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EC number: 220-180-6 | CAS number: 2654-57-1
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Justification for type of information:
- data is from study report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Federal Register Vol 50 no 188, Part II, 27 September 1985
- Version / remarks:
- section 798-1175-Acute oral toxicity
- Principles of method if other than guideline:
- Acute Oral toxicity test was carried out to study the effects of the given test chemical on rats.
- GLP compliance:
- yes
- Remarks:
- statement by study director and statement by QA
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- 4-methyl-1-phenyl-3-pyrazolidone
- EC Number:
- 220-180-6
- EC Name:
- 4-methyl-1-phenyl-3-pyrazolidone
- Cas Number:
- 2654-57-1
- Molecular formula:
- C10H12N2O
- IUPAC Name:
- 4-Methyl-1-phenylpyrazolidin-3-one
- Test material form:
- solid: particulate/powder
- Details on test material:
- white powder
stored at ambient temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Ltd, Margate, Kent, England
- Strain: pretest CFY, main test CD
- Age at study initiation: 4-6 weeks
- Weight at study initiation: 100-149 g
- Fasting period before study: overnight and 4 hours after dosing
- Housing: in metal cages with wire mesh floors
- Diet: Labsure LAD 1 ad libitum
- Water: ad libitum
- Acclimation period: at least 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23 °C
- Humidity (%): average 57%
- Air changes (per hr): 15 air changes/hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Details on oral exposure:
- VEHICLE: 1% methylcellulose
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
- Doses:
- pre-test: 800, 1600 and 5000 mg/kg bw
main test: 500, 800 and 1260 mg/kg bw - No. of animals per sex per dose:
- pre-test: 2/sex/dose
main test: 5/sex/dose - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days (pre-test 5 days)
- Frequency of observations: twice daily (and at regular intervals on day 1)
- Bodyweight: on day 1, 8 and 15
- Necropsy of survivors performed: no (only on animals that died)
- Other examinations performed: clinical signs daily - Statistics:
- Probit analysis (Finney)
Results and discussion
- Preliminary study:
- All animals died at 1600 and 5000 mg/kg bw on day 1
At 800 mg/kg bw 1 male died on day 1
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 627 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 425 - <= 783
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 578 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 329 - <= 787
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 685 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 437 - <= 983
- Mortality:
- males: 500 mg/kg bw 2/5 before day 4; 800 mg/kg bw 5/5 before day 3; 1260 mg/kg bw 4/5 on day 1
females: 500 mg/kg bw 0/5 before day 4; 800 mg/kg bw 4/5 on day 1; 1260 mg/kg bw 5/5 on day 1 - Clinical signs:
- other: pilo-erection, hunched posture, waddling, decreased respiratory rate and pallor of the extremities in all animals Ptosis, prostrate and facial swelling were observed less frequently.
- Gross pathology:
- No abnormalities was observed.
- Other findings:
- not specified
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- The acute oral toxicity dose (LD50) value was considered to be 627 mg/kg bw, with 95% confidence limit of 425-783 mg/kg bw in combined male and female rats; 578 mg/kg bw, with 95% confidence limit of 329-787 mg/kg bw in male rats and 685 mg/kg bw, with 95% confidence limit of 437-983 mg/kg bw in female rats.
- Executive summary:
The acute oral toxicity study was conducted as per OECD Guideline 401 (Acute Oral Toxicity) and Federal Register Vol 50 no 188, Part II, 27 September 1985 by using the given test chemical in male and female Sprague-Dawley rats.
The given test chemical (Purity 100%) was dissolved in 1% methylcellulose and administered as 10 mL/kg bw via oral gavage route.
In pre-test: 2/sex/dose male and female Sprague-Dawley rats were treated with the given test chemical at the dose concentration of 800, 1600 and 5000 mg/kg bw. Animals were observed for mortality for 5 days. Necropsy was performed only on animals that died. All animals died at 1600 and 5000 mg/kg bw on day 1. At 800 mg/kg bw 1 male died on day 1.
In main test: 5/sex/dose male and female Sprague-Dawley rats were treated with the given test chemical at the dose concentration of 500, 800 and 1260 mg/kg bw.
Animals were observed for mortality daily twice (and at regular intervals on day 1). Body weight was observed on day 1, 8 and 15. Necropsy of survivors performed only on animals that died. Clinical signs were observed daily. LD50 value was calculated by the method of probit analysis (Finney).
Mortality was observed as - males: At 500 mg/kg bw 2/5 before day 4; At 800 mg/kg bw 5/5 before day 3; At 1260 mg/kg bw 4/5 on day 1. Females: At 500 mg/kg bw 0/5 before day 4; At 800 mg/kg bw 4/5 on day 1; At 1260 mg/kg bw 5/5 on day 1. Clinical signs like, piloerection, hunched posture, waddling, decreased respiratory rate and pallor of the extremities in all animals and Ptosis, prostrate and facial swelling were observed less frequently in treated animals. Body weight change was observed for survivors within normal ranges. No abnormalities were observed after necropsy.
Under the condition of the study, the acute oral toxicity dose (LD50) value was considered to be 627 mg/kg bw, with 95% confidence limit of 425-783 mg/kg bw in combined male and female rats; 578 mg/kg bw, with 95% confidence limit of 329-787 mg/kg bw in male rats and 685 mg/kg bw, with 95% confidence limit of 437-983 mg/kg bw in female rats.
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