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EC number: 946-103-2 | CAS number: -
In a GLP compliant combined repeated dose inhalation toxicity study and reproduction/developmental toxicity screening test performed according to OECD guideline 422 and 412, male and female Wistar rats were exposed to the test substance. The test substance was administered by inhalation (nose only, during 6 hours per exposure day) to groups of 12 male and 12 female rats during a premating period of 2 weeks and during mating and gestation op to GD19. Male animals were sacrificed after a total of 25 exposure days. Dams and pups were sacrificed four days after delivery. The test substance was administered at target concentrations of 0 (clean air only), 10, 50 or 200 mg/m3. The average actual concentrations of the test substance in the test atmospheres, as determined by gravimetric analysis, were close to the respective target concentrations, namely 10.3, 50.3 and 205.8 mg/m3. One female rat of the high-concentration group was found dead during the mating period. The death of this rat was not ascribed to treatment. Pre-exposure and postexposure observations did not reveal treatment-related clinical signs. Neurobehavioural observations and motor activity assessment did not indicate any neurotoxic potential of the test substance. There were no treatment-related differences in body weights or food consumption during the premating period, during the post-mating period in males, or in dams during the gestation period and the lactation period. Haematology and clinical chemistry was conducted in 5 rats/sex/group at the end of the premating period. Total protein and albumin concentrations were decreased in males of the high-concentration group. Lung weights were increased in the high-concentration group in both sexes. Adrenals weights were increased in the high-concentration group in females. Microscopic examination revealed bronchiolitis in the lungs in the mid- and high-concentration group, and accumulation of alveolar macrophages in the high-concentration group. There were no effects of the test substance on fertility and reproductive performance, litter data or pup observations in any group. Based on the effects noted in the lungs, the local NOAEL for parental effects was placed at the low-concentration of 10.3 mg/m3. The systemic NOAEL was placed at 50.3 mg/m3 based on adrenal effects. Because fertility parameters, reproductive performance and development were not affected by the test substance, the NOAEL for reproduction and developmental effects was placed at ≥ 205.8 mg/m3 (the highest concentration tested).
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