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EC number: 203-212-3 | CAS number: 104-54-1
- 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
- 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
Ames assay:
In vitro bacterial reverse gene mutation assay for the test chemical was studied using S. typhimurium and Escherichia coli WP2 uvrA strains. The mutagenicity assay was conducted as described by Ames et al. with slight modifications. Ames test was performed using Salmonella typhimurium strains TA100, TA1535, TA98, TA1537 and TA1538 and Escherichia coli WP2 uvrA strains in the presence and absence of S9 metabolic activation system at dose level of 0, 250, 750, 1500 or 3000 µg/plate. For Salmonella strains, the assays without S9 were performed by the plate-incorporation method and the assays with S9 were conducted by the pre-incubation method described by Yahagi et al. (1975). The pre-incubation method is useful in detecting weak mutagenicity in samples (Yahagi et al., 1977). Histidine-independent colonies were scored after incubation at 37°C for 48-72 h. For E. coli strains, the assay was performed in the same manner as with the Salmonella assay except that the supplement of 0.1 µmole histidine plus 0.1 mole biotin in the soft agar was replaced with a supplement of 0.1 µmole of tryptophan. Tryptophan-independent revertant colonies were scored with E. coli. No mutagenicity was noted at the tested dose levels. Based on the observations made, the test chemical was negative in Ames test carried out using Salmonella typhimurium strains TA100, TA1535, TA98, TA1537, TA1538 as well in Escherichia coli WP2 uvr A in the presence and absence of S9 metabolic activation. Hence it is not likely to classify as a gene mutant in vitro.
In vitro mammalian chromosome aberration study:
This information will be submitted later based on ECHA communication/decision number CCH-C-2114632477-44-01/F.
Gene mutation in Mammalian cells:
In vitro gene mutation study in mammalian cells according to OECD TG 476 with the registered substance will be performed if negative results are obtained from OECD 471 and OECD 473 (ongoing) studies and will be submitted later based on ECHA communication/decision number CCH-C-2114632477-44-01/F.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- In vitro gene mutation study in mammalian cells according to OECD TG 476 with the registered substance will be performed if negative results are obtained from OECD 471 and OECD 473 (ongoing) studies and will be submitted later based on ECHA communication/
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- An in vitro cytogenicity study according to OECD TG 473 with the registered substance is ongoing.
- Data waiving:
- other justification
- Justification for data waiving:
- other:
- Endpoint:
- in vitro gene mutation study in bacteria
- 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 peer-reviewed journal.
- Qualifier:
- according to guideline
- Guideline:
- other: Refer below principle
- Principles of method if other than guideline:
- In vitro bacterial reverse gene mutation assay for test chemical was studied in S. typhimurium and Escherichia coli strains. The mutagenicity assay was conducted as described by Ames et al. with slight modifications. All tester strains were examined periodically for the markers indicated by Ames et al.
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Histidine for Salmonella strains and tryptophan for E. coli strains
- Species / strain / cell type:
- S. typhimurium, other: TA100, TA1535, TA98, TA1537, TA1538
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
S9 mix (500 µM) consisted of 100µL of S9, 50 µmoles sodium phosphate buffer (pH 7.4), 4 µmoles MgCl2, 16.5 µmoles KCl, 2.5 µmoles G-6-P, 2 µmoles NADH and 2 µmoles NADPH.
- source of S9 : PCB-treated male Sprague-Dawley rats
- method of preparation of S9 mix : No data
- concentration or volume of S9 mix and S9 in the final culture medium : No data
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): No data - Test concentrations with justification for top dose:
- 0, 250, 750, 1500 or 3000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: No data available - Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- Untreated negative controls:
- not specified
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- benzo(a)pyrene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
For Salmonella strains:
The assays without S9 were performed by the plate-incorporation method.
The assays with S9 were conducted by the pre-incubation method described by Yahagi et al. (1975). The pre-incubation method is useful in detecting weak mutagenicity in samples (Yahagi et al., 1977).. Histidine-independent colonies were scored after incubation at 37°C for 48-72 h.
For E. coli strains:
The assay was performed in the same manner as with the Salmonella assay except that the supplement of 0.1 µmole histidine plus 0.1 mole biotin in the soft agar was replaced with a supplement of 0.1 µmole of tryptophan. Tryptophan-independent revertant colonies were scored with E. coli.
DURATION
- Preincubation period: 37°C
- Exposure duration: 48-72 h. - Rationale for test conditions:
- No data available
- Evaluation criteria:
- A bacterial cell line was observed for biologically relevant increase in the number of revertants. Revertants per plate represent average values from 3 to 5 replications.
- Statistics:
- No data available
- Species / strain:
- S. typhimurium, other: TA100, TA1535, TA98, TA1537, TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- valid
- Additional information on results:
- All test compounds showed killing on bacteria at the highest doses used.
- Remarks on result:
- other: No mutagenic potential
- Conclusions:
- The test chemical was negative in Ames test carried out using Salmonella typhimurium strains TA100, TA1535, TA98, TA1537, TA1538 as well in Escherichia coli WP2 uvr A in the presence and absence of S9 metabolic activation. Hence it is not likely to classify as a gene mutant in vitro.
- Executive summary:
In vitro bacterial reverse gene mutation assay for test chemical was studied using S. typhimurium and Escherichia coli WP2 uvrA strains. The mutagenicity assay was conducted as described by Ames et al. with slight modifications. Ames test was performed using Salmonella typhimurium strains TA100, TA1535, TA98, TA1537 and TA1538 and Escherichia coli WP2 uvrA strains in the presence and absence of S9 metabolic activation system at dose level of 0, 250, 750, 1500 or 3000 µg/plate. For Salmonella strains, the assays without S9 were performed by the plate-incorporation method and the assays with S9 were conducted by the pre-incubation method described by Yahagi et al. (1975). The pre-incubation method is useful in detecting weak mutagenicity in samples (Yahagi et al., 1977). Histidine-independent colonies were scored after incubation at 37°C for 48-72 h. For E. coli strains, the assay was performed in the same manner as with the Salmonella assay except that the supplement of 0.1 µmole histidine plus 0.1 mole biotin in the soft agar was replaced with a supplement of 0.1 µmole of tryptophan. Tryptophan-independent revertant colonies were scored with E. coli. No mutagenicity was noted at the tested dose levels. Based on the observations made, the test chemical was negative in Ames test carried out using Salmonella typhimurium strains TA100, TA1535, TA98, TA1537, TA1538 as well in Escherichia coli WP2 uvr A in the presence and absence of S9 metabolic activation. Hence it is not likely to classify as a gene mutant in vitro.
Referenceopen allclose all
Table: RESULTS OF MUTAGENICITY TEST OF THE TEST CHEMICAL
Chemical |
Dose (µg/plate) |
Revertants/plate (mean±S.D.) |
|||||
Salmonella typhimuriumstrains |
Escherichia coli |
||||||
Without S9 |
|
||||||
DMSO |
50µL |
99±6 |
8±2 |
24±4 |
4±2 |
15±3 |
55±6 |
Positive control |
|
769±54 |
266±34 |
660±30 |
822±88 |
301±33 |
452±68 |
Test chemical |
250 |
98±5 |
10±4 |
28±1 |
3±1 |
9±1 |
50±9 |
750 |
81±6 |
5±1 |
24±1 |
3±1 |
10±2 |
57±6 |
|
1500 |
81±13 |
7±1 |
22±8 |
5±0 |
14±0 |
46±3 |
|
3000 |
24±13 |
2±1 |
20±8 |
2±2 |
6±1 |
33±6 |
|
With S9 |
|
|
|
|
|
|
|
DMSO |
50µL |
106±9 |
10±3 |
32±4 |
7±2 |
21±4 |
59±5 |
Positive control |
|
431±92 |
158±45 |
180±7 |
125±37 |
154±17 |
753±95 |
Test chemical |
250 |
87±1 |
7±2 |
31±3 |
9±2 |
24±8 |
58±6 |
|
750 |
130±3 |
10±1 |
27±3 |
7±2 |
18±4 |
62±3 |
|
1500 |
123±12 |
9±2 |
24±3 |
8±3 |
21±3 |
42±4 |
|
3000 |
72±11 |
12±2 |
21±2 |
4±2 |
11±0 |
39±8 |
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:
Data available from various sources for the target chemical and the closely related test chemicals was reviewed to determine the mutagenic nature of the given test chemical. The studies are as mentioned below:
Ames assay:
Study 1
In vitro bacterial reverse gene mutation assay for test chemical was studied using S. typhimurium and Escherichia coli WP2 uvrA strains. The mutagenicity assay was conducted as described by Ames et al. with slight modifications. Ames test was performed using Salmonella typhimurium strains TA100, TA1535, TA98, TA1537 and TA1538 and Escherichia coli WP2 uvrA strains in the presence and absence of S9 metabolic activation system at dose level of 0, 250, 750, 1500 or 3000 µg/plate. For Salmonella strains, the assays without S9 were performed by the plate-incorporation method and the assays with S9 were conducted by the pre-incubation method described by Yahagi et al. (1975). The pre-incubation method is useful in detecting weak mutagenicity in samples (Yahagi et al., 1977). Histidine-independent colonies were scored after incubation at 37°C for 48-72 h. ForE. colistrains, the assay was performed in the same manner as with theSalmonellaassay except that the supplement of 0.1 µmole histidine plus 0.1 mole biotin in the soft agar was replaced with a supplement of 0.1 µmole of tryptophan. Tryptophan-independent revertant colonies were scored withE. coli.No mutagenicity was noted at the tested dose levels. Based on the observations made, the test chemical was negative in Ames test carried out usingSalmonella typhimuriumstrains TA100, TA1535, TA98, TA1537, TA1538 as well inEscherichia coliWP2 uvr A in the presence and absence of S9 metabolic activation. Hence it is not likely to classify as a gene mutant in vitro.
Study 2:
Bacterial gene mutation assay was performed to evaluate the mutagenic potential of the test material. The test chemical was non mutagenic at concentrations up to 500–4000 µg/plate in E. coli strain WP2 uvrA (trp-) and hence, according to CLP criteria, it can be concluded that the test chemical was non mutagenic in nature.
Study 3:
Ames assay as per OECD 471 was performed to investigate the potential of the test chemical to induce gene mutations in comparison to vehicle control according to the plate incorporation test (Trial I) and the pre-incubation test (Trial II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the negative, vehicle and positive controls was tested in triplicate. Based on the solubility and precipitation test results eight different concentrations viz., 0.0 (NC), 0.0(VC), 0.002, 0.005, 0.016, 0.050, 0.158, 0.501, 1.582 and 5 mg/plate were selected for pre-experiment. B
Based on the pre-experiment results, the test item was tested with the following concentrations 0.0 (NC), 0.0(VC), 0.005, 0.016, 0.050, 0.158 and 0.501 mg/plate for main study, both in the presence of metabolic activation (+S9) and in the absence of metabolic activation (-S9).
No substantial increase in revertant colony numbers in any of the tester strains were observed following treatment with the test chemical at any dose level in both the confirmatory trials, neither in the presence nor in the absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
The spontaneous reversion rates in the negative, vehicle and positive controls are within the range of our historical data.
The positive controls used for various strains showed a distinct increase in induced revertant colonies in both the methods i.e. Plate incorporation method and Pre-incubation method.
Conclusion
In conclusion, it is stated that during the described mutagenicity test and under the experimental conditions reported, the test chemical did not induce gene mutations by base pair changes or frame shifts in the genome of the strains used.
Study 4:
Bacillus subtilis recombination assay was performed to evaluate the mutagenic potential of the test material. The study was performed using B. subtilis M45 (rec-) & H17 (rec+) strains in the absence of S9 metabolic activation system. In Bacillus subtilis recombination assay, the test chemical at dose of 21 µg/disk was not mutagenic in B. subtilis M45 (rec-) & H17 (rec+) without metabolic activation and hence it is not likely to classify as a gene mutant in vitro.
Justification for classification or non-classification
Based on the data available for the target chemical and its closely related test chemicals, the target chemical Cinnamyl alcohol (CAS 104-54-1) is likely to be “Non-mutagenic” based on 471 (Bacterial gene mutation studies). Also, the structurally and functionally closely related test chemicals support the non-mutagenic classification in vitro. Hence the test chemical is “Not classified” for gene mutation end point as per the criteria mentioned in CLP regulation.
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