Registration Dossier
Registration Dossier
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EC number: 237-253-3 | CAS number: 13709-42-7
Endpoint summary
Administrative data
Description of key information
A screening for reproductive / developmental toxicity study has been conducted according to OECD Guideline 422. Upon review of the draft study report the validity of the study has been called into question because of the high number of non-pregnant females and total litter losses observed in the treated groups during the study period. Discussions between the laboratory which conducted the study and representatives of the registrants are ongoing. As soon as this matter is resolved a registration update will be provided to include data to address this endpoint.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
In accordance with section 1 of REACH Annex XI, the repeated dose toxicity studies via the dermal and inhalation routes (required in section 8.6.1 of Annex VIII) as well as the 90-day sub-chronic study (required in section 8.6.2 of Annex IX) do not need to be conducted if the studies do not appear to be scientifically necessary. Once finalised, an oral study conducted to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) will sufficiently addresses the repeated dose toxicity data requirements.
This section will be completed upon availability of a finalised OECD 422 study.
Justification for classification or non-classification
Pending availability of the finalised OECD 422 study, the substance does not require classification for repeated dose toxicity endpoints under Regulation (EC) No 1272/2008.
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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