Registration Dossier
Registration Dossier
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EC number: 214-730-4 | CAS number: 1191-16-8
Endpoint summary
Administrative data
Description of key information
- Acute oral toxicity: LD50 = 3000/2900 (males/females; TSCATS, 1978)
- Acute dermal toxicity: LD50 > 5000 mg/kg bw in rabbits (Moreno, 1977)
Key value for chemical safety assessment
Additional information
There are valid in vivo data available for the assessment of the oral and dermal acute toxicity potential of prenyl acetate (CAS No. 1191-16-8).
Oral
In the key study, an acute toxicity study similar to OECD Guideline 401 (TSCATS, 1978), doses of 1500, 2000, 3000, 4000 and 5000 mg/kg bw of the test substance were administered by gavage to 10 Sprague Dawley rats per sex and dose. The animals were observed for a post-dosing period of 14 days for lethality, body weight gain and clinical signs of intoxication. A necropsy was also performed at the end of the observation period. Based on the results of the study, the acute oral LD50 of 3000 mg/kg bw for male rats and 2900 mg/kg bw for female rats were determined for prenyl acetate. In a supportive acute oral toxicity study in rats, an acute oral LD50 of 3000 has been derived (Moreno 1977).
Inhalation
No data are available for acute inhalative toxicity of prenyl acetate. For the coverage of a second and human relevant route of exposure, data on acute dermal toxicity are available. Based on the available acute oral and dermal data, no evident acute inhalative toxicity for prenyl acetate is indicated.
Dermal
In the chosen key study for acute dermal toxicity, 10 rabbits were treated with 5000 mg/kg bw prenyl acetate and observed for 14 days for mortality and/or toxic signs (Moreno 1977). Necropsy was also performed at the end of the observation period. While no mortality occurred, toxic signs included diarrhea and necropsy findings included a brown exudate in the anogenital area, and changes in intestines, liver, lungs, kidneys, and spleen in single animals. Based on the results of the study, the acute dermal LD50 > 5000 mg/kg bw was determined.
Conclusion
In animal studies, prenyl acetate (3-methylbut-2-en-1-ol) showed low toxicity after single oral uptake in rats and was practically nontoxic after single dermal application to rabbits.
Justification for classification or non-classification
The present data on acute oral and dermal toxicity do not fulfill the criteria laid down in 67/548/EEC and regulation (EU) 1272/2008, and therefore, a non-classification is warranted. According to UN-GHS, the test substance needs to be classified as acute oral toxicant (Category 5).
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