Registration Dossier
Registration Dossier
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EC number: 209-141-4 | CAS number: 556-82-1
Endpoint summary
Administrative data
Description of key information
Acute oral toxicity: LD50 = 1591 mg/kg bw, (rat, similar to OECD Guideline 401, BASFXX/24)
Acute dermal toxicity: LD50 > 4000 mg/kg bw (rat, similar to OECD Guideline 402, BASFXX/24)
Key value for chemical safety assessment
Additional information
There are valid in vivo data available for the assessment of the oral, inhalative and dermal acute toxicity potential of
3-methylbut-2-en-1-ol.
Oral
In the key study, an acute toxicity study similar to OECD Guideline 401 (BASFXX/24), doses of 172, 1376, 1720, 2150, 2752 and 5504 mg/kg body weight of the test substance 3-methylbut-2-en-1-ol were administered by gavage to 10 rats per sex and dose. The animals were observed for a post-dosing period of 7 days for lethality and clinical signs of intoxication. The symptoms reported were described as staggering, dyspnea, restlessness (172 mg/kg bw or higher), apathy, abdominal position, reddened eyes and ears (1376 mg/kg bw or higher), lateral and partly dorsal positions, secretion out of eyes and mouth (1720 mg/kg bw or higher).
The acute oral LD50 of 3 -methylbut-2 -en-1 -ol for male and female rats was determined to be 1591 mg/kg body weight.
In a additional study reported from secondary source (Moreno 1977), an acute oral toxicity study was reported. Doses of 0.34, 0.67, 1.31, 2.56 and 5 g/kg body weight were orally administered to 10 rats per dose. Toxic signs were lethargy, flaccid, ataxia, ptosis and piloerection and lethargy.
The acute oral LD50 of 3-methylbut-2-en-1-ol was reported as 810 mg/kg body weight for rats.
Inhalation
No key study is available for acute inhalative toxicity.
In an Inhalation Risk Test, which used a highly enriched/saturated vapor exposure system at 20°C, 6 rats and 3 rats per sex were exposed to a vapor of 3-methylbut-2-en-1-ol at a concentration of 10.25 and 8.4 mg/l for 3 and 8 hours, respectively (BASFXX/24). One of 6 animals out of the 8 hour exposed rats died within the first 24 hrs after the exposure. Clinical symptoms were attempts to escape, strong secretion out of eyes and nose, and tremors after exposure. No mortality was observed after 3 hours of exposure.
Dermal
In the key study, an acute dermal toxicity in rats (BASFXX/24) similar to OECD Guideline 402, a single dermal administration of the test substance 3-methylbut-2-en-1-ol was performed under occlusive conditions by applying doses of 2000 and 4000 mg/kg body weight of the undiluted test substance for 24 hours (3 animals per sex and group). At the end of the exposure period the residual test substance was rinsed and dried. The observation period following administration was 14 days.
No mortality occurred. The clinical symptoms noted were slight apathy, irregular breathing, and slight local skin irritation which were reversible during the post observation period.
The LD50 for dermal exposure of 3-methylbut-2-en-1-ol in female and male rats is higher than 4000 mg/kg body weight.
In a supportive study reported from secondary source (Moreno 1977), doses of 1.25, 2.5 and 5 g/kg body weight were dermally administered to 4 rabbits per dose. In the high dose group (5 g/kg body weight) 3 of 4 animals died. Toxic sign was ataxia in the mid and high dosed animals.
The LD50 for dermal exposure of 3-methylbut-2-en-1-ol was reported to be 3900 mg/kg body weight for rabbits.
Conclusion
In animal studies, 3-methylbut-2-en-1-ol showed moderate toxicity after single oral uptake and low toxicity after single dermal application. In the Inhalation-risk test (IRT), mortality within 8 hours was observed. Therefore, inhalation of a highly saturated vapor-air mixture may represent a hazard.
Justification for classification or non-classification
Based on the oral LD50 of 1591 mg/kg body weight for rats, 3 -methylbut-2 -en-1 -ol has to be classified according to EU Annex VI of directive 67/548/EEC (R22: Harmful if swallowed) and according to 1272/2008/EEC (Cat. 4) classification for the oral route.
Based on the dermal LD50 of 3900 mg/kg body weight for rabbits, 3 -methylbut-2 -en-1-ol has not to be classified according to EU Annex VI of directive 67/548/EEC and 1272/2008/EEC.
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