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Administrative data

Key value for chemical safety assessment

Toxicity to reproduction: other studies

Additional information

Gulati et al. (1990) reported a continuous breeding phase study. Male and female mice were offered concentrations of 120, 230 or 370 mg/kg (= 0.06, 0.12 or 0.24%) via the drinking water. No adverse effect on reproductive performance or necropsy endpoints were found. The NOAEL for parental animals was >= 370 mg/kg b.w.

Anderson et al. (1978) reported about effects of imipramine, nitrite and dimethylnitrosamine on reproduction in mice. Female mice were offered a concentration of 190 mg/kg via the drinking water. The administration of imipramine or sodium nitrite in drinking water before and during pregnancy resulted in increased perinatal death of the offspring compared to controls. Administration of imipramine and nitrite together had no effect on perinatal survival, but instead resulted in infertility or delayed impregnation in some females. A biological synergism or in vivo chemical interaction of the two chemicals is suggested.

Chapin et al. (1997) reported a two-generation study. Male and female mice were offered concentrations of 0.06, 0.12 or 0.24% (= 125, 260 or 425 mg/kg) via the drinking water. The following findings/symptoms were recorded: No treatment-related effects on mean number of litters/pair, cumulative days to deliver each litter, mean litter size, birth weight, or pup viability. No effect on postnatal mortality of pups exposed during lactation. Reduced body weights of nursing pups. No effects on reproduction of high-dose F1 animals, or on viability and weight of F2 offspring. No effects on post-delivery estrous cycle or sperm parameters. Nine deaths during the study period were not considered to be treatment related. No effect on F1 terminal body and organ weights. The NOAEL for reproductive toxicity was found to be 425 mg/kg bw/day.

Roth et al. (1987) reported about the evaluation of the developmental toxicity of sodium nitrite in rats. Sodium nitrite administered in the drinking water to Long-Evans rats during pregnancy and lactation severely affected erythropoietic development, growth, and mortality in their offspring. Pregnant rats were maintained throughout gestation on 0.5, 1, 2, or 3 g NaNO2/liter. There were no significant differences between treated and control litters at birth. Thereafter, pups of treated dams on 2 and 3 g NaNO2 /liter gained less weight progressivelv became severely anemic, and began to die by the third week postpartum. By the second week postpartum, hemoglobin levels, RBC counts, and mean corpuscular volumes of these pups were all drastically reduced compared to controls. Blood smears showed marked anisocytosis and hypochromasia. Gross chylous serum lipemia and fatty liver degeneration were noted. Histopathology demonstrated cytoplasmic vacuolization of centrilobular hepatocytes and decreased hematopoiesis in bone marrow and spleen. Administration of 1 g NaNO2/liter resulted in hematological effects but did not affect growth or mortality. NaNO2 (0.5 g/liter) was at or near the no observed effect level. Cross-fostering indicated that treatment during the lactational period was more instrumental in producing lesions than treatment during the gestational period.

Globus and Samuel (1978) reported about the effect of maternally administered sodium nitrite on hepatic erythropoiesis in fetal mice. The animals were administered a concentration of 0.5 mg NaNO2 per mouse per day (about 17 mg NaNO2/kg bw/day) via gavage until day 18 of gestation. No significant differences between groups for: litter size, weight, resorptions, fetal death, or skeletal abnormalities or variations were found. Significant changes in hepatic erythropoiesis were reported.

Justification for classification or non-classification

Classification concerning reproductive toxicity and developmental toxicity is not warranted.

Additional information