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EC number: 269-087-2 | CAS number: 68187-32-6
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- Aquatic toxicity
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- Short-term toxicity to fish
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Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 March 1994 to 31 May 1994
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Principles of method if other than guideline:
- Only four bacterial strains were tested. But these were two strains each with base pair substitution and frameshift mutation and thus did not influence the quality and validity of the study.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- L-Glutamic acid, N-coco acyl derivs., monosodium salts
- EC Number:
- 269-087-2
- EC Name:
- L-Glutamic acid, N-coco acyl derivs., monosodium salts
- Cas Number:
- 68187-32-6
- Molecular formula:
- C17 H32 N1 O4 Na1
- IUPAC Name:
- l-Glutamic acid, N-coco acyl derivs., monosodium salts
Constituent 1
Method
- Target gene:
- - Histidine requirement in the Salmonella typhimurium strains (Histidine operon).
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (Aroclor 1254 induced)
- Test concentrations with justification for top dose:
- 0, 4, 20, 100, 500, 2500, 5000 µg/plate
(all doses were tested in triplicates) - Vehicle / solvent:
- bi-distilled water
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- other: 2- aminoanthracene
- Remarks:
- TA 98, TA 100, TA 1535, TA 1537 with S9
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA 1537 without S9 Migrated to IUCLID6: 9AA
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100, TA 1535 without S9 Migrated to IUCLID6: NaN3
- Details on test system and experimental conditions:
- Test group
Top agar was prepared for the Salmonella strains by mixing 100 mL agar (0.6% agar, 0.5% NaCI) with 10 mL of a 0.5 mM histidine-biotin solution.
The following ingredients were added (in order) to 2 mL of molten top agar at approx. 45°C:
0.1mL of an overnight nutrient broth culture of the bacterial tester strain
0.1 mL test compound solution
0.5 mL S-9 Mix (if required) or buffer
After mixing, the liquid was poured into a petridish with minimal agar (1.5% agar, Vogel-Bonner E medium with 2% glucose). After incubation for approximatly 48 hours at approx. 37°C in the dark, colonies (his* revertants) were counted.
Two independent experiments were performed.
Positive controls
Positive control plates were included for each strain. The following substances were used as positive controls.
a) without metabolic activation:
sodium-azide: TA 100, TA 1535 9-aminoacridine: TA 1537 2-nitrofluorene: TA 98
b) with metabolic activation:
2-aminoanthracene: TA 98, TA 100, TA 1535, TA 1537
Negative controls
a) solvent controls (0 microgram/plate)
b) untreated controls - Evaluation criteria:
- A test article is classified mutagenic if either of the following conditions under a) and b) is achieved:
a) a test article produces at least a 2-fold increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn
b) a test article induces a dose-related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test article at complete bacterial background lawn.
The test results must be reproducible.
Results and discussion
Test results
- 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:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: the test material did not precipitate on the plates up to the highest investigated doses
- Precipitation: no
RANGE-FINDING/SCREENING STUDIES: The test material proved to be toxic for the bacterial strain TA 100 in the absence of a metabolising system at a dose of 5000 µg/plate only in the cytotoxic experiment. Therefore 5000 µg/plate was chosen as the highest dose in the experiment. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- The test material did not induce mutations in any of the test strains at any concentration.
- Executive summary:
The test material was investigated for its mutagenicity in accordance with the standardised guideline OECD 471 in test strains TA 98, TA 100, TA 1537 and TA 1538 in two independant experiments. The study was conducted under GLP conditions.
Under the conditions of the study, none of the test strains showed an increased mutation rate at any test concentration. The respective positive controls were valid. The test material was therefore not considered to be mutagenic in this test system.
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