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Diss Factsheets

Toxicological information

Repeated dose toxicity: dermal

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Administrative data

short-term repeated dose toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
Justification for type of information:
According to Annex VIII, point 8.6.1, column 2 of Regulation No 1907/2006, information on short-term toxicity (28-day study) by the dermal route shall be provided 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. For hydraulic lime, inhalation can be anticipated. Therefore, provision (1) of Annex VIII, point 8.6.1 is not fulfilled. Testing of short-term toxicity (28 days) via the dermal route is therefore not required. Furthermore, following the HERAG guidance for metals and metal salts (see section 7.1.2 of the technical dossier), a dermal absorption rate in the range of maximally 0.1-1.0 % can be anticipated. Dermal absorption in this order of magnitude is not considered to be “significant”. Therefore, also provision (3) of Annex VIII, point 8.6.1 is not fulfilled. In conclusion, testing for short-term toxicity of hydraulic lime via the dermal route is not required according the criteria laid down in Annex VIII , point 8.6.1. It can safely be anticipated that there will be no systemic risk in case of dermal short-term exposure to hydraulic lime. Additional toxicity studies are not expected to provide further information, thus there is no need for any further repeated dose testing.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion