Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters

Endpoint summary

Description of key information

Skin irritation (OECD 404): not irritating (RA CAS 68334-05-4)
Eye irritation (OECD 405): not irritating (RA CAS 68334-05-4)

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Justification for grouping of substances and read-across

There are only limited data available on skin and eye irritation of Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters (CAS 68440-06-2). In order to fulfil the standard information requirements set out in Annex VII and 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:

CAS	Chemical name	Molecular weight [g/mol]	Skin irritation	Eye irritation
68440-06-2 (a)	Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters	789	RA: CAS 68334-05-4	RA: CAS 68334-05-4
68334-05-4 (b)	Fatty acids, C18-unsaturated, dimers, 2-ethylhexyl esters	673	Experimental result: not irritating	Experimental result: not irritating

(a) The substance subject to registration is indicated in bold font.

(b) Reference (read-across) substances are indicated in normal font. Lack of data for a given endpoint is indicated by “--“.

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., dimers, hydrogenated, 2-ethylhexyl esters (CAS 68440-06-2). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

Discussion

Skin irritation

CAS 68334 -05 -4

No data on skin irritation is available with Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters (CAS 68440-06-2). Therefore, read across from the structural analogue substance Fatty acids, C18-unsaturated, dimers, 2-ethylhexyl esters (CAS 68334-05-4) was applied. In the key skin irritation study performed according to OECD TG 404 and in compliance with GLP three female New Zealand White rabbits were exposed to 0.5 mL of the neat test material (CAS 68334-05-4) for 4 hours applied onto the shaved skin via semi-occlusive dressing (Stitzinger, 2010). Skin reactions were evaluated 1, 24, 48 and 72 hours post-application. No symptoms of systemic toxicity were observed in any animal during the test period and no mortality occurred during the course of the study. Very slight erythema and edema (grade 1) formation were observed for all animals four hours post-application which were fully reversible within 48 hours. The mean value for erythema and edema were calculated to be 0.33 and 0, respectively. Based on the result of the study and according to EU classification criteria, the test substance is considered to be not-irritating to skin.

Eye irritation

CAS 68334 -05 -4

No data on eye irritation is available with Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters (CAS 68440-06-2). Therefore, read across from the structural analogue substance Fatty acids, C18-unsaturated, dimers, 2-ethylhexyl esters (CAS 68334-05-4) was applied. In the key eye irritation study with Fatty acids, C18-unsaturated, dimers, 2-ethylhexyl esters (CAS 68334-05-4) performed according to OECD TG 405 and in compliance with GLP (Stitzinger, 2010) 0.1 mL of the neat test material was instilled in the eye of three New Zealand White rabbits. The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours post-application. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred during the course of the study. Neither iridial irritation nor corneal opacity and chemosis were observed in any animal during the course of the study. All animal showed conjunctivae irritation (grade 0.33) which was fully reversible within 48 hours. Based on the result of the study and according to EU classification criteria, the test substance is considered to be not-irritating to eyes.

Justification for selection of skin irritation / corrosion endpoint:
Hazard assessment is conducted by means of read-across from structural analogues/surrogates. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substances and overall quality assessment.

Justification for selection of eye irritation endpoint:
Hazard assessment is conducted by means of read-across from structural analogues/surrogates. All available studies are adequate and reliable based on the identified similarities in structure and intrinsic properties between source and target substances and overall quality assessment.

Justification for classification or non-classification

The available data on skin and eye irritation of Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters do not meet the criteria for classification according to Regulation (EC) 1272/2008 and are therefore conclusive but not sufficient for classification.