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EC number: 939-039-1 | 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:
- key study
- Study period:
- 20 October 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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 (incl. QA statement)
Test material
- Test material form:
- solid: particulate/powder
- Details on test material:
- Name of test material (as cited in study report): 20231250
- Physical state: white powder
- Storage condition of test material: room temperature (ca. 20°C) in the dark
Constituent 1
Test animals / tissue source
- Species:
- other: bovine cornea
- Details on test animals or tissues and environmental conditions:
- Species: bovine cattle.
Origin: bovine eyes were obtained from freshly slaughtered cattle at the local slaughterhouse.
Age: not provided.
Reason for choice: bovine corneas are recommended by regulatory authorities for this type of study. They are adapted for the evaluation of potential ocular irritants since they are part of the target organ.
Transport from Supplier to laboratory: the eyes were transported to the laboratory at ambient temperature, immerged in buffered Hanks medium containing an antibiotic [Hank’s Balanced Salts Solution (HBSS) plus penicillin/streptomycin (100 units/100 µg/mL final)].
Upon arrival at the laboratory, the selection and preparation of corneas was performed as soon as possible. At each step of the preparation procedure, care was taken to avoid touching the corneas in order not to damage them.
Selection: a careful macroscopic examination was performed on all eyes to detect the presence of any defects (opacity, scratches, pigmentation, etc). Any eyes with defects were discarded. The examination was performed under a lamp, using HBSS in order to keep the eyes moistened and shiny.
Preparation of the selected corneas: the tissues surrounding the eyeball were carefully pulled away and the cornea, surrounded by approximately 2 to 3 mm of sclera, was dissected out. The isolated corneas were stored in HBSS until all corneas had been prepared.
Washing of the corneas: the corneas were rinced in HBSS plus penicillin/streptomycin (100 units/100 µg/mL final) at room temperature.
The eyes were used 4 hours 16minutes after slaughter.
(Pre)Incubation T°C: 32°C
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 20% (w/w)
VEHICLE
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 0.9%
- Lot/batch no. (if required): Sigma S8776, Lot batch 128K2337 - Duration of treatment / exposure:
- 4 hours
- Observation period (in vivo):
- not applicable
- Duration of post- treatment incubation (in vitro):
- 90-min for tPermeability measurement
- Number of animals or in vitro replicates:
- 3 cornea per treatment groups
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Following incubation, the test substance, positive and negative controls were removed and the epithelial surface of the corneas washed, at least three times or until the wash medium (MEM with phenol red) was clear and there was no discolouration. The wash medium was added via the holes on the top of the holder. The test substance required eight washes.
- Time after start of exposure: 4 hours
SCORING SYSTEM / TOOL USED TO ASSESS SCORE:
- Opacity:
Using an opacitometer
The average change in opacity during exposure is determined. It is corrected by subtracting the average negative control value from values of positive control and test item treated corneas.
- Permeability:
Using a spectrophotometer: optical density (OD) at 490 nm wavelength
The optical density is corrected by subtracting the average negative control value from values of positive control and test item treated corneas.
- Scoring:
In vitro irritancy score (IVIS) = Corrected Opacity + (15 x Corrected OD)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Value:
- -0.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks:
- 133
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Value:
- -1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Remarks:
- 0.0
- Positive controls validity:
- valid
- Remarks:
- 90.3
- Irritation parameter:
- fluorescein leakage
- Value:
- 0.004
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Remarks:
- 0.018
- Positive controls validity:
- valid
- Remarks:
- 2.83
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system:
No notable opaque spots or irregularities were observed on the three test substance and negative control-treated corneas.
Opacity, fluorescein fixation and thickening of the corneas were observed on those treated with the positive control.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes (Negative control: opacity = 0.000 +/- 1.00; permeability = 0.018 +/- 0.008.)
- Acceptance criteria met for positive control: yes ( IVIS = 133 +/- 2.60 The positive control IVIS was within the range of historical mean +/- 2 SD: 112.8 - 164.3).
Any other information on results incl. tables
Table 7.3.2/2: Individual and Mean Corneal Opacity and Permeability Measurements
Treatment |
Cornea Number |
Opacity |
Permeability (OD) |
In vitro Irritancy Score (IVIS) |
||||
Pre-Treatment |
Post-Treatment |
Change Post -Pre-Treatment |
Corrected Value |
|
Corrected Value |
|||
Negative Control |
1 |
5 |
6 |
1 |
|
0.022 |
|
|
14 |
5 |
4 |
-1 |
|
0.024 |
|
|
|
16 |
5 |
5 |
0 |
|
0.009 |
|
|
|
Mean |
|
|
0.000 |
0.018 |
|
|||
Positive Control |
2 |
6 |
99 |
93 |
93.000 |
2.475 |
2.457 |
129.850 |
3 |
6 |
100 |
94 |
94.000 |
2.635 |
2.617 |
133.250 |
|
4 |
4 |
88 |
84 |
84.000 |
3.420 |
3.402 |
135.025 |
|
Mean |
|
|
|
90.333 |
|
2.825 |
132.7 |
|
Test Item |
8 |
6 |
4 |
-2 |
-2.000 |
0.022 |
0.004 |
-1.945 |
9 |
6 |
8 |
2 |
2.000 |
0.033 |
0.015 |
2.220 |
|
10 |
6 |
3 |
-3 |
-3.000 |
0.013 |
-0.005 |
-3.080 |
|
Mean |
|
|
-1.000 |
|
0.004 |
-0.9 |
OD= Optical density
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- the test substance is considered as not requiring classification for eye irritation or serious eye damage.
- Executive summary:
A study was performed to assess the ocular irritancy potential of the test substance to the isolated bovine cornea. The study was conducted according to the OECD guideline No. 437 and in compliance with the principles of Good Laboratory Practice .Negative (Sodium chloride 0.9%) and positive (imidazole purity 99.7%) control items were tested concurrently.
The test substance was mixed using a mortar and pestle. The 0.9% sodium chloride solution was added to achieve the desired concentration of 20%. Then 750 µL of the diluted test substance was applied on each cornea (3 corneas/treatment condition). The corneas were incubated for 4 hours at 32°C. Following incubation, the test substance, positive and negative controls were removed and the epithelial surface of the cornea washed.
The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined to generate an In Vitro Irritancy Score (IVIS).
To consider the study as valid, the positive control should elicit an In Vitro Score that falls within two standard deviations of the historical mean for the laboratory, which was the case; IVIS of imidazole was found to be 132.7 +/- 2.60. Furthermore, the negative control mean opacity change value should be<2.0 and the permeability mean value<0.1, which was the case as opacity of sodium chloride 0.9% was 0.000 +/- 1.00 and the permeability was 0.018 +/- 0.008.
IVIS of the test item was determined to be -0.90 +/- 2.80, which was below the cut-off value of 3 and thus indicating that the test substance was not requiring classification for eye irritation or serious eye damage.
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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