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EC number: 240-734-0 | CAS number: 16690-93-0
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP-guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 998
- Report date:
- 1998
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Remarks:
- (BASF AG, Department of Toxicology)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium β-alaninate
- EC Number:
- 240-734-0
- EC Name:
- Sodium β-alaninate
- Cas Number:
- 16690-93-0
- Molecular formula:
- C3H7NO2.Na
- IUPAC Name:
- sodium 3-aminopropanoate
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Natrium-ß-alaninat, roh ber. 100%
- Physical state: colorless liquid
- Analytical purity: not reported
- Lot/batch No.: not reported
- Date of manufacturing: 11 April 1996
- Stability under test conditions: verified
- Storage condition of test material: room temperature (protected from light)
Constituent 1
Method
- Target gene:
- Histidine and tryptophan auxotrophy
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:
- Aroclor 1254 induced rat liver S-9 mix
- Test concentrations with justification for top dose:
- 1st Experiment (standard plate test): 0; 60; 300; 1500; 7500; 15000 µg/plate
2nd Experiment (preincubation test): 0; 12; 60; 300; 1500; 7500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water for test substance and DMSO for positive controls
Controlsopen allclose all
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S-9 mix
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without S-9 mix Migrated to IUCLID6: for WP2 uvrA
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-N-nitro-N-nitrosoguanidine for TA1535
- Remarks:
- without S-9 mix
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylendiamine for TA98
- Remarks:
- without S-9 mix
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S-9 mix Migrated to IUCLID6: for TA1537
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 20 min at 37°C
- Exposure duration: 48-72 hr at 37°C
NUMBER OF REPLICATIONS: 3 - Evaluation criteria:
- - doubling of the spontaneous mutation rate (control)
- dose-response relationship
- reproducibility of the results - Statistics:
- Mean and standard deviation calculated in result tables. No further data.
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:
- cytotoxicity
- Remarks:
- at dose level 7500 µg/plate and above
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at dose level 7500 µg/plate and above
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Mean Reverants/ plate in Standard plate test
Dose (µg/ml) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2uvrA |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
0 |
33 |
36 |
108 |
12 |
16 |
17 |
9 |
9 |
40 |
51 |
60 |
33 |
42 |
135 |
133 |
14 |
17 |
8 |
9 |
40 |
43 |
300 |
23 |
37 |
135 |
143 |
15 |
14 |
9 |
11 |
46 |
44 |
1500 |
29 |
36 |
128 |
124 |
15 |
15 |
7 |
7 |
40 |
43 |
7500 |
26 |
29 |
126 |
137 |
15 |
15 |
9 |
10 |
35 |
37 |
15000 |
22 |
20 |
110 |
133 |
9 |
13 |
7 |
8 |
23 |
26 |
Positive control |
1105 |
1050 |
1121 |
1263 |
1207 |
136 |
516 |
114 |
762 |
188 |
Mean Reverants/ plate in Pre incubation test
Dose (µg/ml) |
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2uvrA |
|||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|
0 |
31 |
50 |
132 |
149 |
18 |
18 |
9 |
11 |
40 |
51 |
312.5 |
27 |
39 |
133 |
128 |
19 |
19 |
8 |
11 |
32 |
49 |
625 |
33 |
45 |
135 |
161 |
22 |
18 |
9 |
14 |
40 |
44 |
1250 |
27 |
33 |
139 |
164 |
23 |
17 |
8 |
17 |
36 |
44 |
2500 |
31 |
43 |
141 |
157 |
23 |
16 |
8 |
9 |
39 |
45 |
5000 |
11 |
20 |
76 |
122 |
12 |
12 |
4 |
8 |
15 |
20 |
Positive control |
1153 |
502 |
1059 |
1570 |
1670 |
148 |
482 |
106 |
758 |
276 |
Applicant's summary and conclusion
- Executive summary:
This study was conducted in accordance with many guidelines for bacterial mutagenicity testing and is reliable with restrictions as analytical purity of the test substance is not reported. The test substance was tested in 4 Salmonella and 1 E.coli strains at dose levels of 12 -15000 µg/plate. No increase in the number of revertants was detected in any strain with and without metabolic activation. Cytotoxic effect was observed at dose level of 7500 µg/plate and above. Vehicle controls and positive controls were valid.
Conclusion: According to the results of the present study, the test substance Natrium-ß-alaninat, roh ber. 100% is not mutagenic in the Ames test under the experimental conditions chosen here.
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