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EC number: 232-753-8 | CAS number: 9014-06-6
- 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 29-SEP-2004 to 25-OCT-2004
- 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:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- 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.
- Reference substance name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Protein as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Inorganic salts as a constituent of enzyme deriving from the fermentation or extraction process
- Reference substance name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process.
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Carbohydrates constituent of enzyme deriving from the fermentation or extraction process.
- Reference substance name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Molecular formula:
- Not available. See remarks.
- IUPAC Name:
- Lipids as a constituent of enzyme deriving from the fermentation or extraction process
- Test material form:
- liquid
- Remarks:
- Tests based on dissolved material in the concentrate
- 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: data not available
- Storage condition of test material: In freezer in the dark
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Constituent 5
Method
Species / strain
- Species / strain / cell type:
- lymphocytes: Cultured peripheral human lymphocytes
- 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:
- First cytogenetic assay:
- With and without S9-mix : 1000, 3330 and 5000 µg Aldolase/ml culture medium (3 h exposure time, 24 h fixation time)
Second cytogenetic assay:
- Without S9-mix : 333, 1000, 1500, 2000,2500 and 3330 µg Aldolase/ml culture medium (24 h exposure time, 24 h fixation time) ; 333, 1000, 2000, 3330, 4000 and 5000 µg Aldolase/ml culture medium (48 h exposure time, 48 h fixation time)
- With S9-mix : 1000, 3330 and 5000 µg Aldolase/ml culture medium (3 h exposure time, 48 h fixation time) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: culture medium
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- culture medium
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: Without metabolic activation: Mitomycin C (0.5 µg/ml for a 3 h exposure period, 0.2 µg/ml for a 24 h exposure period and 0.1 µg/ml for a 48 h exposure period. With metabolic activation: Cyclophosphamid (15 µg/ml for a 3 h exposure period)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 3, 24 or 48 hours
- Expression time (cells in growth medium): 24 or 48 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 24 or 48 hours
SPINDLE INHIBITOR : colchicine (0.5 µg/ml medium)
STAIN (for cytogenetic assays): 5% (v/v) Giemsa (Merck) solution in tap water
NUMBER OF REPLICATES: two
NUMBER OF CELLS EVALUATED:
- The mitotic index of each culture was determined by counting the number of metaphases per 1000 cells
- 100 metaphase chromosome spreads per culture were examined by light microscopy for chromosome aberrations
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index - Evaluation criteria:
- A test substance was considered positive (clastogenic) in the chromosome aberration test if:
a) it induced a dose-related statistically significant (Chi-square test, P < 0.05) increase in the number of cells with chromosome aberrations
b) a statistically significant and biologically relevant increase in the frequencies of the number of cells with chromosome aberrations was observed in the absence of a clear dose-response relationship
A test substance was considered negative (not clastogenic) in the chromosome aberration test if none of the tested concentrations induced a statistically significant (Chi-square test, P < 0.05) increase in the number of cells with chromosome aberrations.
The preceding criteria are not absolute and other modifying factors might enter into the final evaluation decision. - Statistics:
- The incidence of aberrant cells (cells with one or more chromosome aberrations, inclusive or exclusive gaps) for each exposure group was compared to that of the solvent control using Chi-square statistics.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- lymphocytes:
- Metabolic activation:
- without
- Genotoxicity:
- positive
- Remarks:
- after 48 hours of exposure
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- lymphocytes:
- Metabolic activation:
- with
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: the pH of a concentration of 5000 µg/ml was 7.68 (compared to 7.87 in the solvent control)
- Effects of osmolality: the osmolarity of a concentration of 5000 µg/ml was 274 mOsm/kg (compared to 282 mOsm/kg in the solvent control)
- Precipitation: a concentration of 5000 µg Aldolase/ml showed no precipitation in the culture medium
RANGE-FINDING/SCREENING STUDIES:
In order to select the appropriate dose levels for the chromosome aberration test cytotoxicity data were obtained in a dose range finding test. Aldolase was tested in the absence and in the presence of 1.8% (v/v) S9-fraction. The highest tested concentration was 5000 µg/ml.
COMPARISON WITH HISTORICAL CONTROL DATA:
The number of cells with chromosome aberrations found in the solvent control cultures was within the laboratory historical control data range. - Remarks on result:
- other: strain/cell type: cultured human lymphocytes
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Chromosome aberrations with Aldolasein the absence of S9 mixin the first cytogenetic assay (3 h exposure time, 24 h fixation time)
Conc µg/ml |
Culture medium |
1000 µg/ml |
3330 µg/ml |
5000 µg/ml |
MMC-C 0.5 µg/ml |
||||||||||
Culture |
A |
B |
A+B |
A |
B |
A+B |
A |
B |
A+B |
A |
B |
A+B |
A |
B |
A+B |
Mitotic Index (%) |
100 |
102 |
102 |
96 |
70 |
||||||||||
No. of cells scored |
100 |
100 |
200 |
100 |
100 |
200 |
100 |
100 |
200 |
100 |
100 |
200 |
100 |
100 |
200 |
No. Of cells with aberrations (+ gaps) |
0 |
2 |
2 |
0 |
1 |
1 |
2 |
4 |
6 |
0 |
2 |
2 |
24 |
35 |
59 (***) |
No. of cells with aberrations (- gaps) |
0 |
2 |
2 |
0 |
0 |
0 |
1 |
2 |
3 |
0 |
2 |
2 |
24 |
35 |
59 (***) |
Table 2: Chromosome aberrations with Aldolase in the presence of S9-mix in the first cytogenetic assay (3 h exposure time, 24 h fixation time)
Conc µg/ml |
Culture medium |
1000 µg/ml |
3330 µg/ml |
5000 µg/ml |
CP 15 µg/ml |
||||||||||
Culture |
A |
B |
A+B |
A |
B |
A+B |
A |
B |
A+B |
A |
B |
A+B |
A |
B |
A+B |
Mitotic Index (%) |
100 |
102 |
102 |
101 |
47 |
||||||||||
No. of cells scored |
100 |
100 |
200 |
100 |
100 |
200 |
100 |
100 |
200 |
100 |
100 |
200 |
100 |
100 |
200 |
No. Of cells with aberrations (+ gaps) |
1 |
1 |
2 |
3 |
0 |
3 |
5 |
0 |
5 |
2 |
3 |
5 |
29 |
31 |
60 (***) |
No. of cells with aberrations (- gaps) |
1 |
0 |
1 |
3 |
0 |
3 |
5 |
0 |
1 |
2 |
3 |
5 |
28 |
31 |
59 (***) |
Table 3: Chromosome aberrations with Aldolase in the absence of S9-mix in the second cytogenetic assay (24 h exposure time, 24 h fixation time)
Conc µg/ml |
Culture medium |
333 µg/ml |
1500 µg/ml |
3330 µg/ml |
MMC-C 0.2 µg/ml |
||||||||||
Culture |
A |
B |
A+B |
A |
B |
A+B |
A |
B |
A+B |
A |
B |
A+B |
A |
B |
A+B |
Mitotic Index (%) |
100 |
87 |
74 |
45 |
29 |
||||||||||
No. of cells scored |
100 |
100 |
200 |
100 |
100 |
200 |
100 |
100 |
200 |
100 |
100 |
200 |
100 |
100 |
200 |
No. Of cells with aberrations (+ gaps) |
0 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
2 |
1 |
0 |
1 |
35 |
36 |
71 (***) |
No. of cells with aberrations (- gaps) |
0 |
1 |
1 |
1 |
0 |
1 |
1 |
1 |
2 |
1 |
0 |
1 |
35 |
36 |
71 (***) |
Table 4:Chromosome aberrations with Aldolase in the absence of S9-mix in the second cytogenetic assay (48 h exposure time, 48 h fixation time)
Conc µg/ml |
Culture medium |
1000 µg/ml |
3330 µg/ml |
5000 µg/ml |
MMC-C 0.1 µg/ml |
||||||||||
Culture |
A |
B |
A+B |
A |
B |
A+B |
A |
B |
A+B |
A |
B |
A+B |
A |
B |
A+B |
Mitotic Index (%) |
100 |
86 |
63 |
42 |
54 |
||||||||||
No. of cells scored |
100 |
100 |
200 |
100 |
100 |
200 |
100 |
100 |
200 |
100 |
100 |
200 |
100 |
100 |
200 |
No. Of cells with aberrations (+ gaps) |
1 |
0 |
1 |
2 |
2 |
4 |
4 |
6 |
10 (**) |
9 |
10 |
19 (***) |
40 |
31 |
71 (***) |
No. of cells with aberrations (- gaps) |
0 |
0 |
0 |
2 |
1 |
3 |
3 |
4 |
7 (*) |
7 |
8 |
15 (***) |
38 |
30 |
68 (***) |
Table 5: Chromosome aberrations with Aldolase in the presence of S9-mix in the second cytogenetic assay (3 h exposure time, 48 h fixation time)
Conc µg/ml |
Culture medium |
1000 µg/ml |
3330 µg/ml |
5000 µg/ml |
CP 15 µg/ml |
||||||||||
Culture |
A |
B |
A+B |
A |
B |
A+B |
A |
B |
A+B |
A |
B |
A+B |
A |
B |
A+B |
Mitotic Index (%) |
100 |
140 |
137 |
184 |
Not calculated |
||||||||||
No. of cells scored |
100 |
100 |
200 |
100 |
100 |
200 |
100 |
100 |
200 |
100 |
100 |
200 |
100 |
100 |
200 |
No. Of cells with aberrations (+ gaps) |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
24 |
25 |
49 (***) |
No. of cells with aberrations (- gaps) |
0 |
1 |
1 |
0 |
0 |
0 |
0 |
1 |
1 |
0 |
0 |
0 |
23 |
25 |
48 (***) |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
positive without metabolic activation after 48 hours of exposure
negative with metabolic activation
Aldolase is clastogenic in human lymphocytes under the experimental conditions described in this report since at the 48 h continuous exposure time a dose related significant increase in the number of chromosome aberrations was observed. - Executive summary:
This report describes the effect of Aldolase on the number of chromosome aberrations in cultured peripheral human lymphocytes in the presence and absence of a metabolic activation system (Aroclor-1254 induced rat liver S9-mix). The possible clastogenicity of Aldolase was tested in two independent experiments. The study procedures described in this report were based on the most recent OECD and EEC guidelines.
In the first cytogenetic assay, Aldolase was tested up to 5000 µg/ml for a 3 h exposure time with a 24 h fixation time in the absence and presence of S9-mix. In the second cytogenetic assay, Aldolase was tested up to 3330 µg/ml for a 24 h continuous exposure time with a 24 h fixation time and up to 5000 µg/ml for a 48 h continuous exposure time with a 48 h fixation time in the absence of S9-mix. Appropriate toxicity was reached at these dose levels. In the presence of 1.8% (v/v) S9-fraction Aldolase was tested up to the recommended 5000 µg/ml for a 3 h exposure time with a 48 h fixation time.
Positive control chemicals, mitomycin C and cyclophosphamide, both produced a statistically significant increase in the incidence of cells with chromosome aberrations, indicating that the test conditions were adequate and that the metabolic activation system (S9-mix) functioned properly.
First cytogenetic assay:
Aldolase did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence and presence of S9-mix.
Second cytogenetic assay:
In the absence of S9-mix, at the 24 h continuous exposure time, Aldolase did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations.
In the absence of S9-mix, at the 48 h continuous exposure time, Aldolase induced a statistically significant, dose dependent increase in the number of cells with chromosome aberrations, both when gaps were included and excluded.
In the presence of S9 mix, Aldolase did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations.
Finally, it is concluded that this test is valid and that Aldolase is clastogenic in human lymphocytes under the experimental conditions described in this report since at the 48 h continuous exposure time a dose related significant increase in the number of chromosome aberrations was observed.
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