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Toxicological information

Carcinogenicity

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Description of key information

No evidence for substance related neoplasms.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Study duration:
chronic
Species:
other: rats and mice
Quality of whole database:
The investigation is classified as invalid based on present assessment criteria. No control group was tested in parallel to evaluate the rate of spontaneous tumor development. No data is documented on age, sex and weight of the animals. No description of the type, significance and proliferation of the tumors is given. The two studies of C.I. Reactive Blue 19 in mice by subcutaneous and oral administration are of too short treatment and duration, respectively, for adequate evaluation.

Additional information

The only data available on C.I. Reactive Blue 19 are from a single Russian study (Pliss, 1967). The dye was administered orally or subcutaneously to mice for up to 15.5 months and to rats for up to 25 months.

Doses of 60 and 10 mg/animal/week were given subcutaneously, and doses of 30 and 5 mg/animal 6 days/week Reactive Blue 19 were administered orally in the diet to rats and mice, respectively. More than 50% of the test animals died during the course of the study (19.5 to 25 months in rats and 11 months in mice studies).The results of the study by subcutaneous administration in rats appear to be negative, although the number of animals surviving to the end of the experiment was not reported. Some of the surviving rats developed tumors after 28.5 months after oral administration.The study by oral administration in rats cannot be adequately evaluated because of the lack of information on the occurrence of tumors in controls. No control group was tested in parallel to evaluate the rate of spontaneous tumor development. No data is documented on age, sex and weight of the animals. No description of the type, significance and proliferation of the tumors is given. The number and nature of the tumors for the test in rats by oral administration indicate that these tumors may not be compound-related, but may have arisen spontaneously, although information on untreated controls would be necessary to confirm this. The two studies of C.I. Reactive Blue 19 in mice by subcutaneous and oral administration are of too short treatment and duration, respectively, for adequate evaluation (Pliss, 1967).

Justification for classification or non-classification

No valid studies on carcinogenicity is available for the substance. However there is a strong case for stating the substance is not carcinogenic, based on decades of manufacture and use of the substance and structural analogues. During this time, no specific carcinogenic effects or concerns have been noted for the substance. This is further reinforced by the lack of genotoxicity demonstrated by the substance. As such, no specific intention to further investigate this endpoint is proposed. 

 

No classification and labelling underthe Dangerous Substance Directive (67/548/EEC) and the CLP Regulation (EC No 1272/2008) is proposed.