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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study with GLP
Cross-referenceopen allclose all
Reason / purpose:
reference to same study
Reason / purpose:
reference to other study

Data source

Referenceopen allclose all

Reference Type:
review article or handbook
Title:
Unnamed
Year:
2000
Reference Type:
other company data
Title:
Unnamed
Year:
1997
Reference Type:
other: monograph provided by ECHA
Title:
Endpoint record: Genetic toxicity in vitro
Author:
ECHA
Year:
2010
Bibliographic source:
Document from ECHA

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Qualifier:
according to
Guideline:
OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
Qualifier:
according to
Guideline:
other: Method B14 of directive 92/96/EEC
Principles of method if other than guideline:
OECD TG 472 Genetic Toxicology: Escherichia coli,
Reverse Assay was merged with TG 471
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
75 - 95% (typical 88%, verified by UV/visible spectrum, Infrared (IR) spectrum, Nuclear Magnetic Resonance (NMR), and Mass spectrum.)

Method

Target gene:
point mutations
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
Metabolic activation system:
10% Sprague Dawley male rat liver S9 fraction (Aroclor 1254-induced) in standard cofactors
Test concentrations with justification for top dose:
0, 50, 150, 500, 1500, 5000 µg/plate
Vehicle / solvent:
acetone
Controlsopen allclose all
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
acetone
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
TA98 + S9: 0.5 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
acetone
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
Remarks:
TA98 – S9: 0.2 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
acetone
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
TA100 + S9: 1 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
acetone
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
Remarks:
TA100 – S9: 3 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
acetone
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
TA1535 +S9: 2 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
acetone
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
Remarks:
TA1535 – S9: 5 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
acetone
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
TA1537 + S9 2 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
acetone
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
9-aminoacridine
Remarks:
TA1537 – S9: 80 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
acetone
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 2-aminoanthracene
Remarks:
CM891 + S9: 10 µg/plate
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
Remarks:
acetone
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
N-ethyl-N-nitro-N-nitrosoguanidine
Remarks:
CM891 – S9: 2 µg/plate
Details on test system and experimental conditions:
Each experiment, in the presence and absence of S9, was repeated once and all concentrations were tested in triplicate.
Evaluation criteria:
no data
Statistics:
no data

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:
cytotoxicity
Remarks:
>5000μg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Species / strain:
E. coli WP2 uvr A
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
>5000μg/plate
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
Cytotoxicity effects were observed in preliminary test and main test, but only above 5000μg/plate.
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Each experiment, in the presence and absence of S9, was repeated once and all concentrations were tested in triplicate.

Precipitation was observed at and above 500 µg/plate but did not interfere with scoring of revertant colonies.

Under the conditions of the study, the test chemical caused no substantial increases in revertant colony numbers over control counts at any concentration in either the presence or absence of the rat liver microsomal enzymes.

All positive and negative controls responded appropriately.

The BDP was considered to be non-mutagenic under the conditions of the assay.

Applicant's summary and conclusion

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

The test chemical was considered to be non-mutagenic under the conditions of the assay.
Executive summary:

This study was well conducted and negative effects were observed with and without S9 indicated that the test material did not cause point mutation in bacterial reverse mutation test.