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Diss Factsheets
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EC number: - | CAS number: -
- 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:
- 2014-11-17 to 2015-05-20
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
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)
Test material
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 003
- Expiration date of the lot/batch: 01 Jan 2020
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, exclusion of direct sunlight, test substance is hygroscopic
- Stability under test conditions: stable
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Schlachthof Bensheim, Am Schlachthof 7-9, 64625 Bensheim, Germany
- Characteristics of donor animals: 12 to 60 months of age
- indication of any existing defects or lesions in ocular tissue samples: Not observed.
Test system
- Vehicle:
- water
- Controls:
- yes
- Amount / concentration applied:
- TEST MATERIAL
- Amount applied: 750 µL
- Concentration (if solution): 20 % (w/v)
VEHICLE
- Amount applied: 750 µL - Duration of treatment / exposure:
- 4 hours
- Number of animals or in vitro replicates:
- 3
- 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 Eagles’s MEM (without phenol red) and then equilibrated in a vertical position at about 32 °C for at least 1 hour. 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 < 537 opacity units 1 were discarded. The remaining corneas were then distributed into negative control, positive control and treatment groups. Each corneal holder was uniquely identified with a number on the chambers.
NUMBER OF REPLICATES
3 corneas were used per treatment group.
SOLVENT CONTROL USED
De-ionized water
POSITIVE CONTROL USED
Imidazole (CAS No. 288-32-4) 20 % (w/v) solution in deionized water for non-surfactant solid test substances
TREATMENT METHOD: open chamber
POST-INCUBATION PERIOD: no
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: The test substance could not be removed with a syringe. Therefore the corneas were rinsed with the open chamber method.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: was observed visually. Final corneal opacity readings were taken for each cornea with an opacitometer.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of microtiter plate reader (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: Evaluation of results were based on the decision criteria used in OECD guideline 437.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 0
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: Not observed
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Range of historical values: Mean ± SD (Mean-2SD - Mean+2SD)
Historic range NC
Opacity = 6.6 ± 2.0 (2.6 - 10.5)
Permeability = 0.001 ± 0.006 (-0.011 - 0.013)
Historic range PC
Opacity = 70.1 ± 13.7 (42.7 - 97.4)
Permeability = 3.039 ± 0.659 (1.721 - 4.358)
IVIS = 115.8 ± 12.0 (91.9 - 139.7)
Any other information on results incl. tables
Opacity score of test substance, NC and PC
Cornea No. |
Initial opacity |
final opacity |
opacity change |
corrected opacity change |
mean |
SD |
|
test substance |
7 |
6.1 |
9.8 |
3.7 |
0.0 |
0.0 |
0.0 |
8 |
2.2 |
4.6 |
2.4 |
0.0 |
|||
9 |
3.5 |
11.1 |
7.6 |
0.0 |
|||
NC |
1 |
2.6 |
18.3 |
15.7 |
NA |
8.4 |
6.4 |
2 |
3.4 |
8.8 |
5.4 |
NA |
|||
3 |
2.1 |
6.1 |
4 |
NA |
|||
PC |
4 |
4.9 |
97.6 |
92.7 |
84.4 |
86.2 |
12.3 |
5 |
1.9 |
85.3 |
83.4 |
75 |
|||
6 |
2.2 |
109.9 |
107.7 |
99.3 |
Permeability score of test substance, NC and PC
Cornea No. |
Mean OD490 |
Dilution factor |
Mean corrected OD490* |
mean |
SD |
|
test substance |
7 |
0.005 |
1 |
0.003 |
0.003 |
0.003 |
8 |
0.008 |
1 |
0.006 |
|||
9 |
-0.002 |
1 |
0 |
|||
NC |
1 |
-0.001 |
1 |
NA |
0.002 |
0.002 |
2 |
0.002 |
1 |
NA |
|||
3 |
0.003 |
1 |
NA |
|||
PC |
4 |
0.559 |
5 |
2.792 |
2.625 |
0.275 |
5 |
0.462 |
5 |
2.308 |
|||
6 |
0.556 |
5 |
2.777 |
In Vitro Irritancy score (IVIS) of the test substance, NC and PC
Cornea No. |
Opacity per cornea |
Permeability per cornea |
IVIS |
|||
per cornea |
mean |
SD |
||||
test substance |
7 |
0.0 |
0.003 |
0.0 |
0.0 |
0.0 |
8 |
0.0 |
0.006 |
0.1 |
|||
9 |
0.0 |
0.0 |
0.0 |
|||
NC |
1 |
15.7 |
0.0 |
15.7 |
8.4 |
6.4 |
2 |
5.4 |
0.002 |
5.4 |
|||
3 |
4 |
0.003 |
4.1 |
|||
PC |
4 |
84.4 |
2.792 |
126.2 |
125.6 |
15.7 |
5 |
75 |
2.308 |
109.7 |
|||
6 |
99.3 |
2.777 |
141 |
* Negative values are set to zero for further calculation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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