Registration Dossier

Diss Factsheets

Administrative data

Description of key information

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 tetradecyl stearate (CAS 17661-50-6). 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.

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 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. 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 93803-87-3

The skin sensitising potential of 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was evaluated in a Guinea Pig Maximisation Test (GMPT) performed according to a protocol similar to OECD 406 (Busschers, 1998). The first induction (Day 1) was performed on 10 animals by intradermal injection of the undiluted test substance. On Day 7, the animals were treated with 10% sodium lauryl sulphate (SDS) in vaseline, to induce skin irritation. During the second induction on Day 8, the undiluted test substance was applied topically and held in place with a semi-occlusive dressing for 48 hours. On Day 21, all the animals were challenged with the undiluted test substance via topical application under semi-occlusive conditions for 24 hours. 5 guinea pigs in the control group were treated according to the same protocol with the vehicle (corn oil). 48 hours after the intradermal induction, slight to severe erythema was noted at most of the injection sites in the treated and control animals. 4/5 control animals also exhibited necrosis at the FCA/test substance injection site. These effects were caused primarily by the injection and not by a reaction to the test substance. Following the topical induction, severe erythema and scabs were observed at the test site in 3/10 treated animals. No sensitisation was observed in the treated animals during the reading time points 48 and 72 hours after the challenge. The test substance did not cause skin sensitisation under the conditions of the study.

Conclusion

A read-across approach was applied to assess the skin sensitising potential of the target substance tetradecyl stearate (CAS 17661-50-6). A LLNA study performed with the source substance decyl oleate (CAS 3687-46-5) was negative, and for the source substance of 2-octyldodecyl isooctadecanoate (CAS 93803-87-3), the result of a GMPT study was negative. Taking into account the available information, the tetradecyl stearate 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 tetradecyl stearate (CAS 17661-50-6) 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.