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Diss Factsheets
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EC number: 938-695-6 | CAS number: -
- 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:
- The study was performed between 08 November 2011 and 10 November 2011.
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: SkinEthic Reconstructed Human Corneal model (HCE, SkinEthic Laboratories, Nice, France)
- Deviations:
- no
- Principles of method if other than guideline:
- The purpose of this study was to determine the eye irritation potential of the test item using the SkinEthic Reconstructed Human Corneal model (HCE, SkinEthic Laboratories, Nice, France) after a treatment period of 10 minutes.
The test is based on the hypothesis that irritant chemicals are able to penetrate the stratum corneum of the SkinEthic HCE model and are sufficiently cytotoxic to cause cell death in the underlying cell layers.
Cytotoxicity was determined by the reduction of MTT to formazan by viable cells in the test item treated tissues (quantitative measurement of tissue viability) relative to the negative control.
One tissue for each treatment group was retained for possible tissue histopathology. - GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- PC-9S
- IUPAC Name:
- PC-9S
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Sponsor's identification: PC-9S
Description: off white powder
Lot number: PS1 011 03
Purity: not supplied
Date received: 11 July 2011
Expiry date: 18 November 2012
Storage conditions: room temperature in the dark
Constituent 1
Test animals / tissue source
- Species:
- other: SkinEthic HCE model
- Strain:
- other: not applicable
- Details on test animals or tissues and environmental conditions:
- Not applicable as an invitro method was used.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 30 mg - Duration of treatment / exposure:
- 10 minutes
- Observation period (in vivo):
- not applicable as an in vitro method was conducted
- Number of animals or in vitro replicates:
- not applicable as an in vitro study was conducted
- Details on study design:
- Pre-Test:
Assessment of Direct Test Item Reduction of MTT:
The MTT assay, a colourimetric method of determining cell viability, is based on reduction of the yellow tetrazolium salt (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyltetrazolium bromide) to a purple formazan dye by mitochondrial succinate dehydrogenase in viable cells.
One limitation of the assay is possible interference of the test item with MTT. A test item may directly reduce MTT to formazan, thus mimicking dehydrogenase activity of the cellular mitochondria of viable cells. This property of the test item is only a problem, if at the time of the MTT test (after the chemical has been rinsed off) there are still sufficient amounts of the test item on or in the tissues. To identify this possible interference, the test item was checked for its ability to reduce MTT directly. 30 mg of test item was added to 1 ml of a 0.5 mg/ml MTT solution and incubated at 37°C, 5% CO2 in air for 3 hours. Untreated MTT solution was used as a control. If the MTT solution turned blue, the test item was presumed to have reduced the MTT.
Preparation of Tissues
Using sterile techniques, 1 ml of maintenance medium at room temperature, was dispensed into the appropriate number of wells of 6-well plates designated 'treatment plates'. Each well was labelled with details of the treatment and the appropriate exposure time. Separate treatment plates were used for the test item, negative and positive controls to avoid the possibility of cross contamination occurring. Before treatment, the 7-Day old tissues were transferred from the 'arrival plates' into the wells of the 'treatment plates' containing the maintenance medium.
Results and discussion
In vivo
Results
- Irritation parameter:
- other: in vitro study
- Basis:
- mean
- Time point:
- other: 10 minute exposure period
- Score:
- 102
- Max. score:
- 102
- Reversibility:
- other: no effects seen
- Remarks on result:
- other: According to the study plan followed the test item was considered to be a Non-Irritant (NI).
- Irritant / corrosive response data:
- The relative mean viability of the test item treated tissues after a 10-Minute exposure period was 102.0%.
- Other effects:
- The MTT solution containing the test item turned yellow which indicated that the test item did not directly reduce MTT.
Any other information on results incl. tables
Assessment of Direct Test Item Reduction of MTT:
The MTT solution containing the test item turned yellow which indicated that the test item did not directly reduce MTT.
The relative mean viability of the test item treated tissues after a 10-Minute exposure period was 102.0%. It was considered unnecessary to proceed with tissue histopathology.
Conclusion:
According to the study plan followed the test item was considered to be a Non-Irritant (NI).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- According to the study plan followed the test item was considered to be a Non-Irritant (NI).
- Executive summary:
Introduction: The purpose of this study was to determine the eye irritation potential of the test item using the SkinEthic Reconstructed Human Corneal model (HCE, SkinEthic Laboratories, Nice, France) after a treatment period of 10 minutes. The test is based on the hypothesis that irritant chemicals are able to penetrate the corneal epithelial tissue and are sufficiently cytotoxic to cause cell death.
Methods.
The experimental design of the study consists of a test for direct reduction of MTT (3-[4,5-dimethylthiazol-2-yl]-2,5-diphenyl-tetrazolium bromide) by the test item followed by the main test. For the main test, triplicate SkinEthic tissues were treated with 30 mg of the test item for 10 minutes. Triplicate tissues treated with 30 µl of Solution A served as the negative control and triplicate tissues treated with 30 µl of 2% w/v Sodium Oodecyl Sulphate served as the positive control.
At the end of the exposure period each SkinEthic tissue was rinsed. The rinsed tissues (two per group) were taken for MTT loading. The remaining tissues were retained for possible histopathology. Following MTT loading the reduced MTT was extracted from the tissues.
After extraction the absorbency of triplicate aliquots of the extracted MTT solution for each SkinEthic tissue was measured. The optical density was measured at 540 nm (00540). Data are presented in the form of percentage viability (MTT conversion relative to negative controls).
The test item was classified according to the following criteria:
If the percentage relative mean tissue viability was > 60% the test item was considered to be non-irritant (NI).
If the percentage relative mean tissue viability was < 60% the test item was considered to be an irritant (I).
Results.
The relative mean viability of the test item treated tissues after a 10-Minute exposure period was 102 % (not an irritant). It was considered unnecessary to proceed with tissue histopathology.
Quality criterion. The quality criterion required for acceptance of results in the test was satisfied.
Conclusion: According to the study plan followed, the test item was considered to be a Non-Irritant (NI).
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