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Diss Factsheets
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EC number: 939-688-0 | CAS number: -
- 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 in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
- Objective of study:
- absorption
- excretion
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 417 (Toxicokinetics)
- Principles of method if other than guideline:
- The radioactively labelled compound was applied as a single oral dose (appr. 10 mg/kg body weight) to three female rats. The intestinal absorption was studied for 96 hours after application.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Imidazolium compounds, 2-(C15-17(odd numbered), C17-unsatd. alkyl)-1-[2-(C16-18(even numbered), C18-unsatd. amido)ethyl]-4,5-dihydro-N-methyl, Me sulfates)
- IUPAC Name:
- Imidazolium compounds, 2-(C15-17(odd numbered), C17-unsatd. alkyl)-1-[2-(C16-18(even numbered), C18-unsatd. amido)ethyl]-4,5-dihydro-N-methyl, Me sulfates)
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- labelled at the C-atom in the N-methyl-group of the imidazolinium-ring, specific activity 2.55 mCi/mMol
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Fa. Winkelmann, Borchen
- Weight at study initiation: 220 g - 235 g
- Housing: individually in metabolism cages
- Diet (e.g. ad libitum): Altromin 1324, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Fasting period: 24 h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
444.7 mg test item (50% solution) was dissolved in 99.114 g bidestilled water, resulting in 2.23 mg test item/g solution
approx. 1 g of this solution was administered to the animals, corresponding to 9.115±0.39 mg/kg bw
Doses / concentrations
- Dose / conc.:
- 10 mg/kg bw/day
- No. of animals per sex per dose / concentration:
- 3
- Control animals:
- no
- Details on dosing and sampling:
- TOXICOKINETIC / PHARMACOKINETIC STUDY (Absorption, distribution, excretion)
- Tissues and body fluids sampled: urine, faeces, expired air, cage washes, gastro intestinal tract, carcass
- Time and frequency of sampling:
Urine: 0 - 8 h; 8 - 24 h; 24 - 48 h; 48 - 72 h; 72 - 96 h
faeces: 0 - 24 h; 24 - 48 h; 48 - 72 h; 72 - 96 h
expired air: 0 - 8 h; 8 - 24 h; 24 - 48 h; 48 - 72 h; 72 - 96 h
cage wash: after 96 h
Results and discussion
Main ADME resultsopen allclose all
- Type:
- absorption
- Results:
- at least 0.792%
- Type:
- excretion
- Results:
- urine: 0.524
faeces: 78.7%
- Type:
- distribution
- Results:
- gastrointestinal tract: 0.077%
carcass: below detection limit
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- An intestinal absorption of at least 0.792 % of the administered dose was found.
- Details on excretion:
- 0.407% of the applied dose was excreted in the urine within 24 hrs after application, 0.221% within the first 8 hrs.
In the faeces 78.7% of the adminstered radioactivity was eliminated within 96 hrs, 54.9% of the adminstered radioactivity within the first 24 hours. Hence it follows that either a great part of the applied substance was not absorbed intestinally or a part was eliminated by biliary excretion after intestinal absorption.
Metabolite characterisation studies
- Metabolites identified:
- no
Applicant's summary and conclusion
- Executive summary:
(N-methyl-14C)-imidazoliniumquat-methosulfate was used for this study. The compound was labelled at the C-atom in the N-methyl-group of the imidazolinium-
ring. The radioactive compound was applied as a single oral dose (appr. 10 mg/kg body weight). Three female rats (SPF-Cpb) were used as a test group (mean body weight: 227 ± 7 g). The intestinal absorption was studied for 96 hours after application.
An intestinal absorption of at least 0.792 % of the administered dose was found.
0.407% of the applied dose was excreted in the urine within 24 hrs after application, 0.221% within the first 8 hrs.
In the faeces 78.7% of the adminstered radioactivity was eliminated within 96 hrs, 54.9% of the adminstered radioactivity within the first 24 hours. Hence it follows that either a great part of the applied substance was not absorbed intestinally or a part was eliminated by biliary excretion after intestinal absorption.
The radioactivity found in the expired air (measured with all rats) was below the detection limit.
Also, the radioactivity found in the carcass 96 hours after application was below the detection limit (except one animal).
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