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

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Justification for read-across

There are no data on the skin sensitisation potential of Fatty acids, coco, decyl esters (CAS 93455-79-9). The assessment was therefore based on studies conducted with analogue (source) 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 sensitisation

CAS 3687-46-5

The skin sensitising potential of decyl oleate (CAS 3687-46-5) was evaluated in a local lymph node assay (LLNA) performed according to OECD Guideline 429 (Beerens-Heijnen, 2010). 25 µl of a 25, 50 and 100% suspension of test substance in acetone/olive oil (4:1 v/v) was applied to the dorsal surface of both ears of 5 CBA mice/dose for 3 consecutive days. On Day 6, each animal was injected via the tail vein with 0.25 mL sterile phosphate buffered saline containing 20 µCi of 3H-methyl thymidine. After approximately 5 hours, the mice were sacrificed and the draining lymph nodes of the ears were excised. The nodes were pooled for each animal in PBS and the DNA precipitated with 5% TCA at 4 °C overnight. The 3H-methyl thymidine incorporation was determined by beta-scintillation counting. Slight edema (score 1 of 4) was noted on the ears of 5/5 mice treated with the undiluted substance. This is not considered to have had a significant effect on the activity of the lymph nodes. All the nodes of the animals in the control and treatment groups were normal in size, and no macroscopic abnormalities were noted in the surrounding area. The positive control group (hexyl cinnamic aldehyde) was valid. The mean DPM/animal values for the control, 25, 50 and 100% groups were 488, 571, 951 and 1013, respectively. The SI values calculated for the 25, 50 and 100% groups were 1.2, 2.0 and 2.1, respectively. The SI was lower than 3 up to and including 100%, therefore the test substance is considered to be not skin sensitising. 

CAS 135800-37-2

A Guinea pig maximisation test was performed with Fatty acids, C8-16, 2-ethylhexyl esters (CAS 135800-37-2) according to OECD Guideline 406 (Steiling, 1991). 20 test and 10 control animals (Dunkin-Hartley guinea pigs, of which 1 test animal died after the first induction) were induced intradermally with 0.5% test substance diluted in peanut oil on both sides of the spine with and without Freud's complete adjuvant. 7 days later a 40% test substance dilution was used for the epidermal induction for 48 hours. Another 14 days later the animals were challenged by epidermal induction of the sheared flank skin with test substance diluted to 20% with paraffin oil. 24 and 48 hours after termination of challenge exposure skin readings revealed no indications for a skin sensitising potential of the test substance.

 

Conclusion

A read-across approach was applied to assess the skin sensitising potential of the target substance Fatty acids, coco, decyl esters (CAS 93455-79-9). A LLNA study performed with the source substance decyl oleate (CAS 3687-46-5) was negative, and for the source substance Fatty acids, C8-16, 2-ethylhexyl esters (CAS 135800-37-2), the result of a GMPT study was negative. Taking into account the available information, the Fatty acids, coco, decyl esters is considered to be not skin sensitising.

Migrated from Short description of key information:
Skin sensitisation (LLNA; GPMT): not sensitising

Justification for selection of skin sensitisation 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).

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information:

Justification for selection of respiratory sensitisation endpoint:
Study not required according to Annex VII-X of Regulation (EC) No 1907/2006.

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 sensitisation 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.