Registration Dossier

Toxicological information

Endpoint summary

Currently viewing:

Administrative data

Description of key information

No animal not produce evidence of skin sensitisation (delayed contact hypersensitivity) in the key study. Based on the evaluation criteria of Annex VI of the Commission Directive 67/548/EEC, the evaluation "sensitizing" is warranted when at least 30 % of the test animals exhibit positive skin reactions in the adjuvant test. Therefore the test article is not sensitizing at skin contact.

Key value for chemical safety assessment

Skin sensitisation

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

In a dermal sensitization study performed according to the EU Method B.6 (Skin Sensitisation) 92/69/EWG, 4-5 weeks old guinea pigs were used to test  for contact sensitization of the test article. The control group consisted of 5 animals and the test group was composed of 10 animals. Intradermal inductions were performed with 1% of the test article in Alembicol D mixed with Freund's complete adjuvant (FCA). 7 days later, topical inductions were carried out under occlusive conditions for 48 hours with the undiluted test article. Following a 2 week treatment free interval, challenge exposures were performed epicutaneously (occlusive, 24 hours) with the undiluted test article in Alembicol D. Evaluation of the skin reactions was performed 24 and 48 hours after challenge exposures. No animal showed a positive reaction in the treatment as well as the control group. Assays with the positive control substance (hexyl cinnamic aldehyde (CAS No. 101-86-0)) performed regularly in the same laboratory caused the expected reaction (Huntingdon Life Sciences Ltd. 1995).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

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

The available experimental test data are reliable and suitable for the purpose of classification under Regulation 1272/2008. Based on the criteria laid down in Regulation (EC) No. 1272/2008, classification as a skin sensitizer is not warranted.