Ammonium iron bis(sulphate)

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:

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, A. Matsuoka

Year:

1984

Bibliographic source:

Food and Chemicals Toxicology, 22, 1984, 623-636

Materials and methods

Test guideline

Qualifier:

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

Test material information

Constituent 1

Reference substance name:

Ammonium chloride

EC Number:

235-186-4

EC Name:

Ammonium chloride

Cas Number:

12125-02-9

Molecular formula:

ClH4N

IUPAC Name:

ammonium chloride

Test material form:

solid

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.

Method

Target gene:

his

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

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

no

Positive controls:

no

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

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Applicant's summary and conclusion

Conclusions:

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.