Fatty acids, C8-C18 (even numbered), decyl esters

Endpoint summary

Description of key information

Skin, rabbit: not irritating
Eye, rabbit: not irritating

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 read-across

Data on the skin and eye irritation potential of Fatty acids, coco, decyl esters (CAS 93455-79-9) are not available. The assessment of acute toxicity was therefore based on studies conducted with analogue substances as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5. For each specific endpoint the source substance(s) structurally closest to the target substance is/are chosen for read-across, with due regard to the requirements of adequacy and reliability of the available data. Structural similarities and similarities in properties and/or activities of the source and target substance are the basis of read-across. A detailed justification for the analogue read-across approach is provided in the technical dossier (see IUCLID Section 13) and within Chapter 5.1 of the CSR.

Skin irritation

CAS 95912-86-0

A skin irritation study was performed with Fatty acids, C8-10, C12-18 alkyl esters (CAS 95912-86-0), according to a protocol similar to OECD Guideline 404 (Dufour, 1991). 0.5 mL of the test substance was applied to the shaved skin of 3 male rabbits and held in place by an occlusive dressing for 4 hours. 1 hour after exposure, all the animals had slight to well-defined erythema (score 1-2), while 2/3 had very slight to slight edema (score 1-2). These effects gradually reduced in severity. 24 hours after exposure ended, 1/3 animals had very slight erythema (score 1) and slight edema (score 2). The edema persisted until the 48-hour reading time point. All skin irritation effects had cleared completely within 72 hours after the exposure ended. The mean erythema scores (over 24, 48 and 72 h) were 0.33, 0 and 0, while the mean edema scores (over 24, 48 and 72 h) were 1, 0 and 0. The test substance is not considered to be irritating to the skin.

CAS 3687-46-5

Decyl oleate (CAS 3687-46-5) was tested for its skin irritation potential in a study similar to OECD Guideline 404 (Dufour, 1994). The shaved skin of 3 male rabbits was exposed to an undisclosed amount of undiluted test material for 4 hours under semi-occlusive conditions. 3/3 animals had very slight erythema (score 1) 1 hour after exposure ended. At the 24-hour reading time point 2/3 animals still had very slight erythema and 1/3 had well-defined erythema (score 2). The mean erythema scores (over 24, 48 and 72 h) were 1, 0.33 and 1.33. Very slight edema (score 1) was observed in 1/3 rabbits from the 1-hour- up to and including the 72-hour reading time point. All irritation reactions were completely reversible within 5 days. The mean edema scores (over 24, 48 and 72 h) were 0, 0 and 1. The test substance is not considered to be irritating to the skin.

Eye irritation

CAS 92044-87-6

One study with Fatty acids, coco, 2-ethylhexyl esters (CAS 92044-87-6) for the assessment of the acute eye irritation/corrosion potential is available (Weterings, 1987). The study was performed according to OECD Guideline 405 under GLP conditions. 0.1 mL of the test substance (approx. 100% pure) was instilled into the eyes of three female New Zealand White rabbits. The animals were observed for 72 hours and scoring according to Draize was performed 1, 24, 48, and 72 hours after application. 2/3 animals showed only slight swelling of the blood-vessels in the conjunctivae (score 1) 1 hour after instillation. The effects were fully reversible within 24 hours. The fluorescein analysis 24 hours after instillation did not reveal any epithelial damage. Based on the results of the study, the test substance is not considered irritating to the eyes.

 

CAS 20292-08-4

An acute eye irritation test performed according to OECD Guideline 405 was performed to evaluate the eye irritation potential of 2-ethylhexyl laurate (CAS 20292-08-4) (Bouffechoux, 1996). The test substance was instilled into one eye of 3 male rabbits. The animals were observed for 7 days. Slight conjunctival effects (score 1-2) were observed up to 24 hours. These effects were fully reversible within 48 h. The mean score for conjunctival effects over 24, 48 and 72 hours were 0.33 for all 3 animals. No information is given if these effects were reddening or swelling of the conjunctivae as only a summary of the results is available. No effects on iris and cornea were noted 1, 24, 48, and 72 hours and 7 days after application. Based on the results of the study the test substance is not considered to be eye irritating.

Overall conclusion for skin and eye irritation

The reliable data available for the read-across analogue substances did not show any skin or eye irritation effects. Therefore, Fatty acids, coco, decyl esters is not considered to be a skin irritant or an eye irritant.

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 the 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 the source and target substances and overall quality assessment (refer to the endpoint discussion for further details).

Justification for classification or non-classification

According to Article 13 of Regulation (EC) No. 1907/2006 "General Requirements for Generation of Information on Intrinsic Properties of substances", information on intrinsic properties of substances may be generated by means other than tests e.g. from information from structurally related substances (grouping or read-across), provided that conditions set out in Annex XI are met. Annex XI, "General rules for adaptation of this standard testing regime set out in Annexes VII to X” states that “substances whose physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity may be considered as a group, or ‘category’ of substances. This avoids the need to test every substance for every endpoint". Since the analogue concept is applied to Fatty acids, coco, decyl esters (CAS 93455-79-9), data will be generated from data for reference source substance(s) to avoid unnecessary animal testing. Additionally, once the analogue read-across concept is applied, substances will be classified and labelled on this basis.

Therefore, based on the analogue read-across approach, the available data on 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.