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 irritation (OECD 404), rabbit: not irritating (RA from CAS 147256-33-5)
Eye irritation (OECD 405), rabbit: not irritating (RA from CAS 147256-33-5)

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 only limited data available on skin and eye irritation 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 and VIII, 8.1. and 8.2., 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 and eye irritation

CAS	Chemical name	Molecular weight [g/mol]	Skin irritation	Eye irritation
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	RA: CAS 147256-33-5
147256-33-5 (b)	Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylol-propane	624.97 - 1762.80	Experimental result: not irritating	Experimental result: not irritating

(a) The substance subject to registration is indicated in bold font.

(b) Reference (read-across) substances are indicated in normal font.

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 and eye irritation 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 irritation

CAS 147256-33-5

Two studies addressing the skin irritating properties of Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5) are available.

In the key skin irritation study performed according to OECD TG 404 and in compliance with GLP three male New Zealand White rabbits were exposed to 0.5 mL of the neat test material (CAS 147256-33-5) for 4 hours applied onto the clipped skin via semi-occlusive dressing (Harlan, 2012a). Skin reactions were evaluated 1, 24, 48 and 72 hours post-application. No symptoms of systemic toxicity were observed in any animal during the test period and no mortality occurred during the course of the study. Very slight erythema formation (grade 1) was noted in 1/3 animals 24 and 48 h post-application which was fully reversible within 72 h. No edema formation was observed at any animal during the course of the study. The mean value for erythema and edema were calculated to be 0.22 and 0, respectively.

In a supporting skin irritation study performed according to OECD TG 404 and in compliance with GLP three Albino rabbits of unknown gender were exposed to 0.5 mL of the neat test material (CAS 147256-33-5) for 4 hours applied onto the shaved skin via semi-occlusive dressing (Henkel, 1989). Skin reactions were evaluated 1, 24, 48 and 72 hours and 7 days post-application. No symptoms of systemic toxicity were observed in any animal during the test period and no mortality occurred during the course of the study. Very slight erythema formation (grade 1) was noted in 1/3 animals 24, 48 and 72 hours post-application but was fully reversible within 7 days. No edema formation was observed at any animal during the course of the study. The mean value for erythema and edema were calculated to be 1 and 0, respectively.

 

Based on the above study results and according to EU classification criteria, the test substance is considered to be not-irritating to skin.

Eye irritation

CAS 147256-33-5

Two studies addressing the eye irritating properties of Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5) are available.

In the key eye irritation study with Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5)performed according to OECD TG 405 and in compliance with GLP (Harlan, 2012b) 0.1 mL of the neat test material was instilled in the eye of three male New Zealand White rabbits. The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours post-application. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred during the course of the study. Neither iridial irritation nor corneal opacity and chemosis were observed in any animal during the course of the study. All animal showed conjunctivae irritation (grade 0.33) which was fully reversible within 48 hours.

In another supporting eye irritation study with Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane (CAS 147256-33-5) performed according to OECD TG 405 and in compliance with GLP (Henkel, 1989b) 0.1 mL of the neat test material was instilled in the eye of three Albino rabbits of unknown gender. The eyes were examined and the changes were graded according to the Draize scoring system 1, 24, 48 and 72 hours post-application. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred during the course of the study. Neither iridial irritation nor corneal opacity and chemosis were observed in any animal during the course of the study. One animal showed conjunctivae irritation (grade 0.33) which was fully reversible within 48 hours.

Based on the above study results and according to EU classification criteria, the test substance is considered to be not-irritating to eyes.

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 and eye irritation do not meet the classification criteria according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.