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EC number: 203-008-4 | CAS number: 102-16-9
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Gene mutation toxicity study was performed to determine the mutagenic nature of benzyl phenylacetate using preincubation assay. The study was performed using Salmonella typhimurium strain TA97, TA98, TA1535 and TA100 with and without 10% and 30% rat liver and hamster liver S9 metabolic activation system. The study was performed at dose level of 0, 0.3, 1, 3, 10, 33, 66, 100, 333, 1000, 3333 or 10000 µg/plate for TA100 and TA98 and at a dose level of 0, 0.3, 1, 3, 10, 33, 100, 333, 1000, 3333 or 10000 µg/plate for TA1535 and TA97 with DMSO as the solvent. The plates were observed for a dose dependent increase in the number of revertants/plate. Benzyl phenylacetate did not induce a a dose dependent increase in the number of revertants per plate and hence exhibited no mutagenic activity under the given test conditions.
Link to relevant study records
- 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:
- data from handbook or collection of data
- Justification for type of information:
- Data is from CEBS (Chemical Effect in Biological System) report
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Principles of method if other than guideline:
- Gene mutation study by the preincubation assay was performed to determine the mutagenic nature of benzyl phenylacetate
- GLP compliance:
- no
- Type of assay:
- bacterial gene mutation assay
- Specific details on test material used for the study:
- - Name of test material: Benzyl phenylacetate
- Molecular formula: C15H14O2
- Molecular weight: 226.2736 g/mol
- Substance type: Organic
- Physical state: No data
- Purity: No data
- Impurities (identity and concentrations): No data - Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: TA97, TA98, TA100 and TA1535
- Details on mammalian cell type (if applicable):
- Not applicable
- Additional strain / cell type characteristics:
- not specified
- Cytokinesis block (if used):
- No data
- Metabolic activation:
- with and without
- Metabolic activation system:
- 10% and 30% rat liver and hamster liver S9 fraction
- Test concentrations with justification for top dose:
- TA100 and TA98: 0, 0.3, 1, 3, 10, 33, 66, 100, 333, 1000, 3333 or 10000 µg/plate
TA 1535 and TA1537: 0, 0.3, 1, 3, 10, 33, 100, 333, 1000, 3333 or 10000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The chemical was solubel in DMSO - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION : Pre incubation
DURATION
No data
SELECTION AGENT (mutation assays):No data
SPINDLE INHIBITOR (cytogenetic assays):No data
STAIN (for cytogenetic assays):No data
NUMBER OF REPLICATIONS: No data
NUMBER OF CELLS EVALUATED:
No data
METHOD OF APPLICATION: preincubation
- Cell density at seeding (if applicable): No data
DURATION
- Preincubation period: No data
- Exposure duration: No data
- Expression time (cells in growth medium): No data
- Selection time (if incubation with a selection agent): No data
- Fixation time (start of exposure up to fixation or harvest of cells): No data
SELECTION AGENT (mutation assays): No data
SPINDLE INHIBITOR (cytogenetic assays): v
STAIN (for cytogenetic assays): No data
NUMBER OF REPLICATIONS: No data
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED: No data
NUMBER OF CELLS EVALUATED: No data
NUMBER OF METAPHASE SPREADS ANALYSED PER DOSE (if in vitro cytogenicity study in mammalian cells): No data
CRITERIA FOR MICRONUCLEUS IDENTIFICATION: No data
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index; cloning efficiency; relative total growth; other: No data
- Any supplementary information relevant to cytotoxicity: Yes, cytotoxicity was noted
OTHER EXAMINATIONS:
- Determination of polyploidy: No data
- Determination of endoreplication: No data
- Methods, such as kinetochore antibody binding, to characterize whether micronuclei contain whole or fragmented chromosomes (if applicable): No data
- OTHER: - Rationale for test conditions:
- No data
- Evaluation criteria:
- The plates were observed for a dose dependent increase in the number of revertants/plate
- Statistics:
- Mean ± standard error of mean
- Species / strain:
- S. typhimurium, other: TA97, TA98, TA100 and TA1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Remarks:
- Slight toxicity was noted
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- No data
- Conclusions:
- Benzyl phenylacetate did not induce a a dose dependent increase in the number of revertants per plate in Salmonella typhimurium strain TA97, TA98, TA1535 and TA100 with and without 10% and 30% rat liver and hamster liver S9 metabolic activation system and hence exhibited no mutagenic activity under the given test conditions.
- Executive summary:
Gene mutation toxicity study was performed to determine the mutagenic nature of benzyl phenylacetate using preincubation assay. The study was performed using Salmonella typhimurium strain TA97, TA98, TA1535 and TA100 with and without 10% and 30% rat liver and hamster liver S9 metabolic activation system. The study was performed at dose level of 0, 0.3, 1, 3, 10, 33, 66, 100, 333, 1000, 3333 or 10000 µg/plate for TA100 and TA98 and at a dose level of
0, 0.3, 1, 3, 10, 33, 100, 333, 1000, 3333 or 10000 µg/plate for TA1535 and TA97 with DMSO as the solvent. The plates were observed for a dose dependent increase in the number of revertants/plate. Benzyl phenylacetate did not induce a dose dependent increase in the number of revertants per plate and hence exhibited no mutagenic activity under the given test conditions.
Reference
Strain: TA100
Dose |
No Activation (Negative) |
No Activation (Negative) |
30% RLI (Negative) |
30% HLI (Negative) |
10% RLI (Negative) |
10% HLI (Negative) |
||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
µg/plate |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
0 |
141 |
7.3 |
106 |
3.7 |
161 |
5.1 |
165 |
4.1 |
145 |
7 |
117 |
8.2 |
0.3 |
|
|
101 |
2.3 |
|
|
|
|
|
|
|
|
1 |
154 |
4.3 |
104 |
4 |
|
|
|
|
|
|
|
|
3 |
154 |
10.8 |
97 |
6.9 |
|
|
|
|
|
|
|
|
10 |
150 |
14.6 |
109 |
8 |
|
|
|
|
|
|
|
|
33 |
152 |
835 |
89 |
1.7 |
|
|
|
|
|
|
|
|
66 |
58 s |
4.8 |
|
|
|
|
|
|
|
|
|
|
100 |
|
|
|
|
157 |
1.5 |
190 |
11.7 |
130 |
9.9 |
123 |
3.6 |
333 |
|
|
|
|
180 |
7.1 |
161 |
12.8 |
128 |
3.5 |
130 |
10.1 |
1000 |
|
|
|
|
163 |
1.7 |
190 |
9.7 |
122 |
5.8 |
118 |
10.1 |
3333 |
|
|
|
|
173 |
4.7 |
148 |
20.2 |
106 |
12.4 |
116 |
3.5 |
10000 |
|
|
|
|
153 |
7.9 |
186 |
17.3 |
104 |
13.8 |
105 |
5.9 |
Positive Control |
466 |
15.3 |
7.4 |
58.5 |
443 |
42.6 |
638 |
10.9 |
422 |
16.5 |
587 |
43.3 |
Strain :TA1535
Dose |
No Activation (Negative) |
No Activation (Negative) |
30% RLI (Negative) |
30% HLI (Negative) |
10% RLI (Negative) |
10% HLI (Negative) |
||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
µg/plate |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
0 |
12 12 |
1.9 |
12 |
1.5 |
12 |
0.3 |
13 |
2.1 |
13 |
2 |
14 |
2.9 |
0.3 |
12 |
1.2 |
8 |
0.9 |
|
|
|
|
|
|
|
|
1 |
9 |
0.9 |
9 |
0.7 |
|
|
|
|
|
|
|
|
3 |
10 |
1.2 |
7 |
0.9 |
|
|
|
|
|
|
|
|
10 |
10 |
2.1 |
10 |
2.3 |
|
|
|
|
|
|
|
|
33 |
9 |
1 |
10 |
1.9 |
|
|
|
|
|
|
|
|
100 |
|
|
|
|
19.3 |
0.3 |
12 |
0.9 |
13 |
2.3 |
12 |
0.3 |
333 |
|
|
|
|
15 |
2.3 |
8 |
1.5 |
13 |
3.7 |
10 |
2.6 |
1000 |
|
|
|
|
12 |
0.3 |
4 |
1.2 |
8 |
2.2 |
12 |
1.7 |
3333 |
|
|
|
|
9 |
0.6 |
8 |
1.5 |
10 |
1.5 |
9 |
1.5 |
10000 |
|
|
|
|
8 |
1.2 |
7 |
0.7 |
8 |
2 |
10 |
2.2 |
Positive Control |
585 |
19.9 |
635 |
37.5 |
106 |
10.8 |
256 |
24.9 |
71 |
8.1 |
61 |
0.9 |
Strain :TA97
Dose |
No Activation (Negative) |
No Activation (Negative) |
30% RLI (Negative) |
30% HLI (Negative) |
10% RLI (Negative) |
10% HLI (Negative) |
||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||
µg/plate |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
0 |
203 |
6.2 |
199 |
0.9 |
231 |
8 |
218 |
10.9 |
188 |
5.5 |
168 |
10 |
0.3 |
207 |
4.1 |
179 |
3.7 |
|
|
|
|
|
|
|
|
1 |
223 |
8.5 |
125 |
5 |
|
|
|
|
|
|
|
|
3 |
199 |
7.5 |
182 |
10.4 |
|
|
|
|
|
|
|
|
10 |
189 |
4 |
176 |
7.2 |
|
|
|
|
|
|
|
|
33 |
191 |
4.8 |
185 |
13.7 |
|
|
|
|
|
|
|
|
100 |
|
|
|
|
237 |
11.7 |
227 |
2.6 |
190 |
5.6 |
187 |
8.6 |
333 |
|
|
|
|
242 c |
15.5 |
211 |
5.9 |
220 |
9.7 |
189 |
15.8 |
1000 |
|
|
|
|
243 |
6.6 |
199 |
11.6 |
187 |
1.8 |
164 |
12.7 |
3333 |
|
|
|
|
254 |
15.7 |
204 |
16.3 |
148 |
10.4 |
146 |
4.3 |
10000 |
|
|
|
|
190 |
2.3 |
185 |
14.6 |
162 |
13.3 |
128 |
5 |
Positive Control |
554 |
8.3 |
470 |
27.7 |
378 |
19.7 |
426 |
12.7 |
282 |
8.6 |
342 |
48.5 |
Strain :TA98
Dose |
No Activation (Negative) |
No Activation (Negative) |
30% RLI (Negative) |
30% HLI (Negative) |
10% RLI (Negative) |
10% HLI (Negative) |
10% RLI (Negative) |
10% HLI (Negative) |
||||||||
Protocol |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
Preincubation |
||||||||
µg/plate |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
Mean |
±SEM |
|
|
|
|
0 |
22 |
3.1 |
21 |
3.7 |
23 |
3.1 |
20 |
2.6 |
27 |
3.2 |
20 |
2.4 |
23 |
0.3 |
22 |
5.8 |
0.3 |
|
|
17 |
0 |
|
|
|
|
|
|
|
|
|
|
|
|
1 |
24 |
2.5 |
20 |
4.4 |
|
|
|
|
|
|
|
|
|
|
|
|
3 |
27 |
1.8 |
12 |
3.2 |
|
|
|
|
|
|
|
|
|
|
|
|
10 |
22 |
1.7 |
19 |
2.8 |
|
|
|
|
|
|
21 |
2.3 |
|
|
16 |
2.1 |
33 |
15 |
1.5 |
17 |
0.6 |
|
|
|
|
|
|
19 |
1.5 |
|
|
15 |
1.5 |
66 |
4s |
1.7 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
100 |
|
|
|
|
23 |
44 |
22 |
2.6 |
18 |
1.5 |
14 |
1.2 |
17 |
0.6 |
18 |
1 |
333 |
|
|
|
|
24 |
2.7 |
24 |
4.8 |
19 |
4.3 |
8 |
1.9 |
16 |
0.6 |
12 |
2.3 |
100 |
|
|
|
|
16 2 |
2 |
22 |
4.3 |
13 |
2.2 |
5s |
0.9 |
11 |
1.2 |
11 |
0.9 |
3333 |
|
|
|
|
15 |
2.9 |
18 |
1.5 |
9s |
2.3 |
|
|
7s |
0.9 |
|
|
1000 |
|
|
|
|
12 s |
1.9 |
10 |
2.2 |
5s |
0.9 |
|
|
4s |
1 |
|
|
Positive Control |
399 |
23.8 |
894 |
16.8 |
129 |
3.8 |
345 |
9.1 |
332 |
30.3 |
341 |
15 |
473 |
18.5 |
584 |
7.8 |
RLI = induced male Sprague Dawley rat liver S9
HLI = induced male Syrian hamster liver S9
s = Slight Toxicity; p = Precipitate; x = Slight Toxicity and Precipitate; t = Toxic; c = Contamination
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Gene mutation in vitro:
Various data available for the target chemical Benzyl phenylacetate was reviewed to determine its mutagenic nature. The summary is as mentioned below:
Gene mutation toxicity study was performed to determine the mutagenic nature of benzyl phenylacetate using preincubation assay (National Institute of Environmetal Health Sciences, 2015). The study was performed using Salmonella typhimurium strain TA97, TA98, TA1535 and TA100 with and without 10% and 30% rat liver and hamster liver S9 metabolic activation system. The study was performed at dose level of 0, 0.3, 1, 3, 10, 33, 66, 100, 333, 1000, 3333 or 10000 µg/plate for TA100 and TA98 and at a dose level of 0, 0.3, 1, 3, 10, 33, 100, 333, 1000, 3333 or 10000 µg/plate for TA1535 and TA97 with DMSO as the solvent. The plates were observed for a dose dependent increase in the number of revertants/plate. Benzyl phenylacetate did not induce a dose dependent increase in the number of revertants per plate and hence exhibited no mutagenic activity under the given test conditions.
In another study by Zeiger and Margolin (2000), gene mutation toxicity study was performed to determine the mutagenic nature of Benzyl phenylacetate. The study was performed as per the preincubation modification of the Salmonella/mammalian microsome mutagenicity (Ames) test. The chemicals were tested in a preincubation procedure in strains TA98 and TA100 without metabolic activation and with activation provided by Aroclor induced rat and hamster liver homogenates (S9). If a positive response was seen in one of these two strains, the strain/metabolic activation combination producing that response was repeated, and no further testing was performed. If no positive responses were seen, the chemical was tested in strains TA97 and TA1535. The plates were observed for a dose dependent increase in the number of revertants/plate. The combination of a questionable (?) and negative (-) response was considered negative (-); the combination of a weakly positive (+w) and negative response was considered questionable (?). Benzyl phenylacetate did not induce a dose dependent increase in the number of revertants in Salmonella typhimurium TA98, TA100, TA97 and TA1535 in the presence and absence of S9 metabolic activation system and hence is not likely to classify as a gene mutant in vitro.
Renne et al (2006) performed gene mutation toxicity studu using cigarette smoke. The mutagenicity of total particulate matter (TPM) in cigarettes was investigated using an Ames assay protocol that conformed to OECD Guideline 471. For this purpose, prototype cigarettes containing a mixture of ingredients, reference cigarettes without these ingredients, and 2R4F cigarettes (a standard reference cigarette). The concentration of benzyl phenylacetate in the test cigarrette was 2.6 ppm. Each sample was tested with and without S9 metabolic activation in five strains ofSalmonella typhimuriumTA98, TA100, TA102, TA1535, and TA1537. Evaluation of the Ames assay data was carried out as mutagenic response, taking into consideration the reproducibly dose-related increase in number of revertants, even if the increase was less than two-fold. The results of Ames assay on test cigarette with and without metabolic activation. TA100, TA98, and TA1537 strains showed a positive response only with metabolic activation. No response was observed in TA 102 or TA1535. No sporadic responses in revertants were recorded. The highest sensitivity and specificity of the mutagenic response were observed using TA98 with metabolic activation. From the comparison of the data obtained for the test and reference cigarettes, it was concluded that the addition of ingredients did not result in a positive mutagenic response in any of the strains under the conditions already described. Benzyl phenylacetate can be considered to be non mutagenic at a test concentration of 2.6 ppm under the test conditions as it did not induce a reproducible dose dependent increase in the number of revertants.
Based on the data available for the target chemical, Benzyl phenylacetate does not exhibit gene mutation ability in vitro. Hence, the target chemical is not likely to classify as a gene mutant in vitro as per the criteria mentioned in CLP regulation.
Justification for classification or non-classification
Based on the data available for the target chemical, Benzyl phenylacetate does not exhibit gene mutation ability in vitro. Hence, the target chemical is not likely to classify as a gene mutant in vitro as per the criteria mentioned in CLP regulation.
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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