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 OECD 422 combined repeated dose study with reproductive and developmental toxicity screening was conducted 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. No significant effects was observed at any dose on male or female reproductive performance. The NOAEL was determined to be 1000 mg/kg bw/day based on sporadic weight gain reductions in the maternal generation.


Short description of key information:
The OECD 422 combined repeated dose study with reproductive and developmental toxicity screening was conducted 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. MThe NOAEL was determined to be 1000 mg/kg bw/day based on sporadic weight gain reductions in the maternal generation. No reproductive or developmental effects were observed at any dose.

Effects on developmental toxicity

Description of key information
The OECD 422 combined repeated dose study with reproductive and developmental toxicity screening was conducted 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. MThe NOAEL was determined to be 1000 mg/kg bw/day based on sporadic weight gain reductions in the maternal generation. No reproductive or developmental effects were observed at any dose.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
1 000 mg/kg bw/day
Additional information

The OECD 422 combined repeated dose study with reproductive and developmental toxicity screening was conducted 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. No significant effects was observed at any dose on male or female reproductive performance. The NOAEL was determined to be 1000 mg/kg bw/day based on sporadic weight gain reductions in the maternal generation.

Justification for classification or non-classification

No reproductive or developmental toxicity was observed at doses up to and including 2000 mg/kg bw/day in rats given repeated oral doses of KGA in the OECD 422 combined study. Therefore, KGA and KGA Greens are not classified.