Fatty acids, C14-18 and C16-18-unsatd., maleated

Endpoint summary

Description of key information

The potential of a structural analogue to cause skin and eye irritation was determined by application of the undiluted substance onto skin and into eyes of rabbits (OECD guideline 404 and 405, under GLP conditions). Effects on kin or eyes, respectively, were scored up to 72h and observed for 14d. The substance caused opacitiy, iritis as well as chemosis and redness in eyes which was not fully reversible within observation period. Application onto skin caused erythema and edema which were also not fully reversible. The material is therefore considered to be irritating to skin and eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Read across justification

The test item is an UVCB and composes mainly of modified fatty acids from sun flower oil (mSOFA) and, to a minor part, of modiefied fatty acids from tall oil (mTOFA). The fatty acids obtained from tall oil and sun flower oil are of comparable chain lenghth and are modified by the same reaction step. In contrast to mTOFA, mSOFA is also produced solely by the very same reaction as the UVCB and consists therefore of the same reaction products and similar impurities. Furthermore, mSOFA was intentively examined for its toxicological properties. Thus, it is acceptable to derive data on skin and eye irritation from the read across substance mSOFA.

Procedures and observations

The potential of the test item to cause damage to the conjunctiva, iris or cornea was assessed by a single ocular application of 0.1 mL of the test item to one eye of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals). 24 hours after application the eye was rinsed with tap water. The ocular reactions were assessed approximately 1, 24, 48 and 72 hours after application and in weekly intervals until day 14. The material caused slight to moderate corneal opacity, moderate iritis, slight to obvious conjunctival redness, slight to severe chemosis, slight to severe discharge and additional findings like small retraction in the eyelid, contracted pupil and injected scleral vessels in a circumscribed or circular area were noted in the animals during observation period. In two animals the ocular reactions were reversible within 14 days, in one animal within 21 days after application.

The potential of the test item to cause acute dermal irritation or corrosion was assessed by a single topical application of an amount of 0.5ml of the material for 4 hours to the intact skin of three White New Zealand rabbits (stepwise procedure starting with one animal and supplementing two additional animals), using a patch of 2.5 cm x 2.5 cm, covered with semi-occlusive dressing. After removal of the patch the application area was washed off. The cutaneous reactions were assessed immediately after removal of the patch, approximately 1, 24, 48 and 72 hours after removal of the patch and in weekly intervals until day 14. The substance caused very slight to moderate erythema, very slight to severe edema, scaling and a yellowish discoloration of the application site. The cutaneous reactions were not reversible in all animals within 14 days after removal of the patch.

Discussion

Considering the described ocular reactions as well as the average score for irritation, the test item shows a skin and an eye irritating potential under the test conditions chosen.

Justification for selection of skin irritation / corrosion endpoint:
key study, suitable read across substance

Justification for selection of eye irritation endpoint:
key study, suitable read across substance

Effects on skin irritation/corrosion: irritating

Effects on eye irritation: irritating

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available studies are considered reliable and suitable for classification purposes under 67/548/EEC. As a result the substance is considered to be classified as irritating for skin and eyes under Directive 67/548/EEC, as amended for the 30th time in Directive 2008/58/EC.

                                             

Classification, Labelling, and Packaging Regulation (EC) No. 1272/2008

The available experimental test data are reliable and suitable for classification purposes under Regulation 1272/2008. As a result the substance is considered to be classified for irritation under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).