Registration Dossier

Administrative data

Key value for chemical safety assessment

Effects on fertility

Effect on fertility: via oral route
Dose descriptor:
NOAEL
10 000 mg/kg bw/day
Additional information

Non-human data:

In a two generation study phenazone was administered by oral feed in concentrations of 0, 1000, 3200 and 10000 ppm to 30 male and 30 female Wistar rats per concentration (Baeder et al., 1981). In the 10000 ppm group a slightly reduced body weight gain in the P-generation was observed. No effect on fertility, duration of pregnancy, birth and postnatal surviving capacity in the F1-generation was reported.

Human data:

No data available.


Short description of key information:
Based on the results of a two generation study with rats, the NOAEL for parents and F1 generation were 3200 ppm and for the F2 generation the NOAEL was 10000 ppm.

Effects on developmental toxicity

Effect on developmental toxicity: via oral route
Dose descriptor:
NOAEL
160 mg/kg bw/day
Additional information

Non-human data:

Two studies assessing the potential for developmental toxicity of phenazone are available. In the first study, phenazone was administered by gavage at doses of 0, 160, 500 and 1600 mg/kg bw/day on gestation days 7-16 in 20 female Wistar rats per doses (Baeder et al., 1981). At 500 mg/kg bw/day two of 20 dams showed piloerection and foetuses showed first anomalies of scapula and ribs. At the highest concentration food consumption, body weight, piloerection and motility decreased. Other clinical symptoms reported were blood around nose and mouth and in the urine. Furthermore, 10 of 20 dams died intercurrently, embryonic deaths and anomalies in foetuses (head, scapula, humerus, ribs, sternum etc.) increased. The NOAEL for developmental toxicity was determined at 160 mg/kg bw/day.

In the second study phenazone was administered by gavage at doses of 0, 50, 160 and 500 mg/kg bw/day on gestation days 6 -19 in 15 female Himalayan rabbits (Baeder et al., 1981). Application of phenazone up to 160 mg/kg bw/day had no impact on the general health status, on the intrauterine development or on the survival rate of the foetuses in the incubator. Animals in the 500 mg/kg bw/day group showed a decrease in food uptake, in body weight and an increased number of intrauterine deaths. There were no signs for teratogenicity of phenazone after morphological investigation of the foetuses. The NOAEL for developmental toxicity was set at 500 mg/kg bw/day.

 

Human data:

No data available

Justification for classification or non-classification

Based on available results for reproductive and developmental toxicity, phenazone was not classified and labelled according to Directive 677548/EEC (DSD) and to Regulation 1272/2008/EC (CLP).

Additional information