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EC number: 444-400-7 | CAS number: 9026-97-5
- 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
- Study period:
- from 03-JUN-2002 to 17-JUN-2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The test was performed according to OECD guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Aldolase enzyme concentrate
- IUPAC Name:
- Aldolase enzyme concentrate
- Reference substance name:
- deoxyribose-phosphate aldolase EC 4.1.2.4.
- Cas Number:
- 9026-97-5
- Molecular formula:
- Not applicable, please see remarks
- IUPAC Name:
- deoxyribose-phosphate aldolase EC 4.1.2.4.
- Details on test material:
- - Name of test material (as cited in study report): ALDOLASE (IUB 4.1.2.4)
- Substance type: enzyme
- Physical state: liquid
- Stability under test conditions: not indicated
- Storage condition of test material: In freezer in the dark
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:
- Rat liver microsomal enzymes were routinely prepared from adult male Wistar rats
- Test concentrations with justification for top dose:
- at least 5 differents doses (increasing with approximately half-log steps) up to 3330 µg protein/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
- Remarks:
- dimethyl sulfoxide (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: WITHOUT S9-mix: sodium azide (5µg/pl, TA1535), 9-aminoacridine (60µg/pl, TA1537), daunornycine (4µg/pl, TA98), methylmethanesulfonate (650µg/pl, TA100), 4-nitroquinoline (10µg/pl, WP2uvrA). WITH S9-mix: 2-aminoanthracene (2.5µg/pl TA1537, 1µg/pl TA1535 &
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48h at 37 +/- 1°C
NUMBER OF REPLITES: three in each strain
OTHER: The revertant colonies were counted automatically with a Protos model 50000 colony counter or manually, if less than 40 colonies per plate were present. Plates with sufficient test article precipitate to interfere with automated colony counting were counted manually. - 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 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:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: ALDOLASE (IUB 4.1.2.4) precipitated in the top agar at concentrations of 1000 and 3330 µg protein/plate.
Precipitation of ALDOLASE (IUB 4.1.2.4) on the plates was observed at the start of the incubation period at the concentration of 3330 µg protein/plate in the first mutation experiment and at 1000 and 3330 µg protein/plate in the second mutation experiment. Precipitation of ALDOLASE (IUB 4.1.2.4) on the plates was observed at the end of the incubation period at 1000 and 3330 µg protein/plate in both experiments.
- Effects of pH, effects of osmolality, evaporation from medium, water solubility: data not available
RANGE-FINDING/SCREENING STUDIES:
ALDOLASE (IUB 4.1.2.4) was tested in the tester strains TA100 and WP2uvrA with concentrations of 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg protein/plate in the absence and presence of S9-mix.
Precipitate: the test substance precipitated in the top agar at concentrations of 1000 µg protein/plate and upwards. Precipitation of ALDOLASE (IUB 4.1.2.4) on the plates was observed at the start and at the end of the incubation period at concentrations of 3330 and 5000 µg protein/plate.
Toxicity: to determine the toxicity of ALDOLASE (IUB 4.1.2.4), the reduction of the bacterial background lawn, the increase in the size of the microcolonies and the reduction of the revertant colonies were examined. No reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed.
COMPARISON WITH HISTORICAL CONTROL DATA:
The negative control values were within our laboratory background historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
The strain-specific positive control values were within our laboratory background historical control data ranges, except for TA1537 in the presence of S9-mix (second experiment). However, since this value was just outside the limit of the range and a more than three-fold increase was observed compared to the solvent control, the validity of the test was considered to be not affected. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Result (Experiment 1)
Dose (µg protein/plate) |
Mean number of revertant colonies/3 replicate plates with different strains ofSalmonella typhimuriumand oneEscherichia colistrain |
||||
|
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
Without S9-mix |
|||||
Positive control |
898 |
478 |
478 |
859 |
809 |
Solvent control |
9 |
6 |
13 |
142 |
15 |
3 |
|
|
|
156 |
16 |
10 |
|
|
|
136 |
17 |
33 |
5 |
5 |
12 |
147 |
17 |
100 |
7 |
7 |
12 |
154 |
15 |
333 |
11 |
4 |
11 |
137 |
10 |
1000 |
11 |
4 |
17 |
143 |
15 |
3330 |
7 |
7 |
15 |
147 |
13 |
5000 |
|
|
|
158 |
15 |
With S9-mix (5% v/v S9 fraction) |
|||||
Positive control |
214 |
278 |
627 |
987 |
80 |
Solvent control |
11 |
6 |
18 |
130 |
13 |
3 |
|
|
|
142 |
17 |
10 |
|
|
|
124 |
10 |
33 |
7 |
6 |
18 |
145 |
14 |
100 |
7 |
4 |
11 |
127 |
17 |
333 |
9 |
5 |
14 |
139 |
15 |
1000 |
6 |
3 |
15 |
117 |
12 |
3330 |
6 |
6 |
16 |
149 |
14 |
5000 |
|
|
|
150 |
13 |
Table 2: Result (Experiment 2)
Dose (µg protein/plate) |
Mean number of revertant colonies/3 replicate plates with different strains ofSalmonella typhimuriumand oneEscherichia colistrain |
||||
|
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2uvrA |
Without S9-mix |
|||||
Positive control |
841 |
399 |
380 |
906 |
685 |
Solvent control |
12 |
4 |
18 |
158 |
12 |
10 |
10 |
5 |
14 |
148 |
15 |
33 |
7 |
7 |
15 |
186 |
15 |
100 |
11 |
8 |
18 |
170 |
9 |
333 |
13 |
6 |
16 |
138 |
15 |
1000 |
6 |
6 |
16 |
123 |
11 |
3330 |
10 |
8 |
19 |
128 |
11 |
With S9-mix (10% v/v S9 fraction) |
|||||
Positive control |
115 |
54 |
356 |
741 |
162 |
Solvent control |
9 |
6 |
28 |
95 |
9 |
10 |
10 |
7 |
22 |
110 |
14 |
33 |
10 |
6 |
22 |
80 |
12 |
100 |
6 |
8 |
23 |
83 |
8 |
333 |
7 |
5 |
25 |
79 |
11 |
1000 |
6 |
4 |
20 |
78 |
11 |
3330 |
8 |
7 |
24 |
92 |
10 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Based on the results of this study it is concluded that ALDOLASE (IUB 4.1.2.4) is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay. - Executive summary:
ALDOLASE (IUB 4.1.2.4) 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. The test was performed in two independent experiments in the presence and absence of S9-mix (Aroclor-1254 induced rat liver S9-mix).
In the first and in the second mutation assay, ALDOLASE (IUB 4.1.2.4) was tested up to concentrations of 3330 µg protein /plate in the absence and presence of S9-mix. ALDOLASE (IUB 4.1.2.4) precipitated on the plates at the dose levels of 1000 and 3330 µg protein /plate. The bacterial background lawn was not reduced at any of the concentrations tested and no decrease in the number of revertants was observed.
The presence of 5 and 10% (v/v) liver rnicrosomal activation did not influence these findings.
ALDOLASE (IUB 4.1.2.4) 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 ALDOLASE (IUB 4.1.2.4) is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
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