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EC number: 285-586-8 | CAS number: 85117-37-9
- 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
- Remarks:
- EpiOcular™ Cornea Epithelial Model
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 12, 2016 to December 23, 2016
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- yes
- Remarks:
- regarding the study plan but the study integrity was not adversely affected by the deviations
- GLP compliance:
- yes
Test material
- Reference substance name:
- Benzene, di-C1 0-14-alkyl derivs., sulfonated, sodium salts
- IUPAC Name:
- Benzene, di-C1 0-14-alkyl derivs., sulfonated, sodium salts
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Benzene, di-C1 0-14-alkyl derivs., sulfonated, sodium salts
- ZS name: ALKYLBENZOLNACHLAUF, SULFONIERT, NA-SALZ
- ZS number: 1344
- Batch: SEALS 2011-104-5-8
- Appearance, colour: brown clear liquid
Constituent 1
Test animals / tissue source
- Species:
- human
- Details on test animals or tissues and environmental conditions:
- The EpiOcular tissue construct is a nonkeratinized epithelium prepared from normal human keratinocytes. It models the cornea epithelium with progressively stratified, but not cornified cells. A cell suspension is seeded into the insert in specialized medium. After an initial period of submerged culture, the medium is removed from the top of the tissue so that the epithelial surface is in direct contact with the air. This allows the test substance to be directly applied to the epithelial surface in a fashion similar to how the corneal epithelium would be exposed in vivo.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 50 µL
- Duration of treatment / exposure:
- 30 minutes
- Observation period (in vivo):
- -
- Duration of post- treatment incubation (in vitro):
- After exposure the cornea epithelial construct was thoroughly rinsed to remove the test substance and transferred to fresh medium for an immersion incubation. Afterwards, the tissues were transferred to fresh medium and incubated for 2 hours at standard culture conditions, prior to determination of the cytotoxic (irritancy) effect.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The test consists of application of the test substance (50 µL) to the surface of the cornea epithelial construct for 30 minutes. After exposure the cornea epithelial construct is thoroughly rinsed to remove the test substance and transferred to fresh medium for an immersion incubation. After transfer to fresh medium for a 2 hours incubation period determination of the cytotoxic (irritancy) effect is performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) at the end of the treatment (mean absorption measurement - optical density reading at 570 nm). Eye hazard potential is expressed as the remaining cell viability after exposure to the test substance.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: cell viability (%)
- Remarks:
- experiment 1
- Run / experiment:
- reduction of MTT
- Value:
- >= 43 - <= 65
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Remarks:
- cell viability was spread over two categories
- Irritation parameter:
- other: cell viability (%)
- Remarks:
- experiment 2 (repeat)
- Run / experiment:
- reduction of MTT
- Value:
- >= 55 - <= 77
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- not determinable
- Remarks:
- cell viability was spread over two categories
- Other effects / acceptance of results:
- - The test substance showed colour interference in aqueous conditions. In addition to the normal procedure, two tissue were treated with test substance. Instead of MTT solution these tissues were incubated with assay medium. The non-specific colour of the test substance was 0.43% of the negative control tissues. True tissue viability was calculated as the percent tissue viability obtained with living tissues exposed to the interfering test chemical and incubated with MTT solution minus the percent non-specific colour obtained with living tissues exposed to the interfering test chemical and incubated with medium without MTT.
- Eye hazard potential is expressed as the remaining cell viability after exposure to the test substance. The relative mean tissue viability obtained after 30 ± 2 minutes treatment with the test substance compared to the negative control tissues was 54%. Since the relative tissue viability for the test substance was spread over two categories (65 and 43%, respectively). The experiment was repeated.
- In this repeat experiment, the non-specific colour of the test substance was 1.00% of the negative control tissues. The OD of the treated tissues without MTT assay was subtracted from the ODs of the test substance treated viable tissues with MTT assay. The relative mean tissue viability obtained after 30 ± 2 minutes treatment with the test substance compared to the negative control tissues was 66%. Again, the relative tissue viability for the test substance was spread over two categories (55 and 77%, respectively).
- The positive control had a mean cell viability of 15% and 4% after 30 ± 2 minutes exposure, in the initial and repeat experiment, respectively. The absolute mean OD570 values (optical density at 570 nm) of the negative control tissues were within the acceptability range from > 0.8 to < 2.5.
- In both tests equivocal results were obtained after 30 minutes treatment. Therefore, no conclusion could be made about the eye hazard potential of the test substance in the EpiOcular™ test under the experimental conditions described in this report.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- Under the study conditions, no conclusion could be made about the eye hazard potential of the test substance in the EpiOcular™ test.
- Executive summary:
A study was conducted to determine the in vitro eye irritation potential of the test substance according to OECD Guideline 492 (EpiOcular™ Cornea Epithelial Model), in compliance with GLP. The EpiOcular tissue construct is a nonkeratinized epithelium prepared from normal human keratinocytes. It models the cornea epithelium with progressively stratified, but not cornified cells. The test consisted of an application of the test substance (50 µL) to the surface of the cornea epithelial construct for 30 min. After exposure, the cornea epithelial construct was thoroughly rinsed to remove the test substance and transferred to fresh medium for an immersion incubation. After transfer to fresh medium for a 2 h incubation period, determination of the cytotoxic (irritancy) effect was performed. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from 3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyl tetrazolium bromide (MTT) at the end of the treatment (mean absorption measurement - optical density reading at 570 nm). Eye hazard potential is expressed as the remaining cell viability after exposure to the test substance. The test substance showed colour interference in aqueous conditions. In addition to the normal procedure, two tissue were treated with test substance. Instead of MTT solution these tissues were incubated with assay medium. The non-specific colour of the test substance was 0.43% of the negative control tissues. True tissue viability was calculated as the percent tissue viability obtained with living tissues exposed to the interfering test chemical and incubated with MTT solution minus the percent non-specific colour obtained with living tissues exposed to the interfering test chemical and incubated with medium without MTT. The relative mean tissue viability obtained after 30 ± 2 min treatment with the test substance compared to the negative control tissues was 54%. Since the relative tissue viability for the test substance was spread over two categories (65 and 43%, respectively). The experiment was repeated. In the repeat experiment, the non-specific colour of the test substance was 1.00% of the negative control tissues. The OD of the treated tissues without MTT assay was subtracted from the ODs of the test substance treated viable tissues with MTT assay. The relative mean tissue viability obtained after 30 ± 2 min treatment with the test substance compared to the negative control tissues was 66%. Again, the relative tissue viability for the test substance was spread over two categories (55 and 77%, respectively). In both tests equivocal results were obtained after 30 min treatment. The positive control had a mean cell viability of 15 and 4% after 30 ± 2 min exposure, in the initial and repeat experiments, respectively. The absolute mean OD570 values (optical density at 570 nm) of the negative control tissues were within the acceptability range from > 0.8 to < 2.5. The tests functioned properly. Under the study conditions, no conclusion could be made about the eye hazard potential of the test substance (Verbaan, 2017).
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