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EC number: 210-233-1 | CAS number: 610-69-5
- 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
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Acetic acid, 2-nitrophenyl ester
- IUPAC Name:
- Acetic acid, 2-nitrophenyl ester
- Reference substance name:
- 2-nitrophenyl acetate
- EC Number:
- 210-233-1
- EC Name:
- 2-nitrophenyl acetate
- Cas Number:
- 610-69-5
- Molecular formula:
- C8H7NO4
- IUPAC Name:
- 2-nitrophenyl acetate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): 2-Nitrophenyl Acetate
- Physical state: solid light yellow
- Analytical purity: 95 % w/w
- Impurities (identity and concentrations):
Phenol <5.0 % (w/w)
2,4-dinitrophenol <5.0 % (w/w)
2,6-dinitrophenol <5.0 % (w/w)
Acetic acid <1.0 % (w/w)
Water <5.0 % (w/w)
2-nitrophenol <5.0 % (w/w)
- Lot/batch No.: 201408
- Expiration date of the lot/batch: unlisted
- Storage condition of test material: The test substance will be stored in dry room in dark in closed container at the room temperature
Constituent 1
Constituent 2
Method
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 fraction of rat liver homogenate and mixture of cofactors
- Test concentrations with justification for top dose:
- The doses used were 5, 15, 50, 125 and 250 μg per plate.
- Vehicle / solvent:
- Solvent: Dimethyl sulfoxide p.a., Merck, Lot. No.: K45609252 424, exp. 05/2017
Controls
- Untreated negative controls:
- yes
- Remarks:
- solvent control
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Remarks:
- untreated control (no solvent)
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 9-aminoacridine
- sodium azide
- other: 4-nitro-o-phenylenediamine (NPD) CAS No.: 99-56-9, Aldrich; 2-aminoanthracene (2-AA) CAS No: 613-13-8, Sigma; N-methyl-N´-nitro-N-nitrosoguanidine (MNNG) CAS No.: 70-25-7, TCI Europe
- Evaluation criteria:
- The main criterion for evaluation of results was modified two-fold increase rule, which is compatible with the application of statistical methods (2, 3). After this rule the result is positive, if a reproducible dose-response effect occurs and/or a doubling of the ratio Rt/Rc is reached.
An increase is considered as „biologically relevant“:
- if the number of reversions is at least twice as high as that in the solvent control for the strains having spontaneous reversion >10;
- if the number of reversions is at least three times as high as that in the solvent control for the strains having spontaneous reversion ≤10;
A test substance producing neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system.
According to OECD TG 471, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test results
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA:
Spontaneous reversions in negative and positive controls were compared with historical controls in our laboratory. The current ranges are given in the Table A - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table A: Current historical ranges of revertant numbers in bacterial strains used in the study and live bacteria count used in the first experiments
Control | Spont.rev. | DMSO | PC -S9 | PC +S9 | Number ofCFU/mL |
Strain | |||||
S.t. TA 100 | 77-181 | 70-174 | 320-824 | 548-1568 | 1.05*109 |
S.t. TA 1535 | 9-29 | 10-26 | 258-626 | 68-260 | 1.09*109 |
S.t. TA 98 | 13-49 | 12-44 | 282-1550 | 545-2209 | 3.63*108 |
S.t. TA 1537 | 5-21 | 4-20 | 461-1401 | 61-281 | 1.93*108 |
E.c. WP2 uvrA | 12-48 | 8-40 | 379-1103 | 0-387 | 1.24*109 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the above-described experimental design, the test substance 2-Nitrophenyl acetate was non-mutagenic for all strains Salmonella typhimurium TA 100, TA 98, TA 1535, TA 1537 and Escherichia coli WP2 uvrA in experiments with as well as without metabolic activation. - Executive summary:
The test substance 2-Nitrophenyl Acetate was assayed for the mutagenicity by the Bacterial Reverse Mutation Test. The performed test was based on EU method B.13/14 Mutagenicity – Reverse mutation test using bacteria, which is analogous to the OECD Test Guideline No. 471. Four indicator Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and one indicator Escherichia coli WP2 uvrA strain were used. The test substance was dissolved in dimethylsulfoxide and assayed in doses of 5-250 (500) microg per plate, which were applied to plates in volume of 0.1 mL. Experiments were performed without as well as with metabolic activation with a supernatant of rat liver and a mixture of cofactors. In the arrangement given above, the test substance 2-Nitrophenyl Acetate was non-mutagenic for all strains Salmonella typhimurium TA 100, Ta 98, TA 1535, TA 1537 and Escherichia coli WP2 uvrA in experiments with as well as without metabolic activation.
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