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EC number: 206-017-1 | CAS number: 288-13-1
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study (OECD)
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 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Principles of method if other than guideline:
- and EC Commission directive 92/69/of July 31, 1992, Part B: Methods for the determination of Toxicity; Toxicity after 28-day administration (oral); Official Journal of the European Communities No. L 383, pp. 136-139, 1992
- GLP compliance:
- yes
Test material
- Reference substance name:
- Pyrazole
- EC Number:
- 206-017-1
- EC Name:
- Pyrazole
- Cas Number:
- 288-13-1
- Molecular formula:
- C3H4N2
- IUPAC Name:
- 1H-pyrazole
- Details on test material:
- Purity: 99.9%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Breeder: Dr. Karl Thomae GmbH, Biberach/Riss, FRG
age of 39 days (males) or 38 days (females)
The rats were identified by ear tattoo.
The rats were housed singly in type DK 111 stainless steel wire mesh cages supplied by Becker & Co., Castrop-Rauxel, FRG (floor area about 800 cm2). Underneath the cages, waste trays were fixed containing absorbent material (type 3/4 dustfree embedding, supplied by SSNIFF, Soest, FRG).
The motor activity measurements were conducted in Polycarbonate cages with wire Covers from Ehret, Emmendingen, FRG (floor area about 800 cm2) and small amounts of absorbent material (see above) .
The animals were housed in a fully air-conditioned room. Central air-conditioning guaranteed a range of 20 - 24°C for temperature and 30 - 70% for relative humidity. The day/night rhythm was 12 hours (12 hours light from 06.00 a.m. - 06.00 p.m., 12 hours dark from 06.00 p.m. - 06.00 a.m.). Deviations from these ranges did not occur.
The food used was ground Kliba maintenance diet rat/mouse/hamster meal, supplied by Klingentalmühle AG, Kaiseraugst, Switzerland. Food and
drinking water (from water bottles) were available ad libitum.
Administration / exposure
- Route of administration:
- oral: drinking water
- Vehicle:
- water
- Duration of treatment / exposure:
- 4 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 20, 100 and 600 ppm
Basis:
- No. of animals per sex per dose:
- Control and high dose group consisted of each 13 animals per sex; low and mid dose group consisted of each 8 animals per sex.
- Control animals:
- yes
Results and discussion
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1.5 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: reduced water consumption, mild anemia, leukocytosis, slight impairment of hepatocellular and renal function, increased synthesis rate of Serum proteins and cholesterol, substance-related changes in thyroid and spleen
- Dose descriptor:
- NOAEL
- Effect level:
- 1.9 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: reduced water consumption, mild anemia, leukocytosis, slight impairment of hepatocellular and renal function, increased synthesis rate of Serum proteins and cholesterol, substance-related changes in thyroid and spleen
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
In conclusion, the following substance-related effects were seen:
600 ppm (38.9 mg/kg bw/day in males, 84.0 mg/kg bw/day in females)
- impairment of water consumption in males and females - impairment of food consumption in males and females
- impairment of body weight, resulting in reduced values of 16.9%/17.3% [males/females] on day 28
- impairment of food efficiency in males and females
- increases in platelets, total bilirubin, total protein, globulins, cholesterol and urinary specific gravity in both sexes
- dark yellow discoloration of the urine specimens in both sexes
- increases in albumin and urinary blood in the males - increases in white blood cells, lymphocytes, alanine aminotransferase, sodium, inorganic phosphate and thyroid stimulating hormone (TSH) in the females - decreases in hemoglobin, alkaline phosphatase, urea, triglycerides and urinary volume in both sexes - decreases in red blood cells, creatinine, glucose and thyroxin (T4) in the females
- vacuolization of the follicular epithelial cells of the thyroid glands of male and female rats
- increased extramedullary hematopoiesis in the spleen of male and female rats
100 ppm (7.3 mg/kg bw/day in males, 9.2 mg/kg bw/day in females)
- slight impairment of water consumption in males
- increases in total protein, albumin, globulins and cholesterol in the males
- increases in platelets and thyroid stimulating hormone (TSH) in the females - decreases in hemoglobin and triglycerides in the females - increased extramedullary hematopoiesis in the spleen of male and female rats
20 ppm (1.5 mg/kg bw/day in males, 1.9 mg/kg bw/day in females)
- no substance-related changes
Applicant's summary and conclusion
- Conclusions:
- Regarding the results of the study, the test substance Pyrazole has the potential for the danger of serious damage to health by prolonged exposure if swallowed.
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