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 skin sensitising potential of ethyl 3,5 -dichloro-4 - hexadecyloxycarbonyloxybenzoate (AF-366) was evaluated in a Guinea Pig Maximisation Test (GMPT) performed according to OECD 406 (Prinsen, 1989). The first induction (Day 1) was performed on 20 animals, by intradermal injection in the scapular region of a 10% solution (in maize oil) of the test substance. On Day 7, the animals were treated with 10% sodium lauryl sulphate in vaseline, to induce skin irritation. The second induction was performed on Day 8: a 50% solution of the test substance in vaseline was applied topically, and held in place with an occlusive dressing for 48 hours. On Day 24, all the animals were challenged with 25 and 50% of the test substance in vaseline via topical application on the flank for 24 hours. 10 guinea pigs in the control group were treated according to the same protocol with the vehicles; maize oil (intradermal injection) and vaseline (topical application).

1/10 males died due to a prolapsed rectum on study day 9. This is not considered to be treatment-related. 24 hours after intradermal induction, slight to moderate erythema and edema was noted at the injections sites where FCA was used in 20/20 treated and 10/10 control animals. Slight erythema and/or edema were observed in 19/20 treated and 2/10 control animals at the test substance/vehicle injection sites. These effects were caused by the injection and not by a reaction to the test substance.

No skin effects were observed in the treated or control group 24 and 48 hours after the challenge with a 25 and 50% solution of the test substance. Under the conditions of this study, the test substance is considered to be not skin sensitising.


Migrated from Short description of key information:
Skin (OECD 406): not sensitising (Guinea pig maximisation test)

Justification for classification or non-classification

The available data on the skin sensitisation of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.