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 GLP-compliant maximization test following the OECD guideline No. 406 the test article's potential to cause skin hypersensitivity was assessed in 30 albino guinea pigs (10 control group, 20 test group). Test substance concentrations were based on the results of a preliminary study. In the Main study, twenty experimental animals were intradermally injected with a 5% concentration of the test item in oleum arachidis. For each injection, three pairs (adjuvant/saline; test item in vehicle; test item in vehicle plus adjuvant/saline) were given. Epidermal challenge was performed by occlusive application for 48 h one week later (50% in vaseline). The 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 for 24 hours. Skin reactions were assessed 24 and 48 hours after the removal of the challenge patches according to the Draize scoring scale. 5% of the animals were sensitised by the test item under the experimental conditions employed. In conclusion, the test substance is considered not to be a skin sensitizer in albino guinea pigs (Ciba-Geigy, 1992).


Migrated from Short description of key information:
The test item was found to have no skin sensitizing properties in a Guinea Pig Maximization Test.

Justification for selection of skin sensitisation endpoint:
GLP-compliant guideline study

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Classification, Labelling, and Packaging Regulation (EC) No 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008 (CLP). As a result the substance is not considered to be classified for sensitization under Regulation (EC) No 1272/2008, as amended for the sixth time in Regulation (EC) No 605/2014.

Dangerous Substance Directive (67/548/EEC)

The available study are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is not considered to be classified for sensitization under Directive 67/548/EEC, as amended for the 31st time in Directive 2009/2/EG.