Registration Dossier
Registration Dossier
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EC number: 920-031-1 | CAS number: -
Endpoint summary
Administrative data
Description of key information
Data for repeated dose toxicity are available from a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats performed according to OECD and EU guidelines as well as GLP principles. From the results of the study, a NOAEL of >=1000 mg/kg bw/d in both male and female rats was established based on lack of treatment related effects and no mortalities observed.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Species:
- rat
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. Based on these results, a parental, reproductive and developmental No Observed Adverse Effect Level (NOAEL) of at least 1000 mg/kg bw/day was derived.
Justification for classification or non-classification
Based on the results of the 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, at this moment the substance does not need to be classified according to the CLP Regulation (EC) 1272/2008 and Council Directive 67/548/EEC (DSD).
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