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Diss Factsheets
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EC number: 200-486-6 | CAS number: 60-80-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Endpoint summary
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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