Registration Dossier
Registration Dossier
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EC number: 227-842-3 | CAS number: 6000-44-8
Carcinogenicity
Administrative data
Description of key information
Groups of 50 male and 50 female F344 DuCrj rats (aged 6 weeks) were given drinking-water containing 0, 2.5 or 5% glycine (equivalent to approximately 0, 2500 or 5000mg/kg bw per day) for 108 weeks. A complete histopathological evaluation performed at necropsy revealed a high incidence of renal calcification in treated and control groups of females (control, 16 out of 41; 2.5%, 15 out of 46; 5%, 13 out of 31). A low incidence of kidney papillomas was reported in females treated with glycine (2.5%, 4 out of 46; 5%, 2 out of 31), but not in males. A renal cell carcinoma was reported in one male (1 out of of 40) treated with 5% glycine. Further detailed histopathology of the urinary system revealed hyperplasia of the transitional epithelium of the renal pelvis in 2 out of 46 of the females at the 2.5% level only. An increased incidence of necrosis of the renal papillae was reported in treated males (2.5%, 2 out of 45; 5%, 3 out of 40) and females (2.5%, 14 out of 46; 5%, 10 out of 31) compared with the controls (0 out of 40 in males; 0 out of 41 in females). A tumour of the transitional epithelium of the renal pelvis was seen in one male control rat (1 out of 40). Owing to the organ distribution and the histological characteristics of the neoplastic lesions observed in the treated animals, with the exception of those in the renal pelvis, the authors concluded that they were spontaneous and not related to administration of glycine. These spontaneous tumours are known to occur in this strain of rats (Kitahori et al., 1994). Lesions of the urinary tract generally occur as a result of the formation of urinary tract calculi induced by exposure at high doses, which causes subsequent chronic irritation and toxicity (Capen et al., 1999; Cohen, 1999).
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Study duration:
- chronic
- Species:
- rat
Justification for classification or non-classification
The available data on carcinogenicity of the read across chemical (glycine) do not meet the criteria for classification.
Additional information
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