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EC number: 204-402-9 | CAS number: 120-51-4
- 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 vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 11 to 18 March 1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-4 (Acute Eye Irritation)
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- six rabbits used rather than three, but this does not affect validity of results
- GLP compliance:
- yes
Test material
- Reference substance name:
- Benzyl benzoate
- EC Number:
- 204-402-9
- EC Name:
- Benzyl benzoate
- Cas Number:
- 120-51-4
- Molecular formula:
- C14H12O2
- IUPAC Name:
- benzyl benzoate
- Test material form:
- other: clear liquid
- Details on test material:
- - Name of test material (as cited in study report): 81-223-02 (benzyl benzoate)
- Physical state: clear liquid
- Analytical purity: no data
- Lot/batch No.: no data
- Stability under test conditions: stable for duration of test, no change in physical appearance noted
- Storage condition of test material: no data
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Hilltop Lab Animals Scottdale, Pennsylvania
- Age at study initiation: no information
- Weight at study initiation: 2.07 to -2.28 kg (males - 2.066, 2.279 and 2.158 kg; females - 2.144, 2.261 and 2.247 kg)
- Housing: individually in laboratory standard cages
- Diet (e.g. ad libitum): Wayne Rabbit Ration ad libitum
- Water (e.g. ad libitum): Potable tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20±3
- Humidity (%):30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 11 March 1982 To: 18 March 1982
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated contralateral eye used as control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Concentration (if solution): undiluted, as supplied - Duration of treatment / exposure:
- single instillation
- Observation period (in vivo):
- 7 days, treated eyes assessed on day 1, 2, 3, 4 and 8 at 1, 24, 48, and 72 hours post instillation and again after 7 days
- Number of animals or in vitro replicates:
- 6, three males, three females
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): No reported flushing the treated eyes
- Time after start of exposure: not applicable
SCORING SYSTEM: standard Draize assesment
TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein -- no details reported
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- conjunctivae score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 20
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- iris score
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 10
- Reversibility:
- fully reversible within: 24 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- other: no effects observed
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: one hour post instillation
- Score:
- 0
- Max. score:
- 80
- Reversibility:
- other: no effects observed
- Remarks on result:
- other: No corneal changes noted in six rabbits
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: one hour post instillation
- Score:
- 0.83
- Max. score:
- 10
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: only one treated eye showed iridial reaction
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: one hour after instillation
- Score:
- 2.67
- Max. score:
- 20
- Reversibility:
- fully reversible within: 24 hours
- Remarks on result:
- other: six rabbits showed slight conjunctival reddening, no chemosis apparent in any treated eyes
- Irritant / corrosive response data:
- Slight or diffuse conjunctival injection apparent for all six rabbits within an hour of benzyl benzoate instillation. A minimal iridial response was also seen in one treated eye at this assessment. All reactions had resolved within 24 hours of dosing and the eyes were overtly normal for the remainder of the observation period (up to Day 8).
- Other effects:
- None observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on only very slight reactions being noted one hour after dosing, all of which had resolved wih in 24 hours, benzyl benzoate was not considered to be irritating to rabbit eyes.
- Executive summary:
Six rabbits were allocated to the study based on a negative response to examination using sodium fluorescein stain 24 hours before dosing, which confirmed no pre-existing ocular damage was present. The right eye in each case was treated with 0.1 ml of undiluted benzyl benzote, instilled into the lower conjunctival sac on day 1. The left eye was used as an untreated control for each rabbit.
Eyes were examined 1, 24, 48 and 72 hours after dosing and again on day 8 (7 days after dosing). The assessment of ocular change was made using the standard Draize scoring scheme.
All six treated eyes developed a low degree of conjuctival vaculature injection within an hour of dosing but this resolved in all animals within 24 hours. A slight iridial response apparent in one rabbit also resolved by day 2.
The mean scores for 24, 48 and 72 hour assessments were all zero and consequently benzyl benzoate is not considered to be an ocular irritant. According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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