chloride, carbonate and bicarbonate salts of ammonium and sodium

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Acceptable, well documented study according to OECD guideline and GLP principles.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes

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

Details on test material:

Hoechst AG, Hoe 0922978, purity: 99.1%, Kept at 4 degree C until use

Method

Target gene:

TA 100, TA 1535, TA 1537, TA 1538, TA 98 of Salmonella typhimurium and Escherichia coll WP2uvrA

Species / strain

Species / strain / cell type:

other: Salmonella tryphimurium TA98,TA100,TA1535,TA1537,TA1538, Escherichia coli WP2uvrA

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

0, 4, 20, 100, 500, 2500, 5000 micro gram/plate

Vehicle / solvent:

see below

Controls

Remarks:

see below

Details on test system and experimental conditions:

Top agar is prepared for the Salmonella strains by mixing 100 ml agar (0.6 % agar, 0.5 % NaCl) with 10 ml of a 0.5 mM histidine-biotin solution. With
E. coli histidine is replaced by tryptophan (2.5 ml, 0.5 mM). The following ingredients are added (in order) to 2 ml of molten top agar at 45° C:
0.1 ml of an overnight nutrient broth culture of the bacterial tester strain 0.1 ml test compound solution 0.5 ml S-9 Mix (if required) or buffer
After mixing, the liquid is poured into a petridish with minimal agar (1.5 % agar, Vogel-Bonner E medium with 2 % glucose). After incubation for 48 to 72 hours at 37° C in the dark, colonies (his"1" revertants) are counted.

Positive controls
Positive control plates were included for each strain. The following substances were used as positive controls.
a) without metabolic activation:
Na-azide: TA 100, TA 1535;
9-Aminoacridine: TA 1537
2-Nitrofluorene: TA 98, TA 1538
N-Methyl-N'-nitro-N-nitrosoguanidine (MNNG): WP2uvrA
b) with metabolic activation:
BenzoTalpyrene: TA 98, TA 100, TA 1535, TA 1537, TA 1538, WP2uvrA
2-Aminoanthracene: TA 98, TA 100, TA 1535, TA 1537, TA 1538, WP2uvrA

Evaluation criteria:

no data

Statistics:

no data

Results and discussion

Test results

Species / strain:

other: see below

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

other: Toxicity was not observed up to 5000 micro gram/plate in six strains with or without S9 mix

Additional information on results:

-Sterility checks and control plates Sterility of S9 mix and the test compound was indicated by the absence of contamination on the  test material and S9 mix sterility check plates. 
Control plates (background control and positive controls) gave the expected number of colonies.

The test compound was tested at doses of 4 to 10 000 ug/plate and proved to be not toxic to the bacteria. For mutagem'city testing 5 000 ug/plate was chosen as the highest dose in the second experiment.

Remarks on result:

other: other: Salmonella tryphimurium TA98,TA100,TA1535,TA1537,TA1538, Escherichia coli WP2uvrA

Remarks:

Migrated from field 'Test system'.

Any other information on results incl. tables

none

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

The test compound did not cause a significant increase in the number of revertant colonies with any of the tester strains either in the absence or presence of S-9 mix. No dose dependent effect was obtained.
It is concluded that the test substance is not mutagenic in these bacterial test systems either in the absence or in the presence of an exogenous metabolizing system.
This test was performed according to the methods described. No unforeseen circumstances were observed which have affected the quality and integrity of this study.