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Diss Factsheets
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EC number: 943-665-0 | 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- the study was conducted between 20 October 2015 and 23 October 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- not specified
- GLP compliance:
- yes
Test material
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Sponsor Lot/Batch No. PW2
- Expiration date of the lot/batch:
- Purity test date:06 Oct 2015
RADIOLABELLING INFORMATION (if applicable)
- Radiochemical purity:
- Specific activity:
- Locations of the label:
- Expiration date of radiochemical substance:
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material:
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle:
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing:
- Preliminary purification step (if any):
- Final dilution of a dissolved solid, stock liquid or gel:
- Final preparation of a solid:
FORM AS APPLIED IN THE TEST (if different from that of starting material)
OTHER SPECIFICS:
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Covance Research Products, Inc. Denver, PA, USA
- Age at study initiation: 28 wks
- Weight at study initiation: 2.9-3.4 kg
- Housing: Individually in suspended cages
- Diet (e.g. ad libitum): Fresh daily
- Water (e.g. ad libitum): ad libitum
- Acclimation period: > 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled but no temperature reported
- Humidity (%): controlled but no humidity reported
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 20 October 2015 To: 23 October 2015
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- other: Contralateral eye served as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 21.6 mg
- Concentration (if solution):
VEHICLE
- Amount(s) applied (volume or weight with unit):
- Concentration (if solution):
- Lot/batch no. (if required):
- Purity: - Duration of treatment / exposure:
- 72h
- Observation period (in vivo):
- 72h
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not done
- Time after start of exposure:
SCORING SYSTEM: Draize technique
TOOL USED TO ASSESS SCORE: hand lamp - Mini-Maglite with high intensity bulb
fluorescein dye at 24h timepoint with UV light source
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1h
- Score:
- >= 6
- Max. score:
- 6
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1h
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1h
- Score:
- 8
- Max. score:
- 8
- Reversibility:
- fully reversible
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- not specified
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- iris score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- animal: all
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Irritant / corrosive response data:
- Corneal opacity and iritis were not noted at any observation period, Conjunctival irritation, noted in three out of three eyes at the 1-hour observation period, cleared by 24 hours.
Additional ocular observations of test article residue in the conjunctival sac were noted at the 1-hour observation period.
The control eyes appeared normal at all observation periods. - Other effects:
- - Lesions and clinical observations:
- Ophthalmoscopic findings:
- Histopathological findings:
- Effects of rinsing or washing:
- Other observations: No physical signe were noted during the observation period.
One animal lest weight, one animal gained weight and one anim's weight remained unchanged.
Applicant's summary and conclusion
- Interpretation of results:
- other: Non irritant
- Conclusions:
- Corneal opacity and iritis were not noted at any observation period, Conjunctival irritation, noted in three out of three eyes at the 1-hour observation period, cleared by 24 hours.
Additional ocular observations of test article residue in the conjunctival sac were noted at the 1-hour observation period.
The control eyes appeared normal at all observation periods.
The substance was non irritant and is not classified according to EU and GHS classifications and is classified as Category IV under the US EPA Classification - Executive summary:
The eye irritation/corrosion effects of RD 14153 were examined in accordance with OECD 405 and US EPA OCSPP 870.2400 guidelines in three New Zealand White Rabbits over a period of 72 hours; one eye per rabbit was treated, the other acted as a control.
Corneal opacity and iritis were not noted at any observation period, Conjunctival irritation, noted in three out of three eyes at the 1-hour observation period, cleared by 24 hours. Additional ocular observations of test article residue in the conjunctival sac were noted at the 1-hour observation period. The control eyes appeared normal at all observation periods.
The substance was non irritant and is not classified according to EU and GHS classifications and is classified as Category IV under the US EPA 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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