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EC number: 220-374-0 | CAS number: 2743-38-6
- 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:
- weight of evidence
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1993
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 995
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)
- GLP compliance:
- yes
Test material
- Reference substance name:
- Dibenzoyl-L-tartaric acid monohydrate
- EC Number:
- 220-374-0
- EC Name:
- Dibenzoyl-L-tartaric acid monohydrate
- Cas Number:
- 2743-38-6
- Molecular formula:
- C18H14O8
- IUPAC Name:
- (2R,3R)-2,3-bis(benzoyloxy)butanedioic acid
- Test material form:
- solid: particulate/powder
- Details on test material:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Aldrich, product no. 34,584-9
- Purity: 98%
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Aldrich.
OTHER SPECIFICS: To ensure blind experimental conditions, in vitro as well as in vivo, chemicals were sampled, coded, and shipped by an independent Company (MCS-Pharma, Erstein, France).
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Bovine eyes were collected from a commercial abattoir.
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): eyes were collected in a plastic jar containing 1 litre HBSS for approximately 25 eyes. Buffer storage and eyes transportation to the laboratories were performed at ambient temperature, and the eyes were used within 2 hr of the killing of the animals.
- Time interval prior to initiating testing: within 2h after collection.
- indication of any existing defects or lesions in ocular tissue samples: no.
- Indication of any antibiotics used: no.
Test system
- Vehicle:
- other: Minimum essential medium (MEM)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 ml was applied on the epithelium with an appropriate syringe and needle.
- Concentration: Solids were prepared as an approximate 20% solution or suspension (200mg + 1ml) in MEM using a mortar and pestle for homogeneous preparations.
VEHICLE
- Concentration (if solution): Minimum essential medium (MEM) was prepared from powder supplemented with glutamine and sodium bicarbonate as indicated by the supplier, the pH was adjusted to 7.4 and the medium was freshly used or stored refrigerated (1-wk stock).
- Lot/batch no.: Sigma M-3024 - Duration of treatment / exposure:
- Corneas were incubated in a horizontal position for 4 h at 32ºC.
- Number of animals or in vitro replicates:
- The number of corneas per experiment was 15, including a control group of 3 corneas treated with MEM, and two groups of 6 corneas treated with test compound.
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
During dissection great care was taken to avoid damage of corneal surfaces (epithelial and endothelial). Each cornea was carefully examined, and those presenting defects, such as neovascularization, pigmentation, opacity or scratches were discarded. Globes were first dissected free of surrounding tissues and placed in a jar containing fresh HBSS. Selected corneas were dissected with a 2-3-mm rim of sclera for easier handling, and stored in a petri dish containing HBSS until use. Corneas were then mounted in holders filled with MEM, and incubated for 1 hr in a water-bath at 32ºC.
NUMBER OF REPLICATES : 6
NEGATIVE/SOLVENT CONTROL USED : MEM
POSITIVE CONTROL USED : 750 μL of 20% (w/v) imidazole solution in MEM
APPLICATION DOSE AND EXPOSURE TIME : 750 μL of 20% (w/v) test item solution in MEM, 4h exposure.
TREATMENT METHOD: [closed chamber / open chamber]
POST-INCUBATION PERIOD: no.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: at least 3 times (until the medium was clear) with approximately 4 ml MEM.
- POST-EXPOSURE INCUBATION: 2h at 32ºC.
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: opacitometer (Electro-Design, Riom, France) previously calibrated with standardized opaque sheets of polyester.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry (490 nm)
- Others: pertinent visual observations.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS) = opacity value + 15 times O.D. value
DECISION CRITERIA: score 0 - 25, mild irritant; 25.1 - 55, moderate irritant; ≥ 55.1, severe irritant..
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- mean of results from 11 laboratories, mean of 6 corneas each
- Value:
- 120.5
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: not specified.
DEMONSTRATION OF TECHNICAL PROFICIENCY: not applicable (100% agreement within all laboratories).
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes
Any other information on results incl. tables
Table 1. In vitro scores from individual laboratories for BCOP assay (n=6)
|
Score in laboratory no.: |
Mean score |
||||||||||||
Compound |
Physical form |
1 |
2 |
3 |
4 |
5 |
6 |
7 |
8 |
9 |
10 |
11 |
12 |
|
Test item 2743-38-6 |
S |
104 |
134 |
82 |
118 |
110 |
66 |
88 |
193 |
82 |
- |
213 |
135 |
120.5 |
Imidazole 288-32-4 |
S |
75 |
73 |
140 |
81 |
96 |
62 |
82 |
122 |
64 |
81 |
114 |
65 |
87.9 |
Table 2. Agreement between laboratories.
Compound |
Physical form |
Mean IVIS |
Agreement(%) |
Result |
Test item 2743-38-6 |
Solid |
120.5 |
100 |
Severe irritant |
Imidazole 288-32-4 |
Solid |
87.9 |
100 |
Severe irritant |
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Remarks:
- EU criteria.
- Conclusions:
- The test item is severely irritant to the eye (IVIS = 120.5)
- Executive summary:
An in vitro (ex vivo) Bovine Corneal Opacity and Permeability study was conducted by 12 laboratories in an interlaboratory validation study, in order to determine the potential severe eye damaging effects of the test item. The study was performed according to the OECD guideline 437 under GLP conditions. Sets consisting of 6 corneas each were exposed to either 750 μL of 20% (w/v) of test item suspension in MEM or 750 μL of 20% (w/v) imidazole in MEM (positive control) for 4h at 32ºC; a negative control was carried out in parallel with 3 corneas, treated with MEM. After exposure, opacity and permeability of the corneas was measured, and an in vitro irritancy score was calculated combining both parameters. As a protocol variation, four of the laboratories performed the study with preserved corneas. The mean value from 11 laboratories and the % agreement were calculated and compared to in vivo data. The mean IVIS score values obtained were 87.9 and 120.5 for imidazole and the test item, respectively. Therefore, the test item causes damage to the eye (Cat.1).
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