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Toxicological information

Genetic toxicity: in vitro

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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
Study period:
September 1984 - October 1984
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Study was performed according to following guidelines: OECD 471 and in compliance with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
GLP compliance:
yes (incl. certificate)
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 5601-10-1
- Physical state: clear liquid
- Analytical purity: responsibility of the Sponsor
- Lot/batch No.: J-214
- Stability under test conditions: no apparent change in the physical state of the test or control articles during the assay
- Storage condition of test material: at ambient temperature in the container received from the Sponsor

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Details on mammalian cell type (if applicable):
not applicable
Species / strain / cell type:
S. typhimurium TA 1538
Details on mammalian cell type (if applicable):
not applicable
Metabolic activation:
with and without
Metabolic activation system:
S-9 fraction of rat liver homogenate obtained from Arcolor 1254-treated Sprague Dawley rats
Test concentrations with justification for top dose:
50, 166, 500, 1666 and 5000 µg/plate
Vehicle / solvent:
-solvent(s) used: distilled/deionized water
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Remarks:
with and without metabolic activation
True negative controls:
no
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
TA1535 and TA100= 10µg/plate

Migrated to IUCLID6: without metabolic activation
Positive controls:
yes
Positive control substance:
2-nitrofluorene
Remarks:
TA1538 and TA98= 5 µg/plate

Migrated to IUCLID6: without metabolic activation
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
TA1537=150 µg/plate

Migrated to IUCLID6: without metabolic activation
Positive controls:
yes
Positive control substance:
other: 2-anthramine
Remarks:
in all strains=5 µg/plate, with metabolic activation
Details on test system and experimental conditions:
METHOD OF APPLICATION: in agar (plate incorporation);


DURATION
- Preincubation period: 48h
- Exposure duration: 48-72h


SELECTION AGENT (mutation assays): histidine and biotin


NUMBER OF REPLICATIONS:
negative, positive controls and compound-treated plates: in triplicate



DETERMINATION OF CYTOTOXICITY
- Method: growth inhibition is tested at following concentrations: 50, 166, 500, 1666 and 5000 µg/plate with strains TA1538 and TA100 ( in duplicate)

Evaluation criteria:
revertant colonies are counted (Artek Counter)
- positive result is defined as a reproducible, dose-related increase in the number of histidine-independent colonies
- negative result is defined as the absence of a reproducible increase in the number of histidine-independent colonies

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:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Species / strain:
S. typhimurium TA 1538
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not determined
Vehicle controls validity:
valid
Untreated negative controls validity:
not examined
Positive controls validity:
valid
Additional information on results:
RANGE-FINDING/SCREENING STUDIES: sreening showed no cytoxicity at any of the doses


COMPARISON WITH HISTORICAL CONTROL DATA: all solvent and positive controls were within acceptable limits of mean historical data

Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

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

The results for test article, 5601-40-1, Lot #J-214, were negative in strains TA1535, TA1537, TA1538, TA98 and TA100 of Salmonella typhimurium both with and without metabolic activation preparation at doses of 50, 166, 500, 1666 and 5000 µg/plate.
Executive summary:

According to guideline OECD 471 different strains of S.typhimurium were investigated in context of gene mutation for 2 -dimethylaminoethanol. The experiment was a bacterial reverse mutation assay (Ames test) and was performed with certificated good laboratory praxis (GLP). S-9 fractions of rat liver homonate were used as metabolic activation system. Destilled / deionized water was used as vehicle, whereby it was incoorparated in agar. The test concentrations were 50, 166, 500, and 5000 µg/plate. S.typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 showed negative results for genotoxicity and the performed screening showed no cytoxicity at any of the dosis.