Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynetrimethanol

Endpoint summary

Description of key information

Skin sensitisation (OECD 429), mouse: not sensitising (RA from CAS 147256-33-5)

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

Justification for grouping of substances and read-across

There are only limited data available on skin sensitisation of Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol (CAS 162353-70-0). In order to fulfil the standard information requirements set out in Annex VII, 8.3., 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 sensitization

CAS	Chemical name	Molecular weight [g/mol]	Skin sensitisation
162353-70-0 (a)	Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol	610.99 - 1209.97	RA: CAS 147256-33-5
147256-33-5 (b)	Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane	624.97 - 1762.80	Experimental result: not sensitising

(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, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol (CAS 162353-70-0). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

Discussion

No reliable data on the skin sensitising properties are available with Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol (CAS 162353-70-0). Therefore, read across from the structurally analogue substance Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5) was applied.

Skin sensitization

CAS 147256-33-5

The skin sensitizing properties of Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5) were tested in a study according to OECD TG 429 and in compliance with GLP (Harlan, 2012c) using the local lymph node assay (LLNA). In this study groups of five female CBA/J mice were treated with the test item at concentrations of 25, 50 and 100% (v/v) in acetone/olive oil (4:1 v/v). Topical application of 25 µL of the appropriate test substance concentrations was performed daily at the dorsal surface of each ear for three consecutive days. Five days following the first topical application of the test item or vehicle all mice were injected via the tail vain with 250 µL PBS containing³H-methylthymidine (20 µCi per mouse). Five hours after injection single cell suspension of pooled lymph nodes was prepared for each animal for each dose group, followed by determination of³HTdR incorporation. Positive and negative controls were included in the study and gave the expected results. The calculated stimulation indices (SI) of the test substance are 1.68, 1.54 and 1.82 at concentrations of 25, 50 and 100% (v/v), respectively and therefore < 3. Due to this fact an EC3 value could not be determined. Thus, under the conditions of the test, the test substance revealed no skin sensitizing properties.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

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, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol (CAS 162353-70-0), 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, and are therefore conclusive but not sufficient for classification.