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Carcinogenicity

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Description of key information

According to the NTP study performed 1994, the concentration of 2500 ppm represents a NOAEL for carcinogenicity (corresponding to Ba doses of 60 and 75 mg/kg bw/d to male and female rats, respectively, and 160 and 200 mg/kg bw/d to male and female mice, respectively). Based on this value the NOAEL for BaCl2 is calculated at 91 mg/kg bw/day.

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
NOAEL
91 mg/kg bw/day
Study duration:
subchronic
Species:
rat

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In a 2-year carcinogenicity study (NTP, 1994) groups of 60 male and 60 female F334/N rats received barium chloride dihydrate in drinking water at concentrations of 0, 500, 1250, and 2500 ppm (corresponding to the average daily dose of 0, 15, 30, and 60 mg Ba/kg bw to males and 0, 15, 45, and 75 mg Ba/kg bw to females). In the same study groups of 60 male and 60 female B6C3F1 mice received BaCl2·2H2O in drinking water at concentrations of 0, 500, 1250, and 2500 ppm (corresponding to the average daily dose of 0, 30, 75, and 160 mg Ba/kg bw to males and 0, 40, 90, and 200 mg Ba/kg bw to females).

In rats, there was no treatment-related effect on survival. At the end of 2 years, there were no increased incidences of neoplasms or non-neoplastic lesions in rats that could be related to the test substance. However, there was dose-related decreased incidence of adrenal medulla pheochromocytoma and mononuclear cell leukemia in male rats. In mice, survival and final mean body weights of male and female mice receiving 2500 ppm were significantly lower than those of controls. No increased incidence of neoplasms was observed in exposed mice. The incidence of nephropathy and lymphoid depletion were significantly increased in male and female groups receiving 2500 ppm. In addition, the relative and absolute spleen weights were lower in these groups than in controls.

In conclusion, there was no evidence of carcinogenic activity (showing no chemical related increase of malignant or benign neoplasms) of barium chloride in both sexes of rats and mice that received 500, 1250, and 2500 ppm. Thus, the concentration of 2500 ppm represents a NOAEL (corresponding to barium doses of 60 and 75 mg/kg bw/d to male and female rats, respectively, and 160 and 200 mg/kg bw/d to male and female mice).


Justification for selection of carcinogenicity via oral route endpoint:
A 2-year carcinogenicity study via the oral route (drinking water) is available for barium dichloride.

Justification for classification or non-classification

There was no evidence of carcinogenic activity (showing no chemical related increase of malignant or benign neoplasms) of barium chloride in both sexes of rats and mice that received 500, 1250, and 2500 ppm. Thus, the concentration of 2500 ppm represents a NOAEL (corresponding to barium doses of 60 and 75 mg/kg bw/d to male and female rats, respectively, and 160 and 200 mg/kg bw/d to male and female mice, respectively). No classification of the substance as CMR substance is required.