Registration Dossier
Registration Dossier
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EC number: 200-486-6 | CAS number: 60-80-0
Endpoint summary
Administrative data
Description of key information
A sub-chronic oral toxicity study in rats revealed a repeated dose NOAEL value of 100 mg/kg bw/day and a subchronic toxicity study in dogs revealed a NOAEL of 63 mg/kg bw/day.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 63 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- dog
Additional information
Non-human data:
Data on repeated dose toxicity of phenazone were available from two studies.
In a repeated dose toxicity study phenazone was administered by gavage at doses of 0, 100, 355 and 1250 mg/kg bw/day for 6 month in 20 male and 20 female rats per doses and group (Fuchs et al., 1984). At the highest concentration the body weight was decreased and the food consumption increased in all doses. In concentrations from 355 to 1250 mg/kg bw/day animals showed increased red discoloured salivation. Serum bilirubin and calcium increased, chloride decreased (from concentration 355 mg/kg bw/day), potassium and GPT increased in the highest concentration. Urine was dark coloured with a dose dependent increase of calcium-oxalate crystals. Furthermore, dose-dependent decreased red blood cell counts and increased reticulocytes, Heinz bodies and thyroid- (male), liver-, spleen- and kidney weight were reported. Histological signs were liver and spleen siderosis and slight kidney damages in some animals.
In two other repeated dose toxicity study phenazone was administered oral in gelatine capsules at doses of 0, 32, 63, 125 and 250 mg/kg bw/day for 6 month in 4 male and 4 female dogs per doses and group (Brunk et al., 1982 and Brunk et al., 1983). In these studies food consumption and body weight gain decreased (at 250 mg/kg bw/day). At 125 and 250 mg/kg bw/day a dose-dependent anaemia with increased Heinz bodies was reported and at 250 mg/kg bw/day a disturbance of erythropoiesis (bone marrow). Histological signs were dose dose-dependent toxicologically damage in erythrocytes, changes in the liver (siderosis, all doses) and in the kidney (siderosis after 125 and 250 mg/kg bw/day).
Human data:
No data available.
Justification for classification or non-classification
Based on the results of repeated oral toxicity testing, phenazone was not classified according to Directive 67/548/EEC (DSD) and
Regulation 1272/2008/EC (CLP)
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