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EC number: 700-402-2 | CAS number: 860035-10-5
- 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- The purpose of the study wasto determine the skin irritation potential of the test material using the SkinEthic Reconstituted Human Epidermal model (SkinEthic Labs, Nice, France) following treatment periods of 4 and 24hrs. The study consists of a test for direct redution of MTT by the test material followed by determination of skin irritation/corrosion potential. For th determination of skin irritation potential, triplicate SkinEthic tissues were treated with approx. 25mg of the test material and exposued for 4 and 24hrs. . At the end of the treatment period tissues were tested for viability using MTT conversion relative to controls.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- human
- Vehicle:
- unchanged (no vehicle)
- Duration of treatment / exposure:
- 4 and 24hrs
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- at 4 hours
- Value:
- ca. 2.7
- Remarks on result:
- positive indication of irritation
- Irritation / corrosion parameter:
- % tissue viability
- Run / experiment:
- at 24 hours
- Value:
- ca. 2
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- The relative viability of test material treated tissues was 2.7% after 4hrs exposure and 2.0% after 24hrs exposure.
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- GSK1873183A was considered to be a skin irritant
- Executive summary:
The purpose of the study was to determine the skin irritation potential of the test material using the SkinEthic Reconstituted Human Epidermal model (SkinEthic Labs, Nice, France) following treatment periods of 4 and 24hrs. The study consists of a test for direct redution of MTT by the test material followed by determination of skin irritation/corrosion potential. For th determination of skin irritation potential, triplicate SkinEthic tissues were treated with approx. 25mg of the test material and exposued for 4 and 24hrs. . At the end of the treatment period tissues were tested for viability using MTT conversion relative to controls. The relative mean viability of the test material treated tissues was 2.7% afetr 4hrs exposure and 2.0% after 24hrs exposure. It was considered unneccesary to proceed with tissue histology and the test material was considered to be a skin irritant (R38)
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Study
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Reconstitured Human Cornea: Determination of eye irritation potential using the SkinEthic Reconstituted Human Corneal model (RHC, SkinEthic Labs, Nice, France) following treatment periods of 10 and 60 minutes. The test is based on the hypothesis that irritant materials are able to penetrate the corneal epitelial tissue and are sufficiently cytotoxic to cuase cell death.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- human
- Vehicle:
- unchanged (no vehicle)
- Irritation parameter:
- other: relative mean viability
- Run / experiment:
- 10 mins
- Value:
- ca. 36.8
- Negative controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- other: relative mean viability
- Run / experiment:
- 60 mins
- Value:
- ca. 4.4
- Negative controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Other effects / acceptance of results:
- RHC Model: The relative mean viability of the test material treated tissue was 36.8% after 10minutes and 4.4% after 60 minute exposure.
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- GSK1873183A was considered to be irritating to eyes based upon the results of the in vitro/ex vivo studies.
- Executive summary:
An in vitro test strategy was adopted to assess the potential eye irritation of GSK1873183A. In the rabbit enulceated eye test (REET), 0.1ml of test material was applied to the cornea of each of three enucleated eyes which had been maintained ata temperature of 32deg C within the superfusion chamber. A further two enucleated eyes were treated with saline solution as controls. Assessment or corneal cloudiness was made approx 60, 120, 180 and 240mins following treatment. Examination of the eye facilitated by use of a slit-lamp biomicroscope and the thickness of the cornea was measured using an ultrasonic pachymeter. In the Human Reconsititued Corneal Model (RHC) determination of eye irritation potential was assessed using the SkinEthic Reconstituted Human Corneal model (RHC, SkinEthic Labs, Nice, France) following treatment periods of 10 and 60 minutes. The test is based on the hypothesis that irritant materials are able to penetrate the corneal epitelial tissue and are sufficiently cytotoxic to cuase cell death.
The REET assay indicated that GSK1873183A is unlikely to have potential to cause severe ocular irritancy in vivo. The RHC model indicated thatthe test material is likley to be a moderate eye irritant and should be classified as R36; Irritating to eyes (GHS Category 2A)
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP Study
- Qualifier:
- according to guideline
- Guideline:
- other:
- Principles of method if other than guideline:
- Rabbit Enucleated Eye Test: 0.1ml of test material was applied to the cornea of each of three enucleated eyes which had been maintained ata temperature of 32deg C within the superfusion chamber. A further two enucleated eyes were treated with saline solution as controls. Assessment or corneal cloudiness was made approx 60, 120, 180 and 240mins following treatment. Examination of the eye facilitated by use of a slit-lamp biomicroscope and the thickness of the cornea was measured using an ultrasonic pachymeter.
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Vehicle:
- unchanged (no vehicle)
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 60 mins
- Value:
- ca. 7.7
- Negative controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 120 mins
- Value:
- ca. 6.7
- Negative controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- percent corneal swelling
- Run / experiment:
- 240 mins
- Value:
- ca. 4.8
- Negative controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- REET Model: Corneal swelling in control eyes was 8.6, 10.6 and 7.8% after 60, 120 and 240mins respectively. In eyes treated with 0.1% GSK1873183A corneal swelling was 7.7, 6.7 and 4.8% at the same time periods
- Interpretation of results:
- moderately irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- GSK1873183A was considered to be irritating to eyes based upon the results of the in vitro/ex vivo studies.
- Executive summary:
An in vitro test strategy was adopted to assess the potential eye irritation of GSK1873183A. In the rabbit enulceated eye test (REET), 0.1ml of test material was applied to the cornea of each of three enucleated eyes which had been maintained ata temperature of 32deg C within the superfusion chamber. A further two enucleated eyes were treated with saline solution as controls. Assessment or corneal cloudiness was made approx 60, 120, 180 and 240mins following treatment. Examination of the eye facilitated by use of a slit-lamp biomicroscope and the thickness of the cornea was measured using an ultrasonic pachymeter. In the Human Reconsititued Corneal Model (RHC) determination of eye irritation potential was assessed using the SkinEthic Reconstituted Human Corneal model (RHC, SkinEthic Labs, Nice, France) following treatment periods of 10 and 60 minutes. The test is based on the hypothesis that irritant materials are able to penetrate the corneal epitelial tissue and are sufficiently cytotoxic to cuase cell death.
The REET assay indicated that GSK1873183A is unlikely to have potential to cause severe ocular irritancy in vivo. The RHC model indicated thatthe test material is likley to be a moderate eye irritant and should be classified as R36; Irritating to eyes (GHS Category 2A)
Referenceopen allclose all
results are from in vitro/ ex vivo studies and time points, score and max score are not applicable endpoints
results are from in vitro/ ex vivo studies and time points, score and max score are not applicable endpoints
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed (irritating)
Additional information
Justification for classification or non-classification
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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