Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin
Justification for type of information:
Acute dermal toxicity
No concern with respect to the acute dermal toxicity can be reliably derived based on the following experimental data:
a)The dermal penetration was investigated according to guideline OECD 428 ( Skin Adsorption; In Vitro method). When 3% formulation of behenyl trimethyl ammonium chloride (major component of the registration substance) was applied for 24 h on human skin the mean total absorption was 0.16+/-0.08%.
b)The acute oral toxicity was investigated by treatment of animals at doses of 800, 1250, 2000, 3200 and 5000 mg/kg. No death occurred at 800 and 1250 mg/kg. One, five and ten rats died at 2000, 3200 and 5000 mg/kg respectively. The LD50 of 3190 mg/kg was obtained.
The internal systemic burden upon dermal exposure will be apparently very low. In combination of low acute oral toxicity, no significant effect upon acute dermal exposure can be reasonably derived.
No classification is warranted for the endpoint acute dermal toxicity and no animal testing is recommended.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion

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