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EC number: 802-122-7 | CAS number: 4494-16-0
- 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
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- 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:
- 12 Dec 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with acceptable restrictions. The solid test substance was applied undiluted with no justification, the evaluation criteria specified an IVIS < 55 to be labelled in no category.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
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)
- Version / remarks:
- adopted Jul 2013
- Deviations:
- yes
- Remarks:
- the solid test substance was applied undiluted without justification
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 802-122-7
- EC Number:
- 802-122-7
- IUPAC Name:
- 802-122-7
- Reference substance name:
- Octadec-9-enedioic acid
- IUPAC Name:
- Octadec-9-enedioic acid
- Details on test material:
- - Name of test material (as cited in study report): Newdioic 12358, C18:1 dioic acid
- Physical state: loose white powder
- Analytical purity: 95.1%
- Lot/batch No.: B2
- Expiration date of the lot/batch: 4 Apr 2014
- Storage condition of test material: at room temperature
Constituent 1
Constituent 2
Test animals / tissue source
- Species:
- other: cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- TEST METHOD
The bovine corneal opacity and permeability (BCOP) test is an in-vitro test method used for identifying i) chemicals inducing serious eye damage and ii) chemicals not requiring classification for eye irritation or serious eye damage. The potential of a test substance to cause ocular corrosivity or severe irritancy is measured by its ability to induce opacity and increased permeability in an isolated bovine cornea. The opacity and permeability assessments of the cornea are combined to derive an in-vitro irritancy score (IVIS), which is used to classify the irritancy level of the test substance.
IDENTIFICATION OF THE SOURCE OF THE EYES, STORAGE AND TRANSPORT CONDITIONS
- Source: slaughter houses of La Talaudière, France
- Donor animals: cattle less than 12 months old
- Date and time of eye collection: 12 Dec 2013
- Time interval prior to initiating testing: maximum 4 h after killing the animal
- Transport medium and temperature conditions: buffered Hanks´ medium at room temperature with 0.2% penicillin/streptomycin
PREPARATION OF THE EYES (BEFORE EXPOSURE)
- Eyes free of defects (scratches, pigmentation, opacity, neovascularisation): yes
- Dissection of the eyes and treatment: Corneas were dissected with a 2 to 3 mm rim of sclera. Isolated corneas were immersed in buffered Hanks medium and mounted in cornea holders.
- Description of the cornea holder: The cornea holders consist of an anterior and a posterior compartment, which interface with the epithelial and endothelial sides of the cornea. Holders were incubated in a water bath at 32 ± 1 °C.
- Test medium and temperature conditions used in the cornea holder: Eagle Minimum Essential Medium (EMEM) with and without phenol red, supplemented with 1% fetal calf serum and 0.25% penicillin/streptomycin; prior to use: pre-warmed to room temperature.
- Equilibration time: 1 h at 32 ± 1 °C
- Quality check of the equilibrated corneas: initial opacity of 0 - 7
DETERMINATION OF THE INITIAL OPACITY
- Method: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer.
- Specification of the device: OPKIT
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: number of eyes for the negative control: 3; number of eyes for the positive control: 3
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied in the test: 750 ± 75 mg
NEGATIVE CONTROL
- Substance: physiological saline
- Concentration (if solution): 0.9% sodium chloride solution in distilled water
- Amount(s) applied in the test: no data
POSITIVE SUBSTANCE
- Substance: imidazole
- Concentration (if solution): 20% (w/w) imidazole solution in physiological saline
- Amount(s) applied in the test: no data - Duration of treatment / exposure:
- 4 h ± 10 min at 32 ± 1 °C
- Observation period (in vivo):
- Not applicable
- Number of animals or in vitro replicates:
- number of eyes for the test item: 3
- Details on study design:
- TEST CONDITIONS
- Short description of the method used: open-chamber method
Open-Chamber method: The glass window from the anterior chamber was removed prior to treatment. The controls or test substance were applied directly to the epithelial surface of the cornea. After dosing, the glass window was replaced on the anterior chamber to recreate a closed system. Corneas were exposed for 4 h with the test substance or the controls.
POST-EXPOSURE TREATMENT
- Removal of the test substance: The test substance was removed from the anterior chamber and the epithelium washed three times.
- Medium for washing the corneas: EMEM containing phenol red
- Medium for final rinsing: EMEM without phenol red
DETERMINATION OF THE FINAL OPACITY
- Method: Corneal opacity was determined by the amount of light transmission through the cornea via an opacitometer.
- Time of determination: Directly after refilling fresh EMEM without phenol red in the anterior chamber.
- Specification of the device: OPKIT
DETERMINATION OF THE CORNEAL PERMEABILITY:
- Method: fluorescein solution was added to the anterior chamber of the cornea holder while the posterior chamber was filled with fresh medium. The amount of fluorescein that crosses into the posterior chamber was quantitatively measured via UV/VIS spectrophotometry at 490 nm recorded as optical density (OD490).
- Amount and concentration of the dye: 5 mg/mL sodium fluorescein solution (final concentration 0.5% in medium)
- Incubation time: 90 ± 5 min at 32 ± 1 °C
- Treatment for measuring: OD490 of a 360 µL aliquot was determined in a flat-bottomed 96-well plate.
- Dilution of the medium: A 1:5 dilution of the medium was made.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: opacity
- Basis:
- mean
- Remarks:
- of all 3 eyes
- Time point:
- other: 4 h
- Score:
- 26.7
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test substance
- Irritation parameter:
- other: permeability
- Basis:
- mean
- Remarks:
- of all 3 eyes
- Time point:
- other: 4 h
- Score:
- 0.048
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test substance
- Irritation parameter:
- other: IVIS
- Basis:
- mean
- Remarks:
- of all 3 eyes
- Time point:
- other: 4 h
- Score:
- 27.4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: test substance
- Irritation parameter:
- other: opacity
- Basis:
- mean
- Remarks:
- of all 3 eyes
- Time point:
- other: 4 h
- Score:
- 138.7
- Reversibility:
- other: not applicable
- Remarks on result:
- other: positive control
- Irritation parameter:
- other: permeability
- Basis:
- mean
- Remarks:
- of all 3 eyes
- Time point:
- other: 4 h
- Score:
- 3.808
- Reversibility:
- other: not applicable
- Remarks on result:
- other: positive control
- Irritation parameter:
- other: IVIS
- Basis:
- mean
- Remarks:
- of all 3 eyes
- Time point:
- other: 4 h
- Score:
- 195.8
- Reversibility:
- other: not applicable
- Remarks on result:
- other: positive control
Any other information on results incl. tables
Table 1: Opacity values
Parameter |
Initial opacity |
Final opacity |
Opacity change |
Mean opacity change of NC |
Corrected opacity change |
Mean opacity value |
Negative control |
0 |
4 |
4 |
- |
|
3.3 |
5 |
8 |
3 |
3.3 |
|||
5 |
8 |
3 |
|
|||
Test substance |
1 |
31 |
30 |
- |
26.7 |
26.1 |
5 |
34 |
29 |
25.7 |
|||
2 |
33 |
31 |
27.7 |
|||
Positive control |
4 |
147 |
143 |
- |
139.7 |
138.7 |
6 |
146 |
140 |
136.7 |
|||
4 |
147 |
143 |
139.7 |
Table 2: Permeability values (optical density (OD) at 490 nm)
Parameter |
OD490 |
Mean Blank OD490 |
OD490 change |
Mean OD490 change of NC |
Corrected OD490 change |
Mean OD490 value |
Negative control |
0.025 |
0.028 |
- |
0.028 |
- |
- |
0.032 |
- |
|||||
0.026 |
- |
|||||
Test substance |
0.079 |
- |
- |
- |
0.051 |
0.048 |
0.089 |
- |
0.061 |
||||
0.060 |
- |
0.032 |
||||
Positive control |
3.740 |
- |
- |
- |
3.712 |
3.808 |
3.792 |
- |
3.764 |
||||
3.976 |
- |
3.948 |
Table 3: In vitro irritancy score (IVIS) values
|
IVIS |
Mean IVIS |
Test substance |
27.4 |
27.4 ± 0.8 |
26.6 |
||
28.2 |
||
Positive control |
195.4 |
195.8 ± 2.9 |
193.1 |
||
198.9 |
Applicant's summary and conclusion
- Interpretation of results:
- other: non-corrosive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- No prediction on the irritation potential can be made based on the results of the test, but the test substance does not have to be classified as serious eye irritant (Eye Dam Cat. 1).
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