Registration Dossier
Registration Dossier
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EC number: 218-129-8 | CAS number: 2051-78-7
Endpoint summary
Administrative data
Description of key information
Chronic oral toxicity study was performed by P. M. JENNER et.al (Food Cosmet. Tex 1964.) to determine the oral toxic nature of Allyl butyrate IUPAC : 2-Propen-1-yl butanoate (2051-78-7). Repeated toxicity study forAllyl butyratein male and femaleOsborne-Mendel rats was observed when they were exposed in a concentration of 50 and 90 mg/kg for 17 and 18 week respectively by oral (gavage). Rough and granular surface, firm consistency, nutmeg appearance was observed in liver at 90 mg/kg/day. At 90 mg/kg/day slight to moderate bile duct proliferation and fibrosis with pseudolobule formation .Necrosis with polymorph nuclear infiltration and swollen, foamy liver in 2-8 rats was observed. At 50 mg/kg/day slight to marked prebrochial lymphocyte infilteration was examined in treated group compare to controls. No effect was observed in liver at 50 mg/kg/day. As no significant change were observed on the clinical sign and gross pathology of other organ Therefore NOAEL was found to be 50 mg/kg/day for Allyl butyrate for chronic study.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- Study duration:
- chronic
- Species:
- rat
- Quality of whole database:
- Data is from K2 publication
- Organ:
- not specified
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Repeated dose oral toxicity:
Various experimental studies were reviewed to determine the toxic nature of 2-Propen-1-yl butanoate (2051-78-7) upon repeated exposure by oral route. The studies are as mentioned below:
Chronic oral toxicity study was performed by P. M. JENNER et.al (Food Cosmet. Tex 1964.) to determine the oral toxic nature of Allyl butyrate IUPAC : 2-Propen-1-yl butanoate (2051-78-7). Repeated toxicity study forAllyl butyratein male and femaleOsborne-Mendel rats was observed when they were exposed in a concentration of 50 and 90 mg/kg for 17 and 18 week respectively by oral (gavage). Rough and granular surface, firm consistency, nutmeg appearance was observed in liver at 90 mg/kg/day. At 90 mg/kg/day slight to moderate bile duct proliferation and fibrosis with pseudolobule formation .Necrosis with polymorph nuclear infiltration and swollen, foamy liver in 2-8 rats was observed. At 50 mg/kg/day slight to marked prebrochial lymphocyte infilteration was examined in treated group compare to controls. No effect was observed in liver at 50 mg/kg/day. As no significant change were observed on the clinical sign and gross pathology of other organ Therefore NOAEL was found to be 50 mg/kg/day for Allyl butyrate for chronic study.
Supported by experimental study was performed by JEAN M. TAYLOR et.al (TOXICOLOGY AND APPLIED PHARMACOLOGY, 1964) to determine the oral toxic nature of Allyl butyrate IUPAC: 2-Propen-1-yl butanoate (2051-78-7). Repeated dose toxicity study for Allyl butyrate was observed in Male and female Osborne-Mendel rats by oral gavage for 4 days. The doses used were1/3 of LD50 'S related to the acute toxicity. The dose85 mg/kg/day was given consecutivelely for 4 days. Significant variation in amount of Liver damage was observed in treated group. No other effects were observed .As though no mortality was observed .Therefore NOAEL was found to be 85 mg/kg/day for Allyl butyrate.
The data available for the target chemical Allyl butyrate IUPAC: 2-Propen-1-yl butanoate (2051-78-7) is insufficient to classify the chemical as toxic. Also the NOAEL value range can be close to50mg/kg bw/day. Based on the observations made, Allyl butyrate does not exhibit toxicity upon repeated exposure by oral route. Hence the test chemical is not likely to classify as a toxicant upon repeated exposure by oral route. Further testing is required to clearly judge the test chemical as toxic upon repeated exposure.
Justification for classification or non-classification
Thus based on above annotation and CLP criteria for target chemial,Allyl butyrate does not exhibit toxicity upon repeated exposure by oral route. Hence the test chemical is not likely to classify as a toxicant upon repeated exposure by oral route.
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