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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

Treatment with Biomass residue obtained after B2 production by oral gavage in male and female Wistar (Han) rats at dose levels of 100, 300 and 1000 mg/kg bw/day revealed no parental toxicity up to 1000 mg/kg bw/day. No reproduction and developmental toxicity was observed for treatment up to 1000 mg/kg bw/day.


Short description of key information:
A reliable combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, according to OECD guideline and GLP principle, is available for evaluation.

Effects on developmental toxicity

Description of key information
A reliable combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test,  according to OECD guideline and GLP principle, is available for evaluation.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

Treatment with Biomass residue obtained after B2 production by oral gavage in male and female Wistar (Han) rats at dose levels of 100, 300 and 1000 mg/kg bw/day revealed no parental toxicity up to 1000 mg/kg bw/day. No reproduction and developmental toxicity was observed for treatment up to 1000 mg/kg bw/day.

Justification for classification or non-classification

In the combined oral repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats, no reproduction and developmental toxicity was observed for treatment up to and including 1000 mg/kg bw/day. Based on these results, Biomass Residue (liquid) obtained after B2 production does currently not need to be classified for reproduction and for developmental toxicity.

Additional information