Registration Dossier
Registration Dossier
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EC number: 205-642-7 | CAS number: 144-83-2
Carcinogenicity
Administrative data
Description of key information
Salicylazosulfapyridine (SASP) can increase the incidence of tumor. But available data is insufficient to conclude the carcinogen potential of sulfapyridine.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
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
Based on the available data, Salicylazosulfapyridine (SASP)can cause thecancer incidence. However, it is inclusive to make the classification for sulfapyridine.
Additional information
Only one study performed by MICHAEL J. IATROPOULOS, et al. 1996, was available to determine the Carcinogenicity ofSASPwithF344/N ratsandB6C3F1 hybrid mice.
In AL-fed rats, urinary bladder papillomas were increased from 0 to 12 % in the high dose (337.5 mg/kg) SASP groups with concomitant reduction (from 26 % to 6 %) of mononuclear cell leukemia (MCL). In the WM (high dose SASP) groups, the neoplastic changes were the same, i.e. the incidence increase (in papillomas) was 12 % and the incidence in MCL was 6 %. In the DR (high dose SASP) groups, no papillomas were present, and the incidence of MCL was 4 % compared to 22 % in the controls.Moreover,SASP caused intraluminal bladder changes in the rats (especially males) consisting of chronic urothelial stimulation, concretions, hyperplasia which resulted in neoplasia.
In the case of mice, SASPcan increase mouse liver tumors under ad libitum (AL) feeding conditions, while under a feed restriction (FR) regimen, these tumors were not increased.
Based on the results of the existing study,an increased incidence of liver tumor in mice andurinary bladder papillomasin rats in both sexes, conducted in a well-conducted study, provide the sufficient evidence ofa causal relationshipbetween the substance and the increased incidence oftumor. Therefore, SASP can cause the cancer incidence.
Carcinogenicity: via oral route (target organ): digestive: liver; urogenital: urinary bladder
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