1-isoctyloxycarbonyl ethylated 2,4,6 tris (2,4- hydroxyphenyl) -1,3,5 triazine derivatives

Endpoint summary

Description of key information

The irritating potential of the test substance to skin was evaluated in a GLP-conform study according OECD guideline 404. Three white New Zealand rabbits were exposed to the test item for 4h at concentrations of 0.5g. Dermal application of the substance caused slight and transient erythema. Application into eyes failed because of the high viscosity of the test article. With regard to the results from skin irritation assay and due to the physical properties of the test item, exposure to eyes is not expected.

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 study available

Additional information

Performance and Observation

The primary skin irritation potential of the test substance was investigated by topical semi-occlusive application of approximately 0.5 g to the intact left flank of each of three young adult New Zealand White rabbits (CIBA 2002a). The duration of treatment was four hours. The scoring of skin reactions was performed 1, 24, 48 and 72 hours, as well as 7, 10 and 14 days after removal of the dressing.

The application to the rabbit skin resulted in mild, early-onset and transient signs of irritation. Erythema was observed in all animals during the observation period but diminished to clear within 7 days of treatment.

The application area was washed after removal of the dressing but a residue of the test item strongly adhered to the test site and was evident on the skin of all animals throughout the 14 day observation period. A light yellow staining was also present at the test site of all animals throughout the observation period. No corrosive effects were noted on the treated skin of any animal at any measuring interval.

In a second study, irritation to eyes was tried to be evaluated. The test item is highly viscous and a resinous type semi-solid product which does not allow to be applied to the rabbit eye. No application methods described in the OECD or EEC guidelines can be followed. There is no solvent known without irritating properties which would allow bringing it in a more liquid form to apply it to the eyes.

 

Discussion

Dermal application of the test substance induced mild and transient irritation to skin. All symptoms resolved within post observation period and are, therefore, not considered as adverse effects.

With regard to the results from skin irritation assay and due to the physical properties of the test item, exposure to eyes is not expected. However, an eye-irritating potential can not be totally excluded.

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 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 not considered to be classified for irritation under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).