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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:
from 01 October 1986 to 13 November 1986
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study design states it complies and it follows OECD guideline 471. Contains sufficient detail to suggest GLP-like characteristics even though no statement of certification is reported (reasonably thorough description of authors, dates, design, results, and interpretation).

Data source

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

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
the data have not been statistically analysed
Qualifier:
according to
Guideline:
other: Literatures ( see Principles of method)
Deviations:
not specified
Principles of method if other than guideline:
1. AMES, B.N., F.D. LEE and W.E. DURSTON (1973), An Improved Bacterial Pest System for the Detection and Classification of Mutagens and Carcinogens. Proc. Natl. Acad. Sci. USA 70, 782786.
2. AMES, B.N., W.E. DURSTON, E. YAMASAKI and F.D. LEE (1973) ,Car cinogens are Mutagens: A Simple Test System Combining Liver Homogenates for Activation and Bacteria for Detection. Proc. Natl. Acad. Sci. USA 70, 22812285.
3. AMES, B.N., J. McCANN, and E: YAMASAKI (1975), Methods for Detecting Carcinogens and Mutagens with the Salmonella/Mammalian Microsome Mutagenicity Test. Mutation Res. 31, 347364.
GLP compliance:
no
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Batch No. lot. 210200
Purity: 98.2%

Method

Target gene:
bacteria
Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
other: histidine-auxotrophic mutants
Metabolic activation:
with and without
Metabolic activation system:
S9 fraction of liver from rats induced with Aroclor 1254
Test concentrations with justification for top dose:
the test were performed with the following concentrations of the trial substance with and without microsomal activation: 20, 78, 313, 1250 and 5000 µg/0.1 ml.
Vehicle / solvent:
Dimethylsulfoxide (DMSO)
Controlsopen allclose all
Untreated negative controls:
yes
Remarks:
DMSO alone has been used as negative controls
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
4-nitroquinoline-N-oxide
Remarks:
for the strain TA 100

Migrated to IUCLID6: 0.125 and 0.25 µg/0.1 ml phosphate buffer
Untreated negative controls:
yes
Remarks:
DMSO alone has been used as negative controls
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: daunorubicin-HCl, 5 and 10 µg/0.1 ml phosphate buffer
Remarks:
for the strain TA 98
Untreated negative controls:
yes
Remarks:
DMSO alone has been used as negative controls
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
sodium azide
Remarks:
for the strain 1535

Migrated to IUCLID6: 2.5 and 5 µg/0.1 ml bidistilled water
Untreated negative controls:
yes
Remarks:
DMSO alone has been used as negative controls
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: 9(5)-aminoacridine hydrochloride monohydrate, 50 and 100 µg/0.1 ml DMSO
Remarks:
for strains TA 98, TA 100 and TA 1537
Untreated negative controls:
yes
Remarks:
DMSO alone has been used as negative controls
Negative solvent / vehicle controls:
yes
Remarks:
DMSO
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
cyclophosphamide
Remarks:
for the strain TA 1535

Migrated to IUCLID6: 250 µg/0.1 ml bidistilled water
Details on test system and experimental conditions:
In the experiments without and with the addition of microsomal activation mixture three Petri dishes are prepared per strain and per group (i.e. per concentration or per control group).
The plates are incubated for about 48 hours at 37 ± 1.5°C in darkness.
Evaluation criteria:
Assay acceptance criteria:
A test is considered acceptable if the mean colony counts of the control values of all strains are within the acceptable ranges indicated in table 9 and if the results of the positive controls meet the criteria for a positive response.
In either case the final decision has to be based on scientific judgement.
Statistics:
Criteria for a positive response
The test substance is considered to be positive in this test system if one or both of the following conditions are met:
a reproducible doubling of the mean number of revertants per plate above that of the negative control at any concentration level for one or more of the following strains: TA 98, TA 1535 and TA 1537,
a reproducible increase of the mean number of revertants per plate for any concentration above that of the negative control by a factor of l.5 for strain TA 100.
Generally a concentration-related effect should be demonstrable.

Results and discussion

Test results
Species / strain:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Metabolic activation:
without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
not specified
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Additional information on results:
In the toxicity tests treatment of the bacteria with the highest concentration (5000 µg/0.l ml) of Atrazine tech. did not lead to a growth-inhibiting effect. This concentration was therefore selected as the highest in the mutagenicity tests.
In the experiments performed without and with microsomal activation, treatment with Atrazine tech. did not lead to an increase in the incidence of histidine-prototrophic mutants in comparison with the negative control.
Owing to a growth-inhibiting effect of the test substance in the experiments without and with microsomal activation, the number of back-mutants was reduced at the highest concentration.
Remarks on result:
other:
Remarks:
Migrated from field 'Test system'.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative