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EC number: 237-235-5 | CAS number: 13703-82-7
- 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:
- 2016-08-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- 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)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Certificate issued by "The Department of Health of the Government of the United Kingdom".
Test material
- Reference substance name:
- Magnesium metaborate
- EC Number:
- 237-235-5
- EC Name:
- Magnesium metaborate
- Cas Number:
- 13703-82-7
- Molecular formula:
- BHO2.1/2Mg
- IUPAC Name:
- magnesium metaborate
- Test material form:
- liquid
1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: adult cattle
- Characteristics of donor animals (e.g. age, sex, weight): 12 to 60 months old
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): After slaughter eyes were excised by an abattoir employee and placed in Hanks' Balanced Salt Solution (HBSS) supplemented with antibiotics (penicillin at 100IU/mL and streptomycin at 100 µg/mL). Transported to test facility over ice packs on the day of slaughter. The corneas were prepared immediately on arrival.
- indication of any existing defects or lesions in ocular tissue samples: Before and after dissection, all eyes were macroscopically examined. Only corneas free of damage were used.
- Indication of any antibiotics used: HBSS supplemented with antibiotics (penicillin at 100 IU/mL and streptomycin at 100 µg/mL).
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): 0.75 mL
- Concentration (if solution): used as provided
- Duration of treatment / exposure:
- The undiluted item applied for 10 minutes.
- Duration of post- treatment incubation (in vitro):
- 120 minutes
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS / QUALITY CHECK OF THE CORNEAS
All eyes were macroscopically examined before and after dissection. Only corneas free of
damage were used. The cornea from each selected eye was removed leaving a 2 to 3 mm rim of sclera to facilitate handling. The iris and lens were peeled away from the cornea. The isolated corneas were immersed in a dish containing HBSS until they were mounted in Bovine Corneal Opacity and Permeability (BCOP) holders. The anterior and posterior chambers of each BCOP holder were filled with complete Eagle’s Minimum Essential Medium (EMEM) without phenol red and plugged. The holders were incubated at 32+/- 1 °C for 60 minutes. At the end of the incubation period each cornea was examined for defects. Only corneas free of damage were used.
NUMBER OF REPLICATES
three replicates for negative controls, positive controls and test samples, each.
NEGATIVE CONTROL USED
Three negative controls were used.
POSITIVE CONTROL USED
Three positive controls were used.
APPLICATION DOSE AND EXPOSURE TIME
Test item was used as provided (undiluted). The exposure time was 10 minutes at 32+/- 1°C.
POST-INCUBATION PERIOD: 90minutes at 32 +/- 1 °C: Evaluation if the permeability of the corneas to sodium fluorescein.
REMOVAL OF TEST SUBSTANCE
- After the exposure period, the corneas were rinsed three times with fresh complete EMEM containing phenol red befor a final rinse with complete EMEM without phenol red. Then, fresh EMEM without phenol red was added to the corneas.
- POST-EXPOSURE INCUBATION:
60 minutes at 32 +/- 1 °C
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Calculated by subtracting the inital opacity reading from the final opacity reading. Values were then corrected by subtracting the average change in opacity observed for the negative control corneas. Then the mean opacity value of each treatment group was calculated.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of a
microtiter plate reader (Anthos 2001) was measured at a wavelenght of 492 nm (OD492).
- Others:
Histopathology: the corneas were retained after testing for possible conduct of histopathology. Each cornea was placed into a pre-labeled tissue cassette fitted with a histology sponge to protect the endothelial surface. The cassette was immersed in 10% neutral buffered formalin.
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: please specify if the decision criteria as indicated in the TG was used.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Value:
- 2.6
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- cornea opacity score
- Value:
- 2.3
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: permeability measurement (OD)
- Value:
- 0.015
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: The corneas treated with the test item were clear post treatment and post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: The positive control In Vitro Irritancy Score was within the range of 29.6 to 52.0. The positive control acceptance criterion was therefore satisfied.
- Acceptance criteria met for positive control: The negative control gave opacity of <2.9 and permeability <0.103. The negative control acceptance criteria were therefore satisfied.
- Range of historical values if different from the ones specified in the test guideline:
Any other information on results incl. tables
Table 1: Individual and Mean Corneal Opacity and Permeability Measurements
Treatment | Cornea Number | Opacity | Permeability (OD) | In Vitro Irritancy Score | |||||
Pre- Treatment | Post- Treatment | Post Incubation | Post-Incubation-Pre- Treatment | Corrected Value | Corrected Value | ||||
Negative Control | 1 | 3 | 3 | 4 | 1 | 0.069 | |||
3 | 3 | 4 | 5 | 2 | 0.005 | ||||
5 | 3 | 4 | 4 | 1 | 0.017 | ||||
1.3a | 0.030c | 1.8 | |||||||
Positive Control | 2 | 2 | 27 | 31 | 29 | 27.7 | 1.373 | 1.343 | |
4 | 4 | 40 | 37 | 33 | 31.7 | 1.204 | 1.174 | ||
6 | 3 | 28 | 31 | 28 | 26.7 | 1.198 | 1.168 | ||
28.7b | 1.228b | 47.1 | |||||||
Test Item | 7 | 3 | 3 | 8 | 5 | 3.7 | 0.076 | 0.046 | |
8 | 4 | 6 | 6 | 2 | 0.7 | 0.017 | 0.000 | ||
9 | 5 | 5 | 9 | 4 | 2.7 | 0.018 | 0.000 | ||
2.3b | 0.015b | 2.6 |
a = mean of the post-incubation – pre-incubation values
b = mean corrected value
c = mean permeability
Applicant's summary and conclusion
- Interpretation of results:
- other: EU GHS (CLP) criteria not met
- Remarks:
- not classified
- Conclusions:
- The test item score of 2.6 for the in vitro irritancy score was more than the negative control and less than the positive control.
- Executive summary:
The purpose of this in vitro test was to identify test items that can induce serious eye damage and to identify test items not requiring classification for eye irritation or serious eye damage in accordance with OECD Guideline 437 and EU Method B.47 and in compliance with GLP criteria. The Bovine Corneal Opacity and Permeability (BCOP) test method is an organotypic model that provides short-term maintenance of normal physiological and biochemical function of the bovine cornea in vitro. In this test method, damage by the test item is assessed by quantitative measurements of changes in corneal opacity and permeability. The undiluted test item was applied for 10 minutes followed by an incubation period of 120 minutes. Negative and positive control items were tested concurrently. The two endpoints, decreased light transmission through the cornea (opacity) and increased passage of sodium fluorescein dye through the cornea (permeability) were combined in an empirically derived formula to generate an In Vitro Irritancy Score (IVIS). The positive control In Vitro Irritancy Score was within the range of 29.6 to 52.0. The positive control acceptance criterion was therefore satisfied. The negative control gave opacity of <2.9 and permeability <0.103. The negative control acceptance criteria were therefore satisfied. The corneas treated with the test item were clear post treatment and post incubation. The corneas treated with the negative control item were clear post treatment and post incubation. The corneas treated with the positive control item were cloudy post treatment and post incubation.
The in vitro irritancy scores for corneas exposed to the test item was 2.6. The mean cornea opacity score for corneas exposed to the test item was 2.3. The mean permeability measurement (OD) for corneas exposed to the test item was 0.015.
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