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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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Endpoint summary
Administrative data
Description of key information
A guideline and GLP-compliant LLNA is available for benzyl benzoate.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21 to 27 July 2004
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline and GLP-compliants study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
- Species:
- mouse
- Strain:
- other: CBA/Ca/Ola/Hsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Interfauna UK limited, Bicester, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: circa 16-20g
- Housing: 4 mice per cage
- Diet (e.g. ad libitum): RM1 from Special Diet Services, ad libitum
- Water (e.g. ad libitum): mains water ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 30-70
- Air changes (per hr):15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 21 July 2004 To: 27 July 2004 - Vehicle:
- other: 1:3 ethanol:diethylphthalate (1:3 EtOH:DEP)
- Concentration:
- 2.5, 5, 10, 25 or 50% v/v
- No. of animals per dose:
- Four female mice
- Details on study design:
- RANGE FINDING TESTS:
Not performed
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Local lymph node assay according to methods of Kimber et al.
- Criteria used to consider a positive response: Stimulaton Index SI value of 3.0 or greater and EC3 value where this can be calculated
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of four female mice were allocated to the study and approximately 25 µL of a 2.5, 5, 10, 25 or 50% v/v preparation of benzyl benzoate in 1:3 EtOH:DEP was applied to the dorsal surface of each ear. A vehicle control group was similarly treated.
Treatment was repeated on three consecutive days and then three days later all animals were intravenously injected, via the tail vein, with 250µL of phosphate buffered saline containing 20 µCi of a 2.0 µCi/mmol specific activity 3H-methyl thymidine. The mice were killed 5 hours later and draining auricular lymph nodes were excised.
Single cell suspensions were prepared in PBS and subject to cycles of centrifugation and following addition of scintillation fluid, the lymph node suspensions were counted using a ß-scintillation counter. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Stimulation Indices evaluated using simple t-test.
EC3 value calculated by interpolation on the SI axis - Positive control results:
- Hexylcinnamaldehyde concentrations of 10 and 25% w/v in acetone:olive oil caused an increase in isotope incorporation with SI values of greater than 3 in each case, confirming the validity of the assay methods.
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- Benzyl benzoate concentration: 2.5%
- Parameter:
- SI
- Value:
- 0.7
- Test group / Remarks:
- Benzyl benzoate concentration: 5%
- Parameter:
- SI
- Value:
- 0.8
- Test group / Remarks:
- Benzyl benzoate concentration: 10%
- Parameter:
- SI
- Value:
- 1.7
- Test group / Remarks:
- Benzyl benzoate concentration: 25%
- Parameter:
- SI
- Value:
- 2.7
- Test group / Remarks:
- Benzyl benzoate concentration: 50%
- Parameter:
- other: DMP (disintegrations per minute)
- Value:
- 2 248
- Test group / Remarks:
- 0 (vehicle control)
- Remarks on result:
- other: SI = NA
- Parameter:
- other: DMP (disintegrations per minute)
- Value:
- 1 538
- Test group / Remarks:
- Benzyl benzoate concentration: 2.5%
- Remarks on result:
- other: SI = 0.7
- Parameter:
- other: DMP (disintegrations per minute)
- Value:
- 1 662
- Test group / Remarks:
- Benzyl benzoate concentration: 5%
- Remarks on result:
- other: SI = 0.7
- Parameter:
- other: DMP (disintegtations per minute)
- Value:
- 1 843
- Test group / Remarks:
- Benzyl benzoate concentration: 10%
- Remarks on result:
- other: SI = 0.8
- Parameter:
- other: DMP (disintegrations per minute)
- Value:
- 3 798
- Test group / Remarks:
- Benzyl benzoate concentration: 25%
- Remarks on result:
- other: SI = 1.7
- Parameter:
- other: DMP (Disintegrations per minute)
- Value:
- 6 024
- Test group / Remarks:
- Benzyl benzoate concentration: 50%
- Remarks on result:
- other: SI = 2.7
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- The increase in disintegrations per minute or per lymph node was less than threefold for all tested concentrations. An EC3 was not calculated but was estimated to exceed 50% (greater than the maximum administered dose of 12500 µg/cm2). SI values ranged from 0.7 to 2.7, generally increased in a linear manner with increasing dose, but none exceeded the threshold value of 3.0
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: Refer to table below. DPM were in range of 1538 to 6024 for 2.5 to 50% concentrations and the control group was 2248.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- None of the calculated SI values exceeded the classification threshold of 3.0 and no EC3 value could be calculated from the pattern of responses.
- Executive summary:
A local lymph node assay was completed using standard procedures but with additional treatment groups. Groups of four female mice were dosed topically at various concentrations on three consecutive days and then injected with tritiated thymidine, following a period of time to allow for lymphocyte proliferation and incorporation of the labelled thymidine, the lymph nodes were excised and prepared or scintillation counting.
The level of isotope incorporation was less than 3 -fold that of the control for treatment group and consequently benzyl benzoate is not considered to be a potential sensitiser.
Reference
Benzyl benzoate concentration |
Number of lymph nodes assayed |
Disintegrations per minute (DPM) |
DPM per lymph node |
Test : control ratio (Stimulation Index, SI) |
0 vehicle control |
8 |
2248 |
281 |
NA |
2.5 |
8 |
1538 |
192 |
0.7 |
5 |
8 |
1662 |
208 |
0.7 |
10 |
8 |
1843 |
230 |
0.8 |
25 |
8 |
3798 |
475 |
1.7 |
50 |
8 |
6024 |
753 |
2.7 |
EC3 |
Estimated to exceed 50% or 12500 µg/cm2 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
A local lymph node assay was completed using standard procedures but with additional treatment groups. Groups of four female mice were dosed topically at various concentrations on three consecutive days and then injected with tritiated thymidine, following a period of time to allow for lymphocyte proliferation and incorporation of the labelled thymidine, the lymph nodes were excised and prepared or scintillation counting. The level of isotope incorporation was less than 3 -fold that of the control for treatment group and consequently benzyl benzoate is not considered potential sensitiser.
Justification for selection of skin sensitisation endpoint:
Only one study available for this endpoint
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Justification for classification or non-classification
According to CLP classification criteria (Regulation (EC) No 1272/2008) a classification is not justified.
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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