Carbendazim

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

A large number of assays with Salmonella typhi. and E.coli were performed to investigate the potential of carbendazim to induce gene mutations in bacterial cells.
Several investigation comparing different batches and prepartions with variable amounts of impurities were performed.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2009

Report date:

2009

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Test guideline 3

Qualifier:

according to guideline

Guideline:

OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)

Principles of method if other than guideline:

Batìcterial reverse mutation assays on S.thyphimurium and E.coli.

GLP compliance:

no

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

Carbendazim

EC Number:

234-232-0

EC Name:

Carbendazim

Cas Number:

10605-21-7

Molecular formula:

C9H9N3O2

IUPAC Name:

carbendazim

Method

Species / strain

Species / strain 1

Species / strain / cell type:

S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2

Species / strain 2

Species / strain / cell type:

S. typhimurium TA 97

Species / strain 3

Species / strain / cell type:

S. typhimurium TA 1538

Metabolic activation:

with and without

Metabolic activation system:

S9 mix

Test concentrations with justification for top dose:

10 - 50000 ug/plate

Results and discussion

Test results

Test results 1

Species / strain:

S. typhimurium TA 98

Metabolic activation:

with

Genotoxicity:

positive

Remarks:

at 100, 500, 2500, 5000 and 10000 ug/plate

Cytotoxicity / choice of top concentrations:

not specified

Test results 2

Species / strain:

S. typhimurium TA 1535

Metabolic activation:

without

Genotoxicity:

positive

Remarks:

at 5000 ug/plate

Cytotoxicity / choice of top concentrations:

not specified

Test results 3

Species / strain:

S. typhimurium TA 1538

Metabolic activation:

with

Genotoxicity:

positive

Remarks:

at 100, 15000 ug/plate

Cytotoxicity / choice of top concentrations:

not specified

Additional information on results:

The use of highly purified carbendazim samples gave consistently negative results using the standard plate incorporation procedure with and without metabolic activation.
In a number of studies, positive findings were obtained with some carbendazim batches at high concentrations (1-50 mg/plate), mainly Salmonella thyphi. tester strains.
Investigation comparing different batches and prepartions with variable amounts of impurities indicate that the positive mutagenic effects could be traced to mutagenic impurities.

Applicant's summary and conclusion

Conclusions:

In a number of studies, positive findings were obtained with some carbendazim batches at high concentrations (1-50 mg/plate), mainly Salmonella thyphi. tester strains.
Investigation comparing different batches and prepartions with variable amounts of impurities indicate that the positive mutagenic effects could be traced to mutagenic impurities.
The studies were evaluated and reviewed by Oesch 1982 (TOX95-51438) and show similar variable (negative and positive) mutagenicity results comparing different carbendazim samples.