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EC number: 221-242-5 | CAS number: 3039-83-6
In a reliable combined repeated dose and reproductive/developmental toxicity screening test (OECD TG 422) with a test solution containing 25.09 % Sodium ethylenesulphonate by oral gavage in rats no systemic toxicity occurred up to the high dose level of 2000 mg/kg bw/day. The NOAEL was determined to be greater than 2000 mg/kg bw/day for the test solution. Based on this study the derived NOAEL for reproduction toxicity and fertility as well as the NOAEL for developmental toxicity in the F1 progeny for 100% Sodium ethylenesulphonate was greater than 500 mg/kg bw/day.
In a GLP compliant combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (IIBAT(d), 2010, OECD 422) a test solution containing 25.09 % Sodium ethylenesulphonate was administered daily to Wistar rats (4 groups of 10 male and 10 female animals each) via oral gavage at dose levels of 0, 500, 1000 or 2000 mg/kg bw/day (corresponding to approximately 0,125, 250 and 500 mg/kg bw/day of 100 % Sodium ethylenesulphonate, respectively). The treatment period covered a 2-week pre-mating and mating period in both sexes. Males were further dosed after the mating period until the minimum dosing period of 28 days was completed and then sacrificed. Dosing of mating confirmed females was continued throughout gestation until day 4 post partum. Mortality, clinical signs, body weight and food consumption were assessed at regular intervals. At the end of the study functional observation battery and motor activity parameters as well as haematology and clinical chemistry parameters were determined. At necropsy, selected organs were weighed and the animals were examined macroscopically and histopathologically. Relevant reproductive parameters and indices were determined. No morbidity or mortality was observed in any of the animals during the entire observation period. Test substance related signs of toxicity were not observed in any of the treated group throughout the study period. No abnormal behavior was observed in offsprings. Body weights and feed consumption revealed no statistically significant changes. No statistically or biologically significant changes were observed at the evaluation of the haematology and clinical chemistry parameters. No test substance related effects were observed in functional observational battery (FOB) parameters in treated groups of males (low, mid and high dose groups) and in the control group male animals. However, in females (500 mg/kg bw) auditory function (acoustic startle) was increased when compared to control group female animals. Mating period, gestation length, mean number of implantation sites, mean litter size, number of dams delivered with live pups, loss of offsprings, sex ratio of pups and external abnormalities showed no test substance related abnormalities. Organ weight and bone marrow cytology revealed no statistically significant changes. No test substance related gross pathological changes and adverse histopathological findings were observed in any of the treated and control groups. All macroscopic and microscopic findings were either related to agonal, spontaneous, or incidental lesions were of the type routinely observed in Wistar rats of this age. In conclusion, under the conditions of the combined repeated dose toxicity study in male and female rats with the test item, containing 25.09% Sodium ethylenesulphonate, the obtained NOAEL was greater than 2000 mg/kg bw/day for the tested solution. Based on this study the derived NOAEL for reproduction toxicity and fertility as well as the NOAEL for developmental toxicity in the F1 progeny for 100% Sodium ethylenesulphonate was greater than 500 mg/kg bw/day. No specific target organ was identified.
Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test
Based on the results obtained from reproduction/developmental testing, the test substance is not considered to be subject to classification and labelling for toxicity to reproduction/development according Regulation (EC) No 1272/2008 (CLP).
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