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:

The key study for skin sensitisation (Morris et al, 1997, Report Number: 96 -8240 -21) was chosen as the only reliable information available to address this endpoint. The study was performed according to the OECD 406 guideline by a certified GLP laboratory. The study is given a reliability rating of 1 according to the criteria of Klimisch, 1997. Dermal irritation observed in animals induced with 5% and challenged with 1% of the test material were equivalent in severity and incidence compared to that observed in corresponding naive control animals. The test material is not considered to be a sensitizer under the conditions tested.

Migrated from Short description of key information:
An OECD 406 Skin Sensitization study in Guinea Pig preceded by a Pilot Phase to select a proper concentration of the test material was performed to evaluate the sensitization potential of CAS# 68784-31-6. The pilot phase animals were subjected to a range of dilutions of substance to identify sufficiently low concentrations to avoid confounding irritation. Testing was conducted under semi-occluded patch conditions. Test solutions of 5 wt% for induction and 1 wt% for challenge were selected for the main study. 20 animals were induced and challenged in the main study. The testing was conducted under occluded patch conditions. Only mild to moderate responses were noted during the main phase of the study and were equivalent between challenge and naive control groups. It was concluded that the test material is non-sensitizing under the condition of this test.

Justification for classification or non-classification

The key parameter chosen for skin sensitisation was greater than the criteria set out in Directive 67/548/EEC and also Regulation (EC) 1272/2008, therefore classification for skin sensitisation was not considered to be necessary.