Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The potential for skin sensitization was tested in two independent assay.

One study was performed in 1980 using the Maurer Optimization procedure (Maurer Th., Thomann P., Weirich E.G., Hess R., The Optimization test in the guinea pig Agents & Actions 5 ( 2 ) , 174-179, 1975 and Predictive evaluation in animals of the contact allergenic potential of medically important substances Contact Dermatitis 4, 321-333, 1978, Contact Dermatitis 5, 1-10, 1979). The test was performed on groups of 10 male and 10 female guinea pigs of the Pirbright White strain. During the induction period the animals received one injection every second day (except weekends) to a total of 10 intracutaneous injections of a freshly prepared 0.1 % suspension in propylene glycole. One control group was treated with the vehicle alone. Fourteen days after the last sensitizing injection, a challenge injection of 0.1 ml of a freshly prepared 0.1 % suspension in propylene glycole was administered into the skin of the left flank.

Twenty-four hours after of the induction period injection the reactions each injection during the first week and 24 hours after the challenge were recorded. Erythema and edema were scored according to the Draize system. Both for the vehicle control and the test item, three of the 20 animals showed a skin reaction. Ten days later a subirritant dose of the test substance was applied for epicutaneous challange for 24h. No skin reactions were observed in any of the 20 animals.

For the second study, the local lymph node assay in its non-radioactive version was applied (Synthesia 2009a). This testing was conducted according to EU method B.42 with modifications as described in publications of Ulrich P, Streich J, Suter W, 2001; Ehling et al., 2005; Ehling et al.,2005A. In this GLP-compliant study the contact allergenic potential of C.I. Pigment Red 177 was evaluated after topical application to female BALB/c mice. Six mice per group were exposed by test and control substances on the dorsum of both ears once a day during three consecutive days. Draining lymph nodes were taken off at 24 hours after the last application. Concentrations: positive control DNCB (dinitrochlorobenzene): 0.5% (w/v) and Pigment Red 177: 10%, 1%, 0.1% (w/v) in DAE 433. Endpoints: ear weight, auricular (ear-draining) lymph node weights and cell counts = lymph node (LN) hyperplasia. The animals exposed to the test substance were no clinical observations attributable to the treatment with test substance in any dose level. There was no difference in body weight increment of all groups in comparison to the vehicle control. The positive contral substance DNCB elicited a reaction pattern with statistically significant increase in ear weight and LN hyperplasia, which was in congruence with his expected mode of action as a contact allergen. The comparison of values between treated groups and control group revealed that the test substance did not cause statistically significant increase in LN cell count or in LN weight. Also index of LN weight and LN cell count were not exceeded in any dose level. In conclusion, at the given experimental conditions the test substance Pigment Red 177 elicited a negative response in LLNA test.


Migrated from Short description of key information:
The substance was found to be non sensitizing upon testing in the local lymph node assay in mice according to OECD testing guideline 429 (Synthesia 2009a) and in the guinea pig maximization test according to OECD testing guideline 406 (Ciba-Geigy Ltd 1980)

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

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