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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 274-765-6 | CAS number: 70693-39-9
Endpoint summary
Administrative data
Description of key information
The assessment of the terrestrial toxicity should be based on the outcome of aquatic toxicity testing. Pursuant to ECHA decision on a compliance check CCH-D-2114588821-38-01/F a new long-term fish toxicity study with the registered substance will be conducted in the future. The finalised study will be reported in an updated dossier and the hazard assessment will be re-evaluated accordingly. Thus, the strategy of terrestrial toxicity will be evaluated later when the long-term fish toxicity is available.
Additional information
The assessment of the terrestrial toxicity should be based on the outcome of aquatic toxicity testing. Pursuant to ECHA decision on a compliance check CCH-D-2114588821-38-01/F a new long-term fish toxicity study with the registered substance will be conducted in the future. The finalised study will be reported in an updated dossier and the hazard assessment will be re-evaluated accordingly. Thus, the strategy of terrestrial toxicity will be evaluated later when the long-term fish toxicity is available.
There are no terrestrial toxicity data available for Monopentaerythritol tetraesters and dipentaerythritol hexaesters of valeric, heptanoic and nonanoic acids. Therefore, read-across to the structurally related substances Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) and 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6) was conducted in order to fulfil the standard information requirements in compliance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Based on the high degree of similarity between the structural and physico-chemical properties of the target and source substances, the source substances are considered as suitable representatives for the assessment of the toxicity to soil macroorganisms and microorganisms. 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 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 (water solubility: < 2.01 mg/L; vapour pressure: <0.0001 Pa).
Experimental data investigating the chronic and acute toxicity of source substances to earthworms are available. Testing of the toxicity on earthworm evaluates the exposure to the test substance via soil pore water, surface contact as well as by ingestion of soil particles. One short-term study is available for the source substance Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) and one long-term study is available for the source substance 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6). However, due to the high adsorption potential (log Koc > 5) of the substance, long-term testing was considered to be relevant to investigate further the effects of the substance on terrestrial organisms.
The available studies were performed according to OECD 207 and OECD 222, respectively. No effects were recorded in both studies up to a concentration of 1000 mg/kg soil dw.
The toxicity to soil microorganisms was determined in a study according to OECD 216 for the source substance 2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25151-96-6). The EC50 for the nitrogen transformation after the test period of 28 days was calculated to be > 1000 mg/kg dw soil. No effects were observed and this result is supported by further evidence from literature data. This data showed 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.
In conclusion Monopentaerythritol tetraesters and dipentaerythritol hexaesters of valeric, heptanoic and nonanoic acids is of low toxicity to terrestrial organisms based on all available data.
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.
