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Diss Factsheets
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EC number: - | 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 20 October 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to OECD test guidelines, and in compliance with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 437. 7 September 2009, OECD Guideline for the Testing of Chemicals: Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The study report included a current certificate of GLP compliance for the test facility, issued by the MHRA.
Test material
- Details on test material:
- - Physical state: Off-white solid
- Storage condition of test material: aprox. -20 degrees in the dark.
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine eyes.
- Details on test animals or tissues and environmental conditions:
- Bovine eyes, excised by an abattoir employee, were collected as soon after slaughter as possible (excised at 11.45 hours on 20 October 2009).
Instructions were given to avoid damaging the corneas during excision. Excised eyes were maintained and transported to the laboratory, at ambient
temperature, in sufficient HBSS, containing 1% (v/v) Penicillin/Streptomycin solution, to cover all the eyes in the receptacle. The eyes were used
4 hours 16 minutes after slaughter (incubation of mounted corneas commenced at 16.01 hours on 20 October 2009).
Test system
- Vehicle:
- other: 0.9% sodium chloride solution.
- Controls:
- other: Concurrent positive and negative control corneas were examined.
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750µL
- Concentration (if solution): 20% (w/w) - Duration of treatment / exposure:
- 4 hours ± 5 minutes at 32 ± 1 °C.
- Observation period (in vivo):
- Corneas were washed after the exposure period, then the opacity of each cornea was measured.
- Number of animals or in vitro replicates:
- Corneas were treated in triplicate with either the test substance, positive control compound or negative control (0.9% sodium chloride solution).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Opacity
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 0.33
- Remarks on result:
- other: S.D. = 2.082
- Irritation parameter:
- other: Permeability
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 0.03
- Remarks on result:
- other: S.D. = 0.057
- Irritation parameter:
- other: In vitro irritancy score
- Basis:
- mean
- Time point:
- other: 4h
- Score:
- 0.7
- Remarks on result:
- other: S.D. = 2.4
- Irritant / corrosive response data:
- The in-vitro irritancy score of Imidazole, the positive control, was 132.7 ± 2.6 (standard deviation).
Any other information on results incl. tables
In Vitro Irritancy Score was calculated as (Opacity + (15 x Corrected OD490)).
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Interpretation is consistent with the criteria quoted in the OECD test guideline.
- Conclusions:
- The test substance elicited an In Vitro Irritancy Score of 0.7 ± 2.4 and was predicted to be a non corrosive/non severe eye irritant.
- Executive summary:
An In-vitro eye irritation / corrosion test was conducted by Huntingdon Life Sciences, UK, to assess the potential for eye irritation of the test substance. The study was conducted according to the OECD Test Guideline 437, and in compliance with GLP. The corneas from freshly excised Bovine eyes were exposed to a 20% (w/w) solution of the test substance in saline solution (sodium chloride 0.9% (w/v) solution) for four hours prior to washing, recording of the opacity, then determination of the permeability. The test substance elicited an in vitro Irritancy Score of 0.7 ± 2.4 and was predicted to be a non corrosive / non severe eye irritant.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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