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Carcinogenicity

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Description of key information

7.7 Carcinogenicity: KS - 2yr rat. Wahle, 1999. KL.1. No increase in tumour incidence; KS - 18m mouse. Wahle, 1999. KL.1. No increase in tumour incidence

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Dose descriptor:
NOAEL
2.3 mg/kg bw/day

Justification for classification or non-classification

There was no evidence of carcinogenicity in studies with amicarbazone; therefore amicarbazone has not been classified as carcinogenic.

Additional information

Of the two available carcinogenicity studies available amicarbazone did not adversely affect survival, there were no clinical signs of toxicity or increases in the incidence of tumour formation. In the rat study a decrease in body weight gain was observed in both sexes at doses of 1000 and 1250 ppm from 3 months onwards. Furthermore, histological effects included liver changes (hepatocellular cytoplasmic vaculoation) at 1250 ppm and increased T3, T4 and cholesterol at both 1000 and 1250 ppm.

 

In the mouse study decreased body weight and body weight gains in both genders, sub-clinical anaemia and haemosiderin pigmentation of the spleens in males was observed.

 

Both the rat and mouse carcinogenicity studies conducted confirm that amicarbazone is not carcinogenic. At the doses tested there was no treatment related increase in tumour incidence when compared to the respective controls. Dosing was considered adequate based on body weight and body weight changes in both sexes.

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