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EC number: 273-535-2 | CAS number: 68988-63-6
- 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
Endpoint summary
Administrative data
Description of key information
Imidazolium compounds, 2-C7-18-alkyl-1-(2-carboxyethyl)-4,5-dihydro-3-(hydroxyethyl), hydroxides, sodium salts as present in commercial form (31-32% active substance in aqueous solution) was shown to be an irritant in vitro (OECD TG 439) but not corrosive (OECD TG 431). Taken together the results indicate that the substance as supplied would be classified as a category 2 skin irritant.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 November 2020 - 27 November 2020
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- ColaTeric CNA-40 batch/lot # 775OI19
31.5% active substance in aqueous solution. - Test system:
- human skin model
- Source species:
- human
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 60 minutes
- Value:
- 0.176
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- ColaTeric CNA-40 was classified as an irritant to the skin.
- Endpoint:
- skin corrosion: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 February 2021 - 25 February 2021
- Reliability:
- 1 (reliable without restriction)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
- GLP compliance:
- yes (incl. QA statement)
- Specific details on test material used for the study:
- Cola®Teric CNA-40
Batch/Lot # 2093C20
Imidazolium compounds, 2-C7-18-alkyl-1-(2-carboxyethyl)-4,5-dihydro-3(hydroxyethyl), hydroxides, sodium salts 31.5 % w/w; Water 68.5 % w/w - Test system:
- human skin model
- Source species:
- human
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 1 hour
- Value:
- 57.85
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- 3 minutes
- Value:
- 88.388
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Conclusions:
- ColaTeric CNA-40 was evaluated for skin corrosion using EpiDerm tissue model following OECD TG 431 and was found to be Non-corrosive
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro eye irritation study does not need to be conducted because adequate data from an in vivo eye irritation study are available
- Endpoint:
- eye irritation: in vivo
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 06 July 2021
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- accepted calculation method
- Justification for type of information:
- a. Category definition
A category of six analogues is defined for the purpose of data-gap filling of acute toxicity by the oral route (as LD50). The analogues are shown in the attached Category Report file.
b. Hypothesis for grouping chemicals
The working hypothesis is that the selected analogues can be grouped together for the prediction of eye irritation. The hypothesis is based on the profilers’ outcome, which supports the assumption that the analogues are structurally related and share similar reactivity. The grouping approach is described further in the attached Prediction Report.
c. Category description
• The category members are tertiary amines that are > 50% structurally similar to the target chemical.
• The covered molecular log Kow range is from -2.08 to 3.69 and the target chemical is within the range. A data matrix report is listed in an attached excel file.
The prediction is based on 9 values, 3 of them (33.3%) equal to predicted value
Prediction confidence is measured by the p-value: 0.00567. - Qualifier:
- according to guideline
- Guideline:
- other: estimated data
- Principles of method if other than guideline:
- OECD Toolbox Read-Across (grouping approach)
- GLP compliance:
- not specified
- Remarks on result:
- probability of mild irritation
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Based on read-across data, EC No. 273-535-2's main (C12) component is a category 2 eye irritant.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
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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