Sodium 3-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-4-hydroxynaphthalene-1-sulphonate

Carcinogenicity

Description of key information

Not carcinogen

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no 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

There are two studies available for carcinogenicity performed on similar substance.

1) Oral administration, rat

Male and female Charles River CD rats of the F0 generation received Curry Red (purity 88%) in concentration of 0 (control), 0.37, 1.39 or 5.19%. The groups consisted of 30 males and 30 females. The rats received Curry Red from 1 week before mating throughout the 3-week breeding period and during the gestation and lactation period. The F1 rats were exposed to the same diary dietary concentration as the F0 rats. Each groups consisted of 50 males and 50 females. The exposure continued until survival of either sex in any group reach approximately 20% at which point all rats at that sex were killed. Deaths, morbidity and gross signs of toxicity were recorded daily. Individual body weights, food consumption and clinical signs of gross observation were recorded every 4 week after 26 weeks. F1 male and female rats received Curry Red for 118 and 121 weeks, respectively. Food consumption among the high dose males and females was elevated, but not significantly so, when compared with controls. The authors conclude that lifetime exposure of rats to the tested substacne as a dietary admixture at concentrations up to 5.19% did not demonstrate carcinogenic effects.

2) Oral administration, mice Curry Red was fed to Charles River HaM/ICR (CD-1) (study A) and CD-1 outbred (study B) mice as a dietary admixture in two separate lifetime toxicity/carcinogenicity studies. Each study included an in utero exposure phase during which the colouring was fed at dietary concentrations of 0 (control), 0.37, 1.39 or 5.19% throughout the mating, gestation and lactation periods. The F0 mice consisted of 50 males and 50 females in study A and 70 males and 70 females in study B. After random selection the lifetime exposure phase was initiated using the same dietary concentrations with 50 male and 50 female per group in study A and 100 males and 100 females per group in study B. Exposure was for 104 weeks in study A and 109 weeks in study B. There were no compound related effects on survival. There were no consistent statistical significant compound-related effects on mean food consumption in either study A or study B. The appearance of lymphocytic lymphoma occurred in study A earlier among treated groups than among controls. Lymphomas were observed in 1 low-dose male, 1 mid-dose female and 2 males and females from the high-dose group between week 31 and week 37. Lymphomas were not observed among controls until week 85 and 70 for males and females, respectively. Increased incidence of lymphocytic lymphoma or acceleration of the appearance of the lymphoma were not observed in study B. The authors state that study B was conducted to determined whether Curry Red had an effect on the appearance of lymphocytic lymphoma (a different strain of mice was used). A critical analysis of the data failed to establish a relationship between the incidence of lymphoma and Curry Red. The authors state that no compound-related adverse effects were observed.

All the available studies does not show any compound related effect and the tested substance could be considered as not carcinogen.