Sodium dicyanoamide

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

Study period:

07 September 1995 - 17 October 1995

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP compliant study conducted in accordance with international guidelines.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1995

Report date:

1995

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)

Deviations:

no

Principles of method if other than guideline:

Not applicable.

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Sodium dicyanamide

IUPAC Name:

Sodium dicyanamide

Constituent 2

Reference substance name:

Sodium dicyanoamide

EC Number:

217-703-5

EC Name:

Sodium dicyanoamide

Cas Number:

1934-75-4

Molecular formula:

C2HN3.Na

IUPAC Name:

sodium dicyanoazanide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Name: P0051
Batch no.: 229
Storage: room temperature
Purity: 99.3%
Description: white powder

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

Details on mammalian cell type (if applicable):

not applicable.

Additional strain / cell type characteristics:

not applicable

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 1538

Details on mammalian cell type (if applicable):

not applicable

Additional strain / cell type characteristics:

not applicable

Metabolic activation:

with and without

Metabolic activation system:

Rat Arochlor 1254 induced microsomal fraction (S9-mix)

Test concentrations with justification for top dose:

0 ug/plate, 50 ug/plate, 150 ug/plate, 500 ug/plate, 1500 ug/plate and 5000 ug/plate

Controls

Untreated negative controls:

no

Remarks:

Concurrent solvent control only

Negative solvent / vehicle controls:

yes

True negative controls:

no

Remarks:

Concurrent solvent control only

Positive controls:

yes

Positive control substance:

4-nitroquinoline-N-oxide

9-aminoacridine

N-ethyl-N-nitro-N-nitrosoguanidine

other: 4-Nitro-o-phenylenediamine (4NOPD), 2-Aminoanthracene (2AA)

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:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Test results 2

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity nor precipitates, but tested up to recommended limit concentrations

Vehicle controls validity:

valid

Untreated negative controls validity:

not examined

Positive controls validity:

valid

Any other information on results incl. tables

Vehicle Control Groups:

The vehicle (sterile distilled water) control plates produced counts of revertant colonies within the normal range.

Positive Control Groups:

All of the positive control chemicals used in the test produced marked increases in the frequency of revertant colonies, both with and without the metabolising system.

The test material caused no visible reduction in the growth of the bacterial lawn at any of the dose levels in any of the strains of Salmonella tested. The test material was, therefore, tested up to the maximum recommended dose of 5000 ug/plate.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative

No significant increase in the frequency of revertant colonies was recorded for any of the bacterial strains with any dose of the test material, either with or without metabolic activation. The test material was found to be non-mutagenic under the conditions of this test.

Executive summary:

A study according to OECD Guideline 471 (Bacterial Reverse Mutation Assay) was carried in year 1995. Tested up to 5000 ug/plate without and with metabolic activation the test substance induced no statistically significant dose-related increase in the numbers of revertant (His+) colonies in each of the five tester strains (TA 1535; TA 1537; TA 1538; TA 98 and TA 100). The positive control values were generally within the range expected for each bacterial strain and activation system. There was no toxicity to the bacteria in any of the experiments performed. It was concluded that the test item was not mutagenic to Salmonella typhimurium when tested up to the predetermined maximum limit of 5000 µg per plate.