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EC number: 272-964-2 | CAS number: 68921-83-5
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- The experimental start date was 13 Nov 2017, the experimental completion date was 17 Nov 2017.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- Adopted 09 October 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Dimethyl[3-[(1-oxooctadecyl)amino]propyl][2-oxo-2-(tetradecyloxy)ethyl]ammonium chloride
- EC Number:
- 272-964-2
- EC Name:
- Dimethyl[3-[(1-oxooctadecyl)amino]propyl][2-oxo-2-(tetradecyloxy)ethyl]ammonium chloride
- Cas Number:
- 68921-83-5
- Molecular formula:
- C39H79N2O3.Cl
- IUPAC Name:
- dimethyl(3-octadecanamidopropyl)[2-oxo-2-(tetradecyloxy)ethyl]azanium chloride
- Reference substance name:
- Propane-1,2-diol
- EC Number:
- 200-338-0
- EC Name:
- Propane-1,2-diol
- Cas Number:
- 57-55-6
- Molecular formula:
- C3H8O2
- IUPAC Name:
- propylene glycol
- Test material form:
- semi-solid (amorphous): gel
- Details on test material:
- Identification Quaternium-70
Appearance Amber gel
Batch 0002000146
Composition UVCB
Test item storage at room temperature
Stable under storage conditions until 02 April 2018 (retest date)
Constituent 1
Constituent 2
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- EpiOcular™ (OCL-200-EIT MatTek Corporation, Lot: 27406 Kit Q.
Source: MatTek Corporation, Ashland MA, U.S.A.
The EpiOcular tissue construct is a non-keratinized epithelium (0.6 cm2) prepared from normal human keratinocytes (MatTek). It models the cornea epithelium with progressively stratified, but not cornified cells. These cells are not transformed or transfected with genes to induce an extended life span in culture.
The “tissue” is prepared in inserts with a porous membrane through which the nutrients pass to the cells. A cell suspension is seeded into the insert in specialized medium. After an initial period of submerged culture, the medium is removed from the top of the tissue so that the epithelial surface is in direct contact with the air. This allows the test material to be directly applied to the epithelial surface in a fashion similar to how the corneal epithelium would be exposed in vivo.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- Neat, the test item (an excessive amount per tissue) was applied directly on top of the skin tissue and spread to match the size of the tissue. Since the test item induced color interference in aqueous conditions, two tissues were treated with test item and incubated with DMEM instead of MTT solution.
- Duration of treatment / exposure:
- 6 hours ± 15 minutes at 37.0 ± 1.0°C
- Duration of post- treatment incubation (in vitro):
- Post-Soak: 25 ± 2 minute immersion incubation at room temperature.
After the Post-Soak period cell culture inserts were each dried carefully and transferred to the 6-well plate containing 1.0 ml of warm Assay Medium and were incubated for 18 hours ± 15 minutes at 37°C.
After incubation, cell culture inserts were dried carefully to remove excess medium and subsequently transferred into a 24-wells plate prefilled with 0.3 ml MTT-medium (1.0 mg/ml). The tissues were incubated for 180 ± 10 minutes at 37°C. - Number of animals or in vitro replicates:
- 2 tissues per test item together with a negative control and positive control
- Details on study design:
- Quaternium-70 was checked for possible color interference and direct MTT reduction before the study was started.
On the day of receipt the tissues were equilibrated (in its 24-well shipping container) to room temperature. Subsequently, tissues were transferred to 6-well plates and incubated for
20 ± 4 hours at 37°C in 1.0 ml fresh pre-warmed Assay Medium, which was refreshed after approximately 1 hour.
DMEM (Dulbecco’s Modified Eagle’s Medium): Supplemented DMEM medium, serum-free supplied by MatTek Corporation.
MTT medium: MTT concentrate (5 mg/ml) diluted (1:5) with MTT diluent.
The tissues were pre-incubated at standard culture conditions for 30 ± 2 minutes.
After the exposure period, tissues were thoroughly rinsed with Ca2+Mg2+-free D-PBS to remove residual test item.
Cell viability was calculated for each tissue as a percentage of the mean of the negative control tissues. Eye hazard potential of the test item was classified according to remaining cell viability following exposure of the test item.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- mean % tissue viability
- Run / experiment:
- Main
- Value:
- 12
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Remarks:
- Milli-Q water
- Positive controls validity:
- valid
- Remarks:
- Methyl Acetate
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
The relative mean tissue viability obtained after 6 hours±15 minutes treatment with Quaternium-70 compared to the negative control tissues was 12%. Since the mean relative tissue viability for Quaternium-70 was below 60%, it is considered to be potentially irritant or corrosive to the eye. The positive control had a mean cell viability after 6 hours ±15 minutes exposure of 31%. The absolute mean OD570 of the negative control tissues was within the laboratory historical control data range . The difference between the percentage of viability of two tissues treated identically was less than 17%, indicating that the test system functioned properly.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 2 or Category 1
- Conclusions:
- Quaternium-70 is potentially irritant or corrosive in the EpiOcular™ test under the experimental conditions described in this report. The test item is identified as potentially requiring classification and labelling according to UN GHS (Category 2 or Category 1). Assuming a worst case scenario, the ultimate classification is set at cat. 1.
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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