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:

Several sensitisation studies including LLNA, GPMT and Buehler tests revealed no sensitising potential of the test substance.

1) Negative in a LLNA study (Geberick, 1991) with Mice. Key study (as LLNA considered most sensitive study type).

2) A dermal sensitization study using the Buehler test was conducted under GLP according to EPA guideline using guinea pig (Bier, 1979). Supporting study. The test substance is neither an irritant nor sensitizer when applied to guinea pigs.

3) Negative in a mouse ear swelling test (Gad, 1985).

4) Negative in a GPMT test (Gad, 1985).

5) Negative in a Buehler test (Gad, 1985).

Two studies in guinea pigs (Lahti 1984, 1985) investigating the potential of the test susbtance to induce contact urticaria were positve. However no effects were reported in rats an mice. The test design is similar to the induction phase of the mouse ear swelling test.

In addition to animal data, many human studies are available investigating effects of the test substance on skin, including immunological and non-immunological responses. Most studies are of limited quality and the test substance is used as a standard substance to elicit a skin reaction in humans.

The test substance does induce skin effects in healthy adults and children after topical application.

An in vitro test (Wilhelm 2001) on cytotoxicity (NR uptake) with human keratinocytes showed an IC50 of 20 mmol. In the same study the test substance did not show any irritant properties to human skin (dose 20 mmol).

No definite conclusion on the mechanism responsible for induction of skin reactions can be drawn. Both in persons with history of atopic eczema as well as in healthy (non-atopic) subjects, skin reactions were increased after application of the test substance (Lahti 1978).

Therefore, the test substance is not considered to be a skin sensitiser.


Migrated from Short description of key information:
Several sensitisation studies including LLNA, GPMT and Buehler tests revealed no sensitising potential of the test substance.
In addition to animal data, many human studies are available investigating effects of the test substance on skin, including immunological and non-immunological responses. Most studies are of limited quality and the test substance is used as a standard substance to elicit a skin reaction in humans. The test substance does induce skin effects in healthy adults and children after topical application.

Justification for selection of skin sensitisation endpoint:
This study was conducted according to a reliable method using mice.

Justification for classification or non-classification

Skin sensitisation: Animal test give negative result.

Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.4.2 the test substance is not classified for the skin sensitisation.