Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

Currently viewing:

Administrative data

Endpoint:
developmental toxicity
Remarks:
Pre-natal developmental toxicity study (1st species)
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
A pre-natal developmental toxicity study (one species) does not need to be conducted if the substance is known to be a genotoxic carcinogen and appropriate risk management measures are implemented, or the substance is a known germ cell mutagen and appropriate risk management measures are implemented.

The substance is currently classified as Carc. Cat 2 (H351: Suspected of causing cancer) and was mutagenic in in-vitro gene mutation studies. The substance has also been identified as a possible alkylating agent.

An in-vivo mammalian alkaline comet assay (OECD TG 489) has been proposed and accepted by ECHA. The results of this study will provide further information/clarification on germ cell mutagenicity (and apporpritate classification) and allow subsequent evaluation of the requirements for further reproductive toxicity testing.

Therefore, although the substance is not confirmed to be a genotoxic carcinogen or germ cell mutagen, there are known hazards for both carcinogenicity and mutagenicity and substance is suspected of being a possible genotoxic carcinogen/germ cell mutagen. Appropriate risk management measures are implemented during use to ensure safety to workers. Therefore, a pre-natal developmental toxicity study is considered unnecessary.

The substance should be used under rigorous risk management measures to minimize exposure to workers. Appropriate risk management measures are implemented during industrial use to ensure safety to workers, based on the substance being classed as a 'high hazard' accordng to ECHA Guidance on IR&CSA Part E: Risk Characterisation.

Therefore, in addition to the study not being scientifically necessary based on carcinogenic/mutagenic issue, it is also not considered necessary based on REACH Annex XI (Section 3, Exposure Considerations).

In addition, there are technical issues/animal welfare issues for a pre-natal developmental toxicity study (see repeated dose toxicity waivers).

Data source

Materials and methods

Test animals

Species:
rat

Results and discussion

Applicant's summary and conclusion