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Repeated dose toxicity: dermal

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sub-chronic toxicity: dermal
Data waiving:
exposure considerations
Justification for data waiving:
Justification for type of information:
In accordance with Column 2 (Specific rules for adaptation from Column 1), point 8.6.2 of Annex IX of the Regulation (EC) No. 1907/2006, which states that the test should be performed on the most appropriate route, it is considered justified to omit dermal testing.
Testing by the dermal route is appropriate if:
(1) inhalation of the substance is unlikely; and
(2) skin contact in production and/or use is likely; and
(3) the physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin.
A test was submitted addressing the repeated dose toxicity of the substance via the oral route. This was considered the most appropriate route of exposure based on the physical properties of the substance, on this basis, testing via the dermal route is considered inappropriate and is therefore omitted.

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