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EC number: 202-815-9 | CAS number: 100-06-1
- 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:
- supporting study
- Study period:
- May 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
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
- Reference substance name:
- 4'-methoxyacetophenone
- EC Number:
- 202-815-9
- EC Name:
- 4'-methoxyacetophenone
- Cas Number:
- 100-06-1
- Molecular formula:
- C9H10O2
- IUPAC Name:
- 1-(4-methoxyphenyl)ethanone
- Test material form:
- solid: crystalline
- Details on test material:
- Designation: p-Methoxyacetophenone
CAS No.: 100-06-1
Batch: 18800(20121125)
Appearance: White crystals
Released until: November 24, 2013
Purity: 99.87 %
Storage: Tightly closed, dark at room temperature (15 to 25°C)
Constituent 1
Test system
- Vehicle:
- physiological saline
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): 20% in 0.9 % NaCl solution - Duration of treatment / exposure:
- 240 min
Results and discussion
In vitro
Results
- Irritation parameter:
- cornea opacity score
- Remarks:
- IVIS
- Run / experiment:
- mean
- Value:
- 116.2
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Collection of bovine eyes
Freshly isolated bovine eyes of donor cattle were collected from
the slaughterhouse. Excess tissue was removed from the eyes. The eyes
were kept and transported in transport medium.
Preparation of corneas
The corneas were prepared immediately after delivery of the eyes
to the laboratory. All eyes were carefully examined macroscopically for
defects. Those presenting defects such as vascularization, pigmentation,
opacity or scratches were discarded. The corneas were carefully removed
from the eye using scalpel and rounded scissors. A rim of about 2 mm of
tissue (sclera) was left for stability and handling of the isolated
cornea. All corneas used in the experiment were collected in incubation
medium (EMEM, pre-warmed at 32 °C).
Each cornea was mounted in a cornea holder (LAB Research, Hungary) with
the endothelial side against the sealing ring (O -ring) of the posterior
part of the holder. The cornea was gently flattened over the O-ring
without stretching the cornea. Afterwards, the anterior part of the
holder was positioned on top of the cornea and fixed in place with
screws. Both compartments of the holder were filled with incubation
medium (EMEM). The posterior compartment was filled first to return the
cornea to its natural convex form.
Opacity measurement before treatment
For equilibration, the corneas in the holder were incubated
(incubator: Grumbach BSS 160) in a vertical position at 32 ± 1 °C for
about one hour.
At the end of the incubation period, the incubation medium (EMEM) was
removed from both compartments and replaced by fresh incubation medium
(EMEM), and the baseline opacity was determined with an opacitometer
(BASF-OP2.0).
The opacitometer measured the light transmission passing through the
corneas and displayed a lux value. This value was recorded in a table
and converted into an opacity value (baseline opacity values). The
opacitometer was calibrated as described in the manual and the opacity
of each cornea was determined by reading each holder placed in the
photoreceptor compartment of the opacitometer.
Any corneas that showed macroscopic tissue damage (e.g., scratches,
pigmentation, neovascularization) or an opacity > 7 opacity units were
discarded. The mean opacity of all equilibrated corneas was calculated.
Three corneas with opacity values close to the median value for all
corneas were selected as negative control corneas. The remaining corneas
were distributed into treatment and positive control groups.
TREATMENT
Fresh incubation medium (EMEM) was placed in the posterior
compartment, while the anterior compartment received the test material,
negative or positive control on the surface of the corneas. Afterwards,
the cornea holders were incubated at 32 ± 1 °C in an incubator (Grumbach
BSS 160) in a horizontal position.
The test material was suspended in a 0.9% sodium chloride solution to a
concentration of 20%. As positive control a 20% Imidazole solution (in
0.9% sodium chloride solution) and as negative control a 0.9% sodium
chloride solution were used. A volume of 750 µL each (negative control,
positive control or test material) was introduced into the anterior
chamber. After the exposure period (240 min), the test material, the
negative control, or the positive control was removed from the
epithelium. The corneal surface was washed at least three times (or
until no visual evidence of the test substance was observed) with wash
medium. Afterwards, incubation medium was used as final rinse to ensure
removal of the phenol red from the anterior chamber prior to the opacity
measurement. In a next step fresh incubation medium was replaced in both
compartments and the opacity value after treatment was measured.
Permeability determination
In the second step of the assay, an increased permeability of the
cornea possibly caused by the test material was determined as an
indication of the integrity of the epithelial cell layers. Fresh
incubation medium (EMEM) was added to the posterior compartment and 1 mL
of a fluorescein solution, dissolved in DPBS (5 mg/mL) was placed in the
anterior compartment.
The corneas were incubated again in a horizontal position for further 90
minutes at 32±1°C.
The amount of sodium fluorescein that crossed into the posterior chamber
was measured spectrophotometrically (BioTek ELx800) at 490 nm (OD490).
Therefore, 3 x 360 µL medium from the posterior chamber per cornea were
well mixed and transferred into a 96-well plate.
Evaluation of results
Opacity
The change of the opacity value of each cornea treated with the test
material, positive or negative control was calculated by subtracting the
initial baseline opacity from the post treatment opacity reading, for
each individual cornea The average change in opacity of the negative
control corneas was calculated and this value was subtracted from the
change in opacity of each cornea treated with the test material or
positive control to obtain a corrected opacity.
The mean corrected opacity value of each treatment group was calculated
from the individual corrected opacity values of the treated corneas.
Permeability
The corrected OD490 value of each cornea treated with the positive
control or the test material was calculated by subtracting the average
negative control cornea value from the original permeability value for
each cornea.
The mean corrected permeability value of each treatment group was
calculated from the individual corrected permeability values of the
treated corneas.
In Vitro Irritancy Score (IVIS) calculation
The following formula was used to determine the In Vitro Irritancy Score
(IVIS) of the negative control:
IVIS = mean opacity value + (15 x permeability OD490 value)
The following formula was used to determine the In Vitro Irritancy Score
(IVIS) of the positive control and the test materials:
IVIS = corrected opacity value + (15 x corrected permeability OD490
value)
The In Vitro Irritancy Score (IVIS) was calculated for each individual
treatment and positive control cornea. The mean In Vitro Irritancy Score
(IVIS) value of each treated group was calculated from the individual In
Vitro Irritancy Score (IVIS) values. A substance that induced an In
Vitro Irritancy Score IVIS > 55.1 is defined as a corrosive or a severe
irritant.
Validity criteria
The test is considered valid if the IVIS of the positive and negative
controls fall within two standard deviations of the current historical
means (IVIS: positive control 73.5 - 142.8, negative control: -0.4 -2.9).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- Under the given experimental conditions, the test material did not show an ocular severe irritant or corrosive potential.
- Executive summary:
Study Design
This in vitro study was performed to assess the ocular severe irritant or corrosive potential of the test item by means of the BCOP (Bovine Corneal Opacity and Permeability Assay). Therefore, the induced opacity and increased permeability was investigated in isolated bovine corneas after exposure to the test material as a 20% suspension in a 0.9% sodium chloride solution. As negative control 0.9% sodium chloride solution and as positive control 20% imidazole was used.
3 corneas were used per group (test material, negative and positive control group).
After a first opacity measurement of the fresh bovine corneas, 750 µL of the suspended test material, positive or negative control were applied on the corneas and incubated for 240 minutes at 32 ± 1 °C. After the incubation phase the test material, the positive, and the negative control were rinsed from the corneas and the opacity was measured again.
After the opacity measurements, the permeability of the corneas was determined by application of 1 mL of a fluorescein solution for 90 minutes at 32 ± 1 °C. The amount of fluorescein solution that crossed the cornea was measured spectrophotometrically.
The opacity and permeability assessments were combined to determine an In Vitro Irritancy Score (IVIS).
Results
The treatment of the corneas with the negative control (0.9% sodium chloride solution) showed neither an increase of opacity nor an increase of permeability. After treatment with the positive control (20% imidazole) the calculated IVIS was 116.2 and, thus, within two standard deviations of the current historical mean (IVIS: 73.5 - 142.8). Therefore, the study fulfilled the validity criteria.
The IVIS obtained after treatment with the test material was 24.1 and, thus, lower than 55.1. Therefore, the test material is not considered to possess an ocular severe irritant or corrosive potential.
Conclusions
Under the given experimental conditions, the test material did not show an ocular severe irritant or corrosive potential.
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