dossier

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:

There are limited but adequate data for the assessment of the sensitization potential of the submission substance. The submission substance caused no reactions indicative of contact sensitization when tested in a manner similar or equivalent to existing OECD test guidelines. Based on these data, the submission substance is not considered to be a skin sensitizer.

Migrated from Short description of key information:
Skin sensitization, 1 key study, negative for guinea pigs (equivalent or similar to OECD TG 406)

Respiratory sensitisation

Endpoint conclusion
Additional information:

No specific respiratory sensitization tests have been conducted in animals. There is no evidence of respiratory sensitization from existing animal study data.

Migrated from Short description of key information:
There are no specific studies available.

Justification for classification or non-classification

Based on assessment of the available data for the submission substance, classification is not warranted as a sensitiser under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.