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Diss Factsheets
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EC number: 241-300-3 | CAS number: 17265-14-4
- 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:
- weight of evidence
- Study period:
- 2016-06-22 to 2016-08-10
- 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:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- 26 July 2013
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE, Experimental Toxicology and Ecology, 67056 Ludwigshafen, Germany
Test material
- Reference substance name:
- Disodium sebacate
- EC Number:
- 241-300-3
- EC Name:
- Disodium sebacate
- Cas Number:
- 17265-14-4
- Molecular formula:
- C10H18O4.2Na
- IUPAC Name:
- disodium sebacate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test-substance preparation was solved in H2O per weight per volume (w/v) and stirred with a magnetic stirrer shortly before application.
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Schlachthof Mannheim, Schlachthofstr. 21, 68165 Mannheim, Germany
- Characteristics of donor animals: age min. 12 months, max. 60 months
- indication of any existing defects or lesions in ocular tissue samples: Only Corneas free of defects were used
Test system
- Vehicle:
- water
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Concentration (if solution):
Treatment: 750 µL, 20 % (w/v) test substance in water
Negative control: 750 µL de-ionized water
Positive control: 750 µL, 20 % (w/v) imidazole/de-ionized water - Duration of treatment / exposure:
- Corneal opacity: 4 h at 32 °C
- Duration of post- treatment incubation (in vitro):
- Permeability: replacement of the test substance with 1 mL sodium fluorescin solution (5 mg/mL) and 90 ±5 min. incubation at 32 °C
- Number of animals or in vitro replicates:
- 3 corneas in each group (Treatment, NC, PC)
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
Corneas free of defects (opacity, scratches, pigmentation etc.) were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were mounted in cornea holders that consists of anterior and posterior chambers. Both chambers were filled to excess with pre-warmed Eagle’s MEM (without phenol red) and then equilibrated in a vertical position at about 32 °C for at least 1 hour.
QUALITY CHECK OF THE ISOLATED CORNEAS
After the equilibration period the medium in both chambers was replaced with fresh prewarmed medium and initial corneal opacity readings were taken for each cornea with an opacitometer. Any corneas that showed macroscopic tissue damage or an opacity value < 548 opacity units were discarded.
NUMBER OF REPLICATES
3
NEGATIVE CONTROL USED
Yes, 750 µL de-ionized water
POSITIVE CONTROL USED
Yes, 20% (w/v) solution of imidazole in de-ionized water
POST-INCUBATION PERIOD
no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least 3 times with Eagle’s MEM (containing phenol red) and once with Eagle’s MEM (without phenol red).
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: corneal opacity readings were taken for each cornea with an opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of a 96-well microtiter plate reader (OD490)
SCORING SYSTEM:
In Vitro Irritancy Score (IVIS)
Evaluation of the test results based on to the criteria given in OECD 437 (July 2013).
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- BCOP Test
- Value:
- 0.1
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: Not reported
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
Any other information on results incl. tables
BCOP Test results:
Test substance identification | Mean Opacity Value | Mean Permeability Value | Mean In Vitro Irritancy Score |
Test substance | 0.0 | 0.004 | 0.1 |
NC | 10.6 | 0.003 | 10.6 |
PC | 84.5 | 2.259 | 118.4 |
Applicant's summary and conclusion
- Interpretation of results:
- other: not severely irritating
- Conclusions:
- Based on the results for BCOP and EpiOcular Test and applying the evaluation criteria described, the test item shows an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen but is not severely irritating or corrosive.
- Executive summary:
The potential of the test tem to cause ocular irritation or serious damage to the eyes was assessed by a single topical application of 750 μL of a 20% test-substance preparation to the epithelial surface of isolated bovine corneas. Three corneas were treated with the test-substance preparation for an exposure period of 4 hours. In addition to the test substance a negative control (NC; de-ionized water) and a positive control
(PC; 20% imidazole in de-ionized water) were applied to three corneas each. Corneal opacity was measured quantitatively as the amount of light transmitted through the cornea. Permeability was measured quantitatively as the amount of sodium fluorescein dye that passes across the full thickness of the cornea. Both measurements were used to calculate an In Vitro Irritancy Score of the test substance.
Based on the results for BCOP and EpiOcular Test and applying the evaluation criteria described, the test item shows an eye irritation potential in the in vitro eye irritation test strategy under the test conditions chosen but is not severely irritating or corrosive.
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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