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Diss Factsheets
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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
Acute oral toxicity studies are available in the rat and mouse; an early acute dermal toxicity study is also available in the rat.
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 31 January 1985 to 26 February 1985
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The test material was probably administered, at various concentrations in peanut oil, as the technical grade material but no information was available to confirm purity.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Principles of method if other than guideline:
- Standard limit test according to OECD 401
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: A Tuck & Sons Ltd, Essex, UK
- Age at study initiation: 4-6 weeks old
- Weight at study initiation: 119-148g males and 118-148g females
- Fasting period before study: yes, overnight unti 2 hours aftre dosing
- Housing: groups of five by se in polypropylene cages
- Diet (e.g. ad libitum):Rat & Mouse Expanded No.1, supplied by SDS Witham, Essex; ad libitum
- Water (e.g. ad libitum): ad libitum access to tap water
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24
- Humidity (%): 40-55%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 31 January 1985 To: 26 February 1985 - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: For range finding test - 20, 100, 200, 300 and 400 mg/ml and for the main study 400 mg/ml
- Amount of vehicle (if gavage): dose volume was 5 mL/kg bw
- Justification for choice of vehicle: arachis oil used basd on suitability during range-finding investigations
MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg
DOSAGE PREPARATION (if unusual): prepared freshly for each dose administration - Doses:
- range-finder: 100, 500, 1000, 1500 and 2000 mg/kg bw
main study: 2000 mg/kg bw - No. of animals per sex per dose:
- 2 in range finder; 5 in main study
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: frequent hourly observations on day of dosing; daily checks thereafter; bodyweights recorded on days 0, 7 and 14
- Necropsy of survivors performed: yes - Statistics:
- Not required
- Preliminary study:
- The range finding investigation revealed no mortalities in the dose range 100 to 2000 mg/kg bw. Hunched posture, lethargy, decreased respiratory rate and piloerection were frequently observed in the range-finder groups but the signs and severity of clinical response showed no treatment relationship. Recovery from systemic effects was complete within three days for all groups.
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths at the limit dose
- Mortality:
- There were no deaths in the main study, following dosing at 2000 mg/kg bw.
- Clinical signs:
- other: Hunched posture, lethargy, piloerection, ptosis and a decreased respiratory rate were commonly observed shortly after dosing with infrequent cases of body tremors also noted. Recovery from all signs was complete by Day 4.
- Gross pathology:
- Macroscopic examination at necropsy revealed congested lungs for one rat (normally an agonal response) and pale areas on the gastric glandular region for one rat. No other macroscopic abnormalities were apparent.
- Other findings:
- No data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute oral LD50 for benzylbenzoate was greater than 2000 mg/kg bw in rats.
- Executive summary:
In a standard acute oral study in rats, in accordance with test guideline OECD 401, groups of five male and female rats were dosed at 2000 mg/kg bw. Clinical signs including hunched posture, decreased respiratory rate, lethargy, ptosis and pilo-erection were apparent shortly after dosing but recovered within 4 days. The acute oral median lethal dose for benzylbenzoate was greater than 2000 mg/kg bw in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- discriminating dose
- Value:
- 2 000 mg/kg bw
- Quality of whole database:
- Reliable rat study supported by data in the mouse
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Published study with limited details relating to methods. Study pre-dates adoption of regulatory test guidelines.
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Screening test
- GLP compliance:
- no
- Test type:
- other: Draize primary skin irritation screening test
- Limit test:
- yes
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- No details provided
- Type of coverage:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- No details provided for method of application
- Duration of exposure:
- Not specified in publication, normal exposure period in Draize method is 4 hours.
- Doses:
- 2.0 mL/kg bw
- No. of animals per sex per dose:
- No data
- Control animals:
- not specified
- Statistics:
- No data
- Preliminary study:
- No information
- Key result
- Sex:
- not specified
- Dose descriptor:
- LD50
- Effect level:
- > 2 mL/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths occurred
- Mortality:
- No mortality in skin irritation tests.
Benzyl benzoate displays a toxic threshold with a sharp demarcation at circa 2.0 mL/kg bw. Delayed deaths occurred following a single high dose topical application. Animals that died exhibited no clinical signs prior to death. - Clinical signs:
- other: No signs of systemic toxicity observed
- Gross pathology:
- no data
- Other findings:
- no data
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The acute dermal LD50 of benzyl benzoate was found to be >2 mL/kg bw (~2000 mg/kg bw) under the conditions of this assay.
- Executive summary:
The acute dermal LD50 of benzyl benzoate was investigated in a screening assay in the rabbit and was found to be >2 mL/kg bw (~2000 mg/kg bw).
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Quality of whole database:
- Non-standard screening study in the rabbit
Additional information
Benzyl benzoate is shown to be of low acute toxicity by the oral and dermal routes. The acute oral LD50 of benzyl benzoate was reported to be >2000 mg/kg bw in the rat (Collier & Hewitt, 1985); an acute oral LD50 of 3253 mg/kg bw is reported in the mouse (Hoffman, 1972). Draize et al (1947) report an acute dermal LD50 value of >2 mL mg/kg bw (~2000 mg/kg bw) in a screening study performed in the rabbit.
Justification for selection of acute toxicity – oral endpoint
Regulatory limit test according to OECD 401, in the preferred species
Justification for selection of acute toxicity – dermal endpoint
Only one study available for this endpoint
Justification for classification or non-classification
No classification is required for acute oral and dermal toxicity according to the CLP Regulation.
Benzyl benzoate harmonised classification according to CLP Regulation 1272/2008 is Acute Tox 4, H302. The interpretation reflects the agreed classification rather than the observed experimental results.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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