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EC number: 419-720-5 | CAS number: 182061-89-8
Oral: LD50 = > 2000 mg/kg bw, male/female rat, OECD 401, EU Method B.1, de Jouffrey 1995aDermal: LD50 = > 2000 mg/kg bw, male/female rat, OECD 402, EU Method B.3, de Jouffrey 1996a
The acute oral toxicity of the test material was determined in accordance with the standardised guidelines OECD 401 and EU Method B.1. Rats received two oral doses 1100 mg/kg under a volume of 11 mL/kg, each. The animals were checked for clinical signs, mortality and body weight gain for a period of 14 days following administration of the test material. A necropsy was performed on each animal at study termination. Under the conditions of the study, none of the animals died and no clinical signs were recorded. The LD50 of the test material was subsequently determined to be in excess of 2000 mg/kg bw.
The acute dermal toxicity of the test material was determined in accordance with standardised guidelines OECD 402 and EU Method B.3. Five male and female rats received a single dermal application of 2000 mg/kg of the test material and were assessed daily for the following 14 days for any signs of systemic toxicity. None of the animals died and there were no signs of systemic toxicity. Very slight to moderate red colouration of the test site was noted in all animals up to day 5. The body weight gain of the animals was not influenced by treatment. There were no macroscopic abnormalities at examination post mortem. The acute dermal median lethal dose of the test material was subsequently estimated to be in excess of 2000 mg/kg to both male and female rats.
Both studies presented to assess the acute toxicity of the test material were performed in line with GLP and accepted standardised guidelines with a high standard of reporting. Both studies were assigned a reliability score of 1 in accordance with the criteria for assessing data quality as outlined in Klimisch (1997) and considered suitable for assessment as an accurate reflection of the test material.
The available data are considered to be complete and the conclusion for both acute oral and acute dermal toxicity, LD50 > 2000 mg/kg, was taken forward for risk assessment.
In accordance with the criteria for classification as defined in Annex I, Regulation 1272/2008, the test material does not require classification for acute oral and acute dermal toxicity as no signs of toxicity were noted during the course of either study.
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