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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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