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EC number: 605-694-4 | CAS number: 173832-46-7
Skin irritation (OECD 404): not irritating (based on read-across from CAS 68334-05-4)Eye irritation (OECD 405) not irritating (based on read-across from CAS 68334-05-4)
Justification for grouping of substances and read-across
There are no data available for the skin irritation/corrosion and eye irritation 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 VIII, 8.1 and 8.2, 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 skin and eye irritation:
Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters
Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters (ESIS: NLP)
RA: CAS 68334-05-4
Experimental result:not irritating
(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 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).
The skin irritation potential of Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters was investigated in a GLP-conform study according to OECD guideline 404 (Stitzinger, 2010). The undiluted test substance (0.5 mL) was applied for 4 h to the clipped skin of 3 male New Zealand White rabbits under semiocclusive conditions. The untreated site of the animals served as control. The scoring of skin reactions (erythema and edema) was performed 1, 24, 48 and 72 h after removal of the dressing and cleaning of residual test substance using tap water and watery ethanol (50% v/v). Very slight erythema and very slight edema (grade 1) were observed on the treated skin of the animals. Skin irritation was fully reversible within 24 h (edema) or 48 h (erythema) after exposure to the test substance. No signs of systemic toxicity were observed in the animals during the test period and no mortality occurred. The mean erythema and edema scores after 24, 48 and 72 h were 0.33 and 0 for all 3 animals.
Based on the results of this study, Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters is not irritating to the skin.
An eye irritation study was conducted with Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters according to OECD guideline 405 and in compliance with GLP (Stitzinger, 2010). The undiluted test substance (0.1 mL) was placed into the conjunctival sac of one eye of 3 male New Zealand White rabbits. The other eye remained untreated and served as control. The eyes were examined and scored 1, 24, 48 and 72 h after application. Instillation of the test substance resulted in redness of conjunctivae in all three animals, which was fully reversible at the 48 h reading. In addition, conjunctival discharge was observed in the treated eyes of all animals at the 1 h reading. No iridial irritation and corneal opacity was noted during the study. Treatment of the eyes with 2% fluorescein 24 hours after test substance instillation revealed no corneal epithelial damage. No evidence of ocular corrosion was seen during the study. Furthermore, no symptoms of systemic toxicity and no mortalities occurred in the animals during the test period. The mean cornea, iris and chemosis scores after 24, 48, and 72 h were 0 for all 3 animals, respectively. The mean score for conjunctivae after 24, 48, and 72 h was 0.3 for all 3 animals.
Based on the results of this study, Fatty acids, C18-unsatd., dimers, 2-ethylhexyl esters is not eye irritating.
Conclusion for skin irritation/corrosion and eye irritation
In conclusion, no data is available on the skin and eye irritation potential of Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters, but there exists reliable studies from the surrogate substance C18-unsatd., dimers, 2-ethylhexyl esters (CAS 68334-05-4), which are used for read-across based on the analogue approach and which are indicating no skin and eye irritating properties. Therefore, Fatty acids, C18 unsatd., trimers, 2-ethylhexyl esters is not skin and eye irritating.
Based on read-across from the surrogate substance, the available data on skin and eye irritation/corrosion 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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