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EC number: 204-101-2 | CAS number: 115-70-8
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:
- 2 004
- Report date:
- 2004
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:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2-amino-2-ethylpropanediol
- EC Number:
- 204-101-2
- EC Name:
- 2-amino-2-ethylpropanediol
- Cas Number:
- 115-70-8
- Molecular formula:
- C5H13NO2
- IUPAC Name:
- 2-amino-2-ethylpropane-1,3-diol
- Details on test material:
- - 2-amino-2-ethyl-1,3-propanediol
- Analytical purity: 99.4%
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium strains)
trp operon (for E. coli strains)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Species / strain / cell type:
- E. coli WP2 uvr A
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9-mix), prepared from the livers of rats treated with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- 156, 313, 625, 1250, 2500 and 5000 μg/plate with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: without S9-mix
- Remarks:
- - S9-mix: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide (0.01 µg/plate) for TA100 and E.coli, (0.1 µg/plate) for TA 98; sodium azide (0.5 µg/plate for TA1535); 2-methoxy-6-chloro-9-[3-(2-chloroethyl)- aminopropylamino] acridine-2HCl for (1.0 µg/plate) TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: with S9-mix
- Remarks:
- + S9-mix: Benzo[a]pyrene (5.0 µg/plate) for TA100, TA98 and TA1537; 2-aminoanthracene (2.0 µg/plate) for TA1535 and (10.0 µg/plate) for E.coli WP2 uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 plates for each concentration
DETERMINATION OF CYTOTOXICITY
- Method: The inhibition of growth of the test bacterial strains by the test substance was observed with a stereoscopic microscope. - Evaluation criteria:
- When the number of reverse mutation colonies increased by almost twice the solvent control or more, and reproducibilityor dependence on the dose of the test substance was observed, the result was considered positive.
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
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of a white crystalline substance was observed in the test substance treatment groups of 2500 µg/plate or higher in the presence of the metabolic activation system, regardless of the kind of bacterial strain used.
RANGE-FINDING/SCREENING STUDIES:
In the range finding study, 8 treatment doses of the test solution were used in the range of 0.305 - 5000 µg/plate. Precipitation of a white crystalline substance was observed at the highest dose of 5000 µg/plate in the presence of a metabolic activation system, regardless of the kind of bacterial strain used. No inhibition of growth of bacterial strains was observed, regardless of the kind of strain and the presence or absence of metabolic activation.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
No inhibition of growth of bacterial strains was observed, regardless of the kind of strain and the presence or absence of metabolic activation (data not shown). - 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 the main test
With or without S9-mix |
Test substance concentration (µg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA 1535 |
E.coli WP2 uvrA |
TA 98 |
TA 1537 |
||
- |
0 |
113 ± 21.4 |
10 ± 1.0 |
29 ± 3.5 |
17 ± 3.1 |
12 ± 1.5 |
- |
156 |
110 ± 12.4 |
8 ± 1.2 |
28 ± 2.6 |
12 ± 2.1 |
9 ± 1.2 |
- |
313 |
108 ± 13.1 |
8 ± 2.3 |
26 ± 3.8 |
13 ± 4.0 |
13 ± 2.0 |
- |
625 |
107 ± 4.7 |
7 ± 1.0 |
27 ± 0.6 |
16 ± 1.7 |
10 ± 1.0 |
- |
1250 |
114 ± 7.1 |
7 ± 2.1 |
27 ± 4.6 |
13 ± 3.1 |
10 ± 2.1 |
- |
2500 |
115 ± 2.3 |
9 ± 4.2 |
28 ± 4.4 |
15 ± 3.0 |
10 ± 2.0 |
- |
5000 |
114 ± 7.4 |
7 ± 1.7 |
19 ± 3.1 |
12 ± 2.5 |
10 ± 1.7 |
Positive controls, -S9 |
Name
Concentrations (µg/plate)
Mean No. of colonies/plate (average of 3 ± SD) |
AF-2
0.01
469 ± 18.1 |
SAZ
0.50
176 ± 34.7 |
AF-2
0.01
235 ± 29.5 |
AF-2
0.10
363 ± 9.8 |
ICR-191
1.0
1194 ± 138.0 |
|
||||||
|
TA 100 |
TA 1535 |
E.coli WP2 uvrA |
TA 98 |
TA 1537 |
|
+ |
0 |
126 ± 5.9 |
13 ± 0.6 |
29 ± 2.9 |
20 ± 2.0 |
12 ± 2.6 |
+ |
156 |
123 ± 2.5 |
8 ± 0.6 |
27 ± 2.7 |
19 ± 0.6 |
14 ± 1.7 |
+ |
313 |
127 ± 12.2 |
8 ± 0.6 |
26 ± 4.4 |
20 ± 1.5 |
13 ± 2.0 |
+ |
625 |
106 ± 6.0 |
9 ± 1.5 |
25 ± 2.5 |
19 ± 2.1 |
11 ± 1.2 |
+ |
1250 |
125 ± 10.2 |
10 ± 2.1 |
22 ± 3.1 |
23 ± 2.1 |
12 ± 1.5 |
+ |
2500 |
126 ± 3.2 |
8 ± 2.1 |
19 ± 2.1 |
18 ± 2.5 |
12 ± 3.0 |
+ |
5000 |
135 ± 9.0 |
7 ± 2.1 |
21 ± 3.8 |
14 ± 2.9 |
10 ± 2.3 |
Positive controls, +S9 |
Name
Concentrations (µg/plate)
Mean No. of colonies/plate (average of 3 ± SD) |
B[a]P
5.00
621 ± 23.8 |
2AA
2.00
117 ± 16.7 |
2AA
10.0
407 ± 12.1 |
B[a]P
5.00
247 ± 5.5 |
B[a]P
5.00
111 ± 6.7 |
SAZ: Sodium azide
AF-2: 2-(2-Furyl)-3-(5-nitro-2-furyl)acrylamide
ICR-191: 2-Methoxy-6-chloro-9-[3-(2-chloroethyl)-aminopropylamino]acridine*2HCl
B[a]P: Benzo[a]pyrene
2AA: 2-Aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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