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:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report Date:
1986

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Version / remarks:
84/449/EWG, B.13, B.14 (Standard Platten-Test und Preincubations-Test)
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:
Reactive Read 239

Method

Species / strain
Species / strain / cell type:
bacteria, other: TA1535, TA1537, TA1538, TA98, TA100, E.coli WP2uvrA
Metabolic activation:
with and without
Metabolic activation system:
S9-Mix from Rats and Hamster liver
Test concentrations with justification for top dose:
Concentration range in the first test (with and without metabolic activation): 4, 20, 100, 500, 2500 and 5000 µg/plate
Concentration range in the second test (with and without metabolic activation): 4, 20, 100, 500, 2500 and 5000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: none
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

Results and discussion

Test results
Species / strain:
bacteria, other: TA1535, TA1537, TA1538, TA98, TA100, E.coli WP2uvrA
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
no cytotoxicity
Remarks:
up to 10'000 ug/plate
Vehicle controls validity:
not applicable
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'. Remarks: First experiment

Applicant's summary and conclusion

Conclusions:
negative with metabolic activation
negative without metabolic activation

negative
Executive summary:

Reaktiv-Rot F-52 167 was tested for mutagenicity with the strains TA100, TA1535, TA1537, TA1538, TA98 of salmonella typhimurium and Escherichia coli WP2uvrA.

The mutagenicity studies were conducted in the absence and in the presence of a metabolizing system derived from rat liver homogenate. A dose range of 6 different dosees from 4 µg/plate to 5000 µg/plate was used.

Control plates without mutagen showed that the number of spontaneous revertant colonies was similar to that described in the literature. All the positiv control compounds gave the expected increase in the number of revertant colonies.

Toxicity: the test compound proved to be not toxic o f the bacterial strains. On the basis of the preliminary test results the top dose level did no exceed 5000 µg/plate.

Mutagenicity: In the absence of the metabolic activation system the test compound did not show a dose dependent increase in the number of revertants in any of the bacterial strains. Also in the presence of a metabolic activation system, treatment of the cells with Reaktiv-Rot F-52 167 did no result in relevant increases in the number of revertant colonies.

Sumarizing, it can be stated that Reaktiv-Rot F-52 167 is not mutagenic in these bacterial test systems niether with or without exogenous metabolic activation at the dose levels investigated.