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EC number: 291-445-1 | CAS number: 90411-68-0
Skin irritation:according to OECD 404, in compliance with GLP, RL1 (Steiling, 1991): not irritatingEye irritation:according to OECD 405, in compliance with GLP, RL1 (Steiling, 1991): not irritating
Table 1: Evaluation of the dermal reaction
amean of readings at 24, 48 and 72 hours
days after exposure
i b S
i = irreversible
b = brownish
S = eschar
+ = reversible
Area of opacity
mean 24-48-72 h
Justification for grouping of substances and read-across
There are no sufficient data available regarding skin and eye irritation/corrosion of Hexanoic acid, 2-ethyl, C16-18 alkyl esters (CAS No. 90411-68-0). 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 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.
Hexanoic acid, 2-ethyl, C16-18 alkyl esters
Fatty acids, C8-10, C12-18-alkyl esters
RA: CAS 59130-69-7
Experimental result: not irritating
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 Hexanoic acid, 2-ethyl, C16-18 alkyl esters (CAS No. 90411-68-0).
A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
A study conducted in accordance with OECD guideline 404 on skin irritation is available for Hexanoic acid, 2-ethyl, C16-18 alkyl esters, but only limited data from the report are available (Dufour, 1997). Skin sites of three New Zealand White rabbits was treated with substance and were assessed for effects 1, 24, 48 and 72 h after removal of the patch. While no edema was seen in any animals, erythema was noted in any animals leading to mean score between 1 and 1.7. However, since no data on later assessment of the erythema later given, the result of this study has to be regarded as inconclusive.
Irritation to skin by the structural analogue hexadecyl 2-ethylhexanoate was evaluated in a GLP study performed in accordance with OECD guideline 404 (Steiling, 1991). The flank skin of three Kleinrussen rabbits were treated with 0.5 mL of the test substance under semiocclusive conditions for 4 h. The readings 24, 48 and 72 hours later revealed mean erythema scores from 1.3 to 2 in the three animals and a mean edema score of 1.3 in any animals, respectively. All skin effects were fully reversible within the 14 days observation period. Based on these results, no skin irritation potential by hexadecyl 2-ethylhexanoate was observed.
Another structural analogue fatty acids, C8-10, C12-18-alkyl esters was tested in a study similar to OECD guideline 404 (no data on GLP compliance), where 0.5 mL of the test substance was applied with an occlusive patch for 4 h to the skin of three male New Zealand White rabbits (Dufour, 1991). 1, 24, 48 and 72 h after the patch removal the treated skin sites were graded according the Draize scoring system. While the mean erythema scores after 24, 48 and 72 h was 0 in two animals, a score of 0.33 was found in the third animal, where the effect was fully reversible within 48 h. The third animal also showed slight edema, but these fully reversed within 72 h leading to a mean score of 1. The two other animals developed no edema. These data show that fatty acids, C8-10, C12-18-alkyl esters is not irritating to skin.
An eye irritation study was performed with Hexanoic acid, 2-ethyl, C16-18 alkyl estersaccording to OECD 405 (Dufour, 1997). The undiluted test substance was instilled into the conjunctival sac of one eye of 3 New Zealand White rabbits. The eyes were examined and scored 1, 24, 48 and 72 h after application. No effects on cornea and iris and no chemosis was observed in any animals at any time point. Conjunctiva mean scores of 1.0, 0.7, and 0.3 (mean over 24, 48, and 72 h) were observed for the three animals, respectively. These were fully reversible within 72 h in 2/3 animals. In one animal a conjunctiva score of 1 was still observed after 72 h. No further reading at a later time point was reported.
In conclusion, the available data on the skin and eye irritation potential ofHexanoic acid, 2-ethyl, C16-18 alkyl esters and structural analogue substances indicate that Hexanoic acid, 2-ethyl, C16-18 alkyl esters is not irritating to the skin and eye.
The available data on skin and eye irritation 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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