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EC number: 249-060-1 | CAS number: 28510-23-8
Acute oral toxicity:equivalent to OECD 401 and in compliance with GLP, RL2 (Duerden, 1994): LD50>2000 mg/kg bwAcute inhalation toxicity:according to OECD 403, no data on GLP compliance, RL2 (Parr-Dobrzanski, 1994): LC50>5.1 mg/L airAcute dermal toxicity:No data available
Animals had normal body weight gain.
Justification for grouping of substances and read-across
There are no sufficient data available for the acute toxicity of 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate (CAS 28510-23-8). In order to fulfil the standard information requirements set out in Annex IX, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances 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, 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.
Fatty acids, C5-10 (linear and branched and without 2-Ethylhexanoic acid), mixed esters with pentaerythritol
Acute toxicity oral
Experimental result: LD50 > 2000 mg/kg bw
Acute toxicity inhalation
RA: CAS 68424-31-7
Experimental result: LC50 > 5100 mg/m³
Acute toxicity dermal
The above mentioned substances are considered to be similar on the basis of the structural similarity resulting in similar properties and/or activities. The available endpoint information is used to predict the same endpoints for 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate (CAS 28510-23-8).
A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
In an acute oral toxicity study similar to OECD guideline 401 and in compliance with GLP, male and female rats were dosed with 2000 mg/kg bw test substance (Duerden, 1994). No detailed information on number of rats or oral administration was given. No clinical signs of toxicity were observed. As no mortality was observed, the LD50 was considered to be >2000 mg/kg bw.
Supporting data were available in an acute oral toxicity study equivalent to OECD guideline 401 (Bouffechoux, 1991). Five female Swiss mice received an oral dose of 2 mL/kg bw (corresponding to 1880 mg/kg bw based on a density of 0.94 g/L) test substance via gavage (limit test). No effect on body weight and no systemic toxicity were observed. As no mortality occurred during the 14-days observation period, the LD50 was considered to be >1880 mg/kg bw.
In conclusion, as no signs of toxicity were observed in studies in rats and mice and no mortality was observed neither in rats nor in mice,2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate is not acutely toxic after oral application. As no mortality occurred in the rats up to 2000 mg/kg bw the LD50 was set to >2000 mg/kg bw.
There are no data available on the acute toxicity of2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate by inhalation.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 the structurally related analogue substanceFatty acids, C5-10 (linear and branched and without 2-Ethylhexanoic acid), mixed esters with pentaerythritolis conducted.
An acute inhalation study equivalent to OECD 403 is available forFatty acids, C5-10 (linear and branched and without 2-Ethylhexanoic acid), mixed esters with pentaerythritol (Parr-Dobrzanski, 1994). Five rats per sex were exposed (nose-only) to 5.1 mg/L (analytical concentration) of an aerosol of the test substance for 4 h. No mortality occurred within the 14-day observation period. Some clinical signs were noticed, which consisted of hunched position, chromodacryorrhea, piloerection, staining around nose and wet fur. These signs however occurred during or just after exposure and were clearly consistent with the use of restraint for exposure. No effect on body weights was noted. Pathological and histopathological examinations revealed no substance-related findings. The LC50 was considered to be >5.1 mg/L.
In conclusion, the available data on the acute toxicity of2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate and analogue substances indicate that 2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate is not acutely toxic after oral and inhalation exposure, resulting in a LD50 > 2000 mg/kg bw and a LC50 >5.1 mg/L, respectively.
The available data on acute toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, 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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