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EC number: 254-837-3 | CAS number: 40203-73-4
- 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 bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study performed under GLP; minor deviation not affecting the reliability of the study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- Minor deviation: first mutation assay: strain TA98, no bacteria were plated at the mid dose 164 μg/plate. However, since at least a total of five dose levels were used at up to the recommended dose level 5000μg/plate, study reliability is unaffected.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- yes
- Remarks:
- Minor deviation; see above
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- yes
- Remarks:
- Minor deviation; see above
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Version / remarks:
- Guideline stipulated by the Japanese Ministry of Health, Labour and Welfare, Ministry of Economy, Trade and Industry and Ministry of the Environment (revised March 31st, 2011)
- Deviations:
- yes
- Remarks:
- Minor deviation; see above
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- inspected March 2013; signature: May 2013
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methyl cyclopentylideneacetate
- EC Number:
- 254-837-3
- EC Name:
- Methyl cyclopentylideneacetate
- Cas Number:
- 40203-73-4
- Molecular formula:
- C8H12O2
- IUPAC Name:
- methyl 2-cyclopentylideneacetate
- Test material form:
- gas under pressure: refrigerated liquefied gas
- Details on test material:
- - Physical state: liquid
- Storage condition of test material: In refrigerator (2-8°C) in the dark
- Other: Clear colourless
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver microsomal enzymes (S9 homogenate)
- Test concentrations with justification for top dose:
- Dose range finding study: 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 ug/plate
Experiment 1: 17, 52, 164, 512, 1600, 5000 ug/plate
Experiment 2: 492, 878, 1568, 2800, 5000 ug/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: The test substance formed an emulsion in water and ethanol at a concentration of 50 mg/ml. The test substance was fully soluble in dimethyl sulfoxide (DMSO) at a concentration of 50 mg/ml.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: ICR-191; 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: the plates were inverted and incubated in the dark at 37.0 ± 1.0 °C for 48 ± 4 h. After this period revertant colonies (histidine independent (His+) for Salmonella typhimurium bacteria and tryptophan independent (Trp+) for Escherichia coli were counted. The revertant colonies were counted automatically with a Colony Counter.
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth (bacterial background lawn) and reduction in the number of revertants
OTHER:
Dose range finding test on TA100 and WP2urvA with and without 5% (v/v) S9-mix; First mutation assay on TA1535, TA1537 and TA98 with and without 5% (v/v) S9-mix. To obtain more information about the possible mutagenicity of the test substance, a second mutation experiment was performed on all strains, in the absence of S9-mix and in the presence of 10% (v/v) S9-mix. Based on the results of the first mutation assay, the test substance was tested up to the dose level of 5000 μg/plate in strains TA1535, TA1537, TA98, TA100 and WP2uvrA. Based on the results of the earlier assays. - Evaluation criteria:
- See 'Any other information on materials and methods' for details on evaluation of the assay and positive criteria.
- Statistics:
- No formal hypothesis testing was done. See 'Any other information on materials and methods' for details on the acceptability and evaluation criteria of the assay.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- 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:
- cytotoxicity
- Remarks:
- Cytotoxicity was only observed at the top dose of 5000 μg/plate in tester strain TA1535 and TA100 (absence and presence of S9-mix) and TA1537 and TA98 (absence of S9-mix) in experiment 2.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of test substance on the plates was not observed at the start or at the end of the incubation period in any tester strain.
RANGE-FINDING/SCREENING STUDIES:
Test substance was tested in the tester strains TA100 and WP2uvrA with concentrations of 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate in the absence and presence of S9-mix. Based on the results of the dose range finding test, the following dose range was selected for the mutation assay with the tester strains, TA1535, TA1537 and TA98 in the absence and presence of S9-mix: 17, 52, 164, 512, 1600 and 5000 μg/plate. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1 Dose range finding test: Mutagenic response of test substance in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (± S.D.) with one strain of Salmonella typhimurium and one Escherichia coli strain
|
|||
|
TA100 |
|
WP2uvrA
|
|
Without S9-mix
|
|
|
|
|
Positive control |
1057 |
± 86 |
1257 |
± 41 |
Solvent control |
139 |
± 26 |
29 |
± 5 |
1.7 |
146 |
± 15 |
35 |
± 3 |
5.4 |
128 |
± 12 |
37 |
± 8 |
17 |
130 |
± 15 |
35 |
± 6 |
52 |
134 |
± 6 |
38 |
± 3 |
164 |
129 |
± 5 |
34 |
± 4 |
512 |
126 |
± 6 |
36 |
± 6 |
1600 |
121 |
± 17 n |
36 |
± 3 n |
5000 |
95 |
± 9 s NP |
38 |
± 15 s NP |
With S9-mix #1
|
|
|
|
|
Positive control |
1420 |
± 45 |
275 |
± 33 |
Solvent control |
132 |
± 19 |
38 |
± 7 |
1.7 |
121 |
± 8 |
44 |
± 5 |
5.4 |
128 |
± 9 |
45 |
± 6 |
17 |
126 |
± 15 |
48 |
± 8 |
52 |
123 |
± 4 |
44 |
± 5 |
164 |
149 |
± 38 |
48 |
± 4 |
512 |
122 |
± 7 |
42 |
± 6 |
1600 |
112 |
± 15 n |
37 |
± 8 n |
5000 |
83 |
± 12 s NP |
28 |
± 5 s NP |
#1 Plate incorporation assay (5% S9)
NP No precipitate
n Normal bacterial background lawn
s Bacterial background lawn slightly reduced
Table 2 Experiment 1: Mutagenic response of test substance in the Salmonella typhimurium reverse mutation assay
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium
|
|||||
|
TA1535 |
|
TA1537
|
|
TA98 |
|
Without S9-mix
|
|
|
|
|
|
|
Positive control |
562 |
± 37 |
541 |
± 36 |
924 |
± 114 |
Solvent control |
25 |
± 7 |
9 |
± 5 |
17 |
± 2 |
17 |
29 |
± 0 |
9 |
± 5 |
19 |
± 1 |
52 |
26 |
± 5 |
5 |
± 2 |
15 |
± 5 |
164 |
30 |
± 3 |
10 |
± 2 |
#2 |
|
512 |
30 |
± 8 |
9 |
± 2 |
16 |
± 6 |
1600 |
27 |
± 5 |
4 |
± 1 |
19 |
± 0 |
5000 |
21 |
± 1 n NP |
9 |
± 4 n NP |
14 |
± 1 n NP |
With S9-mix #1
|
|
|
|
|
|
|
Positive control |
251 |
± 27 |
259 |
± 41 |
715 |
± 48 |
Solvent control |
16 |
± 3 |
6 |
± 1 |
23 |
± 1 |
17 |
18 |
± 6 |
8 |
± 3 |
24 |
± 2 |
52 |
18 |
± 7 |
13 |
± 5 |
20 |
± 6 |
164 |
18 |
± 4 |
13 |
± 10 |
#2 |
|
512 |
18 |
± 4 |
8 |
± 2 |
26 |
± 6 |
1600 |
15 |
± 4 |
7 |
± 4 |
26 |
± 2 |
5000 |
11 |
± 1 n NP |
8 |
± 1 n NP |
19 |
± 1 n NP |
#1 Plate incorporation assay (5% S9)
#2 No bacteria plated
NP No precipitate
n Normal bacterial background lawn
Table 3 Experiment 2: Mutagenic response of test substance in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates (± S.D.) with different strains of Salmonella typhimurium and one Escherichia coli strain
|
|||||||||
|
TA1535 |
|
TA1537
|
|
TA98 |
|
TA100 |
|
WP2uvrA |
|
Without S9-mix
|
|
|
|
|
|
|
|
|
|
|
Positive control |
753 |
± 28 |
710 |
± 95 |
867 |
± 63 |
901 |
± 42 |
1154 |
± 106 |
Solvent control |
22 |
± 5 |
8 |
± 4 |
22 |
± 6 |
133 |
± 8 |
35 |
± 11 |
492 |
26 |
± 3 |
9 |
± 4 |
29 |
± 7 |
124 |
± 23 |
29 |
± 17 |
878 |
26 |
± 4 |
5 |
± 5 |
21 |
± 3 |
131 |
± 16 |
33 |
± 11 |
1568 |
22 |
± 7 |
7 |
± 4 |
25 |
± 4 |
123 |
± 2 |
32 |
± 6 |
2800 |
24 |
± 8 n |
6 |
± 2 n |
22 |
± 9 n |
107 |
± 3 |
26 |
± 6 |
5000 |
17 |
± 4 s NP |
9 |
± 2 s NP |
13 |
± 6 s NP |
93 |
± 25 s NP |
23 |
± 3 n NP |
With S9-mix #1
|
|
|
|
|
|
|
|
|
|
|
Positive control |
166 |
± 10 |
443 |
± 138 |
1047 |
± 68 |
1275 |
± 218 |
153 |
± 41 |
Solvent control |
13 |
± 2 |
14 |
± 2 |
39 |
± 2 |
134 |
± 13 |
42 |
± 13 |
492 |
17 |
± 6 |
15 |
± 3 |
42 |
± 2 |
130 |
± 16 |
41 |
± 8 |
878 |
13 |
± 3 |
7 |
± 4 |
34 |
± 5 |
129 |
± 21 |
46 |
± 9 |
1568 |
17 |
± 8 |
15 |
± 4 |
36 |
± 6 |
121 |
± 12 |
40 |
± 11 |
2800 |
12 |
± 6 n |
4 |
± 1 |
33 |
± 14 |
103 |
± 11 n |
37 |
± 5 |
5000 |
11 |
± 4 s NP |
13 |
± 6 n NP |
33 |
± 6 n NP |
77 |
± 2 s NP |
21 |
± 2 n NP |
#1 Plate incorporation assay (10% S9)
NP No precipitate
n Normal bacterial background lawn
s Bacterial background lawn slightly reduced
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of this study the test substance is not considered to be mutagenic. Negative and strain specific positive control values were within laboratory historical control data. - Executive summary:
The study was performed to OECD 471, EU Method B.13/14, EPA OPPTS 870.5100 and the Japan Guidelines for Screening Mutagenicity of Chemicals in accordance with GLP; to evaluate the mutagenic activity of the test substance in the Salmonella typhimurium and the Escherichia coli in a reverse mutation assay (with independent repeat). The dose range finding test, the test substance was tested up to concentrations of 5000 μg/plate in the absence and presence of S9-mix in the strains TA100 and WP2uvrA. The test substance did not precipitate on the plates at this dose level. Cytotoxicity, as evidenced by a decrease of the bacterial background lawn, was observed at the top dose of 5000 μg/plate in both tester strains. Based on the results of the dose range finding test, the test substance was tested in the first mutation assay at a concentration range of 17 to 5000 μg/plate in the absence and presence of 5% (v/v) S9-mix in tester strains TA1535, TA1537 and TA98. The bacterial background lawn was not reduced at any of the concentrations tested and no biologically relevant decrease in the number of revertants was observed. In an independent repeat of the assay with additional parameters, the test substance was tested at a concentration range of 492 to 5000 μg/plate in the absence and presence of 10% (v/v) S9-mix in tester strains TA1535, TA1537, TA98, TA100 and WP2uvrA. Cytotoxicity, as evidenced by a decrease of the bacterial background lawn, was only observed at the top dose of 5000 μg/plate in the tester strains TA1535 and TA100 (absence and presence of S9-mix) and TA1537 and TA98 (absence of S9-mix). The test substance did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in an independently repeated experiment. In this study, the negative and strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. Under the conditions of this study it is concluded that that the test substance was not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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