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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
![](https://echa.europa.eu./o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Endpoint summary
Administrative data
Description of key information
Guideline-compliant studies are available for skin and eye irritation.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP and Test Guideline compliant study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: A Smith , Warlingham, Surrey
- Age at study initiation: no data
- Weight at study initiation: no data
- Housing: individually housed in anodised aluminium caging with grid flooring
- Diet (e.g. ad libitum): Dalgety-Spillers pelleted rabit diet ref. 680 ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 42-65
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 16 April 1985 To: 23 April 1985 - Type of coverage:
- semiocclusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- 0.5 mL applied to dorsum of each of four rabbits
- Duration of treatment / exposure:
- 4 hour exposure
- Observation period:
- 7 days
- Number of animals:
- 4
- Details on study design:
- Four rabbits were treated simultaneously with four test materials (two per flank placed distally and caudally on the shaved dorsum). 0.5 mL of undiluted test material was applied to a square of surgical lint whicwas held in situ on the rabbit by means of an encircling elasticated adhesive bandage. The dressing was removed after four hours (treated sites were swabbed with cotton wool and warm water to remove residual material immediately after removal of the dressing) and treated sites assessed after 1, 24, 48, 72 and 168 hours for signs of dermal change that was scored using the standard Draize assessment scheme
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.2
- Max. score:
- 4
- Reversibility:
- fully reversible within: completely resolved within 7 days for 3 of the 4 rabbits
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.4
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Three of the four treated sites showed evidence of slight erythema within an hour of the dressing removal. For two of these rabbits well defined erythema developed over the following 72 hours with slight reactions remaining for the third rabbit. slight erythema persisted for seven days in one animal but was showing a degree of amelioration over the study time course although not fully resolved by termination. No reactions developed in one rabbit throughout the study.
Very slight oedema was observed for three rabbits but the reactions did not progress in severity and resolved with 48 or 168 hours. - Other effects:
- None observed
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Generally slight or very slight erythema or oedema was apparent in three of four treated rabbits, with reactions persisting for three days but typically resolved by day 8. Mean scores for erythema and oedema assessed over the 24 to 72 hour assessments were less than 2.0 and did not trigger classification thresholds for benzyl benzoate.
- Executive summary:
Four rabbits were each treated with four test materials on four dorsal locations, for an exposure period of 4 hours. After removal of the semi-occlusive dressing the sites were swabbed with cotton wool and warm water to remove test material residues. Dermal assessments were recorded 1, 24, 48, 72 and 168 hours after removal of the dressing. Generally slight or very slight erythema or oedema was apparent in three of four rabbits treated with benzyl benzoate, with reactions persisting for three days but typically resolved by day 8. Mean scores for erythema and oedema assessed over the 24 to 72 hour assessments were less than 2.0 and did not trigger classification thresholds for benzyl benzoate.
Reference
Dermal reactions with benzyl benzoate
Rabbit number |
1 hr |
24 hr |
48 hr |
72 hr |
168 hr |
591 |
|
|
|
|
|
Erythema |
0 |
0 |
0 |
0 |
0 |
596 |
|
|
|
|
|
Erythema |
1 |
2 |
2 |
1 |
0 |
598 |
|
|
|
|
|
Erythema |
1 |
1 |
1 |
1 |
0 |
600 |
|
|
|
|
|
Erythema |
1 |
2 |
2 |
2 |
1 |
Mean |
|
Erythema = 1.2 |
|
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- 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
- 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
- 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 - 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 - 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
- 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.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Slight to well defined erythema was evident in three rabbits (Haynes 1985), generally resolving within 72 hours of exposure but slight erythema was still present at termination for one rabbit although a reduction in the degree of reaction was evident over time for this animal. Very slight oedema was noted for three rabbits, reactions generally resolving within 48 or 72 hours. The mean scores were less than the classification thresholds and no classification is required for benzyl benzoate in respect of skin irritation. No significant skin irritation was seen in a supporting study.
Ocular changes were limited to slight vascular injection in the conjunctivae of all six rabbits within an hour of instillation of undiluted benzyl benzoate (Mallory & Naismith, 1982), and a slight iridial response in one rabbit at the same time point. All reactions had resolved within 24 hours and the mean scores for the 24, 48 and 72 hour assessments were all zero. The transient slight responses were insufficient to trigger classification of benzyl benzoate as an ocular irritant based on GHS and CLP classification criteria.
Justification for selection of skin irritation / corrosion endpoint:
Guideline-compliant study
Justification for selection of eye irritation endpoint:
Guideline-compliant study
Justification for classification or non-classification
The mean skin irritation scores were less than the classification thresholds and no classification is required for benzyl benzoate in respect of skin irritation. No significant skin irritation was seen in a supporting study.
Ocular reactions had resolved by the 24 hour assessment. Mean scores for the 24, 48 and 72 hour assessments were all zero. The transient slight responses were insufficient to trigger classification of benzyl benzoate as an ocular irritant.
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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