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EC number: 203-431-4 | CAS number: 106-79-6
- 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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 October 2012 to 7 May 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Fully GLP compliant and in accordance with current test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dimethyl sebacate
- EC Number:
- 203-431-4
- EC Name:
- Dimethyl sebacate
- Cas Number:
- 106-79-6
- Molecular formula:
- C12H22O4
- IUPAC Name:
- 1,10-dimethyl decanedioate
- Test material form:
- other: Solid to liquid (melting point 23°C)
- Details on test material:
- Name: Dimethyl sebacate
CAS number: 106.79.6
Batch number: 120801
Purity: 99.08%
Expiry date: 31 August 2013
Date of receipt: 11 October 2012
Storage details: stored in a sealed container, at room temperature in the dark,
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Upon arrival at the test facility, the corneas were excised from the eyes and loaded onto the specifically designed holders. Both chambers of each holder were filled with pre-warmed Eagle's Minimal Essential Medium (EMEM) (posterior chamber first), ensuring that no bubbles were formed. The holders were incubated at 32±1°C for at least 1 hour. After the incubation, the media was removed from both the anterior and posterior chmabers. Fresh media was added to the the posterior chamber first and then the anterior chamber (this media replacement order ensured the cornea retained its natural curvature as much as possible). The opacity of each cornea was measured using an opacitometer. Any corneas found to have scratches or increased neovascularization or an opacity of >7 opacity units when examined prior to treatment were discarded.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- A volume of 750 µL of undiluted test article was applied to each of the three corneas.
- Duration of treatment / exposure:
- After the initial application the corneas were incubated for 10 minutes.
- Observation period (in vivo):
- After the initial 10 minute exposure period the corneas were washed with media containing phenol red (as a pH indicator) until the indicator showed no effect. The corneas were then washed with fresh media and incubated (horixontally) for 2 hours ± 10 minutes. For the permeability endpoint, 1 mL of sodium flourescein (4 mg/mL solution) was added into the anterior chamber and the corneas were incubated in the vertical position for 1.5 hours ± 5 minutes.
- Number of animals or in vitro replicates:
- Three corneas were used for both dosed and control groups
- Details on study design:
- A volume of 750 µL was applied to each of the three corneas followed by a ten minute incubation at 32°C. After this incubation the corneas were waswashed with media containing phenol red (as a pH indicator) until the indicator showed no pH effect occuring (demonstrating that the test article had been removed successfully). The corneas were then washed once in media without phenol red and the opacities measured. The corneas were incubated (horizontally) for 2 hours ± 10 minutes after which, the opacities were measured and then the anterior chamber emptied. For the permeability endpoint, 1 mL of sodium flourescein (4 mg/mL solution) was added into the anterior chamber and the corneas were incubated in the vertical position for 1.5 hours ± 5 minutes. Following this period, the media in the posterior chamber was removed and held in a labelled tube. Three 350 µL aliquots of this media (per cornea) were analysed for optical density at 490 nanometers (OD490) using a spectrophotometer.
A volume of 750 µL of the negative or positive control was similarly applied to further groups of three corneas. These groups were subject to the procedures detailed above.
All corneas were preserved in 10% Neutral Buffered Formalin.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Value:
- -0.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: mean group corrected optical density
- Value:
- -0.158
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Value:
- -3.04
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
In vivo
- Irritant / corrosive response data:
- The mean opacity reading for the test article was -0.7 and the mean group corrected optical density was -0.158.
The mean opacity reading and the mean group corrected optical density for the negative control were 0.0.
The mean opacity reading for the positive control was 54.7 and the mean group corrected optical density was 1.017.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test article, Dimethyl Sebacate, produced an IVIS score of -3.04 and was considered not to be corrosive or severely irritating to the eye.
- Executive summary:
A bovine corneal opacity and permeability (BCOP) assay was conducted. Three corneas were treated by application of 750 µL of the undiluted test article onto the anterior surface of the cornea followed by a 10 minute incubation at 32°C ± 1°C. A volume of 750 µL of the negative or positive control was similarly applied to further groups of three corneas.
The corneas were then washed and the anterior chamber filled with pre-warmed EMEM (without phenol red). The corneas were then incubated for an additional 2 hours at 32°C ± 1°C. At the end of the post-incubation period the corneas were assessed for opacity. Permeability was determined by the amount of sodium fluorescein dye that penetrated all corneal layers. The media in the anterior chamber was replaced with 4 mg/mL sodium fluorescein, while the posterior chamber was filled with fresh EMEM. The corneas were then incubated for 90 minutes ± 5 minutes at 32 ± 1°C after which the media in the posterior chamber was assessed for presence of sodium fluorescein by measuring the optical density at 490 nanometers using a spectrophotometer.
The mean opacity reading for the test article was -0.7 and the mean group corrected optical density for the test article was -0.158. The test article produced an IVIS score of -3.04 and was considered not to be corrosive or severely irritating to the eye. The in vivo test was therefore conducted.
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