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EC number: 222-394-5 | CAS number: 3458-72-8
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- PRIMARY MUTAGENICITY SCREENING OF FOOD ADDITIVES CURRENTLY USED IN JAPAN
- Author:
- M. ISHIDATE, JR, T. SOFUNI, K. YOSHIKAWA, M. HAYASHI, T. NOHMI,
M. SAWADA and A. MATSUOKA - Year:
- 1 984
- Bibliographic source:
- Fd Chem. Toxic. Vol. 22, No. 8, pp. 623-636, 1984
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar 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:
- Ammonium chloride
- EC Number:
- 235-186-4
- EC Name:
- Ammonium chloride
- Cas Number:
- 12125-02-9
- Molecular formula:
- ClH4N
- Test material form:
- not specified
Constituent 1
Method
- Target gene:
- his locus
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 98, TA 100, TA 1535, TA 1537
- Metabolic activation:
- with
- Metabolic activation system:
- The liver microsome fraction (S-9) was prepared from the liver of Fischer rats (Charles River Japan Co.) pretreated 5 days before with polychlorinated biphenyls (500 mg/kg body weight of Kanechlor KC-400 in olive oil, ip).
- Test concentrations with justification for top dose:
- Six different concentrations were used, the highest dose for citric acid was 5000 µg/plate and for Ammonium sulfate 10000 µg/plate. Only the highest dose was reported because up to this dose no cytotoxicity occured and no significant increase of revertants was observed.
- Vehicle / solvent:
- phosphate buffer
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: duplicate
- Evaluation criteria:
- The result was considered positive if the number of colonies found was twice the number in the control (exposed to the appropriate solvent or untreated).
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537
- Remarks:
- test item: citric acid
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
- Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537
- Remarks:
- test item:ammonium chloride
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- not specified
- Untreated negative controls validity:
- not specified
- True negative controls validity:
- not specified
- Positive controls validity:
- not specified
Applicant's summary and conclusion
- Conclusions:
- According to the publication of Yamanaka et al., 1990, ammonium chloride and citric acid was negative when test in abacterial reverse mutation assay in S. typhimurium strains TA98, TA100, TA1535, TA1537 up to the top-concentration of 10000 µg/plate and 5000 µg/plate, respectively. Thus, according to Regulation (EC) No 1272/2008 (CLP) and the Globally Harmonized System for Classification and Labelling of Chemicals (GHS) both substances do not need to be classified as mutagenic.
- Executive summary:
In a reverse gene mutation assay in bacteria according to OECD guideline 471 (adopted 21 July 1997), Salmonella typhimurium strains TA98, TA100, TA1535, TA1537 were exposed to Ammonium sulfate in concentrations of up to 10000 µg/plate in all strains in the presence of mammalian metabolic activation (rat liver S9 mix). No cytotoxic effects were noted in all strains in the presence of metabolic activation.
No biologically relevant increases were observed in the number of revertant colonies in any of the five tester strains following treatment with Ammonium sulfate at any concentration levels in the presence of S9 Mix in the performed experiments. Based on the results obtained under the experimental conditions applied, the test item did not induce gene mutations.
In conclusion, the test item Ammonium sulfate has no mutagenic activity in the bacterial tester strains under the test conditions used in this study.
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