Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate

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:

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.

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified