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 order to assess the cutaneous allergenic potential under GLP conditions, the Maximisation-Test was performed in 30 (20 test and 5 control) female albino guinea pigs, in accordance with OECD Guideline 406 (Notox 1993e). Test substance concentrations selected for the main study were based on the results of a preliminary study.

In the main study, ten experimental animals were intradermally injected with a 5 % concentration in PEG and epidermally exposed to a 50% concentration in vaseline. Five control animals were similarly treated, but with vehicle alone. Approximately 24 hours before the epidermal induction exposure all animals were treated with 10 % SDS.

Two weeks after the epidermal application all animals were challenged with a 50 % test substance concentration and the vehicle.

No skin reactions were observed in response to the 50 % test substance concentration. No skin reactions were evident in the control animals. Red staining was observed at the test substance treated skin sites, 24 and 48 hours after challenge. This staining did hamper the scoring of the skin reactions. Therefore, treated skin was evaluated by histopathology for infiltration of immune cells. This confirmed absence of sensitized animals.

Since comparable skin reactions were observed in one control animal and based on the inconsistency in results, it was considered that all reactions observed were signs of non-specific irritation.These results indicate a sensitisation rate of 0 per cent.


Migrated from Short description of key information:
in vivo, Guinea Pig Maximization Test (GPMT), guinea pig: not sensitising (GLP, OECD 406)

Respiratory sensitisation

Endpoint conclusion
Additional information:
Migrated from Short description of key information:
No 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 substance is 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, Labeling, 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 substance is not considered to be classified for skin sensitisation under Regulation (EC) No. 1272/2008.