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EC number: 601-327-7 | CAS number: 114772-54-2
- 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:
- From 25 July 1995 to 31 July 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- OECD guideline not specified.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4'-(bromomethyl)-[1,1'-biphenyl]-2-carbonitrile
- EC Number:
- 601-327-7
- Cas Number:
- 114772-54-2
- Molecular formula:
- C14H10BrN
- IUPAC Name:
- 4'-(bromomethyl)-[1,1'-biphenyl]-2-carbonitrile
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Test compound/batch: SR 48941 2/batch 5SNP501.
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Three New Zealand White rabbits, two males and one female, identified by vendor attached plastic ear tag or implanted microship and study animal identification number written with indelible ink pen inside the right ear and housed one per cage.
- Source: Hazleton Research Products, Inc
- Age at study initiation: three to six months old
- Weight at study initiation: rabbits were weighed on Day-1 and body weights ranged from 3.0 to 3.5 kg.
- Housing: the rabbits were caged in an environmentally controlled room
- Diet: 125 grams/rabbit/day of Purina Certified High Fiber Rabbit Chow No. 5325 Lot 17 May 95 2A and 15 June 95 1B
- Water (e.g. ad libitum): municipal water (via an automatic watering system)
ENVIRONMENTAL CONDITIONS
- Temperature: 64-68°F
- Relative Humidity: 40-60 %
- Photoperiod (hrs dark / hrs light): 12 hour light/dark cycles.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: No control article was used; untreated sites served as controls
- Amount / concentration applied:
- 100 mg of pulverized solid compound
- Observation period (in vivo):
- 72 hrs
- Number of animals or in vitro replicates:
- 3, two males and one female
- Details on study design:
- On Day 4 of the study, 100 mg of pulverized solid compound was placed in the conjunctival sac of the right eye, the left eye serving as control. Sodium fluorescein was instilled into the eye, followed by irrigation with 10 mL saline, at pretreatment and beginning at the 24 hr grading to determine the presence or absence of stainable corneal opacification and to evaluate the affected areas. If an effect was observed at 24 hr, sodium fluorescein was intilled into eye at 48 and 72 hrs.
OBSERVED EFFECTS AND MORTALITY
The rabbits were observed at least once daily throughout the study, until termination on Day 7, for changes in appearance and behavior and mortality.
BODY WEIGHTS
The rabbits were weighed on Day -1.
OBSERVATION AND SCORING
Control and treated eyes were assessed for ocular lesions 1 hr (Day 4), then 24 (Day 5), 48 (Day 6) and 72 (Day 7) hrs after application of the test compound.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hrs
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- Degree Opacity
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- Surface Opacity
- Basis:
- animal #1
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within the 72 hrs of observation
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- Degree Opacity
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- Surface Opacity
- Basis:
- animal #2
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- conjunctivae score
- Remarks:
- Discharge
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within the 72 hrs of observation
- Irritation parameter:
- conjunctivae score
- Remarks:
- Redness
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- not reversible
- Remarks:
- within the 72 hrs of observation
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hrs
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- cornea opacity score
- Remarks:
- Degree Opacity
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Remarks:
- Surface Opacity
- Basis:
- animal #3
- Remarks:
- mean
- Time point:
- other: 24, 48 and 72 hrs
- Score:
- 0
- Max. score:
- 4
- Irritant / corrosive response data:
- SR 48941 (batch 5SNP501) produced a slight reponse in all three animals. Mild conjunctival redness (vessels more injected than normal), conjunctival discharge (score 1 or 2), and chemosis (score 1 or 2) were observed in all three animals. The irritation responses were diminished or absent within 72 hours exposure. The cornea and iris were unaffected.
- Other effects:
- No clinical signs of toxicity were observed in any rabbit and no deaths occurred during the study.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study, SR 48941 (batch 5SNP501) is not a reportable eye irritant.
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