Registration Dossier

Toxicological information

Genetic toxicity: in vitro

Currently viewing:

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:
other: The study was performed according to OECD guideline study with GLP compliance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1999

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Principles of method if other than guideline:
OECD TG 471 & 472' Genetic Toxicology (Salmonella typhimurium and Escherichia coli)
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
solid
Specific details on test material used for the study:
purity: 98%

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Test concentrations with justification for top dose:
-S9: 0, 156, 313, 625, 1250, 2500, 5000 µg/plate;
+S9: 0, 156, 313, 625, 1250, 2500, 5000 µg/plate
Controlsopen allclose all
Positive controls:
yes
Remarks:
-S9 mix
Positive control substance:
other: 2-(2-furyl)-3-(5-nitro-2-furyl)acrylamide
Remarks:
TA100, TA98, WP2
Positive controls:
yes
Remarks:
-S9 mix
Positive control substance:
sodium azide
Remarks:
TA1535
Positive controls:
yes
Remarks:
-S9 mix
Positive control substance:
other: 9-aminoacridine hydrochloride
Remarks:
TA1537
Positive controls:
yes
Remarks:
+S9 mix
Positive control substance:
other: 2-aminoanthracene
Remarks:
all strains
Details on test system and experimental conditions:
Ames test, metabolic activation system: S9 from rat liver,induced with phenobarbital and 5,6-benzoflavone

Results and discussion

Test resultsopen allclose all
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:
other: Toxicity was not observed up to 5000 µg/plate in five strains with or without S9mix.
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
other: Toxicity was not observed up to 5000 µg/plate in five strains with or without S9mix.

Any other information on results incl. tables

GENOTOXIC EFFECTS: 
-with metabolic activation:
Salmonella typhimurium TA100, TA1535, TA98, TA537; negative
Escherichia coli WP2 uvrA; negative
-without metabolic activation:
Salmonella typhimurium TA100,TA1535,TA98,TA537; negative
Escherichia coli WP2 uvrA; negative
PRECIPITATION CONCENTRATION:
At the dose level more than 2500 µg/plate, visible precipitation was shown at the end of exposure period.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation

The presented study is reliable and adequte for the chemical safety assessment of Benzoguanamine.
Executive summary:

In a reverse gene mutation assay in bacteria, Salmonella typhimurium (TA100, TA98,TA1535, TA1537) and E. coli (WP2uvrA)  were exposed to this substance included DMSO at concentrations of 0, 156, 313, 625, 1250, 2500, 5000 µg/plate in the presence and absence of mammalian metabolic activation

 

This substance was tested up to limit concentration 5000µg/plate.  The positive controls did not induce the appropriate responses.  There was no evidence of induced mutant colonies over background.

 

This study satisfies the requirement for Test Guideline  OECD 471and 472 for in vitromutagenicity (bacterial reverse gene mutation) data.