Yellow PE 3260

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Data waiving:

exposure considerations

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

Justification for type of information:

The REACH regulation requests the conduct of a subacute toxicity study for fulfilling Annex VIII repeated dose toxicity requirements. According to ECHA's "Guidance on information requirements and chemical safety assessment - Chapter R.7a: Endpoint specific guidance", p330, the dermal route is appropriate if the physico-chemical properties suggest potential for a significant rate of absorption through the skin.
Looking at the data set and the structure of the molecule, it can be concluded that this material has very little bioavailability by the dermal route. Furthermore, local dermal effects caused by the substance have adequately been characterized via valid in-vivo studies on skin sensitization, skin and eye irritation, and acute dermal toxicity. The acute dermal toxicity study further revealed no systemic toxic effects up to a dose level of 2000 mg/kg bw.
Based on this argumentation it is being proposed to fulfil the Annex VIII requirement on repeated dose toxicity by an oral subacute toxicity study, which is also considered as the preferred route of exposure according to ECHA's "Guidance on information requirements and chemical safety assessment - Chapter R.7a: Endpoint specific guidance", p329.
The study on repeated dose toxicity via the dermal route therefore is waived.

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified