Fatty acids, C16-18 and C18-unsatd., Et esters

Endpoint summary

Description of key information

Skin irritation/corrosion: not irritating (OECD 404, analogue approach)
Eye irritation: not irritating (OECD 405, analogue approach)

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 no data available for the skin and eye irritating potential of Fatty acids, C16-18 and C18-unsatd., ethyl esters (CAS 85049-36-1). 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, a 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 for skin and eye irritation

CAS #	Skin irritation	Eye irritation
85049-36-1 Target substance	RA: 544-35-4 RA: 111-62-6	RA: 544-35-4
111-62-6	Not irritating	--
544-35-4	Not irritating	Not irritating

The above mentioned substance is considered to be similar on the basis of structural similarity resulting in similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Fatty acids, C16-18 and C18-unsatd., ethyl esters (CAS 85049-36-1).

A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

Skin irritation

CAS 111-62-6

Ethyl oleate (CAS 111-62-6) was tested in an acute dermal irritation study in rabbits according to OECD Guideline 404 (Masson, 1986). Six New Zealand White rabbits were exposed to 0.5 mL of the test substance (no data on purity) for 24 hours under occlusive conditions. 24 and 72 hours after patch removal the test sites were examined for evidence of primary irritation and scored according to Draize. Slight erythema (grade 1 to 2) occurred in all treated skin sites, which were all fully reversible within 72 hours. No edema was detected. Based on the study results, the test substance shows no skin irritating potential.

CAS 544 -35 -4

Ethyl linoleate (CAS 544-35-4) was tested in a primary dermal irritation study in New Zealand White rabbits (Bouffechoux, 1995). The skin of 3 animals was exposed to the test substance (no data on purity) for 24 hours. Treated skin sites were examined using the Draize scoring system 24, 48 and 72 hours after application. At the time point 24 hours, all 3 animals displayed erythema graded 2. Erythema graded 2 was reported for 2 animals whereas the remaining animal showed no erythema. At time point 72 hours one animal showed erythema grade 1 and one animal showed erythema grade 2. All effects were reversible within 7 days. No edema was detected. Based on the study results, ethyl linoleate exerts no skin irritating potential.

Eye irritation

CAS 544 -35 -4

Ethyl linoleate (CAS 544-35-4) was tested for its acute eye irritation potential in a study performed equivalent to OECD Guideline 405 (Bouffechoux, 1995). The test substance (no data on purity) was instilled into one eye of 3 male rabbits. 1, 24, 48 and 72 hours later, treated eyes were examined for ocular lesions according to Draize. After a single instillation the test substance resulted in redness of the conjunctivae, which warranted a conjunctivae score of 3 in the first hour after application. The irritation had completely resolved within 48 or 72 hours in all animals. No iridial irritation or corneal opacity was observed. Thus, the test material is not considered irritating to the eyes in this study.

Conclusion:

There are two skin irritation studies available with the structure related substances ethyl oleate (CAS 111-62-6) and ethyl linoleate (CAS 544-35-4). All studies revealed no indication for skin irritation.

Eye irritation potential has been investigated based on an analogue read-across approach with ethyl linoleate (CAS 544-35-4) in an in vivo assay. There was no indication of eye irritating potential.

Therefore, Fatty acids, C16-18 and C18-unsatd., ethyl esters is not considered to be skin or eye irritating.

Justification for selection of skin irritation / corrosion endpoint:
Hazard assessment is conducted by means of read-across from structural analogues. 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 (refer to the endpoint discussion for further details).

Justification for selection of eye irritation endpoint:
Hazard assessment is conducted by means of read-across from structural analogues. 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 (refer to the endpoint discussion for further details).

Justification for classification or non-classification

Based on read-across from the structurally similar substances, the available data for skin and eye irritation 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.