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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 605-150-6 | CAS number: 15848-49-4
- 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:
- 2011-05-26 to 2011-07-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study without restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997-07-21
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- signed 2009-03-30
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- ethyl 2-(cyclopent-2-en-1-yl)acetate
- EC Number:
- 605-150-6
- Cas Number:
- 15848-49-4
- Molecular formula:
- C9H14O2
- IUPAC Name:
- ethyl 2-(cyclopent-2-en-1-yl)acetate
- Test material form:
- other: liquid
- Details on test material:
- - Physical state: liquid
- Molecular formula: C9H14O2
- Molecular weight: 154.21 g/mol
Constituent 1
Method
- Target gene:
- not applicable
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix prepared from phenobarbital /β-naphthoflavone induced male rat liver (age: 8-12 weeks old; induction: 3 consecutive days)
- Test concentrations with justification for top dose:
- Pre-experiment/Experiment 1 (plate incorporation test):
3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate (with and without metabolic activation)
Experiment 2 (pre-incubation assay):
3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate (without S9-mix)
33, 100, 333, 1000, 2500, and 5000 µg/plate (with S9 mix) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (MERCK, 64293 Darmstadt/Germany; purity > 99%)
- Justification for choice of solvent/vehicle: the solvent was chosen because of its solubility properties and its relative non-toxicity to the bacteria (Maron et al. 1981)*
*Reference:
Maron D.M., J. Katzenellenbogen, and B.N. Ames (1981): Compatibility of organic solvents with the Salmonella/Microsome Test. Mutation Res. 88, 343-350.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Positive control substanbce without metabolic activation; strains TA 1535 (10 µg/plate), TA 100 (10 µg/plate)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine (4-NOPD)
- Remarks:
- Positive control substance without metabolic activation; strains TA 1537 (50 µg/plate), TA 98 (10 µg/plate)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Positive control substance without metabolic activation; strain WP2 uvrA (3 µg/plate)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2-AA)
- Remarks:
- Positive control substance with metabolic activation; strains TA 1535 (2.5 µg/plate), TA 1537 (2.5 µg/plate), TA 98 (2.5 µg/plate), TA 100 (2.5 µg/plate), WP2 uvrA (10 µg/plate)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation (experiment 1) and preincubation (experiment 2)
NUMBER OF REPLICATIONS: 3
PRE-EXPERIMENT FOR TOXICITY:
To evaluate the toxicity of the test item a pre-experiment was performed with strains TA 1535, TA 1537, TA 98, TA 100, and WP2 uvrA. Eight concentrations were tested for toxicity and mutation induction with three plates each. The pre-experiment was reported as experiment 1.
EXPERIMENTAL PERFORMANCE:
For each strain and dose level including the controls, three plates were used.
The following materials were mixed in a test tube and poured onto the selective agar plates:
- 100 µL test solution at each dose level (solvent or reference mutagen solution (positive
control)),
- 500 µL S9 mix (for test with metabolic activation) or S9 mix substitution buffer (for test
without metabolic activation),
- 100 µL bacteria suspension (cf. test system, pre-culture of the strains),
- 2000 µL overlay agar
In the pre-incubation assay 100 µL test solution (solvent or reference mutagen solution (positive control)), 500 µL S9 mix / S9 mix substitution buffer and 100 µL bacterial suspension were mixed in a test tube and shaken at 37 °C for 60 minutes. After preincubation 2.0 mL overlay agar (45 °C) was added to each tube. The mixture was poured on selective agar plates.
After solidification the plates were incubated upside down for at least 48 hours at 37 °C in the dark (de Serres and Shelby, 1979)*.
DATA RECORDING:
The colonies were counted using the Petri Viewer Mk2 (Perceptive Instruments Ltd, Suffolk CB9 7BN, UK) with the software program Ames Study Manager. Due to reduced background growth and wide spread bacterial colony growth the revertant colonies were partly counted manually.
ACCEPTABILITY OF THE ASSAY:
The Salmonella typhimurium and Escherichia coli reverse mutation assay is considered acceptable if it meets the following criteria:
- regular background growth in the negative and solvent control
- the spontaneous reversion rates in the negative and solvent control are in the range of historical data
- the positive control substances should produce a significant increase in mutant colony frequencies
*Reference:
de Serres F.J. and M.D. Shelby (1979). Recommendations on data production and analysis using the Salmonella/microsome mutagenicity assay. Mutation Res. 64, 159-165 - Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and WP2 uvrA) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed (Hollstein, McCann, Angelosanto and Nichols, 1979)*.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration (de Serres and Shelby, 1979)*.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent controls such an increase is not considered biologically relevant.
*References:
- de Serres F.J. and M.D. Shelby (1979). Recommendations on data production and analysis using the Salmonella/microsome mutagenicity assay. Mutation Res. 64, 159-165.
- Hollstein,M., J. McCann, F.A. Angelosanto, and W.W. Nichols (1979). Short-term tests for carcinogens and mutagens. Mutation Res. 65, 133-226. - Statistics:
- A statistical analysis of the data is not mandatory.
Results and discussion
Test resultsopen allclose all
- 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:
- please refer to "Any other information on results incl. tables" (table 1)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- please refer to "Any other information on results incl. tables" (table 1)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation of the test item occurred up to the highest investigated dose.
EXPERIMENTS 1 AND 2:
The plates incubated with the test item showed reduced background growth at the following concentrations as shown in Table 1 (please refer to "Any other information on results incl. tables).
Toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups at the following concentrations as shown in Table 2 (please refer to "Any other information on results incl. tables).
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with PI26133 at any dose level, neither in the presence nor 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.
Appropriate reference mutagens were used as positive controls. They showed a distinct increase of induced revertant colonies. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1
Strain |
Experiment 1 |
Experiment 2 |
||
|
without S9 mix |
with S9 mix |
without S9 mix |
with S9 mix |
TA 1535 |
2500 - 5000 |
/ |
2500 - 5000 |
/ |
TA 1537 |
5000 |
/ |
1000 - 5000 |
5000 |
TA 98 |
5000 |
/ |
1000 - 5000 |
/ |
TA 100 |
1000 - 5000 |
/ |
1000 - 5000 |
/ |
WP2 uvrA |
/ |
/ |
1000 - 5000 |
/ |
Table 2
Strain |
Experiment 1 |
Experiment 2 |
||
|
without S9 mix |
with S9 mix |
without S9 mix |
with S9 mix |
TA 1535 |
5000 |
/ |
2500 - 5000 |
/ |
TA 1537 |
2500 - 5000 |
/ |
1000 - 5000 |
5000 |
TA 98 |
5000 |
/ |
1000 - 5000 |
/ |
TA 100 |
2500 - 5000 |
/ |
2500 - 5000 |
/ |
WP2 uvrA |
/ |
/ |
2500 - 5000 |
/ |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
According to the EC-Commission directive 67/548/EEC and its subsequent amendments, the test substance is not mutagenic.
According to the EC-Regulation 1272/2008 and subsequent regulations, the test item is not classified as mutagenic.
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.