Ammonium sulphite

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:

no data available

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Essential details given; well-documented publication, although no positive control substance was stated/used.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

Primary mutagenicity screening of food additives used in japan

Author:

Ishidate, M.; et al.

Year:

1983

Bibliographic source:

Food Chem. Toxicol. 8, 623-636

Reference 2

Reference Type:

publication

Title:

Methods for detecting carcinogens and mutagens with the Salmonella/mammalian-microsome mutagenicity test.

Author:

Ames, B.N.; et al.

Year:

1975

Bibliographic source:

Mutation Research 31, 347-364

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Reverse mutation assays using Salmonella typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 were carried out according to the method of Ames, McCann & Yamasaki (1975).

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Disodium disulphite

EC Number:

231-673-0

EC Name:

Disodium disulphite

Cas Number:

7681-57-4

IUPAC Name:

disodium disulphite

Constituent 2

Reference substance name:

Sodium metabisulfite

IUPAC Name:

Sodium metabisulfite

Constituent 3

Reference substance name:

Disodium disulfite

IUPAC Name:

Disodium disulfite

Details on test material:

- Name of test material (as cited in study report): Sodium disulphite, anhydrous
- Substance type: pure active substance
- Physical state: solid
- Analytical purity: 95 %
No further details are given.

Method

Target gene:

not applicable

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

Additional strain / cell type characteristics:

not specified

Species / strain 2

Species / strain / cell type:

S. typhimurium, other: TA 92 and TA 94

Additional strain / cell type characteristics:

not specified

Metabolic activation:

with and without

Metabolic activation system:

S9-mix

Test concentrations with justification for top dose:

six test concentrations, up to 50 mg/plate

Vehicle / solvent:

- Vehicle(s)/solvent(s) used: phosphate buffer
- Justification for choice of solvent/vehicle: no data

Controls

Untreated negative controls:

no

Negative solvent / vehicle controls:

yes

Remarks:

phosphate buffer

True negative controls:

no

Positive controls:

not specified

Positive control substance:

not specified

Details on test system and experimental conditions:

METHOD OF APPLICATION: in agar (preincubation)

DURATION
- Preincubation period:20 minutes at 37°C
- Exposure duration: 48 hours at 37°C

NUMBER OF REPLICATIONS: Duplicate plates were used for each of the 6 different concentrations of the test item.

EVALUATION: The number of revertant (his+) colonies was scored.

DETERMINATION OF CYTOTOXICITY
- Method: no data

Evaluation criteria:

The result was considered positive if the number of colonies found was twice the number in the control (vehicle control).

Statistics:

Statististical analysis is not mandatory for this test.

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 1535, TA 1537, TA 98 and TA 100

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

Test results 2

Species / strain:

S. typhimurium, other: TA 92 and TA 94

Metabolic activation:

with and without

Genotoxicity:

negative

Remarks:

No significant increases in the numbers of revertant colonies were detected in any S. typhimurium strains at the highest dose tested.

Cytotoxicity / choice of top concentrations:

not specified

Vehicle controls validity:

valid

Untreated negative controls validity:

not specified

Positive controls validity:

not specified

Additional information on results:

No further details are reported.

Remarks on result:

other: all strains/cell types tested

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

Sodium bisulfite was negative in the Ames test, no significant increases in the number of revertant colonies were detected in any S. typhimurium strains at the maximum dose.

Executive summary:

Reverse mutation assays using Salmonella typhimurium strains TA92, TA1535, TA100, TA1537, TA94 and TA98 were carried out according to the method of Ames, McCann & Yamasaki (1975). The cells were preincubated with 6 different concentrations up to 50 mg/plate for 20 minutes before plating. Plates in duplicate were incubated for 2 days at 37°C, and then the number of revertant colonies were counted. The result was considered positive if the number of colonies found was twice the number in the vehicle control (phosphate buffer).

Sodium disulfite was negative in the Ames test, no significant increases in the number of revertant colonies were detected in any S. typhimurium strains at the maximum dose.