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EC number: 605-694-4 | CAS number: 173832-46-7
There are no data available on the toxicity to reproduction of Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters (CAS 173832-46-7). In order to fulfil the standard information requirements set out in Annex IX, 8.7, 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, 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.
Overview of toxicity to reproduction:
Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters
Toxicity to reproduction – screening studies
Toxicity to reproduction – (pre-natal) development
RA: CAS 104-76-7
Experimental result:NOAEL (mouse) ≥ 191 mg/kg bw/day
(a) Category members subjected to the REACh Phase-in registration deadline of 31 May 2013 are indicated in bold font.
(b) Surrogate substances are indicated in normal font and are precursors/breakdown products of the target substance (i.e. alcohol and fatty acid moieties). Available data on these substances are used for assessment of toxicological properties by read-across on the same basis of structural similarity and/or mechanistic reasoning as described for the present analogue approach.
The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters (CAS 173832-46-7).
A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Toxicity to reproduction - fertility
This information is not available.
Conclusions for toxicity to reproduction (fertility)
There are no data available on the toxicity to reproduction (fertility) of Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters.
However, data on the oral repeated dose toxicity of the hydrolysis product 2-Ethylhexanol (CAS 104-76-7) and Fatty acids, C18-unsatd., dimers (61788-89-4), which shows a strong structural relationship to the hydrolysis product Fatty acids, C18 unsatd., trimers, demonstrate no adverse effects on reproduction organs and tissues after subchronic exposure up to and including the highest dose tested. Therefore, based on the weight of evidence, a reproduction toxicity study by any route of exposure is considered scientifically unjustified and not necessary in terms of animal welfare.
In summary, the available data provide sufficient evidence to conclude that the substance of Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters is not toxic to reproduction.
Based on read-across from 2-ethylhexanol (CAS 104-76-7), which is a hydrolysis product of the target substance, no hazard was identified.NOAEL developmental toxicity (mouse, m/f) = 1428.0-1736.5 mg/kg bw/day (based on read-across from 2-ethylhexanol and after correction for differences in molecular weight)
In conclusion, 2-EH administered in the diet during gestation (gd 0-17) in CD1 mice at concentrations comparable to or exceeding those employed for DEHP and MEHP in the same study design, resulted in no maternal or developmental toxicity. It is therefore clear that 2-EH plays essentially no role in the expression of DEHP-induced maternal and developmental toxicity.
Justification for grouping of substances and read-across
There are no data available on the repeated dose toxicity of Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters (CAS 173832-46-7). In order to fulfil the standard information requirements set out in Annex IX, 8.7, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from structurally related substances was conducted.
(a) Category members subjected to the REACh Phase-in registration deadline of 31 May 2013 are indicated in bold font
Toxicity to reproduction – (pre-natal) development
A developmental toxicity study was performed with 2-ethylhexanol, which was administered microencapsulated in the diet to pre-mated CD-1 mice (Tyl, 1991). Twenty-eight animals per group were treated continuously from Day 0 to Day 17 of gestation with dietary concentrations of 0.009, 0.03 or 0.09% in feed equivalent to 17, 59 and 191 mg/kg/day of the test substance. No females died, delivered early or were removed from the study. Pregnancy rates were high and equivalent across all groups (93-96%), maternal weight change for the gestational (and treatment) period (GD 0-17) was unaffected, as was weight change corrected for gravid uterine weight and maternal organ weights and food consumption were also unaffected. There were no effects of exposure on the number of ovarian corpora lutea, or of uterine implantation sites (resorptions, dead foetuses or live foetuses) per litter. Live litter size and foetal body weight per litter (all foetuses, males or females) were equivalent across all groups. There were also no treatment-related effects on the incidence of malformations (external, visceral, skeletal or total) or variations, whether expressed as number or percentage of foetuses per litter or of litters with one or more affected foetuses. Examination of individual foetal findings also indicated no specific malformations or variations with a dose-related incidence. In conclusion, the administered in the diet during gestation (GD 0-17) in CD1 mice at concentrations of 17, 59 and 191 mg/kg bw/day resulted in no maternal or developmental toxicity.
Based on the results, the developmental NOAEL for 2-ethylhexanol in mice was found to be 191 mg/kg bw/day.
Conclusions for toxicity to reproduction (development)
No study is available investigating the developmental toxicity of Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters (173832-46-7). However, a study with the surrogate substance 2-Ethylhexanol (CAS 104-76-7), which is the toxicologically most critical metabolite of the substance to be registered, did not show any treatment-related effects up to the highest dose level tested (191 mg/kg bw/day). .
The NOAEL of 191 mg/kg bw/day for 2-ethylhexanol (molecular weight = 130.23 g/mol) is selected for hazard assessment of Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters (molecular weight = 973.62-1184.02 g/mol). In order to account for differences in molecular weight, full enzymatic hydrolysis of Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters into Fatty acids, C18 unsatd., trimers and 2-ethylhexanol is assumed. A resulting estimated NOAEL for developmental toxicity ranging from 1428.0-1736.5 mg/kg bw/day was established for Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters.
Thus, no hazard for developmental toxicity is expected for Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters.
Based on read-across from the surrogate substance, the available data on the toxicity to reproduction do not meet the classification criteria 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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