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Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

Key Study 1

The first key study for skin sensitisation (Morriset al, 1997, HTR report number: 96-1104-70A, B) was chosen as this study was conducted in humans which are the most relevant species. There is no recognized guideline for this type of test however a well documented study with good scientific principles was undertaken at a certified GLP laboratory which followed a protocol. This study has a reliability rating of 1 according to the criteria of Klimisch, 1997. However, as this is read across, the Klimisch code assigned is 2.

Key Study 2

The second key study (Morris, 1997) study was conducted on the substance. The potential of the test material, as a 25% w/v formulation in Mineral Oil, to produce delayed contact hypersensitivity in guinea pigs was evaluated using an adaptation of the method of Ritz and Buehler.

Following primary challenge using the test material, as a 5% w/v formulation in Mineral Oil, the incidence of grade I responses in the test group at 48 hours was comparable in the test group (2 of 20) and the naive control group (2 of 10). The study is Klimisch coded as a 2 due to the excessive irritation observed in the naïve controls.

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) no 1272/2008, therefore classification for sensitisation was not considered to be necessary.