Carbazamidine monohydrochloride

Genetic toxicity: in vitro

Administrative data

Endpoint:

in vitro gene mutation study in bacteria

Type of information:

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

Adequacy of study:

key study

Study period:

2000

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

The read across justification is detailed in section 13.

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

2000

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:

Similar Substance 01

IUPAC Name:

Similar Substance 01

Method

Species / strain

Species / strain / cell type:

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

Metabolic activation:

with and without

Metabolic activation system:

S9-mix from livers of 7 week old male Sprague-Dawleey rats, enzyme induction by intraperitoneal injection of sodium phenobarbital and 5,6-benzoflavone prior to sacrifice

Test concentrations with justification for top dose:

first trial: 0 (DMSO), 1.22, 4.88, 19.5, 78.1, 313, 1250, 5000 µg/plate
second trial: 0 (DMSO), 313, 625, 1250, 2500, 5000 µg/plate

Vehicle / solvent:

DMSO

Controls

Untreated negative controls:

yes

Negative solvent / vehicle controls:

yes

True negative controls:

not specified

Positive controls:

yes

Positive control substance:

2-acetylaminofluorene

9-aminoacridine

sodium azide

other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide

Details on test system and experimental conditions:

preincubation methodology

Evaluation criteria:

Chemicals were consitered to be mutagenic when a dose related increase in revertant colony count was observed and the number of revertant colonies per plate with the test substance was nore than twice that of the negative control and when a reproducibility of the test result was observed.

Results and discussion

Test results

Species / strain:

other: Salmonella Typhimurium TA98, TA100, TA1535, TA1537, e. coli WP2uvrA/pKM101

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

not determined

Vehicle controls validity:

valid

Untreated negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Conclusions:

The substance does not show a mutagenic activity and it is thus negative under test conditions

Executive summary:

The substance was tested in the Ames test according to the OECD TG 471 and GLP using Salmonella typhimurium TA98, TA100, TA1535, TA1537, E. coli WP2uvrA/pKM101 in the presence and absence of S9-mix and preincubation methodology. The concentrations used ranged from 0 (solvent control) up to 5000 µg/plate according to the requirement of the guideline.

It did not show mutagenic activity in any of the strains used. The positive controls were valid.