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Diss Factsheets
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EC number: 460-100-9 | CAS number: 342573-75-5
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: limited documentation but sufficient for evaluation
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 008
Materials and methods
- Objective of study:
- toxicokinetics
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Deviations:
- no
- GLP compliance:
- not specified
Test material
- Details on test material:
- - Name of test material (as cited in study report): 1-Butyl-3-methylimidazolium Chloride
- Physical state:
- Analytical purity: Bmim-Cl reference standard (98% Bmim-Cl)
- Radiochemical purity (if radiolabelling): [14C] Bmim-Cl was 97.5%
- Specific activity (if radiolabelling): 27.5 mCi/mmol.
- Locations of the label (if radiolabelling): RTI International (Research Triangle Park, NC)
- Stability under test conditions: stable
- Storage condition of test material: 8°C
- Lot/batch No.: 9719-75
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- C14
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: rat: Harlan Sprague-Dawley, Inc. (Indianapolis, IN)
- Age at study initiation: 8–9 weeks ;
- Weight at study initiation: 161–200 g
- Fasting period before study: 12 h Animals used in the dermal or the repeated dose study were not fastened
- Acclimation period: 5-7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25 °C
- Photoperiod (hrs dark / hrs light): 12 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Duration and frequency of treatment / exposure:
- once for the absorbtion study (iv and oral)
once/ day in the 5 day accumlation study
Doses / concentrations
- Remarks:
- Doses / Concentrations:
50 mg/kg was administered by oral gavage (single administration)
0.5, 5 and 50 mg/kg/day by oral gavage (repeated administration)
5 mg/kg was selected for the i.v. route of administration.
- No. of animals per sex per dose / concentration:
- 4
- Control animals:
- no
- Details on study design:
- - Dose selection rationale: oral 1/10 of the LD50; Iv 1/100 of the LD50
- Details on dosing and sampling:
- PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
iv application
- Tissues and body fluids sampled : urine, faeces, blood, cage washes
- Time and frequency of sampling:
Blood: 0.7.5 min h; 15 min ; 30 min; 45 min; 1 h, 1,5 h 3h; 6 h; 9h; 12 h; 24 h; 36 h; 48 h.
Other samples 6h 12 h 24 h, 48 h,
oral application (single application)
- Tissues and body fluids sampled : urine, faeces, blood, cage washes adipose tissue, blood, heart, intestine, intestinal contents, kidneys, lung, liver, muscle, spleen, stomach, stomach contents, skin, and testes.
- Time and frequency of sampling: 6h (urine only), 12 h 24 h, 48 h, 72 h
METABOLITE CHARACTERISATION STUDIES
- Tissues and body fluids sampled: urine
- Time and frequency of sampling: 6 h and 12 h
- From how many animals: Not pooled
- Method type(s) for identification: HPLC-UV/vis-radiometric analysis and LC/MS for non radioactive samples - Statistics:
- mean +/- SD
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Systemic bioavailability was determined to be 62.1% of a 50 mg/kg oral dose in rats.
- Details on distribution in tissues:
- Cumulative Dose recovered from all tissues 24 h after the final dose following one or five serial daily oral administrations of Bmim-Cl (50 mg/kg/day) to male F-344 rats was 1.1 +/- 0.2 %. This is even less the cumulative dose recovery from all tissues 24 h after one administration (5.3 +/- 2.4 %). This suggest that bioaccumulation potential of BMIM Cl is low. distribution to dissues to single organs was not reported.
- Details on excretion:
- Urinary excretion of the parent compound by rats was the major route of elimination (i.v.: 91% in 24 h; oral: 55–74% in 24 h). The rates and routes of elimination were not affected by escalation of dose (0.5–50 mg/kg) or repeated oral administration (five daily administrations, 50 mg/kg) and were similar in male rats and B6C3F1 female mice (86–95% of dose eliminated in 24 h).
Metabolite characterisation studies
- Metabolites identified:
- no
- Details on metabolites:
- 94.7 +/- 10 % of the iv applied radiactivity were recoverd as Butyl-3-methylimidazolium Chloride, no other peak was detected HPLC-UV Vis- radiometric analysis in blood and urine samples.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): no bioaccumulation potential based on study results
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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