Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters

Endpoint summary

Description of key information

Skin irritation/corrosion: not irritating (OECD 404, GLP)
Eye irritation: irritating (OECD 405, GLP)

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:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

The skin irritation properties of Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO) were tested in a study according to OECD guideline 404 under GLP conditions (Steiling, 1991a). In the study, 3 male rabbits (Kleinrussen) were exposed to 0.4 g of the unchanged test substance, applied onto the shaved skin for 4 h using a semiocclusive dressing. The treated skin was observed and evaluated at 24, 48 and 72 h post-application. No skin reactions were observed in any animal during the study period resulting in mean erythema and edema scores of 0 out of all 3 animals over 24, 48 and 72 h. No further local or systemic effects were apparent. Thus, under the experimental conditions described, no evidence of skin irritation properties were seen after treatment with Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO).

The eye irritation properties of Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO) were tested in a study according to OECD guideline 405 under GLP conditions (Steiling, 1991b). In a group of 3 male rabbits (Kleinrusse), 0.1 mL of the undiluted test substance was applied into one eye and the eye was rinsed with warm water 24 h later. The eyes were observed and reactions were evaluated 1, 24, 48 and 72 h and 8 days after application.

No effects on cornea were observed after 1 h in any animal. After 24 h, slight corneal opacity was noted in 2/3 animals being fully reversible in 1 animal after 48 h and on Day 8 in the second animal resulting in a mean cornea score over 24, 48 and 72 h out of all 3 animals of 0.44.

After 24, 48 and 72 h, 2/3 animals showed mild iritis which was fully reversible at 8 days post-application with a mean score over 24, 48 and 72 h out of all 3 animals of 0.67.

After 1 h, mild conjunctival redness was observed in all animals. After 24 h, 2/3 animals showed strong effects persisting up to 72 h and being fully reversible at 8 days post-application resulting in individual mean scores over 24, 48 and 72 h of 3.0in animals #1 and 2, respectively. The third animal showed mild effects after 24 h only.

Mild chemosis was observed in all animals which was fully reversible at the maximum after 8 days with a mean score over 24, 48 and 72 h out of all 3 animals of 0.67. Mild exsudation was observed in all animals 1 h after application. Later on, only one animal presented strong effects which were reduced to mild effects 72 h after application, being fully reversible after 8 days. No further local or systemic effects were reported.

Under the experimental conditions described, it was concluded, that evidence of eye irritation properties were seen after treatment with Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO). Thus, the substance does meet the criteria for classification according to Regulation (EC) 1272/2008 and Directive 67/548/EEC, to have the potential to induce reversible eye irritation and is classified in Category 2.

Conclusion for irritation/corrosion

In conclusion, no evidence of skin irritation properties were seen after treatment with Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO).

Under the experimental conditions described, it was concluded, that evidence of eye irritation properties were seen after treatment with Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO).

A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.

Justification for selection of skin irritation / corrosion endpoint:
There is only one study available.

Justification for selection of eye irritation endpoint:
There is only one study available

Effects on eye irritation: irritating

Justification for classification or non-classification

The available data on skin irritation of Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO) (CAS 91031-45-7) do not meet the criteria for classification according to Regulation (EC) 1272/2008 or Directive 67/548/EEC, and the data are therefore conclusive but not sufficient for classification.

The available data on eye irritation of Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters (3EO) (CAS 91031-45-7) do meet the classification criteria for Eye irritation Category 2 (H-319) according to Regulation (EC) 1272/2008 and for R36 (Irritating to eyes) according to Directive 67/548/EEC.