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EC number: 943-693-3 | 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:
- Feb 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- 09 Oct 2017
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- (from the competent authority) Landesamt für Umwelt Rheinland-Pfalz
Test material
- Reference substance name:
- Reaction mass of diammonium (2R,3R)-2,3-dihydroxybutanedioate and diammonium bis[(2R,3R)-2,3-dioxidobutanedioato]diantimonate(2-)
- EC Number:
- 943-693-3
- IUPAC Name:
- Reaction mass of diammonium (2R,3R)-2,3-dihydroxybutanedioate and diammonium bis[(2R,3R)-2,3-dioxidobutanedioato]diantimonate(2-)
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No.of test material: 170492F01
- Expiration date of the lot/batch: 22 Jun 2019
- Purity: 100.0 area-% (HPLC fingerprint)
- Content:
21.4 g/100 g Test Item
23.5 g/100 g (NH4)2C4H4O6
30 g/100 g Tartrate
6.7 g/100 g Ammonium
9.1 g/100 g Antimony
53.5 g/100 g Water
- pH value: ca. 9 (undiluted test substance)
- Physical state / color: Liquid / colorless to yellowish, clear
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Schlachthof Alzey, Emil Färber GmbH & Co. KG, Robert-Bosch-Straße 23, 55232 Alzey, Germany
- indication of any existing defects or lesions in ocular tissue samples: no
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL - Duration of treatment / exposure:
- approx. 10 min
- Duration of post- treatment incubation (in vitro):
- 2 h
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: Bovine eyes are obtained as a by-product of freshly slaugthered cattle (age of the animals: minimum 12 months, maximum 60 months).
QUALITY CHECK OF THE ISOLATED 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. After the equilibration period, the medium in both chambers was replaced by fresh pre-warmed 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 < 554 opacity units were discarded. The remaining corneas were then distributed into negative control, positive control and treatment groups.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: deionized water
POSITIVE CONTROL USED: 100 % ethanol for liquid test substances and surfactants
APPLICATION DOSE AND EXPOSURE TIME: 750 µL for 10 minutes
POST-INCUBATION PERIOD: yes, 2 hours
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: Before measurement, each cornea was visually observed an observations were recorded. Final corneal opacity readings were taken for each cornea with an opacitometer.
- Corneal permeability: For determination of permeability, the medium in the anterior chamber was replaced by 1 mL sodium fluorescein solution (4 mg/mL for liquid test substances and surfactants) and incubated for 90 +/- 5 minutes in a horizontal position at about 32 °C. The amount of sodium fluorescein that permeated through the corneas into the posterior chamber was spectrophotometrically measured. Three aliquots per cornea were transferred to a 96-well microtiter plate and the optical density (OD490) was determined.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA:
IVIS ≤ 3: No UN GHS Category
IVIS > 3; ≤ 55: No prediction can be made
IVIS > 55: UN GHS Category 1
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean
- Value:
- 4.9
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Opacity score of the test substance, the NC and the PC
Test substance identification |
Cornea-No. |
Initial opacity |
Final opacity |
Opacity change |
Corrected opacity change |
Mean |
SD |
Test substance |
16 17 18 |
6.1 4.7 6.4 |
15.7 10.9 15.0 |
9.6 6.2 8.6 |
6.4 3.0 5.4 |
4.9 |
1.8 |
NC |
10 11 12 |
3.8 5.6 4.8 |
4.1 8.4 11.4 |
0.3 2.8 6.6 |
NA NA NA |
3.3 |
3.2 |
PC |
13 14 15 |
4.7 5.3 4.4 |
35.6 41.0 39.3 |
31.0 35.7 34.9 |
27.7 32.4 31.6 |
30.6 |
2.5 |
NC: negative control
PC: positive control
SD: standard deviation
NA: not applicable
Table 2: Permeability score of the test substance, the NC and the PC
Test substance identification |
Cornea-No. |
Mean OD490 |
Dilution factor |
Mean corrected OD490 |
Mean |
SD |
Test substance |
16 17 18 |
0.004 0.008 0.000 |
1 1 1 |
0.000 0.002 0.000 |
0.001 |
0.001 |
NC |
10 11 12 |
0.000 0.016 0.004 |
1 1 1 |
NA NA NA |
0.007 |
0.008 |
PC |
13 14 15 |
1.260 1.157 0.993 |
1 1 1 |
1.253 1.150 0.986 |
1.130 |
0.135 |
NC: negative control
PC: positive control
SD: standard deviation
NA: not applicable
Table 3: In Vitro Irritancy Score (IVIS) of the test substance, the NC and the PC
Test substance identification |
Cornea-No. |
Opacity per cornea |
Permeability per cornea |
IVIS |
||
Per cornea |
Per group |
|||||
Mean |
SD |
|||||
Test substance |
16 17 18 |
6.4 3.0 5.4 |
0.000 0.002 0.000 |
6.4 3.0 5.4 |
4.9 |
1.7 |
NC |
10 11 12 |
0.3 2.8 6.6 |
0.001 0.016 0.004 |
0.3 3.1 6.7 |
3.4 |
3.2 |
PC |
13 14 15 |
27.7 32.4 31.6 |
1.253 1.150 0.986 |
46.5 49.7 46.4 |
47.5 |
1.9 |
NC: negative control
PC: positive control
SD: standard deviation
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- No prediction can be made for eye irritation according to GHS criteria based on the results of this in vitro study alone.
- Executive summary:
The potential of the test substance to cause ocular irritation or serious eye damage to the eyes was assessed by a single topical application of 750 µL undiluted test substance to the epithelial surface of isolated bovine corneas.
Three corneas were treated with the test substance for 10 minutes followed by a 2-hours post-incubation period.
In addition to the test substance, a negative control (NC, deionized water) and a positive control (PC, 100 % ethanol) were applied to three corneas each.
Corneal opacity was quantitatively measured as the amount of light transmitted through the cornea. Permeability was quantitatively measured 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 (IVIS) of the test substance.
The following results were obtained in the BCOP Test:
Test substance identification
Mean Opacity Value
Mean Permeability Value
Mean IVIS
Test substance
4.9
0.001
4.9
NC
3.3
0.007
3.4
PC
30.6
1.130
47.5
NC: negative control
PC: positive control
IVIS: in vitro irritancy score
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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