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EC number: 272-296-1 | CAS number: 68797-35-3
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:
- 16/01/2002-18/01/2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- no
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- α-d-Glucopyranosiduronic acid, (3β,20β)-20-carboxy-11-oxo-30-norolean-12-en-3-yl 2-O-β-d-glucopyranuronosyl-, dipotassium salt
- EC Number:
- 272-296-1
- EC Name:
- α-d-Glucopyranosiduronic acid, (3β,20β)-20-carboxy-11-oxo-30-norolean-12-en-3-yl 2-O-β-d-glucopyranuronosyl-, dipotassium salt
- Cas Number:
- 68797-35-3
- Molecular formula:
- C42H62O16.2K
- IUPAC Name:
- α-d-Glucopyranosiduronic acid, (3β,20β)-20-carboxy-11-oxo-30-norolean-12-en-3-yl 2-O-β-d-glucopyranuronosyl-, dipotassium salt
Constituent 1
- Specific details on test material used for the study:
- Preparation : By mixing 300 mg of the test substance with 6 mL of distilled water, the highest concentration (5000 µg / 0.1 µL / plate) was prepared. This solution was serially diluted to half its concentration to prepare the others concentrations.
Method
- Target gene:
- Not specified
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:
- S9mix (from Sprague dawley rats + 9 mL of distilled water contaiing S9 cofactors)
- Test concentrations with justification for top dose:
- 312.5 ; 625 ; 1250 ; 2500 ; 5000 µg/0.1 µL/plate
- Vehicle / solvent:
- distilled water
Controls
- Untreated negative controls:
- yes
- Remarks:
- Distilled water
- Negative solvent / vehicle controls:
- not specified
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 2-(2-furyk)-3-(5-nitro-2furyl) acrylamide (AF2) and 2-aminoanthracène (2-AA)
- Details on test system and experimental conditions:
- Culture media :
- Nutrient broth
Nutrient broth No.2 was dissolved in distilled water to prepare a 2.5% culture medium and 20mL of the medium added in each Erlenmeyer flask was sterilized for 15 min. at 121°C.
- Minimum glucose agar medium
TESMEDIA AN (Wako Pure Chemical Industries) was used. Each plate was marked by writing an ID number on the top of the rid.
- Top agar
For four Salmonella typhimurium strains, 10-part of 0.6 % agar containing 0.5 % Na i, 1-part of 0.5 mM D-biotin and. 1-part of 0.5 mM L-histidine were mixed.
For Escherichia coli; 10-part of agar and 1-part of 0.5mM L-tryptophan were mixed - Evaluation criteria:
- Assessment
Positive reaction (+) : The number of revertant colonied per plate was more than twice that for the negative control group and this increased number of revertant colonies was reproducible and dose-dependent.
Negative reaction (—) : Other reactions
Growth inhibition : The background lawn for the test substance group was clearly rougher or clearer compared to that of the negative control group. - Statistics:
- Not specified
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Not specified
Applicant's summary and conclusion
- Executive summary:
Based on these findings, it was concluded that under the conditions established for the present study, DIPOTASSIUM GLYCYRRHIZINATE was judged as non-mutagen.
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