Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 218-080-2 | CAS number: 2050-08-0
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- not specified
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- To address toxicological endpoints as part of the REACH registration of the REACH registration of Amyl Salicylate (Target Substance) it is proposed to read-across to Benzyl Salicylate (Source Substance). The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible. The Target Substance and Source Substance have been characterised using the categories and databases present in the OECD [Q]SAR Toolbox. From the profiling, it can be seen that the two substances share structural similarities and also ‘mechanistic action’ similarities which are both general and endpoint specific. Therefore read across is justified.
- Justification for type of information:
- The justification for read across from Benzyl Salicylate is attached in section 13.2 (Other assesment report).
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
- 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 substance name:
- Benzyl salicylate
- EC Number:
- 204-262-9
- EC Name:
- Benzyl salicylate
- Cas Number:
- 118-58-1
- Molecular formula:
- C14H12O3
- IUPAC Name:
- benzyl salicylate
- 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
Constituent 1
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
Any other information on results incl. tables
To address toxicological endpoints as part of the REACH registration of the REACH registration of Amyl Salicylate (Target Substance) it is proposed to read-across to BenzylSalicylate (Source Substance).
The use of read-across works within the spirit of REACH and the stated aim of the legislation to reduce animal testing where possible.
The Target Substance and Source Substance have been characterised using the categories and databases present in the OECD [Q]SAR Toolbox. From the profiling, it can be seen that the two substances share structural similarities and also ‘mechanistic action’ similarities which are both general and endpoint specific.
See Section 13, document Read across justification_Tox_Amyl salicylate_Benzyl salicylate.
Applicant's summary and conclusion
- Conclusions:
- 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.
Data are taken from results of study on the structural analgue, Benzyl salicylate, EC# 204-262-9. Read across is justified based on similarity in chemical structure and biological activity of salicylates.
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.