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Diss Factsheets
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EC number: 200-521-5 | CAS number: 61-82-5
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- GLP study performed according to OECD Guideline 401 without any deviation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- dated 24 February 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- dated 31 July 1992
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Amitrole
- EC Number:
- 200-521-5
- EC Name:
- Amitrole
- Cas Number:
- 61-82-5
- Molecular formula:
- C2H4N4
- IUPAC Name:
- amitrole
- Test material form:
- solid: particulate/powder
- Remarks:
- whitish powder
- Details on test material:
- - Storage condition of test material: Room temperature
- Manufacturing date: February 1995
- Expiration date: February 1997
- Purity test date: 30 October 1996
Constituent 1
- Specific details on test material used for the study:
- Date of receipt: 06 July 1995
Name as cited in the report: TECHNICAL AMITROLE
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Credo, 69210 L'Arbresle, France
- Age at study initiation: ca. 6 weeks
- Weight at study initiation: 184 ± 7 g for males; 142 ± 12 g for females
- Fasting period before study: ca. 18 hours before dosing
- Housing: Animals were housed by group of five of the same sex in polycarbonate cages during the treatment period.
- Diet (e.g. ad libitum): A04 C pelleted diet (U.A.R., 91360 Villemoisson-sur-Orge, France), ad libitum
- Water (e.g. ad libitum): Drinking water filtered by a F.G. Millipore membrane (0.22 micron), ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 21 ± 2 °C
- Humidity: 30-70%
- Air changes: 12/hour
- Photoperiod: 12 hours dark / 12 hours light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 10 mL/kg bw
- Lot/batch no.: 5698
DOSAGE PREPARATION: On the day of treatment, the test substance was prepared in distilled water. - Doses:
- 2000 and 10000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- other: historical data
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations and mortality were recorded frequently during the hours following each administration of the test substance, and then once daily for 14 days. Animals were weighed individually just before administration of the test substance on Day 1 and then on Days 8 and 15.
- Necropsy of survivors performed: Yes; on Day 15, all animals were killed by CO2 inhalation in excess and a macroscopic examination was performed. After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. In case of macroscopic lesions, organ samples were taken and preserved in 10% buffered formalin. No microscopic examination was performed. - Statistics:
- No data
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- >= 10 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred during the observation period.
- Clinical signs:
- other: Signs of hypoactivity were observed at 2000 mg/kg bw in one female, 30 minutes after treatment and in two females after 1 and 2 hours. No clinical signs were noted at 10000 mg/kg bw.
- Gross pathology:
- No abnormalities were observed at necropsy.
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the test conditions, the oral LD50 of the test substance is =10000 mg/kg bw in rats. Therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the Globally Harmonised System of classification and labelling of chemicals (GHS). No signal word or hazard statement is required.
- Executive summary:
In an acute oral toxicity study performed according to the OECD Guideline 401 and in compliance with GLP, a single dose of 2000 or 10000 mg/kg bw (in two fractions of 5000 mg/kg bw each) of the test substance was given by oral gavage to groups of Sprague Dawley rats (5/sex/dose). Animals were then observed for mortality, clinical signs and body weight changes for 14 days, and were all sacrificed for macroscopic examinations.
No death occurred at 2000 or 10000 mg/kg bw. Signs of hypoactivity were observed at 2000 mg/kg bw within two hours after treatment in two females only. No clinical signs were noted at 10000 mg/kg bw. The body weight gain of the animals was not affected by treatment with the test substance. No abnormalities were observed at necropsy.
Rat Oral LD50 =10000 mg/kg bw.
Under the test conditions, the oral LD50 of the test substance is =10000 mg/kg bw in rats. Therefore it is not classified according to the Regulation (EC) N° 1272-2008 and according to the Globally Harmonised System of classification and labelling of chemicals (GHS). No signal word or hazard statement is required.
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.
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.
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