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 test substance was investigated for its sensitizing potential in a GLP-compliant Maximization test according to OECD guideline 406 (CIBA-GEIGY Ltd., 850044, 1993). Pirbright White guinea pigs received intradermal induction treatments with 1% in sesame oil and one epicutaneous induction treatment with 30% in vaseline. For intradermal induction, three pairs of injections (adjuvant/saline; test item in vehicle; test item in vehicle plus adjuvant/saline) were given. Epidermal challenge was performed by occlusive application for 24 h two weeks later (10% in vaseline). No skin reactions were observed either for control or test group animals and therefore no animal was sensitized by the test article under the experimental conditions employed. The sensitivity of the strain is controlled every six month with p - phenylenediamine. In conclusion, the test substance is not considered to be a skin sensitizer in albino guinea pigs and does not require classification.


Migrated from Short description of key information:
Skin sensitization (OECD 406, in vivo maximization test in guinea pigs): not sensitizing (CIBA-GEIGY Ltd., 850044, 1985)

Respiratory sensitisation

Endpoint conclusion
Additional information:

No data

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the present data, classification for sensitization is not warranted under Directive 67/548/EEC.

 

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

The available experimental test data are reliable and suitable for the purpose of classification under Regulation (EC) No.1272/2008. Based on the present data, classification for sensitization is not warranted under Regulation (EC) No.1272/2008.