Reaction mass of calcium carbonate and calcium dihydroxide and calcium peroxide

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Remarks:

Type of genotoxicity: gene mutation

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was carried out in accordance with the principles layed down for the standard S. typhimurium plate-incorporation assay with metabolic activation by the S9 mix.

Data source

Reference

Reference Type:

publication

Title:

Bacterial mutagenicity testing of 49 food ingredients gives very few positive results

Author:

Prival MJ, Simmon VF, Mortelmans KE

Year:

1991

Bibliographic source:

Mutation Research 260, 321-329

Materials and methods

Principles of method if other than guideline:

Method: other: slightly modified from Ames, B.N. et al.: Mutation Research 31, 347-361 (1975)

GLP compliance:

not specified

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Hydrogen peroxide

EC Number:

231-765-0

EC Name:

Hydrogen peroxide

Cas Number:

7722-84-1

Molecular formula:

H2O2

IUPAC Name:

hydrogen peroxide

Details on test material:

3% hydrogen peroxide solution obtained from Mallinckrodt, St. Louis, USA

Method

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 TA 1538

Additional strain / cell type characteristics:

not specified

Species / strain 3

Species / strain / cell type:

E. coli WP2

Additional strain / cell type characteristics:

other: tryptophan-requiring

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

Without S9 mix: 0.0033 to 0.67 mg per plate in S. typhimurium strains TA1535, TA1538 and TA98; from 0.001 to 0.33 mg per plate in strains TA1537 nd TA100; from 0.033 to 3.3 mg per plate in E. coli strain WP2
With S9 mix: 0.01 to 3.3 mg per plate in all five S. typhimurium strains and from 0.01 to 30 mg per plate in E. coli strain WP2

Vehicle / solvent:

Hydrogen peroxide was dissolved in 0.067 M potassium or sodium phosphate buffer, pH 7

Controls

Untreated negative controls:

not specified

Negative solvent / vehicle controls:

not specified

True negative controls:

no

Positive controls:

yes

Positive control substance:

other: Without S9 mix: 2-nitrofluoren (TA98, TA1538), sodium azide (TA100, TA1535), 9-aminoacridine (TA1537), furylfuramide or N-methyl-N'-nitro-N-nitrosoguadinine (E. coli); With S9 mix: 2-Anthramine (all tested strains)

Details on test system and experimental conditions:

The S9 mix contained 10 % Aroclor 1254-induced S9 from male Sprague-Dawley rats. All platings were performed in duplicate and all tests were repeated. An additional test was performed with the test substance to see if the substance supported the growth of histidine-requiring strains of S. typhimurium in the absence of added histidine. In addition to the tested strains of S. typhimurium also strain SL4024 was used in this test.

Evaluation criteria:

Test results were considered valid only if the positive control compounds induced increases in mutant counts to at least twice background.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

positive

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

not specified

Untreated negative controls validity:

not specified

Positive controls validity:

valid

Remarks on result:

other: strain/cell type:

Remarks:

Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
positive in S. typhimurium TA100
negative in all other strains tested

Hydrogen peroxide was found to be mutagenic in an in-vitro Ames test performed with S. typhimurium TA100, whereas it was negative in Ames tests carried out with other S. typhimurium strains and with E. coli WP2 strain.

Executive summary:

The mutagenicity of hydrogen peroxide was tested in the Ames test with S. typhimurium strains TA98, 100, 1535, 1537 and 1538 and E. coli WP2 strain. The test substance was found to increase the number of revertant colonies of S. typhimurium TA100 significantly, both in the absence and the presence of S9 metabolic activation. The test was negative in all other strains tested in the study. It was concluded that hydrogen peroxide exhibits mutagenicity to S. typhimurium TA100 in the Ames test.