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EC number: 201-891-0 | CAS number: 89-25-8
- 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
- Study period:
- From September 25th, 1997 to January, 20th, 1998
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 24th February 1987
- Deviations:
- yes
- Remarks:
- The relative humidity recorded in animals room was outside of the target ranges specified in the protocol. The minor deviation was not considered to compromise the validity or integrity of the study.
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 3-methyl-1-phenyl-5-pyrazolone
- EC Number:
- 201-891-0
- EC Name:
- 3-methyl-1-phenyl-5-pyrazolone
- Cas Number:
- 89-25-8
- Molecular formula:
- C10H10N2O
- IUPAC Name:
- 5-methyl-2-phenyl-2,4-dihydro-3H-pyrazol-3-one
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 91N058
- Expiration date of the lot/batch: no data
- Purity test date: mesured on 4th June 1997, certificated on 18th September 1997
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: glass flask at room temperature
- Stability under test conditions:no data
- Solubility and stability of the test substance in the solvent/vehicle: no data
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: no data
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Final preparation of a solid: suspension in the vehicle
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Crédo 69210 L'Arbresle, France
- Females (if applicable) nulliparous and non-pregnant: Yes
- Age at study initiation: approximately 6 weeks old
- Weight at study initiation: males 163±5g and female 138±5g
- Fasting period before study: fasted for an overnight period
- Housing: animals were housed in polycarbonate cages (48 cm x 27 cm x 20cm). Each cage contained four to seven animals of the same sex during the acclimation period and five rats of the same sex during the treatment period. Each cage contained dust free sawdust (SICSA, 94142 Alfortville, France). Bacteriological analysis of the sawdust and detection of possible contaminants (pesticides, heavy metals) are performed periodically.
- Diet (e.g. ad libitum): free access to A04C pelleted diet. Each batch of food was analysed (composition and contaminants) by the supplier.
- Water (e.g. ad libitum): free access to water filtered by F.G. Millipore membrane (0.22 micron) Bacteriological and chemical analysis of the water and diet and detection of possible contaminants (pesticides, heavy metals and nitrosamines) are performed periodically.
- Acclimation period:5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±2°C
- Relative humidity : 30 to 70%
- Air changes (per hr): 12 cycles per hours of filtered air and non recycled air
- Photoperiod (hrs dark / hrs light): 12h/12h
IN-LIFE DATES: From 3rd October 1997 to 22th October 2017
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Vehicle 1 : 0.5% methylcellulose Vehicle 2 : 0.5% CMC (carboxymethylcellulose) Vehicle 3 : propylene glycol
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10ml/kg
- Justification for choice of vehicle: no data
MAXIMUM DOSE VOLUME APPLIED: 10ml/kg
DOSAGE PREPARATION (if unusual): The test substance was ground using a mortar and pestle, then prepared in each vehicle
- Doses:
- 2000 mg/kg bodyweight
- No. of animals per sex per dose:
- 5 rats per sex per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:observations frequently during the hours following administration, thereafter observations were made once a day. Weighing just before administration, at day 1, 8 and 15.
- Necropsy of survivors performed: yes ; A macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed.
- Other examinations performed: clinical signs, body weight - Statistics:
- not applicable
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- Limit dose doesn't reach 50% of mortality in the study
- Mortality:
- Mortality was 20% in group 1 ion day 1 and 2, 30% in group 2 on 4 and 6 hours after administration, and 0% of mortality in group 3.
- Clinical signs:
- other: In treated group 1 (vehicle: 0.5% methylcellulose), hypoactivity or sedation, piloerection, ptosis of the eyelids, reddish colouration of the extremites, dyspnoe and rhinorrhea were observed in all animals on day 1. Lateral recumbence was noted in one fem
- Gross pathology:
- At necropsy, no apparent macroscopic abnormalities were observed in the animals which died during the study or in the animals killed at the end of the observation period.
Any other information on results incl. tables
Clinical signs and mortality
Dosage mg/kg |
Clinical Signs |
Number of animals after treatment |
Level % |
||||||||||
Hours |
Days |
||||||||||||
1/2 |
1 |
2 |
4 |
6 |
2am |
2pm |
3 |
4 |
5 |
6 to 15 |
|||
2000 Group 1 (MALE) |
Death |
|
|
|
|
|
1 |
|
|
|
|
|
20 |
Surviving |
5 |
5 |
5 |
5 |
5 |
4 |
4 |
4 |
4 |
4 |
4 |
80 |
|
No abnormality |
|
|
|
|
|
4 |
4 |
4 |
4 |
4 |
4 |
|
|
Hypoactivity |
|
1 |
1 |
2 |
|
|
|
|
|
|
|
|
|
Sedation |
5 |
4 |
4 |
3 |
5 |
|
|
|
|
|
|
|
|
Tremors |
|
|
|
|
1 |
|
|
|
|
|
|
|
|
Piloerection |
5 |
5 |
5 |
5 |
|
|
|
|
|
|
|
|
|
Dyspnea |
|
|
5 |
5 |
5 |
|
|
|
|
|
|
|
|
Rhinorrhoea |
|
|
|
2 |
|
|
|
|
|
|
|
|
|
Ptosis of the eyelids |
5 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
Redish colouration of extremities |
|
|
5 |
|
|
|
|
|
|
|
|
|
Dosage mg/kg |
Clinical Signs |
Number of animals after treatment |
Level % |
||||||||||
Hours |
Days |
||||||||||||
1/2 |
1 |
2 |
4 |
6 |
2 |
3 |
4 |
5 |
6 |
7 to 15 |
|||
2000 Group 2 (MALE) |
Death |
|
|
|
1 |
|
|
|
|
|
|
|
20 |
Surviving |
5 |
5 |
5 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
80 |
|
No abnormality |
1 |
|
|
4 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
|
|
Sedation |
4 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
Piloerection |
|
5 |
5 |
|
|
|
|
|
|
|
|
|
|
Dyspnea |
|
|
5 |
|
|
|
|
|
|
|
|
|
|
Ptosis of the eyelids |
4 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
Redish colouratio nof extremities |
|
|
5 |
|
|
|
|
|
|
|
|
|
Dosage mg/kg |
Clinical Signs |
Number of animals after treatment |
Level % |
||||||||||
Hours |
Days |
||||||||||||
1/2 |
1 |
2 |
4 |
6 |
2 |
3 |
4 |
5 |
6 |
7 to 15 |
|||
2000 Group 3 (MALE) |
Death |
|
|
|
|
|
|
|
|
|
|
|
0 |
Surviving |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
100 |
|
No abnormality |
|
|
|
|
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
|
Hypoactivity |
|
|
|
2 |
|
|
|
|
|
|
|
|
|
Sedation |
5 |
5 |
5 |
3 |
|
|
|
|
|
|
|
|
|
Piloerection |
5 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
Dyspnea |
|
|
5 |
3 |
|
|
|
|
|
|
|
|
|
Ptosis of the eyelids |
5 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
Redish colouration of extremities |
|
|
5 |
5 |
|
|
|
|
|
|
|
|
Dosage mg/kg |
Clinical Signs |
Number of animals after treatment |
Level % |
||||||||||
Hours |
Days |
||||||||||||
1/2 |
1 |
2 |
4 |
6 |
2 |
3 |
4 |
5 |
6 |
7 to 15 |
|||
2000 Group 1 (FEMALE) |
Death |
|
|
|
|
1 |
|
|
|
|
|
|
20 |
Surviving |
5 |
5 |
5 |
5 |
4 |
4 |
4 |
4 |
4 |
4 |
4 |
80 |
|
No abnormality |
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypoactivity |
|
1 |
1 |
|
|
|
|
|
|
|
|
|
|
Sedation |
5 |
4 |
4 |
5 |
4 |
|
|
|
|
|
|
|
|
Lateral decubitus |
|
|
|
1 |
|
|
|
|
|
|
|
|
|
Piloerection |
5 |
5 |
5 |
4 |
|
|
|
|
|
|
|
|
|
Dyspnea |
|
|
5 |
5 |
4 |
|
|
|
|
|
|
|
|
Rhinorrhoea |
|
|
|
5 |
|
|
|
|
|
|
|
|
|
Ptosis of the eyelids |
5 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
Redish colouration of extremities |
|
|
5 |
4 |
|
|
|
|
|
|
|
|
Dosage mg/kg |
Clinical Signs |
Number of animals after treatment |
Level % |
||||||||||
Hours |
Days |
||||||||||||
1/2 |
1 |
2 |
4 |
6 |
2 |
3 |
4 |
5 |
6 |
7 to 15 |
|||
2000 Group 2 (FEMALE) |
Death |
|
|
|
1 |
1 |
|
|
|
|
|
|
40 |
Surviving |
5 |
5 |
5 |
4 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
60 |
|
No abnormality |
1 |
|
|
2 |
3 |
3 |
3 |
3 |
3 |
3 |
3 |
|
|
Sedation |
4 |
5 |
5 |
2 |
|
|
|
|
|
|
|
|
|
Piloerection |
|
5 |
5 |
2 |
|
|
|
|
|
|
|
|
|
Dyspnea |
|
|
5 |
2 |
|
|
|
|
|
|
|
|
|
Ptosis of the eyelids |
4 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
Redish colouration of extremities |
|
|
5 |
|
|
|
|
|
|
|
|
|
Dosage mg/kg |
Clinical Signs |
Number of animals after treatment |
Level % |
||||||||||
Hours |
Days |
||||||||||||
1/2 |
1 |
2 |
4 |
6 |
2 |
3 |
4 |
5 |
6 |
7 to 15 |
|||
2000 Group 3 (FEMALE) |
Death |
|
|
|
|
|
|
|
|
|
|
|
|
Surviving |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
5 |
100 |
|
No abnormality |
|
|
|
|
5 |
5 |
5 |
5 |
5 |
5 |
5 |
|
|
Hypoactivity |
|
|
|
5 |
|
|
|
|
|
|
|
|
|
Sedation |
5 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
Piloerection |
5 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
Dyspnea |
|
|
5 |
|
|
|
|
|
|
|
|
|
|
Ptosis of the eyelids |
5 |
5 |
5 |
|
|
|
|
|
|
|
|
|
|
Redish colouration of extremities |
|
|
5 |
5 |
|
|
|
|
|
|
|
|
Mean body weight change of treated rats (g)
Group |
Dose |
Volume |
Sex |
Days |
||
mg/kg |
ml/kg |
|
1 to 8 |
8 to 15 |
||
1 |
2000 |
10 |
Male |
M |
69 |
50 |
SD |
3 |
7 |
||||
2 |
2000 |
10 |
M |
74 |
55 |
|
SD |
6 |
15 |
||||
3 |
2000 |
10 |
M |
70 |
60 |
|
SD |
6 |
12 |
||||
1 |
2000 |
10 |
Female |
M |
47 |
23 |
SD |
10 |
9 |
||||
2 |
2000 |
10 |
M |
43 |
20 |
|
SD |
8 |
2 |
||||
3 |
2000 |
10 |
M |
40 |
17 |
|
SD |
6 |
5 |
M = Mean
SD = Standart Deviation
Applicant's summary and conclusion
- Interpretation of results:
- Category 5 based on GHS criteria
- Conclusions:
- Under the experimental conditions of this study, the oral LD50 of the test substance PHENYL METHYL PYRALOZONE is higher than 2000mg/kg in rats, whatever the vehicle used. Thus, the test material is not classified as hazardous for acute oral toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) criteria. Nevertheless, this substance is classified in Category 5 of GHS, as some mortality occured at the limit dose (2000 mg/kg bw).
- Executive summary:
This GLP-compliant study was performed to assess the acute oral toxicity of Phenyl Methyl Pyrazolone, according to fixed dose OECD Guideline 401 method (dated 24th February 1987).
Material and Method
The test material diluted in 0.5% of methylcellulose (vehicle 1) 0.5 % carboxymethylcellulose (vehicle 2) and propylen glycol (vehicle 3) was administered by oral route (gavage) to a group of 5 females and 5 males Sprague Dawley rats per vehicle at a single dose of 2000 mg/kg body weight. Animals were observed for mortality, clinical signs and body weight for 14 days and were then subjected to necropsy at day 15.
Results
In treated group 1 (vehicle: 0.5% methylcellulose), hypoactivity or sedation, piloerection, ptosis of the eyelids, reddish colouration of the extremites, dyspnoe and rhinorrhea were observed in all animals on day 1. Lateral recumbence was noted in one female prior to death. Tremors were also observed in one male, which was found dead on day 2. Recovery was mentioned to be complete in the other animals.
In treated group 2 (vehicle: 0.5% carboxymethylcellulose), hypoactivity or sedation, piloerection, ptosis of the eyelids, reddish colouration of the extremities, dyspnoea and rhinorrhea were observed in all animals on day 1. One male died 4 hours after treatment,and 2 females died 4 hours or 6 hours after treatment, respectively. Recovery was mentioned to be complete in the other animals.
In the treated group 3 (vehicle: propylene glycol) hypoactivity or sedation, piloerection, ptosis of the eyelids, reddish colouration of the extremities, dyspnoea and rhinorrhea were observed in all animals on day 1. No death occurred. Recovery was complete in all animals 6 hours after dosing.
Conclusion
Under the experimental conditions of this study, the oral LD50 of the test substance PHENYL METHYL PYRALOZONE is higher than 2000mg/kg in rats, whatever the vehicle used. Thus, the test material is not classified as hazardous for acute oral toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) criteria. Nevertheless, this substance is classified in Category 5 of GHS. As some mortality occured at the limit dose (2000 mg/kg bw).
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Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.