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Key value for chemical safety assessment

Effects on fertility

Additional information
Short description of key information:
In the oral range finding study conducted in the rat, a marked reduction of pup growth was observed during lactation at the highest dose level tested (1000 mg/kg bw/day). Further there were no maternal or foetal signs of toxicity observed.
The NOAEL for mating behaviour, fertility and gestation, of each generation is 1000 mg/kg/day, based on the range finding study. The NOAEL for parental toxicity is 40 mg/kg bw/day for the males based on signs of hyperactivity of the thyroid glands at the next highest dose level of 200 mg/kg for mating behavior, fertility and gestation, of each generation and for development, growth and survival of offspring is 1000 mg/kg/day, based on the range finding study (Gaoua 2004a).

From the two-generation reproduction study the NOAEL for parental toxicity is 70 mg/kg bw/day for the females, based on signs of hyperactivity of the thyroid glands (grade 4) at the next highest dose level. The NOAEL for mating behaviour, fertility and gestation, of each generation and for development, growth and survival of each progeny is 500 mg/kg/day (Gaoua 2004b).

Effects on developmental toxicity

Description of key information
In the rabbit teratology study, the maternal NOAEL was determined at 475 mg/kg bw/day, the highest dose level tested and the developmental NOAEL was established to be higher than 475 mg/kg/day. It was concluded that sodium chlorate was not teratogenic in rats or rabbits (George and Price 2002). These findings are supported by a second study performed with rats (Schroeder 1987).

Justification for classification or non-classification

From existing studies there is no indication for reproductive toxicity of sodium chlorate therfore sodium chlorate is not classified.