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EC number: 692-614-6 | CAS number: 5660-53-7
- One Acute oral toxicity study (Gemio dos Reis, 2011; OECD 423, Rel. 1) is available and showed a LD50 > 2000 mg/kg bw in female WIstar rats. This study indicates that the acute toxicity of 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol is low for the oral route.- One acute dermal toxicity study (R. Leclère, 2013; OECD 402, Rel. 2) is available on the analogue substance 2,2-dimethyl-1,3-dioxolane-4-methanol and showed a LD50 > 2000 mg/kg bw in rats . By analogy, 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol is expected to be of no to low acute dermal toxicity.
The median lethal dose of 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol after a single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000 mg/kg body weight.
In an acute oral toxicity study, performed in compliance with the GLP and according to the OECD 423 Guideline, 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol was administered sequentially, by oral gavage, to female Wistar rats at the doses of 300 and 2000 mg/kg bw (6 animals/dose level). At 300 mg/kg bw, the test substance was diluted in corn oil. Clinical signs, mortality and body weight gain were checked for a period of up to 14 days. All animals were sacrificed at the end of the study and necropsied for gross abnormalities.
Oral LD50in female rats > 2000 mg/kg bw
No mortalities occurred in any animals at the tested doses. No clinical signs were observed at 300 mg/kg bw. Animals treated at 2000 mg/kg bw presented prostration, ataxia, salivation and/or dyspnea in the first 4 hours post dosing. These clinical signs had totally ceased afterwards. Body weight gain was not affected by the test substance treatment. Macroscopic observations consisted in congestion with or without multifocal pale areas in the liver of all animals at both doses and congestion in the lungs in few animals at both doses.
Based on the results of this study, 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol is not classified for acute oral toxicity according to the Regulation (EC) 1272/2008 (CLP) and the Directive 67/548/EEC.
2,2-Dimethyl-1,3-dioxolane-4-methanol was tested for acute dermal toxicity in Sprague-Dawley rats in a GLP-compliant limit dose assay according to OECD guideline 402. Groups of rats (5/sex) were administered a single dermal dose of undiluted test material at 2000 mg/kg bw on clipped skin (approximately 10 % of the total body surface area) using a semi-occlusive patch held in place for 24 h. Residual test item was removed using a dry cotton pad at the end of the 24 h exposure period. Examinations for mortality, clinical signs, body weight gain and dermal reactions were performed during a 14-day observation period. All surviving animals were necropsied at the end of the observation period.
No deaths occurred during the observation period. When compared to historical control animals, the mean body weight gain was unaffected by the test item treatment in females. A lower mean body weight gain was noted in males between day 1 and day 8 due to one animal which had lost weight during this period. The mean body weight gain returned to normal thereafter. This change in males was considered incidental. At necropsy, macroscopic examination of main organs showed no abnormalities. The acute dermal combined LD50 was greater than 2000 mg/kg bw.
Some dermal changes were observed in some animals. On the application site, two females presented scabs from day 11 or 12 and up to day 13 or 14, and a very slight erythema was noted in one of these two females on days 3 and 4. No cutaneous reactions were observed in any males.
In a GLP-compliant acute oral toxicity study performed in accordance with OECD 423, no mortality and no major clinical signs were observed in Wistar rats given a single oral administration of 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol at the doses of 300 or 2000 mg/kg bw . Therefore,
2-isobutyl-2-methyl-1,3-dioxolane-4-methanol LD50 is > 2000 mg/kg bw.
In a GLP-compliant acute dermal toxicity study performed in accordance with OECD guideline 402, no mortality was observed in Sprague Dawley rats given a single dose of the analogue substance 2,2-Dimethyl-1,3-dioxolane-4-methanol at the limit test dose of 2000 mg/kg bw. Thus, by analogy,
2-isobutyl-2-methyl-1,3-dioxolane-4-methanol dermal LD50 is considered to be > 2000 mg/kg bw.
In the absence of mortality following oral exposure of rats to the limit test dose of 2000 mg/kg bw and a 2-week observation period , no classification for acute oral toxicity is warranted according to the criteria of Annex VI Directive 67/548/EEC or EU Regulation 1272/2008 (CLP).
The dermal LD50 of the analogue substance 2,2-Dimethyl-1,3-dioxolane-4-methanol was higher than 2000 mg/kg in rats and no mortality occurred at this concentration. Therefore, by analogy, 2 -isobutyl-2 -methyl-1,3-dioxolane-4-methanol is not classified for acute dermal toxicity according to the Regulation (EC) N° 1272-2008 (CLP) and according to the Directive 67/548/EEC.
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