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Key value for chemical safety assessment

Effects on fertility

Description of key information
In a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD TG422) with ammonium perrhenate, treatment of rats by gavage at 330 mg/kg bw/day was associated with decreased pup viability over Days 1-4 (two dams with total litter loss). There was evidence of maternal toxicity at this dose level (increased thyroid weights). No effects on reproductive/developmental screening parameters were found at 110 mg/kg bw/day.

Toxicity to reproduction: other studies

Additional information

A good-quality Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD TG422) was conducted with ammonium perrhenate. Male and female rats were treated by gavage at 0, 110, 330 and 1000 mg/kg bw/day. OECD TG422 provides initial information in relation to reproduction and development. Treatment at 1000 mg/kg bw/day was associated with significant toxicity in both males and females. Several reproductive endpoints were affected including reduced implantation sites, reduced birth index, decreased litter size, and decreased pup viability over Days 1 -4 of lactation, and increased bruising/discolouration of pups. Treatment at 330 mg/kg bw/day was associated with an increase in thyroid weights in both sexes and a decrease in pup viability over Days 1 -4 of lactation, with two dams having total litter loss, an observation considered to be related to lack of maternal care. The decrease in pup viability was not dose-related, and 5/7 litters at this dose level had 100% viability. There were no effects on reproductive/developmental screening parameters at 110 mg/kg bw/day.

Justification for classification or non-classification

The data do not indicate a significant concern over specific reproductive/developmental toxicity.

There was no adverse effect on reproductive organs or tissues in males or females. Reproductive/developmental effects seen at the top dose of 1000 mg/kg bw/day were in association with significant toxicity to the males and females. There is still evidence of some maternal toxicity at the 330 mg/kg bw/day dose (increased thyroid weight), with the only significant reproductive toxicity parameter affected being the decreased pup survival over Days 1 -4, an observation considered likely to have resulted from lack of maternal care. This decrease in pup viability was not dose-related. Two dams given 330 mg/kg bw/day had total litter loss, although 5/7 litters at this dose had 100% viability.