2-ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate

Endpoint summary

Description of key information

Skin irritation: not irritating,  (OECD 404, analogue approach)
Eye irritation: not irritating, (OECD 405, analogue approach)

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 no data available for the irritation/corrosion of 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1). In order to fulfil the standard information requirements set out in Annex VIII, 8.1 and VIII, 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 put 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, the substance listed below are selected as reference substances for hazard assessment.

Overview irritation/corrosion

CAS	Skin irritation	Eye irritation
25111-05-1 Target substance	RA: CAS 403507-18-6 RA: CAS 91050-90-7	RA: CAS 403507-18-6 RA: CAS 91050-90-7
403507-18-6	Not irritating	Not irritating
91050-90-7	Not irritating	Not irritating

The above mentioned substances are considered to be similar on the basis of structural similarity resulting in similar properties and/or activities. The available endpoint information is used to predict the same endpoints for 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate (CAS 25111-05-1). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).

Skin irritation

CAS 403507-18-6

A primary dermal irritation study was performed with Fatty acids, C16-18 and C18-unsatd., branched and linear ester with trimethylolpropane (CAS 403507-18-6) comparable to OECD Guideline 404 and GLP (Sanders, 2002). The clipped skin of three male New Zealand White rabbits was exposed to 0.5 mL unchanged test material for 4 hours under semiocclusive conditions. The rabbits were observed for 3 days following exposure. Skin reactions were assessed 1, 24, 48 and 72 hours after removal of the test substance. Very slight to well-defined erythema was noted in all animals one hour after patch removal and at the 24 h observation time point. Very slight erythema was seen for 2/3 animals at the 48 and 72 h observations. The mean erythema score over 24, 48 and 72 hours were 1.33 for animal #1 and #3 and 0.33 for animal #2. The mean edema scores were 0.33, 0, and 1.33 for animals#1, #2 and #3 respectively. All effects were at the latest reversible within 7 days. Thus, the test material is not considered irritating to the skin in this study.

CAS 91050-90-7

A primary dermal irritation study performed with Fatty acids, C16-18, triesters with trimethylolpropane (CAS 91050-90-7) comparable to OECD Guideline 404 and GLP (Steiling, 1989). The clipped skin of three male Kleinrussen Chbb:HM rabbits was exposed to 0.5 g unchanged test material for 4 hours under semiocclusive conditions. The rabbits were observed for 3 days following exposure. Skin reactions were assessed 1, 24, 48 and 72 hours after removal of the test substance. All 3 animals displayed very slight erythema at the 24 h reading time point. In one animal, erythema remained up to 48 h. The finding was fully reversible for all 3 animals within 48 to 72 h. No edema was observed in any animal. The mean erythema scores over 24, 48 and 72 hours were 0.7 for animal #1 and 0.3 for animals #2 and #3. Thus, the test material is not considered irritating to the skin in this study.

 

Eye Irritation

CAS 403507-18-6

Fatty acids, C16-18 and C18-unsatd., branched and linear ester with trimethylolpropane (CAS 403507-18-6) was tested for its acute eye irritation potential in a study performed comparable to OECD Guideline 405 (Sanders, 2002). The undiluted test material (0.1 mL) was applied into the conjunctival sac of two male and one female New Zealand White rabbits. The animals were observed for 72 hours and reactions were assessed 1, 24, 48, and 72 hours after instillation according to the Draize scoring system. No corneal or iridal effects occurred during the study. Moderate conjuctival irritation was observed in all treated eyes one hour after application. Minimal conjuctival irritation was noted in two treated eyes (2/3 animals) at the 24 h observation time point. The mean conjunctivae scores over 24, 48 and 72 hours were 0.33 and 0 for animal #1 and #2 and 0.33 for animal ##3. Thus, the test material is not considered irritating to the eyes in this study.

CAS 91050 -90 -7

Fatty acids, C16-18, triesters with trimethylolpropane (CAS 91050-90-7) was tested for its acute eye irritation potential in a study performed comparable to OECD Guideline 405 under GLP conditions (Steiling, 1989). The undiluted test material (0.1 mL) was applied into the conjunctival sac of three male Kleinrussen, Chbb rabbits each. The animals were observed for 72 hours and reactions were assessed 1, 24, 48, and 72 hours after instillation according to the Draize scoring system. No effects were observed except redness of the conjuctivae of grade 1 in all 3 animals at reading time point 1 h only. In 2 cases this was accompanied by exudation. These effects disappeared within 24 h. Thus, the test material is not considered irritating to the eyes in this study.

Conclusions

In conclusion, the two skin irritation studies conducted with source substances Fatty acids, C16-18, triesters with trimethylolpropane (CAS 91050-90-7) and Fatty acids, C16-18 and C18-unsatd., branched and linear ester with trimethylolpropane (CAS 403507-18-6) indicate no skin irritating properties. Therefore, 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate is considered not to be skin irritating.

The two eye irritation studies conducted with source substances Fatty acids, C16-18, triesters with trimethylolpropane (CAS 91050-90-7) and Fatty acids, C16-18 and C18-unsatd., branched and linear ester with trimethylolpropane (CAS 403507-18-6) indicated no eye irritating properties. Therefore 2-Ethyl-2-(hydroxymethyl)-1,3-propanediyl oleate is not considered to be eye irritating.

 

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

Justification for classification or non-classification

The available data on skin/eye irritation potential of structural related substances 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.