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

A single dose of 2000 mg/kg bw of the test substance was administrated oral or dermal to groups of male and female rats (5/sex, OECD guideline 401 and 402, GLP conform). Application of the test substance did not induce any signs of toxicity. None of the animals died, viability and bodyweight gain were unaffected by the test article. Gross necropsy did not reveal any treatment related abnormalities. LD50 after single oral or dermal administration is > 2000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Acute toxicity: via dermal route

Endpoint conclusion

Dose descriptor:

LD50

Value:

2 000 mg/kg bw

Additional information

Procedure and observations

 To evaluate the acute oral toxicity, a single dose (2000 mg/kg bw) of the test article was administrated to a group of 5 male and 5 female rats by oral gavage (Ciba 1991a). Following dosing, the animals were observed for 14d. Examination of clinical signs and viability were performed daily, weighing once a week.

There were no deaths as a result of treatment with the test article. Piloerection, hunched posture, exophthalmos, and dyspnea were seen. Clinical signs of toxicity or changes in body weight gain were not observed during the observation period. Gross necropsy was without any findings.

 Dermal toxicity of the test substance was evaluated on a group of five male and 5 female rats which were treated with the test article at 2000 mg/kg by dermal application (Ciba 1991b). The substance was administered unchanged (no vehicle). Animals were examined daily for mortality, clinical signs and viability. Body weights were recorded immediately before administration and on days 7 and 14. All animals were necropsied and examined macroscopically.

No deaths occurred during the study period. Neither clinical signs of systemic toxicity nor local effects of the test article on the skin at the application site were observed during the observation period. Macroscopic organ findings were not observed at necropsy.

 Discussion

Application of the test substance via oral or dermal route did not induce any sings of toxicity. None of the animals died, viability and bodyweight gain were unaffected by the test article.

LD50 after single oral or dermal administration is 2000 mg/kg bw.

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 for acute toxicity 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 acute toxicity under Regulation (EC) No. 1272/2008, as amended for the second time in Directive (EC 286/2011).