1,3,5-Triazine-2,4,6-triamine, N2,N2'-1,6-hexanediylbis[N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethyl-4-piperidinyl)-

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Since the results of the skin sensitization testing battery did not allow for a conclusion (1 test positive, 1 test negative, 1 test equivocal), an in vivo test was performed.

In a GLP-compliant Buehler assay following OECD guideline 406, the possible allergenic activity of the test item was evaluated after topical administration in guinea pigs. After induction of 20 guinea-pigs by 3 topical applications with the test item applied diluted at 50% in liquid paraffin under occlusive dressing and a 13-day rest phase, the challenge phase, under occlusive dressing for 6 hours, consisted of a single topical application of the test item diluted at 50% in liquid paraffin and of a negative control (liquid paraffin). In the treated group a slight to intense erythema in 100% (20/20) of the animals, 24, 48 and 72 hours after the challenge phase, was recorded on the treated area. In the control group, a slight to moderate erythema in 60% (6/10), 40% (4/10) and 30% (3/10) of the animals, 24, 48 and 72 hours after the challenge phase, was recorded on the treated area. No cutaneous reaction was recorded in animals from the treated and control groups after the challenge phase, on the treated area with liquid paraffin.

As irritation was observed in the control group animals, only reactions in the test group animals that exceeded the most severe reactions seen in the control group animals were attributed to skin sensitization. So, a sensitization reaction was noted in 60%, 50% and 20% of the animals from the treated group, 24, 48 and 72 hours after the challenge phase, on the area challenged with the test item at 50%. The severity of the reactions were 2.5, 2.45 and 2.15 in the treated group versus 0.8, 0.5 and 0.4 in the control group 24, 48 and 72 hours after the challenge phase, respectively.

To confirm the results obtained with the test item, a second challenge phase (re-challenge) was performed with the test item diluted at 25% in liquid paraffin after a 6 day rest phase. A sensitization reaction was noted in 10%, 5% and 5% of the animals from the treated group, 24, 48 and 72 hours after the challenge phase, on the area challenged with the test item at 25%. The severity of the reactions were 1.65, 1.0 and 0.2 in the treated group versus 1.0, 0.7 and 0.2 in the control group 24, 48 and 72 hours after the challenge phase, respectively. In conclusion, the test item was considered as a skin sensitizer, taking into account the result of the 1st challenge.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no study available

Justification for classification or non-classification

Dangerous Substance Directive (67/548/EEC)

The available experimental test data is reliable and suitable for the purpose of classification under Directive 67/548/EEC. Based on the data, classification for sensitization is warranted under Directive 67/548/EEC.