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Administrative data

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:
In line with Column 2, point 8.6.1, Annex VIII of Regulation 1907/2006, a 28-day repeat-dose dermal study does not need to be performed as a reliable chronic toxicity (oral) study on a structural analogue (EC#607-733-0) is available that uses an appropriate species and route of administration. Hence, it is considered unnecessary to conduct this study.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion