Registration Dossier
Registration Dossier
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EC number: 261-245-9 | CAS number: 58430-94-7
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
Toxicokinetic Assessment 3,5,5-Trimethylhexyl Acetate
No ADME and dermal absorption studies with 3,5,5-trimethylhexyl acetate are available.
The acute and repeated dose toxicity studies give an indication about the bioavailability after oral and dermal application. In the acute and repeated dose oral toxicity studies with 3,5,5-trimethylhexyl acetate systemic toxicity was seen leading to the conclusion that the test substance is bioavailable after oral application.
After dermal application of 5000 mg test substance/kg bw in a rabbit acute toxicity study and dermal application in three guinea pig sensitization studies no systemic effects could be observed. The octanol/water partition coefficient of 4.6 (25°C) indicates lipophilic property of the substance and, also considering the low molecular weight of 186.29 g/mol, it can be assumed that the substance penetrates to some extent through the skin. However, due to the low toxicological potential of the test substance no clinical signs could be observed after dermal exposure.
The substance 3,5,5-trimethylhexyl acetate is a liquid at room temperature with a vapour pressure of 136 Pa. Inhalation exposure might be possible via evaporation and as aerosol.
It is concluded by EFSA that 3,5,5-trimethylhexyl acetate as an ester is easily hydrolysed and either conjugated or further metabolised via common metabolic pathways (EFSA Journal (2008) 709-60). Therefore, the substance is unlikely to bioaccumulate to any significant extent.
References:
EFSA Journal (2008) 709-60: Flavouring Group Evaluation 2, Revision 1: Branched- and straight-chain aliphatic saturated primary alcohols and related esters of primary alcohols and straight-chain carboxylic acids and one straight-chain aldehyde from chemical groups 1 and 2 (Commission Regulation (EC) No 1565/2000 of 18 July 2000)
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