Registration Dossier

Administrative data

Description of key information

An OECD 422 combined repeated dose study with reproductive and developmental toxicity screening was conducted on KGA to determine the subchronic toxicity to rats.  The resultant NOAEL was 1000 mg/kg bw/day.

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
Study duration:
subchronic
Species:
rat

Additional information

An OECD 422 combined repeated dose study with reproductive and developmental toxicity screening was conducted on KGA to determine the subchronic toxicity to rats. Groups of rats were exposed by oral gavage to doses of 0, 500, 1000 and 2000 mg/kg bw/day of KGA Greens. Males were exposed for 28 days and females were exposed up through lactation day 4 or 53 days, after which surviving rats were sacrificed and necropsied. Observations of mortality and a suite of other examinations were conducted. Results show sporadic effects on various endpoints in the 2000 mg/kg bw/day high dose. At this 2000 mg/kg bw/day level the test substance appeared to be so irritating or distasteful that the animals tended to struggle and/or resist dosing, which in turn led to deaths likely caused by aspiration of gavaged material. No significant dose-related effects were observed in the 500 and 1000 mg/kg bw/day doses. The NOAEL was determined to be 1000 mg/kg bw/day.

Justification for classification or non-classification

Due to the lack of significant effects at 1000 mg/kg bw/day, KGA and KGA Greens are not classified.