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Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
3 mg/kg bw/day
Additional information

Toxicity to reproductive-fertility:

OECD 414 One-Generation study:

NOAEL for maternal toxicity = 0.3 mg/kg/day in rabbit

F1-NOEL = 3.0 mg/kg/day.

OECD 422 screening test:

NOEL for reproductive parameters examined is 20 mg/kg bw/day that is the highest dose level tested.

Parental: NOAEL for Parent animal is 5 mg/kg bw/day for male and less than 2.5 mg/kg bw/day for female based on histological lesion in the stomach.


Short description of key information:
Toxicity to reproductive-fertility (OECD414): NOAEL = 0.3 mg/kg/day based on the maternal toxicity due to irritative property of this substance in rabbit. NOEL F1 = 3 mg/kg/day.
Toxicity to reproductive-fertility (OECD422 screening test): NOEL (reproductive parameters) 20 mg/kg/day. Parental NOEL 5 mg/kg/day (male) & < 2.5 mg/kg/day (female).

Effects on developmental toxicity

Description of key information
Developmental toxicity study in rabbits: (Key study): NOEL (developmental toxicity) 3 mg/kg/day. NOEL (maternal toxicity) 0.3 mg/kg/day.
Developmental toxicity study in rats (Supporting study): NOEL (developmental toxicity) 20 mg/kg/day. NOEL (maternal toxicity) 20 mg/kg/day.
Based on the results of these studies, a dosage level of 3.0 mg/kg/day was considered a NOEL for developmental toxicity.
Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
3 mg/kg bw/day
Additional information

Developmental toxicity study in rabbits: (Key study)

NOEL (developmental toxicity) 3 mg/kg/day. NOEL (maternal toxicity) 0.3 mg/kg/day.

Developmental toxicity study in rats (Supporting study)

NOEL (developmental toxicity) 20 mg/kg/day. NOEL (maternal toxicity) 20 mg/kg/day.

Based on the results of these studies, a dosage level of 3.0 mg/kg/day was considered a NOEL for developmental toxicity.

Justification for classification or non-classification

The substance is not classified as toxicity to reproduction in accordance with GHS due to the absence of any reproductive effects at the highest dose levels, which themselves resulted in maternal toxicity.