1-o-tolylbiguanide

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:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 471 (Bacterial Reverse Mutation Assay)

GLP compliance:

yes (incl. QA statement)

Type of assay:

bacterial reverse mutation assay

Test material

Test material information

Constituent 1

Reference substance name:

1-o-tolylbiguanide

EC Number:

202-268-6

EC Name:

1-o-tolylbiguanide

Cas Number:

93-69-6

Molecular formula:

C9H13N5

IUPAC Name:

1-o-tolylbiguanide

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

- Name: Casamid 710
- Chemical name: 1-o-tolylbiguanide
- Batch no: PT9999/108873/8336
- Appearance: white powder
- Homogeneity: not stated
- Purity: 97.81%
- Stability Solubility: not fat soluble
- Production date: not stated
- Expiry date: 22.08.2013
- Storage: room temp (20 ± 5°C), keep sontainers tightyl closed in a dry, cool nd well-ventilated place

The item was stored in a closed vessel at room temperature

Method

Species / strain

Species / strain / cell type:

S. typhimurium TA 100

Metabolic activation:

with and without

Controls

Positive controls:

yes

Remarks:

The following mutagenic substances were used as positive controls: 6.2.1 4-Nitro1,2-phenylene diamine 4-Nitro-1,2-phenylene diamine, C6H7N3〇2; CAS-No.: 99-56-9

Details on test system and experimental conditions:

General Preparation: Per strain and dose, four plates with and four plates without S9 mix were used. The test item solutions were prepared and membrane filtered in order to accomplish sterility.
Top agar basis was melted in a microwave oven, after melting 10 mL of histidine-biotin-solution 0.5mMol per 100 mL basis was added and the bottle was placed in the water bath at 43°C.

Plate incorporation method: the following materials were slightly vortexed in a test tube and poured onto the selective agar plates:
• 100 µL test suspension at each dose level, solvent (negative control) or reference mutagen solution (positive control)
• 500 µL S9 mix or phosphate buffer
• 100 µL bacteria suspension
• 2200 µL overlay agar
The plates were closed and left to harden for a few minutes, then inverted and placed in the dark incubator at 37°C.

Pre incubation method: The following materials were gently vortexed in a test tube and incubated at 37°C for 20 minutes:
• 100 µL test suspension at each dose level, solvent (negative control) or reference mutagen solution (positive control)
• 500 µL S9 mix or phosphate buffer
• 100 µL bacteria suspension
After pre-incubation 2000µL overlay agar (top agar) was added, the tube was gently vortexed and the mixture was poured onto the selective agar plate.

Results and discussion

Test results

Species / strain:

S. typhimurium TA 100

Metabolic activation:

with and without

Genotoxicity:

negative

Cytotoxicity / choice of top concentrations:

no cytotoxicity

Any other information on results incl. tables

The test item Casamid 710 is considered as "not mutagenic under the conditions of the test".

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information):
negative with metabolic activation

The test item Casamid 710 is considered as "not mutagenic under the conditions of the test".