Registration Dossier
Registration Dossier
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EC number: 695-988-9 | CAS number: 100556-82-9
Carcinogenicity
Administrative data
Description of key information
The investigation is classified as invalid based on present assessment criteria. Consequently, the studies cannot be used for the assessment of the carcinogenicity of the test substance. As far as these studies can be evaluated, no test substance related carcinogenic effects have been observed.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
- Species:
- other: rat and mice
Carcinogenicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Carcinogenicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
The studies reported by Pliss are not reliable due to insufficient data availability and inappropriate study design.
Inconclusive: No classification necessary
Additional information
In the studies reported by Pliss, doses of 60 and 10 mg/animal/week were given subcutaneously, and doses of 30 and 5 mg/animal 6 days/week Reactive Black 5 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 (23 to 24 months in rats and 12 to 16.5 months in mice studies). Some of the surviving rats developed tumors after 16 and 19 months. 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. Especially no clear-cut differentiation is made between the development of chronic lipoid nephropathia in the kidney glomerula (fat type deposits) or pigment type deposits in the tubules of the kidney (probably resulting from the high dyestuff doses used) and the alleged tumors. The investigation is classified as invalid based on present assessment criteria. Consequently, the studies cannot be used for the assessment of the carcinogenicity of Reactive Black 5.
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