Registration Dossier
Registration Dossier
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EC number: 619-383-6 | CAS number: 98967-40-9
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Effect on fertility: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
The study for this endpoint is a reliable EPA guideline study conducted to GLP standard. No significant adverse toxicological effects on fertility were observed.
Short description of key information:
One two-generation toxicity to reproduction study is available:
Zempel JA, Mensik DC, Szabo JR (1990): oral two-generation study in rats: NOEL (F0, F1a, F1b, F2): 1000 mg/kg bw/day (actual ingested) (male/female)
The no-observable-effect-level (NOEL) for reproductive effects was 1000 mg/kg bw/day. No paternal or maternal toxicity was demonstrated at any dose level tested including the high dose level of 1000 mg/kg bw/day.
Effects on developmental toxicity
Description of key information
Two developmental toxicity studies are available:
Zielke GJ, Hanley TR, Yano BL (1988): Prenatal Developmental Toxicity Study in rats: NOAEL (maternal toxicity): 1000 mg/kg bw/day (actual ingested); NOEL (teratogenicity): 1000 mg/kg bw/day (actual ingested); NOEL (developmental toxicity): 1000 mg/kg bw/day (actual ingested) based on: test mat.
Hanley TR, Zielke GJ, Yano BL (1989): Prenatal Developmental Toxicity Study in rabbits: NOEL (developmental toxicity): 700 mg/kg bw/day; NOEL (maternal toxicity): 100 mg/kg bw/day
Effect on developmental toxicity: via oral route
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
Additional information
The key study for this endpoint is a reliable EPA guideline study conducted to GLP standard. No significant adverse toxicological effects on fertility were observed. This study was selected as key on the basis it was conducted on rats, which is the normal species used for classification for this endpoint. In the key study no evidence of embryo/fetotoxicity or teratogenicity was observed at any dose level tested. Based on these results, the developmental no-observed effect level for Flumetsulam in rats was 1000 mg/kg/day.
Due to the fact that rabbits are not a typical species used for classification of a substance under CLP, this was not selected as the key study, despite the lower NOAEL for developmental toxicity. However, the effects demonstrated in this study should not be ignored when assessing the risk of the chemical.
Justification for classification or non-classification
With reference to the information available on this substance, no classification for reproductive or developmental toxicity is required in accordance with Directive 67/548/EEC or Regulation (EC) No. 1272/2008.
Additional information
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
