Registration Dossier
Registration Dossier
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EC number: 227-842-3 | CAS number: 6000-44-8
Endpoint summary
Administrative data
Description of key information
NOAEL (male, oral, glycine) ≥ 2000 mg/kg bw/d (28 days)
Key value for chemical safety assessment
Additional information
Oral repeated dose toxicity of glycine was investigated in a guideline study (Guidelines for toxicity studies of drugs) performed under GLP conditions (Taniguchi, 2006). 6 male Crj: CD(SD) rats were treated via gavage with the test substance dissolved in water at concentrations of 500, 1000, and 2000 mg/kg bw d for 28 days. Control animals received the vehicle. No unscheduled death, clinical signs, effects on body weight gain, food/water consumption and haematology were observed during the treatment time. Phospholipids were significantly increased in animals of the 2000 mg/kg bw/d dose group in comparison with controls.Urinalysis revealed an increase in total urine volume and chloride in animals of the 2000 mg/kg bw/d dose group in comparison with controls. Both effects were regarded as not treatment-related, since they occurred sporadically, without dose-relation and related effects on organ weights and histopathology. No effects were observed at gross- and histopathology and with regard on organ weights. In particular, no effects on testes, prostate, and seminal vesicles were observed. Therefore, a NOAEL ≥ 2000 mg/kg bw/d was determined for male rats.
Justification for classification or non-classification
The available data on repeated dose toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008 and Directive 67/548/EEC, and are therefore conclusive but not sufficient for classification.
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