Registration Dossier
Registration Dossier
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EC number: 203-761-9 | CAS number: 110-38-3
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
Based on the available study, and on the category approach, the target substance was not considered as reprotoxic. Hence, ethyl decanoate was not classified for reprotoxicity according to CLP criteria.
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 5 500 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
Additional information
This category groups covers esters (including ethanol, isopropanol, octanol, hexanol and 2-ethylhexanol) linked to fatty acids chain satured and unsatured (C8 to C18). This category includes monoconstituent substances and UVCB substances varying fatty acid chain length and based on the alcohol sources. This category group was made in order to provide sufficient information for physico-chemical, environmental, ecotoxicological and toxicological caracterisation of ethyl decanoate (CAS 110-38-3). This approach covers these endpoints including skin irritation, eye irritation, and in vitro gene mutation study in bacteria for which some data on the target substance of the category are available.
This category includes:
- Target substance:
o Ethyl decanoate (CAS 110-38-3)
- Source substances:
o Ethyl undecylenate (CAS 692-86-4)
o Isopropyl laurate (CAS 10233-13-3)
o Octyl octanoate (CAS 2306-88-9)
o Isopropyl myristate (CAS 110-27-0)
o Dodecanoic hexyl ester (CAS 34316-64-8)
o Ethyl linoleate (CAS 544-35-4)
o Ethyl oleate (CAS 111-62-6)
o 2-Ethylhexyl laurate (CAS 20292-08-4)
o Fatty acids, coco, 2-ethylhexyl esters (CAS 92044-87-6)
One available relevant study was performed on ethyl oleate to assess the potential reprotoxicity. The study was performed according 1993 FDA draft “Redbook II” guideline. Rats were exposed in diet at 1.8, 3.6 and 5.5 g/kg bw/day during 91 days. Signs of toxicity, reproductive functions were assessed on parental animals. No treatment related effects on reproductive capacity of the animals was observed. Hence, the NOAEL was defined to be higher than 5500 mg/kg bw/day. Based on the structural similarities between the substances and on the category approach, the NOAEL value is validated for the category substances.
Justification for classification or non-classification
Based on the available study, and on the category approach, the target substance was not considered as reprotoxic. Hence, ethyl decanoate was not classified for reprotoxicity according to CLP criteria
Additional information
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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