Registration Dossier

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:
1994-01-06 and 1994-04-06
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The test was conducted by means of Read Across approach. The reliability of the source study report is 1. Further information was attached at section 13

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1994
Report Date:
1994

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
1983
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
Version / remarks:
1992
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
Version / remarks:
1987
Deviations:
no
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Metabolic activation system:
post mitochondrial supernatant (S9 fraction) induced by Aroclor 1254
Test concentrations with justification for top dose:
61.73, 185.19, 555.56, 1666.67, 5000.00 µg/plate
Vehicle / solvent:
distilled water
Controls
Untreated negative controls:
no
Negative solvent / vehicle controls:
yes
Remarks:
DMSO and bidistilled water
True negative controls:
no
Positive controls:
yes
Positive control substance:
other: with S9: 2-aminoanthracene (TA 100, TA 102, TA 98, TA 1537), cyclophosphamide (TA 1535); without S9: sodium azide (TA 100, TA 1535), mitomycin-C (TA 102), 2-nitrofluorene ( TA 98), 9-aminoacridine (TA 1537)
Remarks:
with metabolic activation:
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation)

DURATION
- Exposure duration: 48 hours

DETERMINATION OF CYTOTOXICITY
- Method: counting the colonies
The test was run 2 times to confirm the results.

Evaluation criteria:
At least a reproducible meaningful increase of the mean number of revertants per plate above that of the negative control at any concentration for one or more of the strains tested. A concentration-related effect should be demonstrable.
Statistics:
not required

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
RANGE-FINDING/SCREENING STUDIES: strain TA 100 (six concentrations ranging from 20.6 to 5000.0 µg/plate), with and without metabolic activation, normal background growth was observed, the numbers of revertant colonies were reduced at the upper concentrations

COMPARISON WITH HISTORICAL CONTROL DATA: yes

ADDITIONAL INFORMATION ON CYTOTOXICITY: The numbers of revertant colonies were reduced at the upper concentrations. The test substance thus exerted a slight inhibitory effect on the growth of the bacteria.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Not mutagenic
Executive summary:

The substances has been tested for its mutagenic effects according to the procedure described in the OECD guideline 471.

Under test condition the substance didn't show mutagenic effects.