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EC number: 253-657-2 | CAS number: 37763-23-8
- 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:
- end on 21-MAR-1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study performed according to OECD guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Methyl (R)-amino(4-hydroxyphenyl)acetate
- EC Number:
- 253-657-2
- EC Name:
- Methyl (R)-amino(4-hydroxyphenyl)acetate
- Cas Number:
- 37763-23-8
- Molecular formula:
- C9H11NO3
- IUPAC Name:
- methyl (2R)-2-amino-2-(4-hydroxyphenyl)acetate
- Details on test material:
- - Name of test material (as cited in study report): FGHM
- Molecular formula (if other than submission substance): C9H11NO3
- Structural formula attached as image file (if other than submission substance): see Fig.
- Substance type: monoconstituent substance
- Physical state: powder
- Stability under test conditions: stability in dimethylsulphoxide not indicated
- Storage condition of test material: in refrigerator in the dark
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 ; Escherichia coli strain WP2uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver microsomal enzymes were routinely prepared from adult male Wistar rats, which were obtained from Charles River, Sulzfeld, Germany
- Test concentrations with justification for top dose:
- Experiment 1 & 2: 100, 333, 1000, 3330, 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: data not available
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9mix: sodium azide (SA, 1µg, TA1535), 9-aminoacridine (9AC, 60µg, TA1537), daunomycine (DM, 4µg, TA98), methylmethanesulfonate (MMS, 650µg, TA100), 4-nitroquinoline-N-oxide (4-NQO, 10µg, WP2uvrA) : +S9mix: 2-aminoanthracene (2AA, all strains, 0.5-5µg)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: after solidification of the top agar, the plates were turned and incubated in the dark at 37°C for 48 h.
NUMBER OF REPLICATES: triplicate in each strain.
DETERMINATION OF CYTOTOXICITY
- Method: the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were observed
OTHER: the revertant colonies (histidine independent c.q. tryptophan independent) were counted automatically with a Artek model 880 colony counter or manually, if less than 40 colonies per plate were present. - Evaluation criteria:
- A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation.
b) The negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) It induces a number of revertant colonies, dose related, greater than two-times the number of revertants induced by the solvent control in any of the tester strains, either with or without metabolic activation.
However, any mean plate count of less than 20 is considered to be not significant.
b) The positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision. - Statistics:
- not applicable
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 ; Escherichia coli strain WP2uvrA
- 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 examined
- Positive controls validity:
- valid
- Additional information on results:
- Precipitate:
HPGM (FGHM) did not precipitate in the top agar. Precipitation of HPGM (FGHM) on the plates was not observed at the start or at the end of the incubation period in all tester strains.
Toxicitv of the test substance:
The bacterial background lawn was not reduced at all concentrations tested and no decrease in the number of revertants was observed.
Number of revertants:
All bacterial strains showed negative responses over the entire dose range, i.e. no dose-related, two-fold, increase in the number of revertants in two independently repeated experiments.
The negative and strain-specific positive control values were within the laboratory background historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1 : results of experiment 1
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates with different strains of Salmonella typhimurium and one Escherichia coli strain |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2uvrA |
|
|
WITHOUT S9-MIX |
||||
3 |
|
|
|
66 |
16 |
10 |
|
|
|
70 |
17 |
33 |
|
|
|
73 |
19 |
100 |
16 |
8 |
26 |
66 |
18 |
333 |
18 |
7 |
32 |
69 |
18 |
1000 |
17 |
7 |
27 |
73 |
17 |
3330 |
13 |
7 |
26 |
69 |
20 |
5000 |
17 |
7 |
31 |
79 |
17 |
Solvent control |
14 |
10 |
23 |
93 |
14 |
Positive control |
251 |
325 |
325 |
720 |
520 |
|
WITH S9-MIX |
||||
3 |
|
|
|
65 |
17 |
10 |
|
|
|
60 |
21 |
33 |
|
|
|
68 |
20 |
100 |
16 |
7 |
35 |
64 |
20 |
333 |
15 |
5 |
36 |
79 |
16 |
1000 |
15 |
7 |
31 |
77 |
13 |
3330 |
13 |
8 |
29 |
70 |
16 |
5000 |
15 |
5 |
28 |
76 |
16 |
Solvent control |
17 |
4 |
30 |
76 |
16 |
Positive control |
79 |
397 |
915 |
740 |
261 |
Table 2 : results of experiment 2
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates with different strains of Salmonella typhimurium and one Escherichia coli strain |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2uvrA |
|
|
WITHOUT S9-MIX |
||||
100 |
8 |
3 |
21 |
96 |
8 |
333 |
9 |
4 |
16 |
90 |
9 |
1000 |
7 |
7 |
21 |
78 |
11 |
3330 |
9 |
4 |
19 |
95 |
13 |
5000 |
6 |
5 |
20 |
91 |
9 |
Solvent control |
8 |
5 |
21 |
93 |
9 |
Positive control |
157 |
301 |
350 |
908 |
269 |
|
WITH S9-MIX |
||||
100 |
7 |
5 |
22 |
96 |
16 |
333 |
6 |
3 |
20 |
88 |
13 |
1000 |
5 |
5 |
18 |
75 |
9 |
3330 |
6 |
5 |
19 |
82 |
14 |
5000 |
7 |
5 |
18 |
81 |
15 |
Solvent control |
7 |
6 |
26 |
88 |
10 |
Positive control |
336 |
686 |
822 |
997 |
240 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
Based on the results of this study it is concluded that HPGM (FGHM) is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. - Executive summary:
HPGM (FGHM) was tested in the Salmonella typhimurium reverse mutation assay with four histidine requiring strains of Salmonella typhimurium (TA1535, TA1537, TA100 and TA98) and in the Escherichia coli reverse mutation assay with a tryptophan-requiring strain of Escherichia coli WP2uvrA in two independent experiments. (OECD 471, GLP).
HPGM (FGHM) was tested up to concentrations of 5000 µg/plate in the absence and presence of S9-mix. HPGM (FGHM) did not precipitate on the plates at this dose-level. The bacterial background lawn was not reduced at all concentrations tested and no decrease in the number of revertants was observed.
HPGM (FGHM) did not induce a dose-related, two-fold, 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.
Based on the results of this study it is concluded that HPGM (FGHM) is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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