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EC number: 500-322-6 | CAS number: 144086-03-3 1 - 6.5 moles ethoxylated
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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 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:
- Glycerol, ethoxylated, esters with acrylic acid
- EC Number:
- 500-322-6
- EC Name:
- Glycerol, ethoxylated, esters with acrylic acid
- Cas Number:
- 144086-03-3
- Molecular formula:
- UVCB substance
- IUPAC Name:
- Glycerol, ethoxylated, esters with acrylic acid
- Details on test material:
- - Name of test material (as cited in study report): Glycerin3EOTA
- Physical state: Beige, turbid liquid
- Analytical purity: >99%
- Lot/batch No.: GK0561/160
- Stability under test conditions: The stability of the test substance under storage conditions throughout the study period is guaranteed until June 15, 2005 as indicated by the sponsor, and the sponsor holds this responsibility
- Storage condition of test material: Room temperature
Constituent 1
Method
- Target gene:
- S. typhimurium: his-
E. coli: trp-
Species / strain
- Species / strain / cell type:
- other: Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98; E. coli WP2 uvrA
- Metabolic activation:
- with and without
- Metabolic activation system:
- Liver S-9 mix from Aroclor 1254 induced male rats
- Test concentrations with justification for top dose:
- 0; 20; 100; 500; 2500 and 5000 µg/plate in both the SPT and the PT
- Vehicle / solvent:
- DMSO
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: see below
- Details on test system and experimental conditions:
- Experiment 1: Standard plate test (SPT)
Test tubes containing 2 ml soft agar kept in a water bath at 45°C, and remaining components added in the following order:
0 .1 ml test solution or vehicle
0 .1 ml bacterial suspension
0 .5 ml S-9 mix (in tests with metabolic activation) or 0 .5 ml phosphate buffer (in tests without metabolic activation).
After mixing, the samples are poured onto Vogel-Bonner agar plates.
Experiment 2: Preincubation assay (PT)
0.1 ml test solution or vehicle, 0.1 ml bacterial suspension and 0 .5 ml S-9 mix are incubated at 37°C for the duration of 20 minutes. Subsequently, 2 ml of soft agar is added and, after mixing, the samples are poured onto the Vogel-Bonner agar plates.
Experiment1 & 2:
In each experiment 3 test plates per dose or per control used; after incubation at 37°C for 48 hours in the dark, the bacterial colonies ( his+/trp+ revertants) are counted.
Positive control:
with metabolic activation: 2.5 (Salmonella) or 60 (E. coli) μg/plate 2-aminoanthracene for all strains;
without metabolic activation: 5 μg/plate N-methyl-N'-nitro-N-nitrosoguanidine for TA 100 and TA 1535, 10 μg/plate 4-nitro-o-phenylendiamine for TA 98, 100 μg/plate 9-aminoacridine for TA 1537 and 5 µg/plate 4-nitroquinoline-N-oxide for E. Coli WP2 uvrA, all substances were dissolved in DMSO.
The titer was determined and in regularly measurements the strain characteristics were checked. Sterility control was performed. - Evaluation criteria:
- The test chemical is considered positive in this assay if the following criteria are met:
A dose-related and reproducible increase in the number of revertant colonies, i.e. about doubling of the spontaneous mutation rate in at least one tester strain either without S-9 mix or after adding a metabolizing system. - Statistics:
- not performed
Results and discussion
Test results
- Species / strain:
- other: Salmonella typhimurium TA 1535, TA 100, TA 1537, TA 98; E. coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: >=2500 µg/plate in both the SPT and PIT; depending on strain and test condition
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Standard plate test (20 - 5000 µg/plate) | |||||
Strain | Metabolic activation system | mean revertants in Controls | maximum revertant factor | dose dependency | Assessment |
TA 98 | no | 33 | 0.9 | no | negative |
yes | 44 | 0.9 | no | negative | |
TA 100 | no | 103 | 1.1 | no | negative |
yes | 114 | 1.2 | no | negative | |
TA 1535 | no | 18 | 1.1 | no | negative |
yes | 18 | 1.0 | no | negative | |
TA 1537 | no | 9 | 1.4 | no | negative |
yes | 11 | 1.1 | no | negative | |
WP2 uvr A | no | 37 | 1.1 | no | negative |
yes | 37 | 1.1 | no | negative | |
Preincubation test (20 - 5000 µg/plate) | |||||
Strain | Metabolic activation system | mean revertants in Controls | maximum revertant factor | dose dependency | Assessment |
TA 98 | no | 26 | 1.0 | no | negative |
yes | 31 | 0.9 | no | negative | |
TA 100 | no | 110 | 1.0 | no | negative |
yes | 108 | 1.0 | no | negative | |
TA 1535 | no | 17 | 1.0 | no | negative |
yes | 17 | 0.9 | no | negative | |
TA 1537 | no | 10 | 1.1 | no | negative |
yes | 10 | 0.9 | no | negative | |
WP2 uvr A | no | 31 | 1.0 | no | negative |
yes | 36 | 1.0 | no | negative |
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