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EC number: 807-596-9 | CAS number: 1428451-07-3
- 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:
- 17.07.2015
- 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 Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(2-bromoacetyl)-3-[(methoxycarbonyl)oxy]phenyl methyl carbonate
- EC Number:
- 807-596-9
- Cas Number:
- 1428451-07-3
- Molecular formula:
- C12H11BrO7
- IUPAC Name:
- 4-(2-bromoacetyl)-3-[(methoxycarbonyl)oxy]phenyl methyl carbonate
- Test material form:
- solid: bulk
Constituent 1
Test animals / tissue source
- Species:
- cattle
Test system
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Duration of treatment / exposure:
- 240 min
- Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- ca. 2.72
- Vehicle controls validity:
- not examined
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Opacity:
The change of opacity value of each treated cornea or positive and negative control corneae was calculated by subtracting the initial basal opacity from the post treatment opacity reading (t240 – t0), for each individual cornea. The average change in opacity of the negative control corneae was calculated and this value was subtracted from the change in opacity of each treated cornea or positive control to obtain a corrected opacity.
Permeability:
The corrected OD490 value of each cornea treated with positive control and test item was calculated by subtracting the average negative control cornea value from the original permeability value for each cornea.
IVIS Calculation:
The following formula was used to determine the IVIS of the negative control: IVIS = opacity value + (15 x OD490 value) The following formula was used to determine the IVIS of the positive control and the test item: IVIS = (opacity value – opacity value mean negative control) + (15 x corrected OD490 value) The mean IVIS value of each treated group was calculated from the IVIS values. Depending on the score obtained, the test item was classified into the following category according to OECD guideline 437:
IVIS |
In vitro Irritancy Score (according to OECD 437) |
<= 3 |
No Category (according to GHS) |
> 3; <= 55 |
No prediction can be made |
> 55 |
Serious eye damage according to CLP/EPA/GHS (Cat 1) |
The test is acceptable because
• the positive control gives an IVIS that falls within two standard deviations of the current historical mean (updated every three months), and because
• the negative control responses result in opacity and permeability values that are less than the established upper limits for background opacity and permeability values for bovine corneae treated with the respective negative control.
Discussion
After a first opacity measurement of the fresh bovine corneae (t0), the 20% (w/v) suspension in saline of the test item 2’,4’-Bis(methoxycarbonyloxy)-2-brom-acetophenone, the positive, and the negative controls were applied to corneae and incubated for 240 minutes at 32 ± 1 °C. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t240). After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C. With the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS = 1.04). The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity and distinctive permeability of the corneae (mean IVIS = 128.43) corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)). The mean IVIS of the positive control (mean IVIS = 128.43) was in the range of the historical data (mean IVIS 116.24 ± 2 * 9.31 (see Fig. 3)). Relative to the negative control, the test item 2’,4’-Bis(methoxycarbonyloxy)-2-brom-acetophenone caused an increase of the corneal opacity but not of the permeability. The calculated mean IVIS was 2.72 (threshold for serious eye damage: IVIS ≥ 55). According to OECD 437 the test item is not categorized.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In conclusion, according to the current study and under the experimental conditions reported, 2’,4’-Bis(methoxycarbonyloxy)-2-brom-acetophenone is not irritating to eyes.
- Executive summary:
An in vitro study was performed to assess the corneal damage potential of 2’,4’-Bis(methoxycarbonyloxy)-2-brom-acetophenone by means of the BCOP assay according to OECD 437 using fresh bovine corneae.
After a first opacity measurement of the fresh bovine corneae (t0), the 20% (w/v) suspension in saline (0.9% (w/v) NaCl in deionised water) of the test item 2’,4’-Bis(methoxycarbonyloxy)-2-brom-acetophenone, the positive, and the negative controls were applied to corneae fixed in an incubation chamber in horizontal position and incubated for 240 minutes at 32 ± 1 °C. The posterior chamber contained incubation medium. After the incubation phase the test item, the positive, and the negative controls were each rinsed from the corneae and opacity was measured again (t240). After the opacity measurements permeability of the corneae was determined by measuring spectrophotometrically the transfer of sodium fluorescein after incubation in a horizontal position for 90 minutes at 32 ± 1 °C. With the negative control (physiological saline) neither an increase of opacity nor permeability of the corneae could be observed. The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity and distinctive permeability of the corneae corresponding to a classification as serious eye damage (CLP/EPA/GHS (Cat 1)). Relative to the negative control, the test item 2’,4’-Bis(methoxycarbonyloxy)-2-brom-acetophenone an increase of the corneal opacity but not of the permeability compared with the values caused by the negative control. The calculated mean in vitro irritancy score was 2.72. According to OECD 437 the test item is not irritating to eyes.
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