Registration Dossier
Registration Dossier
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EC number: 600-809-4 | CAS number: 1072-53-3
Developmental toxicity / teratogenicity
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:
- the study does not need to be conducted because relevant human exposure can be excluded as demonstrated in the relevant exposure assessment
- 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) was planned but found to be not technically feasible.
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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