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 evaluation of sensitisation potential of the substance has been based on a study conducted on the Similar Substance 01. The complete hypothesis and justification for the read across approach has been attached in section 13.

The guinea pig maximisation test (GPMT) was chosen as test method used to evaluate skin sensitisation potential. The test was performed according to the OECD Guideline 406 (1992).

In the present experiment, contrary to what it is possible to read in the concluding statement of the report (hypersensitivity in 1 out of the 20 treated animals), two of the animals tested showed a marked skin reaction, as described in the pathologist's report of the biopsies performed at 48 hours on the treated groups. This different in the evaluation of the effects does not affect the interpretation of the outcomes. The new percentage of sensitization reaction obtained (10 %) does not justify a classification as sensitising substance, according to the CLP Regulation (EC 1272/2008).

Migrated from Short description of key information:

Not sensitising

Justification for selection of skin sensitisation endpoint:

The test results described do not totally comply with the specific testing guideline (OECD 406) but they are sufficient in quantity and quality to permit an evaluation of the effects of the test substance.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

In the CLP Regulation (EC n. 1272/2008), in the section 3.4 Respiratory or skin sensitisation, a skin sensitizer is defined as a substance that will lead to an allergic response following skin contact.

A substance shall be classified as skin sensitisers (Category 1) where data are not sufficient for sub- categorisation (1A and 1B) in accordance with the following criteria:

(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b) if there are positive results from an appropriate animal test ( according to 3.4.2.2.4.1).

If, in order to evaluate skin sensitisation potential, a Guinea pig maximisation test is performed, a substance is classified as skin sensitiser when the response of at least 30 % of the animals is considered as positive.

In the present experiment, contrary to what it is possible to read in the concluding statement of the report (hypersensitivity in 1 out of the 20 treated animals), two of the animals tested showed a marked skin reaction, as described in the pathologist's report of the biopsies performed at 48 hours on the treated groups. This difference in the evaluation of the effects does not affect the interpretation of the outcomes. The new percentage of sensitization reaction obtained (10 %) does not justify a classification as sensitising substance, according to the CLP Regulation (EC n. 1272/2008).