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Diss Factsheets
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EC number: 211-765-7 | CAS number: 693-98-1
- 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- 2-methylimidazole
- EC Number:
- 211-765-7
- EC Name:
- 2-methylimidazole
- Cas Number:
- 693-98-1
- Molecular formula:
- C4H6N2
- IUPAC Name:
- 2-methyl-1H-imidazole
- Details on test material:
- - Name of test material (as cited in study report): 2-Methylimidazol
- Substance no.: XXIII/189
- Analytical purity: > 99%
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: Firma WIGA (Sulzfeld)
- Age at study initiation: 36 days
- Weight at study initiation: 137 g (males) and 125 g (females)
- Housing: V2A-wire cages with a bottom surface of ca. 900 cm2
- Diet: Altromin-R (Firma Altrogge, Lage/Lippe), ad libitum
- Water: ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 2
- Humidity (%): 55 ± 5
- Photoperiod (hrs dark / hrs light): 12 / 12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1 to 8%
- Amount of vehicle: 10 mL - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 4 weeks (28 days)
- Frequency of treatment:
- 5 days per week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 400 mg/kg bw/day (nominal)
- Dose / conc.:
- 800 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 10
- Control animals:
- yes
- Details on study design:
- Post-exposure period: no
- Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: yes
- Time schedule: daily
BODY WEIGHT: yes
- Time schedule for examinations: weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study):
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: yes
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: no
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: no
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): no
OPHTHALMOSCOPIC EXAMINATION: no
HAEMATOLOGY: yes
- Schedule for collection of blood: at study initiation and after the 28-day exposure period
- How many animals: 5 males and 5 females per exposure group
- Parameters examined: haemoglobin, erythrocytes, haematocrit, mean cell volume, mean corpuscular haemoglobin concentration, leukocytes and differential blood count.
CLINICAL CHEMISTRY: yes
- Schedule for collection of blood: at study initiation and after the 28-day exposure period
- How many animals: 5 males and 5 females per exposure group
- Parameters examined: sodium, potassium, carbon dioxide, chloride, calcium, phosphate, glucose, urea, total protein, total lipids, total bilirubin, creatinine, serum glutamic pyruvic transaminase and alkaline phosphatase .
URINALYSIS: yes
- Time schedule for collection of urine: after 3 weeks of exposure
- Metabolism cages used for collection of urine: yes
- Parameters examined: pH value, protein, glucose, urobilinogen and sediment
NEUROBEHAVIOURAL EXAMINATION: no - Sacrifice and pathology:
- HISTOPATHOLOGY: heart, liver, kidneys, spleen, testicles/ovaries, thyroid glands, suprarenal glands, hypophysis, brains, lungs, pancreas, stomach, small intestine, large intestine, lymph nodes, urinary bladders, skin, eyes with optic nerve, rhinitis and pharyngitis, tongue, skull with teeth, salivary gland, skeletal muscles, thymus gland, tracheae, oesophagus, thoracic aorta, prostate/uterus, seminal vesicles, epididymis and adipose tissue.
- Other examinations:
- Weight of: heart, liver, kidneys, spleen, thyroid glands, suprarenal glands and testicles
- Statistics:
- A variance analysis was perform with all exposure groups, when one or more of the doses showed a statistically significant effect (p ≤ 0.05) a mean t-test was performed for between the dose group and the control group.
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY: no mortality observed, slight ruffled fur at 200 mg/kg bw dose; 400 and 800 mg/kg bw: yellow urine, ruffled fur and increased salivation.
BODY WEIGHT AND WEIGHT GAIN: normal body weight gain in all exposure groups, except for males at 800 mg/kg bw.
HAEMATOLOGY: no changes.
CLINICAL CHEMISTRY: decreases in total protein in males and females in all dose groups (not dose related in males) and increased creatinine at 800 mg/kg bw in males.
URINALYSIS: no changes.
ORGAN WEIGHTS:
Increased absolute weights for:
- liver: females in 800 mg/kg bw exposure group
- thyroid glands: males of the 200 to 800 mg/kg bw exposure groups and females of the 800 mg/kg bw exposure group
Increased relative weights for:
- liver: females in 400 and 800 mg/kg bw exposure group
- thyroid glands: males of the 200 to 800 mg/kg bw exposure groups and females of the 800 mg/kg bw exposure group
- kidneys: females of the 800 mg/kg bw exposure group
MACROSCOPY: no substance treatment related effects
MICROSCOPY: no substance treatment related effects
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
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.
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