Registration Dossier

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.