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EC number: 616-307-3 | CAS number: 76205-19-1
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
- Objective of study:
- bioaccessibility (or bioavailability)
- toxicokinetics
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.7485 (Metabolism and Pharmacokinetics)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 616-307-3
- EC Number:
- 616-307-3
- Cas Number:
- 76205-19-1
- Molecular formula:
- C9 H7 Cl N2 O
- IUPAC Name:
- 616-307-3
Constituent 1
- Specific details on test material used for the study:
- Batch Identification: 724-2102
CAS No.: 76205-19-1
Radiochemical purity: >98 %
Homogeneity: given
Chemical name: 1-(4-chlorophenyl)-1H-pyrazol-3-ol
Radio label: phenyl-U-14C
Specific activity (active ingredient): 8.99 MBq/mg
Storage conditions: keep in refrigerator (approx. +4°C) or cooler
Non-labeled test substance
Batch Identification: L84-174
Purity: 99.6 % (tolerance +- 1.0 %)
Homogeneity: given
Storage stability: expiry date: 01 Apr 2020
Chemical name: 1-(4-chlorophenyl)-1H-pyrazol-3-ol
Physical state /appearance: solid, yellow
Storage conditions: refrigerator
Stability in vehicle: The stability of the radioactive test substance in the vehicle was verified in the experiments by LSC and Radio-HPLC.
Homogeneity and achieved concentrations: The homogeneity and achieved radioactivity concentrations of the test substance preparations
were verified by HPLC and liquid scintillation counting in the experiments. - Radiolabelling:
- yes
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, 97633 Sulzfeld, Germany
- Weight at study initiation: about 30 – 40 g
- Housing: During acclimatization and prior to the experiment animals were housed individually in Macrolon cages type M III. During the experiments animals were housed individually in steel
wire mesh cages
- Diet (e.g. ad libitum): Kliba lab diet (mouse / rat “GLP”) pelleted, ad libitum prior to and during the experiments
- Water (e.g. ad libitum): drinking water ad libitum
- Acclimation period: at least 8 days before the beginning of the experimental phase
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24°C
- Humidity (%): 30-70%
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- CMC (carboxymethyl cellulose)
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
A stock solution of the radiolabeled test substance in acetone and unlabeled substance were mixed in appropriate amounts. The acetone was evaporated and the mixture was solved in 0.5% CMC in drinking water. 10 mL/kg bw were dosed. The target quantity of radioactivity per animal was about 10 MBq. Therewith, the concentration of the test substance in the test substance preparation and its specific activity was about 100 mg/mL and 27.6 MBq/mL, respectively. - Duration and frequency of treatment / exposure:
- frequency of treatment: once; sacrifice 5 hours after dosing
Doses / concentrations
- Dose / conc.:
- 1 000 mg/kg bw (total dose)
- No. of animals per sex per dose / concentration:
- 5
- Control animals:
- yes, concurrent no treatment
- Details on study design:
- The study was designed to obtain data on kinetics and to demonstrate that the test substance reaches the systemic circulation and the bone marrow.
- Details on dosing and sampling:
- TOXICOKINETIC / PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
The radioactivity was determined in the following samples:
blood cells, plasma, bone marrow.
Results and discussion
Bioaccessibility (or Bioavailability)
- Bioaccessibility (or Bioavailability) testing results:
- The mean total radioactive residues (TRR) 5h post dosing were 25.3 μg Eq/g in bone marrow corresponding to 0.001 % of dose. In blood cells mean total radioactive
residues of 7.62 μg Eq/g were found, corresponding to 0.003 % of dose. The mean residues in plasma were 29.83 μg Eq/g corresponding to 0.008 % of dose.
Applicant's summary and conclusion
- Conclusions:
- The current study demonstrated that radioactive residues of 14C- Pyrazolone are present in the systemic circulation and in bone marrow of mice 5 h after single oral administration of the test substance at a target dose level of 1000 mg/kg bw.
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