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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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 990
- Report date:
- 1990
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Principles of method if other than guideline:
- Study Type; Mutagenicity; Gene Mutation in Cultured Chinese Hamster un Cells (HGPRT).
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian cell gene mutation test using the Hprt and xprt genes
Test material
- Reference substance name:
- Benzyl benzoate
- EC Number:
- 204-402-9
- EC Name:
- Benzyl benzoate
- Cas Number:
- 120-51-4
- Molecular formula:
- C14H12O2
- IUPAC Name:
- benzyl benzoate
- Test material form:
- solid
- Details on test material:
- generic
Constituent 1
- Specific details on test material used for the study:
- Purity: 99%
Method
- Target gene:
- (HGPRT)
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 derived from 8-12 week old male Wistar
Aroclor 1254 induced rat liver - Test concentrations with justification for top dose:
- Test Compound Concentrations Used:
(a) Preliminary cytotoxicity assay: Eight doses (0.1, 1.0, 10, 30, 60, 100, 250, and 500 µg/mL) were evaluated with andw ithout S9 activation.
b) Mutation assay:
Without S9 activation: Eight doses 10, 50, 60, 75, 80, 90, 100, and 120 µg/mL) were evaluated in the initial assay, an five doses (50, 90, 100, 120, and 150 µg/mL) were evaluated in the conflrmatory assay.
With S9 activation: Four doses (50, 100, 250, and 500 µg/mL) were evaluated in botht he initial and confirmatory assays. - Vehicle / solvent:
- Solvent/volume: Ethanol/1% v/v
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- other: Negative; Dulbecco s minimal essential medium (DMEM)/F12 supplemented wich 10% fetal calf serum (FCS)
- Positive control substance:
- other: Nonactivation (concentration, solvent): Ethyl methanesulfonate (EMS) was prepared in culture medium to yield a final concentration of 1 mg/ml. Activation concentration, solvent): 7,12-dimethylbenz(a)anthracene (DMBA) was prepared in dimethyl sulfoxide.
- Details on test system and experimental conditions:
- 1. Preliminary Cytotoxicity Assay; Eight doses of the test material (0.1 to 500 µg/mL) were evaluated with and without S9 activation. The solubility limit was 500 µg/mL. Nonactivated benzyl benzoate reduced the relative initial survival (RIS) at 250 µg/mL to 65.4%, and to 5.9% a 500 µg/mL. No cytotoxicity was observed at lower nonactivated doses, or at any S9-activated dose up to the solubility limit.
2. Mutation Assav: Doses for the mutation assays were chosen so that the high dose would reduce the plating efficiency to 20-50%. The study author stated that the first two assays without S9 activation were repeated, since cytotoxicity at levels >100 µg/mL prevented the evaluation of a sufficient number of doses; data from these experiments were not provided. Accordingly, benzyl benzoate was evaluated in the first successful nonactivated mutation assay at six doses ranging from 10 to 120 µg/mL; four S9-activated doses ranging from 50 to 500 µg/mL were also evaluated. The author reported that precipitation of the test material was observed at concentrations above 50 µg/mL. No explanation was provided for the differences in solubility between the preliminary cytotoxicity assay and the mutation assay.
Benzyl benzoate was not cytotoxic at doses <= 50 µg/mL -S9. Cytotoxicity at higher nonactivated concentrations (60-120 µg/mL) was not dose-dependent; RIS was <= 18.6% at all levels. The author attributed the lack of a dose-dependence effect to the insolubility of the compound. In the presence of S9 activation, benzyl benzoate was not cytotoxic at any tested dose. There was no evidence of a mutagenic effect of benzyl benzoate at any assayed concentration with or without S9 activation. In contrast, the positive controls (EMS at 1 mg/mL and DMBA at 15.4 µg/mL) induced marked increases in the number and frequency of mutants.
In the confirmatory assay, the test material was investigated at 50, 90, 100, 120, and 150 µg/mL -S9 and at 50, 100, 250, and 500 µg/mL +S9. RIS for cultures exposed co nonactivated benzyl benzoate ranged from 64.4% at the low dose (50 µg/mL) to 21.8% at the high dose (150 µg/mL); the cytotoxic response was dose-related. Severe cytotoxicity (i.e. <50 cells recovered 7 days postseeding) was reported for the cultures treated with 150 µg/mL -S9 after the expression period. As in the first assay, no cytotoxicity was observed at any S9-activated dose. Also in agreement with the findings of the initial assay, the test material was not mutagenic at any nonactivated or S9-activated dose.
The study author concluded that benzyl benzoate was not mutagenic in this test system.
Results and discussion
Test results
- Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
Any other information on results incl. tables
The US EPA has reviewed the study: REVIEWERS DISCUSSION AND INTERPRETATION OF RESULTS: We assess that the study author’s interpretation of the data was correct. Benzyl benzoate was tested to the limit of solubility, and to cytotoxic doses without S9 activation, but showed no evidence of inducing forward mutations at the HGPRT locus in V79 cells. The response of the test system to the positive controls indicated that the assay was sufficiently sensitive to detect mutagenic response. We, therefore, conclude that benzyl benzoate was not mutagenic in this assay.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
- Executive summary:
CONCLUSIONS-EXECUTIVE SUMMARY: Under the conditions of the Chinese hamster lung cell HGPRT forward gene mutation assay, doses of non-activated benzyl benzoate (10 to 120 µg/mL), and doses of S9- activated benzyl benzoate (50 to 500 µg/mL) did not induce a mutagenic response in two independent assays. The test material precipitated at levels above 50 µg/mL +/- S9. Marked cytotoxicity was observed at all nonactivated doses >= 60 µg/mL in the first trial, and at 150 µg/mL in the second trial. The S9-activated test material was not cytotoxic. Based on these findings, it was concluded that benzyl benzoate was tested to the limit of solubility, and to cytotoxic levels without S9 activation, with no evidence of a mutagenic effect.
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