Tetrasodium 4-amino-6-[[2,5-dimethoxy-4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-5-hydroxy-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

Testing for sensitizing properties of Reactive Blue 203 was performed in female guinea pigs according to the method of BUEHLER. Dermal induction was performed using 25 % Reactive Blue 203 in deionised water. The control group was exposed to deionised water only.

Determination of the primary non-irritant concentration:

No signs of irritation occurred after application of the different test concentrations.

Based on these results, challenge treatment was carried out with 25 % Reactive Blue 203 in deionised water.

Challenge treatment

At both of the designated examination times it was found that challenge treatment did not cause any effects on the treated skin in either the control or the treatment group. The skin on the treated areas was slightly discoloured blue from the test substance. Based on the results of this study Reactive Blue 203 showed no evidence for sensitizing properties.

Body weight gains and clinical signs:

There were no recognizable differences in body weight gains between the control and treated animals.

No clinical signs of intoxication were observed at any time during the study.

No signs of irritation occurred on the treated skin areas during the sensitization phase from days 1 to 19. The skin on the treated areas was slightly discoloured blue from the test substance. Despite this blue discolouration, it would have been possible to recognize any signs of skin irritation. The animals of the control group showed no signs of irritation.

Under the conditions of the present study, none of twenty animals of the treatment group showed a positive skin response after the challenge procedure. Based on the results of this study Rective Blue 203 showed no evidence for sensitizing properties.

In addition, the structural analogues Reactive Black 5 and SA01 were not sensitizing in the guinea pig maximization test.

However, literature data report on urticaria and eczema observed in workers with a high occupational exposure to

Reactive Black5

Consequently, it was agreed between members of the ETAD to classify Reactive Black 5 as skin sensitizer. This classification has also been applied to Reactive Blue 203.

Migrated from Short description of key information:
Not sensitising in animal studies, however clasified as skin sensitiser based on human data of highly exposed workers with Reactive Black 5

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (sensitising)

Additional information:

According to EU Guidelines, Reactive Black 5 was not sensitizing in an inhalative guinea pig sensitization test performed according to the European Discussion Group of Inhalation Toxicologists (EDIT) (referring to Botham P.A., Rattray N.J., Woodcock D.R., Walsh S.T. and Hext P.M. "The induction of respiratory allergy in guinea-pigs following intradermal injection of trimellitic anhydride: a comparison with the response to 2,4-dinitrochlorobenzene ", Toxicology Letters, Volume 47, Issue 1, April 1989, Pages 25-39). However, literature data report on symptoms of respiratory allergy observed in workers with a high occupational exposure to reactive dyes.

Consequently, it was agreed between members of the ETAD to classify Reactive Black 5 as respiratory sensitizer. This classification has also been applied to Reactive Blue 203.

Migrated from Short description of key information:
Not sensitising in animal studies, however clasified as respiratory sensitiser based on human data of highly exposed workers with Reactive Black 5

Justification for classification or non-classification

No adverse effects were seen in animal studies for skin or respiratory sensitisation. However, literature data report on respiratory allergy, urticaria and eczema observed in workers with a high occupational exposure to reactive dyes

Consequently, it was agreed between members of the ETAD to classify Reactive Black 5 as skin and respiratory sensitizer. This classification has also been applied to Reactive Blue 203.