Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July/August 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 427 (Skin Absorption: In Vivo Method)
- 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:
- label on C-atom of N-Methylgroup of the Imidazolinium ring; specific radioactivity: 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: Winkelmann, Borchen
- Weight at study initiation: 208 g - 252 g
- Housing: individually
- Individual metabolism cages: yes
- Diet (e.g. ad libitum): Altromin Alleindiät 1324 ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Duration of exposure:
- 48 h
- Doses:
- 200 mg/animal
- No. of animals per group:
- 5 (0.1% group), 8 (0.5% group)
- Control animals:
- no
- Details on study design:
- TEST SITE
- Preparation of test site: clipped
- Area of exposure: 10 cm²
- Time intervals for shavings or clipplings: 24 h before exposure
SITE PROTECTION / USE OF RESTRAINERS FOR PREVENTING INGESTION: yes: glass capsule fixed with Sicomet 99
REMOVAL OF TEST SUBSTANCE
- Washing procedures and type of cleansing agent: the test item remained on the skin for 48 h until study termination
SAMPLE COLLECTION
- Collection of blood: no
- Collection of urine: 0 - 8 h; 8 - 24 h; 24 - 48 h
- Collection of faeces: 0 - 24 h; 24 - 48 h
- Collection of expired air: 0 - 8 h; 8 - 24 h; 24 - 48 h (3 animals of group 1, 6 animals of group 2)
- Terminal procedure: The animals were killed with CO2, the application site was cut out and the radioactivy determined; teh remaining carcass was homogenised
- Analysis of organs: no
- the metabolism cages were rinsed and the radiactivite determined in the rinsing solution
ANALYSIS
- Method type(s) for identification: Liquid scintillation counting
- Limits of detection: 2x background value; ca. 0.2% (urine, faeces)to ca. 6% (carcass) (% of applied radioactivity)
Results and discussion
Percutaneous absorptionopen allclose all
- Time point:
- 48 h
- Concentrate / Dilution:
- dilution
- Dose:
- 0.5% dilution, approx. 200 mg solution
- Parameter:
- percentage
- Absorption:
- >= 2 - <= 3 %
- Time point:
- 48 h
- Concentrate / Dilution:
- dilution
- Dose:
- 0.1% dilution, approx. 200 mg solution
- Parameter:
- percentage
- Absorption:
- < 0.51 %
Applicant's summary and conclusion
- Executive summary:
14C-(N-methyl)-imidazoliniumquat - methosulfate was used for this study. The compound was labelled at the first C-atom in the N-methyl-group of the imidazolinium-ring. 5 and 8 female rats of Wistar-strain (SPF-Cpb) were used respectively as two test groups. The mean body weights amounted to 222 ± 15.4 g (group 1, five animals) and 241 ± 9.72 g (group 2, eight animals). The compound was applied cutaneously as a solution in water. The concentration of 14C-(N-methyl)-imidazoliniumquat-methosulfate was 0.1 % (group 1) and 0.5 % (group 2). The concentrations used in this study were guided by results from skin compatibility studies.
10 cm² of the intact, clipped skin of the rats were exposed for 48 hours to the test substance. Approx. 200 mg of the solutions were applied. In a 48 hour period <0.51 % (group 1) and 2 - 3 % (group 2) were absorbed through the skin of the rats. An exact value cannot be given because the radioactivity of some samples was below the detection limit.
Additionally the expired air with three rats of the first group and with six rats of the second group was measured for radioactivity. For both groups the radioactivity found was below the detection limit.
The cutaneously absorbed radioactivity was eliminated with the urine and with the feces. The excretion by these two pathways was very low: 0.182% group 1) or 0.149% (group 2) of the applied radioactivity with the urine and 0.330 or 0.919% with the feces.
The radioactivity found in carcass 48 hours after application was below the detection limit in the case of group 1 and below 1.79% for group 2. The radioactivity found in the carcass was, in three of eight animals, below the detection limit. Therefore an exact value cannot be given. The mean value of 1.79% refers to the remaining five animals.
From the results the conclusion can be drawn that the percutaneous absorption of the substance ist quite low. The larger scattering of the single results and the slightly higher value for the percutaneous absorption for the group 2 can probably be ascribed to commencement of skin damage.
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.