Reaction products of 2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-hydroxyphenol with ((C10-16, rich in C12-13 alkyloxy)methyl)oxyrane

Endpoint summary

Description of key information

To evaluate the irritation potential of the test article, skin or eyes of New Zealand rabbits were treated with the test substance and reactions were observed and scored up to 72h (OECD guideline 404 and 405). Application onto skin provoked oedema and erythema. In contact with eyes, slight reactions in conjunctiva and cornea were observed. All reactions were reversible within observation period and are below the threshold of classification and labelling. The test substance is considered to be as non-irritating to skin or eyes.

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)

Additional information

Procedure and observations

The irritation potential of the test substance was evaluated in four studies.

In the first study, primary skin irritation properties of the test material were investigated by topical application of 0.5 g onto intact flank skin of each of three female rabbits (OECD guideline 404, Ciba 1991c). The scoring of skin reactions was performed 1, 24, 48 and 72 hours after removal of the dressing. Under the conditions of this experiment, the test substance induced slight, transient erythema and oedema when applied to healthy intact rabbit skin.

Another study was performed with one white rabbit only. 0.5g of the test article was applied for 4h onto shaved intact skin (Ciba 1990a). Skin reactions were observed and scored 1, 24, 48 and 72h after removal of the gauze patch. The substance provoked mild erythema and oedema after dermal application.

In the course of the third study, the eye irritation potential of the test article was investigated by instillation of 0.1 ml into one eye of each of three young rabbits (OECD guideline 405, Ciba 1991d). The treated eyes were not rinsed after application. Scoring of irritation effects was performed 1, 24, 48 and 72 hours after test article application. The substance induced transient redness and chemosis when instilled into the conjunctival sac of the rabbit eye. Effects on iris or cornea of the treated eyes were not observed.

In a former study, 0.1 g of the test article was instilled for 4h into the eye of one rabbit (Ciba 1990b). Scoring and evaluation of reactions was performed 1, 24, 48 and 72h after installation. The substances provoked slight reactions on cornea, conjunctiva and iris. Blepharadenitis at the upper lid was noticed from 24 hours until the end of the observation period on day 14. Whether this was an effect of the test article or was caused by scratching cannot be decided.

Discussion

Application of the test substance onto skin induced slight erythema and oedema. Administration of the test article into the conjunctival sac of the rabbit eye induced slight redness, chemosis and mild reactions on cornea. All reactions were reversible within recovery period. Therefore, the test substance is considered to be as non-irritating to skin or eyes.

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 not considered to be classified as irritating for skin or eyes under Directive 67/548/EEC, as amended for the 28th time in Directive 2001/59/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 not considered to be classified for irritation under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).