Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 807-157-1 | CAS number: 129677-93-6
Endpoint summary
Administrative data
Description of key information
Additional information
There are no data available on the toxicity of Fatty acids, C8-10, C8-10 alkyl esters (CAS 129677-93 -6) to terrestrial organisms.
In order to fulfil the standard information requirements set out in Annex IX, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from one structurally related substance was conducted.
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity. The source substance is representative to evaluate the terrestrial toxicity of Fatty acids, C8-10, C8-10 alkyl esters to earthworms. Fatty acids, C8-C10, C12-18-alkyl esters is characterized by the same fatty acid chain length (C8 -C10) and a comparable alcohol component since it mainly contains of C12 alcohol esters. A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Exposure of the soil compartment is generally considered to be low. Even if exposed to the soil the target substance is readily biodegradable indicating that it will not be persistent in the environment. Indirect exposure via irrigation or atmospheric transport is considered to be negligible based on the physico-chemical properties of the target substance Fatty acids, C8-10, C8-10 alkyl esters (water solubility: 4.6 µg/L; vapour pressure: 0.000115 - 0.0152 Pa at 20 °C). Experimental data investigating the toxicity of the target substance to earthworms are available from the representative source substances Fatty acids, C8-C10, C12-18-alkyl esters (CAS 95912-86-0). Testing of the toxicity on earthworm evaluates the exposure to the test substances via soil pore water, surface contact as well as by ingestion of soil particles. Due to the high adsorption potential (log Koc 3.90 - 4.94), long-term testing was considered to be relevant to investigate the effects of the substance on terrestrial organisms. The available study according to OECD 222 was performed for the source substance Fatty acids, C8-C10, C12-18-alkyl esters (CAS 95912-86-0). The available study resulted in a NOEC (56 d) of 500 mg/kg soil dw.
After absorption, the target substance is expected to be enzymatically hydrolyzed by carboxylesterases yielding to the corresponding alcohol and fatty acid. Bioaccumulation and biomagnification through the food chain of the substance is not expected. This is supported by (Q)SAR calculations using BCFBAF v3.01 (Arnot-Gobas, including biotransformation, upper trophic). All constituents of the UVCB substance are within the applicability domain of the model and clearly indicate a low potential for bioaccumulation with BCF values of 14.07 - 207.8 L/kg whole body ww and BAF values of 230.8 - 314 L/kg whole body ww. Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the substance.
Available reliable data for toxicity to aquatic microorganisms from related source substances (Fatty acids, C8-10, C12-18-alkyl esters (CAS 95912-86-0) and octyl octanoate (CAS 2306-88-9)) support the determination of a lack of toxicity to soil microorganisms. No inhibition of respiration rate of aquatic microorganisms was observed in the available experimental studies. The Guidance Document (ECHA, 2017, page 149) states that a test on soil microbial activity will only be additionally necessary for a valid PNEC derivation if inhibition of sewage sludge microbial activity has occurred and this is clearly not the case. This is supported by further evidence from literature data. These data show that soil microorganism communities are well capable of degrading fatty acid esters (Hita et al., 1996 and Cecutti et al., 2002) and use them as energy source (Banchio & Gramajo, 1997). Based on the available information, effects on soil microorganisms are not expected to be of concern, and consequently, no further testing is required.
In conclusion the target substance is of low toxicity to terrestrial organisms based on all available data.
A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
