Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (sensitising)
Additional information:

According to EU Guidelines, Reactive Black 5 was 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 dyes

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 250.


Migrated from Short description of key information:
Skin sensitiser

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., Rattraya N.J., Woodcocka D.R., Walsha S.T. and Hexta 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 250.


Migrated from Short description of key information:
Respiratory sensitiser

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 250.