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EC number: 943-330-9 | CAS number: -
Oral (similar to OECD 401), rat: LD50 > 5000 mg/kg bw (limit test)
Dermal (OECD 402), rabbit: LD50 > 5000 mg/kg bw (limit test)
All data read-across from the source substance bis(2-(2-butoxyethoxy)ethyl)adipate (CAS No. 141-17-3)
Justification for grouping of substances and read-across
The read-across approach uses 'bis(2-(2-butoxyethoxy)ethyl)adipate' (CAS No. 141-17-3) as structurally similar source substance to transfer (read-across) data to the target substance 'reaction mass of bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl]adipate and [2-[2-(2-butoxyethoxy)ethoxy]ethyl](3,6,9,12-tetraoxahexadecyl)adipate' (EC No. 943-330-9). The common feature of the source substance and the target substance is that they are diester derivatives of adipic acid, containing only even numbered and linear ethoxylated side chains. Both carboxylic functions of adipic acid are used to form esters with ethylene glycol monobutyl ethers of varying length. While the side chains of the target substance contain tri- and/or tetraethylene glycol monobutyl ether moieties, the side chains in the source substance are made up solely of diethylene glycol monobutyl ether. Thus, the ethylene glycol monobutyl ether substituents in the target substance contain 1 or 2 additional ethylene glycol monobutyl ether units. Although the constituents of the target substance are hence larger in size and have a higher molecular weight, it can be assumed that no significant steric hindrance is introduced when compared to the smaller side chains of the source substance. All parts of the ethylene glycol monobutyl ether side chains are freely rotatable due to the fact that neither a ring system nor π-bonds exert any constraints on rotatability. Therefore, it is feasible to assume an identical environmental and metabolic fate of both substances. In order to avoid the need to test every substance for every endpoint, the read-across from an analogue substance concept is applied for the assessment of environmental fate and environmental and human health hazards. Thus, where applicable, environmental and human health effects are predicted using adequate and reliable data from the source substance in accordance with Annex XI, Item 1.5, of Regulation (EC) No. 1907/2006 (REACH). Structural similarity and similarities in properties and/or activities of the source and target substance are the basis of read-across.
No data regarding acute toxicity obtained with the target substance are available and therefore read-across of adequate information from the source substance is used.
Acute oral toxicity
A key study (Consumer Products Testing, 1997a) was conducted according to the EPA OTS 798.1175 test guideline (simillar to OECD TG 401) and in compliance with GLP (limit test). Five Wistar rats per sex received the undiluted test item by oral gavage at the limit dose of 5000 mg/kg bw. A single male rat died during the 14-day observation period and showed depression before death. Slight depression was recorded in a single other male rat, but this resolved by the 24-h observation point. All other male rats appeared normal. Slight depression was noted in 3/5 females, which resolved within 24-h post dosing. Red anal and urethral discharges were noted, with peri-anal hair loss, which was resolved in all animals by observation day 13. Body weight gain was as expected in all animals. Based on these results, the oral LD50 was determined to be > 5000 mg/kg bw for both male and female rats.
Acute dermal toxicity
A key study (BSL, 2013a) was conducted according to OECD TG 402 and in compliance with GLP (limit test). The shaved dorsal skin of 5 Wistar rats per sex was exposed to the undiluted test substance at a limit dose of 5000 mg/kg bw for 24 h under semiocclusive conditions. After removal of the test substance, animals were observed for a period of 14 days. No mortality and no clinical signs of toxicity were observed up to the end of the observation period. Signs of slight dermal irritation were noted in females only, including scratches (2/5), desquamation (1/5) and eschar (1/5). The body weight development of all male and female animals was within the expected range. Necropsy revealed no substance-related findings. Based on these results, the dermal LD50 was determined to be > 5000 mg/kg bw for both male and female rats.
Acute inhalation toxicity
There are no data regarding the acute inhalation toxicity of the target substance. However, accounting for Regulation (EC) No. 1907/2006 (REACH), Annex VIII, 8.5.3 Column 2, and for animal welfare reasons, performing an acute toxicity study with inhalative exposure is not scientifically necessary and, considering concerns regarding the use of vertebrate animals for experimental purposes, unjustified.
Conclusion on acute toxicity
Reliable and adequate studies performed with the source substance are available investigating the acute oral and dermal toxicity. Both studies yield LD50 values of > 5000 mg/kg bw for male and female rats. The available data, therefore, indicate a very low level of acute toxicity for the source substance and thus, no hazard for acute oral and dermal toxicity is identified for the target substance either.
According to Article 13 of Regulation (EC) No. 1907/2006 (REACH) information on intrinsic properties of substances may be generated by means other than tests, e.g. using information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI states that “substances whose physico-chemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Thus, data gaps can be filled by a read-across approach from a structural analogue source substance to avoid unnecessary animal testing.
The analogue concept is also used to derive the C&L of the target substance taking the properties of the source substance into account. Based on the analogue concept, all available data on acute toxicity do not meet the classification criteria according to Regulation (EC) No. 1272/2008 (CLP) and are therefore conclusive but not sufficient for classification.
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.
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