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EC number: 611-084-9 | CAS number: 54041-17-7
- 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:
- May - July 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- incomplete strain selection (tester strain with AT reversion site missing)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted version 1983
- Deviations:
- no
- Remarks:
- no prior stability testing of compound, compared to current guideline only 4 strains tested and incomplete strain selection (tester strain with AT reversion site missing)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- N-(4-fluorophenyl)-2-hydroxy-N-(propan-2-yl)acetamide
- EC Number:
- 611-084-9
- Cas Number:
- 54041-17-7
- Molecular formula:
- C11H14FN
- IUPAC Name:
- N-(4-fluorophenyl)-2-hydroxy-N-(propan-2-yl)acetamide
Constituent 1
- Specific details on test material used for the study:
- Batch/Lot No.: 17001/93
Manufacturer: Bayer AG
Identity analysis: May 10, 1993
Stability: until March 29, 1995
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male SD rats treated with aroclor 1254 (metabolic activity of each batch was verified with reference mutagen(s)
- Test concentrations with justification for top dose:
- 0, 8, 40, 200, 1000 and 5000 µg/plate (tested up to the recommended maximum dose)
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- sodium azide
- other: nitrofurantoin (NF), 4-nitro-1,2-phenylene diamine (4-NPDA), 2-aminoanthracene (2-AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); in suspension (preincubation method)
DURATION
- Preincubation period:
20 min
- Exposure duration:
48 h
NUMBER OF REPLICATIONS:
4 plates/strain, 2 replications
DETERMINATION OF CYTOTOXICITY
- Method: The first method was a gross appraisal of background growth on the plates for mutant determination. Secondly, a toxic effect of the substance was assumed when there was a marked and dose-dependent reduction in the mutant count per plate, compared to the negative controls. Thirdly, the titer was determined. Total bacterial counts were taken on two plates for each concentration studied with S9 mix. However, if an evaluation was performed only without S9 mix, the bacterial count was taken without S9 mix. - Rationale for test conditions:
- The results of the first experiment were considered as a pre-test for toxicity. Since solubility was not limited, 5000 µg/plate was chosen as the highest dose. Doses of repeats were chosen on the basis of the results obtained in the first experiment.
- Evaluation criteria:
- A reproducible and dose-related increase in mutant counts of at least one strain is considered to be a positive result.
For TA 1535, TA 100 and TA 98 this increase should be about twice that of negative controls, whereas for TA 1537, at least a threefold increase should be reached. Otherwise, the result is evaluated as negative.
The following criteria determined the acceptance of an assay:
a) The negative controls had to be within the expected range, as defined by published data (e.g. Maron and Ames, 1983) and/or the laboratories' own historical data.
b) The positive controls had to show sufficient effects, as defined by the laboratories' experience.
c) Titer determinations had to demonstrate sufficient bacterial density in the suspension.
Only trials which complied with all three of the above criteria were accepted for assessment. Even if the criteria for points (b) and (c) were not met, a trial was accepted if it showed mutagenic activity of the test compound. Furthermore, an unacceptable trial would have been repeated. - Statistics:
- Means of colony numbers were calculated.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slight cytotoxicity at 5000 µg
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slight cytotoxicity at 5000 µg
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- True negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 3: Results as mean values without S9 mix
Compound | Method | concentration | TA 1535 | TA 100 | TA 1537 | TA 98 |
DMSO | plate | 0 | 11 | 70 | 9 | 21 |
Test substance | 8 | 10 | 87 | 8 | 24 | |
40 | 13 | 79 | 8 | 26 | ||
200 | 8 | 88 | 8 | 19 | ||
1000 | 14 | 70 | 8 | 23 | ||
5000 | 13 | 74 | 3 | 20 | ||
Sodium azide |
| 825 | - | - | - | |
NF |
| - | 337 | - | - | |
4-NPDA |
| - | - | 64 | 74 | |
DMSO | tube | 0 | 10 | 97 | 7 | 23 |
Test substance | 8 | 10 | 85 | 9 | 22 | |
40 | 10 | 98 | 7 | 26 | ||
200 | 7 | 88 | 9 | 28 | ||
1000 | 9 | 93 | 7 | 28 | ||
5000 | 8 | 73 | 4 | 24 | ||
Sodium azide |
| 564 | - | - | - | |
NF |
| - | 424 | - | - | |
4-NPDA |
| - | - | 58 | 70 |
NF: nitrofurantoin, 4-NPDA : 4-nitro-1,2-phenylene diamine
Table 3: Table 2: Results as mean values with S9 mix
Compound | Method | concentration | TA 1535 | TA 100 | TA 1537 | TA 98 |
DMSO | plate | 0 | 14 | 108 | 7 | 33 |
Test substance | 8 | 14 | 128 | 8 | 33 | |
40 | 11 | 120 | 9 | 34 | ||
200 | 11 | 113 | 9 | 25 | ||
1000 | 11 | 124 | 9 | 23 | ||
5000 | 14 | 108 | 7 | 30 | ||
2-AA |
| 59 | 775 | 56 | 1286 | |
DMSO | tube | 0 | 11 | 129 | 10 | 34 |
Test substance | 8 | 12 | 80 | 1 | 37 | |
40 | 13 | 91 | 09 | 28 | ||
200 | 10 | 64 | 9 | 28 | ||
1000 | 12 | 68 | 5 | 33 | ||
5000 | 8 | 64 | 4 | 30 | ||
2-AA |
| 111 | 903 | 231 | 1102 |
2-AA: 2-aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- FOE 5043-Hydroxy was considered to be non-mutagenic without and with S9 mix in the plate incorporation as well as in the preincubation modification of the Salmonella/microsome test.
- Executive summary:
FOE 5043-Hydroxy was investigated in an independent repeat using the Salmonella/microsome test for point mutagenic effects in doses up to 5000 ng per tube after preincubation for 20 minutes at 37°C on four Salmonella typhimurium LT2 mutants. These comprised the histidine-auxotrophic strains TA 1535, TA 100, TA 1537 and TA 98. Doses up to and including 40 ng per tube did not cause any bacteriotoxic effects: Total bacteria counts remained unchanged and no inhibition of growth was observed. At higher doses, the substance had only a weak, strain-specific bacteriotoxic effect, so that this range could nevertheless be used for assessment purposes. Evidence of mutagenic activity of FOE 5043-Hydroxy was not seen. No biologically relevant increase in the mutant count, in comparison with the negative controls, was observed. The positive controls sodium azide, nitrofurantoin, 4-nitro-1,2-phenylene diamine and 2-aminoanthracene had a marked mutagenic effect, as was seen by a biologically relevant increase in mutant colonies compared to the corresponding negative controls.
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