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Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference Type:
Primary mutagenicity screening of food additives currently used in Japan
M. Ishidate, Jr, T. Sofuni, K. Yoshikawa, M. Hayashi, T. Nohmi, M. Sawada, A. Matsuoka
Bibliographic source:
Food and Chemicals Toxicology, 22, 1984, 623-636

Materials and methods

Test guideline
no guideline followed
Principles of method if other than guideline:
Reverse mutation assays using S. typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 were carried out according to the method of Ames, McCann & Yamasaki (1975).
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Ammonium chloride
EC Number:
EC Name:
Ammonium chloride
Cas Number:
Molecular formula:
ammonium chloride
Test material form:
Specific details on test material used for the study:
Purity: 99.7 %. Samples were supplied from the Japan Food Additives Association, Tokyo, at the request of the Ministry of Health and Welfare of Japan, where the purity and quality of each sample were checked.


Target gene:
Species / strain
Species / strain / cell type:
S. typhimurium, other: TA92, TA94, TA98, TA100, TA1535, TA1537
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix prepared from the liver of Fischer rats pretreated with polychlorinated biphenyls
Test concentrations with justification for top dose:
six different concentrations, maximum dose: 10 mg/plate
Vehicle / solvent:
phosphate buffer
Untreated negative controls:
Negative solvent / vehicle controls:
True negative controls:
Positive controls:
Details on test system and experimental conditions:
Cells cultured overnight were pre-incubated with both the test sample and the S-9 mix for 20 min at 37°C before plating. Duplicate plates were used for each of six different concentrations of the sample. The number of revertant (his +) colonies was scored after incubation at 37°C for 2 days.
Evaluation criteria:
The scoring 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 results
Species / strain:
S. typhimurium, other: TA92, TA94, TA98, TA100, TA1535, TA1537
Metabolic activation:
with and without
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
Untreated negative controls validity:
not specified
Positive controls validity:
not specified

Applicant's summary and conclusion

Ammonium chloride was not mutagenic in an Ames test with and without metabolic activation.
Executive summary:

In this publication by Ishidate Jr et al. (published in 1984) the mutagenicity of broad variety of substances used as food additives is evaluated. A bacterial reverse mutation assay is used to investigate the mutagenicity of ammonium chloride. Six test strains were used in the experiments and each was conducted with and without metabolic activation. The results of all tests were negative.