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) Pirbright white guinea pigs, in accordance with OECD Guideline 406 (Ciba-Geigy 1993a). 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 20% aquaeous PEG and epidermally exposed to a 50% concentration in vaseline.Ten control animals were similarly treated, but with vehicle alone. As determined in the range-finder test, the test item causes skin irritation at 50% in vaseline.

Two weeks after the epidermal application all animals were challenged with a non-irritant dose (20 %) and the vehicle.

No skin reactions were observed in response to the 20 % test substance concentration. No skin reactions were evident in the control animals.


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.