Registration Dossier

Administrative data

Description of key information

Skin sensitisation: - in vivo skin sensitisation, guinea pig, Bühler, OECD 406: negative for skin sensitisation (slight delayed irritations in test and control group) (BASF SE, 2013, 32H0674/12X410) for read across substance Amines, triC8-10-alkyl.

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Additional information:

There is no data available for tridodecylamine. A suitable read across candidate for which data is available is Amines, tri-C8 -10 -alkyl (CAS # 68814 -95 -9):

Guideline conform studies:

The possible allergenic activity of the test item Amines, tri-C8- 10-alkyl after topical administration in guinea pigs was investigated according to OECD 406 (Bühler) (BASF SE, 2013, 32H0674/12X410) . After induction of 20 guinea pigs by 3 topical applications with the test item Amines, tri-C8-10-alkyl applied as supplied (100%) for the inductions No.1 & No.2 and diluted at 75% in liquid paraffin for the induction No.3 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). The experimental protocol was established from the O.E.C.D. guideline n°406 dated July 17th, 1992, and the method B.6 of the Council regulation No. 440/2008. In the treatment group (treatment dose of 50%), it was recorded a slight to moderate erythema in 100% (20/20) of the animals from the treated group, 24, 48 and 72 hours after the challenge phase, on the treated area. A slight to moderate oedema was noted in 65% (13/20), in 55% (11/20) and in 50% (10/20) of the animals from the treated group, 24, 48 and 72 hours respectively after the challenge phase, on the treated area. In the control group (associated with the treatment dose of 50%), it was recorded a slight to moderate erythema in 100% (10/10), of the animals from the treated group, 24, 48 and 72 hours after the challenge phase, on the treated area. A slight oedema was noted in 70% (7/10), in 60% (6/10) and in 60% (6/10) of the animals from the treated group, 24, 48 and 72 hours respectively after the challenge phase, on the treated area. In the treatment group (liquid paraffin), no cutaneous reaction attributable to allergy was recorded in animals from the treated group after the challenge phase, on the control area. In the control group, no cutaneous reaction attributable to allergy was recorded in animals from the control group after the challenge phase, on the control area. In view to confirm or infirm these results, a new challenge phase was performed with the test item diluted at 10% in liquid paraffin and with liquid paraffin as control (vehicle), after a rest phase of 6 days. In the treatment group (treatment dose of 10%), it was recorded a slight to moderate erythema in 20% (4/20) and 30% (6/20) of the animals from the treated group, 48 and 72 hours after the challenge phase, on the treated area respectively. In the control group (associated with the treatment dose of 10%), it was recorded a slight to moderate erythema in 30% (3/10), of the animals from the treated group, 48 and 72 hours after the challenge phase, on the treated area. 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, no sensitization reaction was noted in animals from the treated group, 24, 48 and 72 hours after the challenge phase, on the area challenged with the test item at 10%. No cutaneous reaction was recorded in animals from the treated and control groups after the challenge phase, on the treated area with liquid paraffin (vehicle). In conclusion, in view of these results, under these experimental conditions, the test item Amines, tri- C8-10-alkyl must not be classified as a skin sensitiser, in accordance with the criteria for classification, packaging and labelling of dangerous substances and preparations of the E.E.C. Directives 67/548, 2001/59 and 99/45.

Justification for classification or non-classification

Negative results from an animal test with a read across substance are available. The substance is therefore not considered to be sensitizing and is therefore not classified for skin sensitization according to GHS (Regulation (EU) 1272/2008) and DSD-DPD (67/548/EEC).

Labelling for sensitisation:

GHS: no label

DSD: no label