Glycine, N-coco acyl derivs., sodium salts

Developmental toxicity / teratogenicity

Administrative data

Endpoint:

developmental toxicity

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure

Justification for type of information:

JUSTFICATION FOR DATA WAIVING:
In Annex IX of Regulation (EC) No 1907/2006, it is laid down that a study on reproductive toxicity shall be proposed by the registrant if the marketed tonnage of the specific substance exceeds 100 t/a and reliable and valid (guideline) studies on this endpoint are not available.
For the test item itself, there is no study available, which was conducted for the endpoint developmental toxicity/teratogenicity. However, for a structurally closely related substance, a guideline study on this specific endpoint is currently planned and will be proposed to the European competent authority (ECHA) in due course. Differing only insignificantly in structure and behaviour, the expected study results are designated to serve as read-across data for covering the endpoint developmental toxicity of the test item.
From relevant data available so far, both for the test item as well as for the structurally closely related substance, both substances can be considered to exhibit only a very low toxicity potential. No evidence of toxicity was observed in any of the experimental studies available.
The hazard assessment of the test item reveals neither a need to classify the substance as dangerous, nor is it a PBT or vPvB substance, nor are there any further indications that the substance may exhibit hazardous properties.
Moreover, relevant data available for physicochemical properties and environmental behaviour of the test item clearly demonstrate, that the test item is rapidly biodegradable and shows no potential for any significant bioaccumulation/secondary poisoning.

Therefore, considering also animal welfare reasons, any performance of an additional experimental study on this endpoint employing vertebrates is scientifically not justified.

Materials and methods

Test animals

Species:

other: data waiving

Strain:

other: data waiving