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Description of key information

Key value for chemical safety assessment

Skin sensitisation

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

Oxypropazone was applied to the skin of guinea pigs to determine its sensitizing properties by the maximization test method according to OECD test guideline 406 and GLP.

5 male and female guinea pigs were initially exposed to three pairs of intracutaneous injections made in two parallel lines in an area of 4x6 cm on day 1; the first pair consisted of Freuds Complete Adjuvants (FCA) in physiological saline (1:1), the second of test substance preparation (5%) and the third of injections made with test substance and FCA (1:1). Control animals (3 males and females) were treated accordingly, i.e. the first pair of FCA(saline), the second of vehicle and the third of vehicle and FCA (1:1). On day 8 of the experiment, the skin area with the injection sites was exposed to 100% test substance (test animals) and vehicle (controls), respectively and covered with an occlusive patch for 48 h. On day 22, the left flanks of all animals of the test and control group were treated epidermally with 30% of the test substance; in contrast, the right flanks of the animals was treates with vehicle. Application sites were then covered with occlusive patches for 24 h and skin reactions scored on the basis of Magnusson and kligmann 24 and 48 h post-exposure (i.e. on day 24 and 25).

48 hours after the end of exposure of epidermal challenge one male animal of the lest substance group showed a discrete or patchy erythema at the vehicle treated site (right flank). 24 and 48 hours after the end of exposure of epidermal challenge one male animal

of the control group exhibited a discrete or patchy erythema at the test substance treated site (left flank).

In addition to the absence of sensitizing effects, systemic toxicity could not be detected in the present study.

Taken together, Oxypropazone is not skin-sensitizing in the guinea maximization test.

Migrated from Short description of key information:
skin sensitisation: negative (OECD guideline 406, Asta Medica, 1996)

Justification for classification or non-classification

Based on the results of the skin sensitisation study, the substance does not need to be classified for skin sensitization according to Directive 67/548/EEC and according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.