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EC number: 692-759-5 | CAS number: 1040916-84-4
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- 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:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- according to
- MatTek Corporation, Ashland, MA 01721, USA: EpiOcularTM human cell construct: Procedure details, Version 3.1a of February 10, 2010.
- Harbell J.W. et al. (2009): COLIPA Program on Optimization of Existing In Vitro Eye Irritation Assays for Entry into Formal Validation: Technology Transfer and Intra/InterLaboratory Evaluation of EpiOcular Assay for Chemicals. Poster # 378, Society of Toxicology, March 2009. - GLP compliance:
- yes
Test material
- Reference substance name:
- 1,3-diethyl-1H-imidazol-3-ium acetate
- EC Number:
- 692-759-5
- Cas Number:
- 1040916-84-4
- Molecular formula:
- C7 H13 N2 . C2 H3 O2
- IUPAC Name:
- 1,3-diethyl-1H-imidazol-3-ium acetate
- Details on test material:
- Name of the test substance used in the study report: EEIM Acetate
Purity: 97.4 ± 0.1 g/ 100 g
pH value: ca. 6 (undiluted test substance)
Constituent 1
Test animals / tissue source
- Species:
- other: Three dimensional human cornea model
Test system
- Vehicle:
- unchanged (no vehicle)
- Amount / concentration applied:
- Single topical application of 50 uL
- Duration of treatment / exposure:
- 30 minutes
- Observation period (in vivo):
- 2 hours post-incubation period
- Number of animals or in vitro replicates:
- 2 samples
- Details on study design:
- The present test is based on the experience that irritant chemicals produce cytotoxicity in human reconstructed cornea after a short-term topical exposure. The test is designed to predict an eye irritation potential of a chemical by using the three dimensional human cornea model EpiOcular. After application of the test material to the surface of the EpiOcular tissue the induced cytotoxicity (= loss of viability) is measured by a colorimetric assay.
Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity. The mitochondrial dehydrogenase reduces the yellow colored water-soluble 3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide (MTT) to the insoluble blue colored formazan. After isopropanol-extraction of the formazan from the tissues, the optical density of the extract is determined spectrophotometrically. Optical density of the extracts of testsubstance treated tissues is compared to negative control values from tissues and expressed as relative tissue viability.
Using a pipette, fifty microliter (50 uL) of the undiluted liquid test substance was applied covering the whole tissue surface.
Control tissues were concurrently applied with 50 uL of sterile de-ionized water (NC) or with 50 uL of methyl acetate (PC).
After application, the tissues were placed into the incubator until the total exposure time of 30 minutes was completed.
To remove the test substance, the tissues were washed with sterile PBS. For this purpose the tissues were immersed and swiveled three times in each of three beakers filled with PBS. Washed tissues were immediately immersed into 12-well plates, pre-filled with 5 mL/well prewarmed medium (post-soak immersion) in order to remove residual test substance. After 12 minutes of post-soak immersion, each tissue was dried on absorbent paper and transferred to fresh 6-well plates filled with 1 mL/well pre-warmed medium. Subsequently, the tissues were incubated at standard culture conditions for 2 hours (postincubation period).
After the post-incubation period, the assay medium was replaced by 0.3 mL MTT solution and the tissues were incubated in the incubator for 3 hours. After incubation, the tissues were washed with PBS to stop the MTT-incubation.
The formazan that was metabolically produced by the tissues was extracted by incubation of the tissues in isopropanol at room temperature overnight or for at least 2 hours on a plate shaker. The optical density at a wavelength of 570 nm (OD570) of the extracts was determined spectrophotometrically. Blank values were established of 4 microtiter wells filled with isopropanol for each microtiter plate.
Results and discussion
In vitro
Results
- Irritation parameter:
- percent tissue viability
- Remarks:
- (%)
- Value:
- 71
Any other information on results incl. tables
Mean tissue viability (% of negative control) | Prediction |
<= 50 | irritant |
> 50 <= 60 | no prediction |
> 60 | non-irritant |
The test substance is not able to reduce MTT directly.
The mean viability of the test-substance treated tissues was 71%.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Conclusions:
- Based on the observed results and the evaluation criteria it was concluded, that EEIM Acetate does not show an eye irritation potential in the EpiOcular™ eye irritation test under the test conditions chosen.
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