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Diss Factsheets
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EC number: 424-560-4 | CAS number: 151257-01-1 SR 48001 A
- 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
- Remarks:
- in vitro
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 13 November 1996 to 30 April 1997
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to OECD and in accordance with GLP. The study material is well characterized.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- GLP compliance:
- yes
Test material
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- At the start of the study the males rabbits weighed 3.0 kg and were 19 weeks old. Free access to mains drinking water and food was allowed throughout the study. The temperature and relative humidity were set to achieve limits of 20+-2 C and 45 to 75% respectively. The rate of air exchange was 10-12 changes per hour and the lighting was controlled by a time switch to give 12 hours continuous light and 12 hours of darkness.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: left eye of each animal was untreated
- Amount / concentration applied:
- 100 mg fine ground test material
- Duration of treatment / exposure:
- 100 mg test material to the non-irrigated eye of three rabbits was performed by placing test material in the conjunctival sac of the right eye and gently pulling the lower eye lid away from the eyeball. The upper and lower eyelid were held closed for about one second after treatment to prevent loose of material and then released. The left eye was left untreated to serve as the control.
- Observation period (in vivo):
- Assessment of ocular damage/irritation was made approximately 1 hour and 24, 48 and 72 hours following treatment. Additional observations were perfomed on day 5 to 9 to assess the reversibilityof the ocular effects.
- Number of animals or in vitro replicates:
- 3 males rabbits
- Details on study design:
- Before treatment both eyes were checked for sign of ocular irritation or defect with the aid of a direct light source. Only animals free of ocular damage were used in the study.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: Max. duration: day 8
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: Max. duration: day 8
- Irritation parameter:
- conjunctivae score
- Remarks:
- (redness)
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9days
- Remarks on result:
- other: Max. duration: day 7
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: overall at 24,48 and 72 hr
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: Max. duration: day 5
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: overall at 24,48 and 72 hr
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: max duration day 6
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: overall at 24,48 and 72 hr
- Score:
- 2.67
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: max duration day 5
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree of opacity
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: Max. duration:day 6
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree of opacity
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: Max. duration: day 7
- Irritation parameter:
- cornea opacity score
- Remarks:
- degree of opacity
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: Max. duration: day 6
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: Max. duration: 72 hr
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: Max. duration: 72 hr
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: overall at 24, 48 and 72 h
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 9 days
- Remarks on result:
- other: Max. duration: 72 hr
- Irritant / corrosive response data:
- Reversibility of any observed effect: Changes fully reversible within 9 days.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test material was classified as an 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.
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