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Diss Factsheets

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:
JUSTIFICATION FOR DATA WAIVING
In accordance with Section 8.6.1. of Column 2 of Annex VIII of the REACH Regulation, Short-term repeated dose toxicity study (28 days) should be conducted on one species, male and female, through the most appropriate route of administration, having regard to the likely route of human exposure which in this case is the oral route.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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