Registration Dossier
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EC number: 204-262-9 | CAS number: 118-58-1
- 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
- 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

Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Conducted in accordance with good scientific principles, suitable for use in classification/ labelling and risk assessment purposes.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
- Report Date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to
- Guideline:
- other: Haworth S, Lawlor T, Mortelmans K, Speck W, Zeiger E (1983): Salmonella mutagenicity test results for 250 chemicals. Environ Mutagen S [Suppl 1]:3-142
- Principles of method if other than guideline:
- Ames test.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): Benzyl salicylate
- Substance type: No data
- Physical state: No data
- Analytical purity: No data
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: No data
- Lot/batch No: No data
- Expiration date of the lot/batch: No data
- Stability under test conditions: No data
- Storage condition of test material: No data
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mixes from rat (RLI) and hamster (HLI), tested separately.
- Test concentrations with justification for top dose:
- EGG: 0, 0.3, 1, 3.3, 10, 20, 33, 100, 333 and 666 µg/plate.
SRI: 0, 3.3, 10, 33.3, 100 and 333 µg/plate. - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Justification for choice of solvent/vehicle: Assessed by each individual laboratory from a choice of distilled water, DMSO, 95 % ethanol, acetone, in that order of preference.
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- Positive controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA1535 -S9 and TA100 -S9 only
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA1537 -S9 only
- Positive control substance:
- other: 4-nitro-o-phenylenediamine
- Remarks:
- TA98 -S9 only
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 1535 +S9, TA 1537 +S9, TA 98 +S9 and TA 100 +S9 only
- Details on test system and experimental conditions:
- The test chemical, Salmonella culture, and S-9 mix or buffer were incubated
at 37"C, without shaking, for 20 min. Chemicals known or suspected to be volatile
were incubated in capped tubes. The top agar was added, and the contents of the
tubes were mixed and poured onto the surface of petri dishes that contained Vogel-
Bonner medium [Vogel and Bonner, 19561. The histidine-revertant (his') colonies
arising on these plates were counted following 2 days incubation at 37°C. The plates
METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Preincubation period:
- Exposure duration:
- Expression time (cells in growth medium):
- Selection time (if incubation with a selection agent):
- Fixation time (start of exposure up to fixation or harvest of cells):
NUMBER OF REPLICATIONS:
NUMBER OF CELLS EVALUATED:
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other:
OTHER EXAMINATIONS:
- Determination of polyploidy:
- Determination of endoreplication:
- Other:
OTHER: - Evaluation criteria:
- As per Haworth et al. 1983:
An individual trial was judged mutagenic (+) if a dose-related increase over the corresponding solvent control was seen, and it was judged weakly mutagenic C+W) if a low-level dose response was seen. A trial was considered questionable (?) if a dose-related increase was judged insufficiently high to justify a call of " + W," if only a single dose was elevated over the control, or if a non-dose-related increase was seen.
The distinctions between a weak mutagenic response and a mutagenic response, or between a weak mutagenic response and a questionable mutagenic response were considered highly subjective.
A chemical was judged to be mutagenic (+), or weakly mutagenic (+W), if it produced a reproducible, dose-related increase in his⁺ revertants over the corresponding solvent controls in replicate trials. A chemical was considered to be questionable (?) if a reproducible increase of hist revertants did not meet the criteria for either a " + " or " + W," or if only single doses produced an increase in his⁺ revertants in repeat trials. The chemicals were decoded by the chemical repository only after a determination had been made regarding their mutagenicity or nonmutagenicity.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- For full results please refer to the attached supporting information.
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Zeiger et al. screened 255 chemicals using Ames tests, including benzyl salicylate, which was screened in two separate tests in two different laboratories. Both test found benzyl salicylate to be negative for genotoxicity. - Executive summary:
As discussed as part of the category of salicylate substances (RAAF Document).
Seven of the category substances including the “target” substance (benzyl salicylate, have negative experimental Ames data, this indicates that although benzyl salicylate has an alert for DNA binding (OECD [Q]SAR Toolbox profile), this alert is not predictive of the actual DNA interaction within anin vitrotest system. Especially when taking into account the lack of DNA alerts based on the OASIS profiling. Therefore this indicates that all the category members would be negative in thein vitroAmes test.
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