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EC number: 241-503-7 | CAS number: 17496-08-1
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ammonium propionate
- EC Number:
- 241-503-7
- EC Name:
- Ammonium propionate
- Cas Number:
- 17496-08-1
- Molecular formula:
- C3H6O2.H3N
- IUPAC Name:
- ammonium propionate
- Test material form:
- liquid
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- other: Defective lipopolysaccharide barrier on the cell wall (rfa).
- Metabolic activation:
- with and without
- Metabolic activation system:
- The cofactor supplemented post-mitochondrial fraction (S9) was employed as the metabolic activation system
- Test concentrations with justification for top dose:
- Eight concentrations of test item, formulated in analytical grade water, corresponding to proposed test doses viz. 5000, 4000, 3000, 2000, 1000, 500, 250 and 125 μg/plate of the test item, were tested for visible precipitation.
During the test, no precipitation was observed at concentration of 5000 μg/plate to125 μg/plate. Hence, 5000 μg/plate with no precipitation was selected as the highest test dose for the preliminary cytotoxicity test.
Results of preliminary cytotoxicity test, evaluated from appearance of the bacterial background lawn and frequencies of histidine revertant colonies, there was no cytotoxicity observed for bacterial background lawn and histidine revertant colonies at the concentrations from 5000 and 125 μg/plate, both in presence and absence of metabolic activation system.
Therefore, 5000 g/plate was selected as the highest test dose for the definitive study, both in presence and absence of metabolic activation system. - Vehicle / solvent:
- Analytical grade water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-acetylaminofluorene
- 4-nitroquinoline-N-oxide
- sodium azide
- methylmethanesulfonate
- other: ICR191, 2-Aminoanthracene, 2-Aminofluorene, Danthron
- Details on test system and experimental conditions:
- MEDIUM
The bacterial strains were cultured in Oxoid Nutrient Broth No. 2. Minimal glucose agar contained agar, Vogel-Bonner minimal medium E and 2% glucose. The top agar contained 0.6% agar, 0.5% NaCl and 0.05 mM solution of L-histidine with D-biotin (Maron and Ames, 1983).
METABOLIC ACTIVATION
The cofactor supplemented post-mitochondrial fraction (S9) was employed as the metabolic activation system.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 97
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
Applicant's summary and conclusion
- Conclusions:
- Salmonella typhimurium, Reverse Mutation Assay of Ammonium propionate (CAS: 17496-08-1) in aqueous solution (50-55%) was carried out in accordance with the Organisation for Economic Co-operation and Development (OECD) Guidelines for Testing of Chemicals (Guideline No. 471, Section 4: Health Effects) on conduct “Bacterial Reverse Mutation Test” adopted by the council on 21st July 1997.
Under the conditions described for this study, it is concluded that Ammonium propionate (CAS: 17496-08-1) in aqueous solution (50-55%) in non-mutagenic in Salmonella typhimurium, Reverse Mutation Assay (AMES Test)
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