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Diss Factsheets
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EC number: 257-440-3 | CAS number: 51812-80-7
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar 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:
- A draft test guideline on RhCE test method pf July 27, 2015
- GLP compliance:
- no
- Remarks:
- Laboratory works with standard operating procedures and according to GLP procedures with the exception of audits by a separate Quality Assurance Unit.
Test material
- Reference substance name:
- 3-(D-gluconoylamino)propyl(2-hydroxyethyl)dimethylammonium chloride
- EC Number:
- 257-440-3
- EC Name:
- 3-(D-gluconoylamino)propyl(2-hydroxyethyl)dimethylammonium chloride
- Cas Number:
- 51812-80-7
- Molecular formula:
- C13H29N2O7.Cl
- IUPAC Name:
- 1-Propanaminium, 3-(D-gluconoylamino)-N-(2-hydroxyethyl)-N,N-dimethyl-, chloride
- Test material form:
- liquid
- Details on test material:
- Batch 0002042127
Constituent 1
- Specific details on test material used for the study:
- Solid fraction: 60.2%
Physical state: Clear yellow to light amber liquid
pH: 4.9
Storage at room temperature
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- Pre-incubation step
· For a given chemical a minimum of 2 tissues were used.
· An appropriate numbers of 6-well plates were filled with 1 ml of EpiOcular™ Assay Medium. EpiOcular™ EIT test kit was open and tissues were transferred into Assay medium filled wells, using sterile forceps.
· Place the tissues at 37°C, 5% CO2 until test substance application (usually 16 – 24 hours).
Test system
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- Treatment of liquid test article:
· After the overnight incubation, the tissues are pre-wetted with 20 μL of Ca2+Mg2+-Free-DPBS. The tissues are incubated at standard culture conditions for 30 ± 2 minutes.
· Each liquid test and control article is tested by applying 50 μl topically on the EpiOcular™ tissues. The tissues are incubated at standard culture conditions for 30 ± 2 minutes.
· At the end of the treatment time, the test articles are removed by extensively rinsing the tissues with Ca2+Mg2+-free D-PBS, and any remaining liquid should be decanted onto the absorbent material.
· Epitheliums were immersed in a new 12-well plate containing 5 mL of fresh Assay Medium, for 12 ± 2 minutes at room temperature. - Duration of treatment / exposure:
- 30 minutes
- Duration of post- treatment incubation (in vitro):
- For Liquids (except colorant):
· 24-well plates were filled with 300 μL MTT solution (1 mg/ml).
· Treated tissues were transferred in the pre-filled MTT 24-well plates and Incubated for 3 hours (± 10 minutes) at 37°C and 5% CO2.
· Treated tissue insert bottom was dried on sterile absorbent paper and transferred in new 24-well plate containing 2 mL of isopropanol so that isopropanol is flowing into the insert on the tissue surface.
· Plate was protected from evaporation by stretching 3 parafilm layers over the plate and adding the lid on the plate and incubated in the dark for 2 hours (± 5 minutes) at room temperature with gentle agitation (about 150 rpm) or overnight at 2-8°C for formazan extraction.
· Tissue and polycarbonate filter were pierced with a tip in order to get the whole extraction solution in the corresponding well.
· Extraction solution was homogenized by pipetting 3 times up and down to complete Formazan crystals solubilization.
· 2 x 200 μL extraction solution per well (= 2 wells per tissue i.e. 2 replicates per tissue) were transferred into a 96-well plate.
· Optical Densities (OD) was read using a 96-well plate spectrophotometer: The concentration of Formazan was measured by determining the OD at 570 nm. - Details on study design:
- ACCEPTANCE CRITERIA
· Negative control: The negative control data meet the acceptance criteria if
o The mean OD value of tissues is > 0.8 and < 2.5
o The variability between two tissue replicates should be less than 20%.
· Positive control: The positive control data meet the acceptance criteria if the mean relative viability, expressed as % of the NC, is:
o ≤ 50% for 30-minute exposure for liquid substances
o ≤ 50% for 6-hrs exposure for solid substances
· Tested Substance: A test meets the acceptance criterion if :
o The variability between two tissue replicates should be less than 20%.
o This applies also to the killed controls and the colorant controls which are calculated as percent values related to the viability of the relating negative control.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Remarks:
- % tissue viability
- Run / experiment:
- EpiOcular™ Eye Irritation test (EIT)
- Value:
- 91.72
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Cell viability results :
Group | Mean Viability (%) | Classification |
Negative Control / Water | 100 | No Category |
Positive Control / Methyl acetate | 33.16 | Cat1/Cat2 |
Tested Product / Neat CERAPHYL™ 60 | 91.72 | No Category |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to EpiOcular™ Eye Irritation test, CERAPHYL™ 60 is not classified for eye irritation or serious eye damage and defined as UN GHS: No category.
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