Registration Dossier

Administrative data

Endpoint:
acute toxicity: dermal
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
The substance FAT41001 has been tested for acute oral toxicity and has been found to be not toxic to the animals investigated LD50 (males/females) >2000 mg/kg bw. None of the animals died and none of the animals exhibit any notable signs of toxicity. In addition in animal tests on skin irritation/corrosion effects the test substance has not been found to cause severe irritating or corrosive effects to the skin or any other effect resulting in a destruction of an intact skin barrier. In addition old tests on skin irritation performed on abraded skin areas of animals resulting in a partial destruction of the skin barrier, also no signs of toxicity were noted. The substance itself is characterized as a dry powdery substance which is marketed in a dedusted form or in a liquid mixture only. The molecular weight of the substance is 882.2 g/mole. From basic research on internal and external barriers of humans it is known, that such molecules are almost not able to permeate the skin resulting in an enhanced bioavailability of the substance applied topically. Experts from the chemical industry, CRO s and regulatory authorities, together with the NC 3Rs, have published a review paper highlighting opportunities to waive requirements for acute toxicity testing of non-pharmaceutical chemicals. The review focuses on acute oral, dermal and inhalation toxicity, skin and eye irritation and skin sensitisation. The paper, which is published as an open access article in Critical Reviews in Toxicology, is intended to provide a focused review for the regulatory community to use when considering the need to generate acute toxicity data. Analysis presented in the paper demonstrates that for pesticide active substances and general chemicals, acute dermal toxicity testing very rarely provides information of value for hazard identification or classification and labelling purposes, when an acute oral study has already been conducted. Only 1 out of 438 chemical substances and 2 out of 240 active pesticide substances have been found to be more severe than after oral application. These findings suggest that acute dermal toxicity studies should not be performed except in exceptional circumstances, for example where information on absorption, toxicokinetics or mode of action suggests that acute toxicity might be greater by the dermal rather than oral route. Since analysis of our substance does not indicate any harm upon oral exposure and neither the chemical structure of the substance nor any toxicokinetic results raise any concern about the toxic behavior of the substance upon dermal absorption, we will not perform any test on this endpoint in in vitro or in vivo test systems.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion