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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:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to a guideline study with acceptable restrictions. Four strains were tested instead of 5.

Data source

Reference
Reference Type:
publication
Title:
No information
Author:
Zeiger E. et al.
Year:
1987
Bibliographic source:
Environ. Mutagen. 9, Suppl. 9, 1-110

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
not specified
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Purity of the test material was 93.7%.

Method

Species / strain
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Additional strain / cell type characteristics:
not specified
Metabolic activation:
with and without
Metabolic activation system:
S-9 from Aroclor 1254-induced rat or hamster liver
Test concentrations with justification for top dose:
100, 333, 1000,
3333 or 5000 micrograms/ml
Vehicle / solvent:
ethanol
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Remarks:
The positive controls in the absence of S-9 were sodium azide (TA1535 and TA100), 9-aminoacridine (TA97 and TA1537), and 4-nitro-o-phenylenediamine (TA98). The positive control in the presence of S-9 was 2-aminoanthracene for all strains.
Positive control substance:
other: The positive controls in the absence of S-9 were sodium azide (TA1535 and TA100), 9-aminoacridine (TA97 and TA1537), and 4-nitro-o-phenylenediamine (TA98). The positive control in the presence of S-9 was 2-aminoanthracene for all strains.
Details on test system and experimental conditions:
Test material was dissolved in 95% ethanol and incubated with S. typhimurium strains TA98, TA100, TA1535 and TA1537 at 100, 333, 1000,
3333 or 5000 micrograms/ml with or without S-9 from Aroclor 1254-induced rat or hamster liver (10%) for 20 min at 37 degrees C without shaking. Top agar was added and the contents of the tubes were mixed and poured onto the surfaces of petri dishes that contained Vogel-Bonner medium. The colonies present after 2 days of incubation at 37 degrees were handcounted if there was a precipitate; otherwise automatic colony counters were used. Tests were performed in triplicate.
Evaluation criteria:
A chemical was judged to be a mutagen if a dose-related increase over the solvent control was observed and weakly mutagenic if a low-level dose
response was seen in duplicate tests. A test was considered questionable if the number of mutants at a single dose was elevated or if an increase that was not dose-related was seen.
Statistics:
no data

Results and discussion

Test results
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 specified
Vehicle controls validity:
valid
Untreated negative controls validity:
not specified
Positive controls validity:
valid
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

None of the concentrations tested caused an increase in the number of mutants in the absence or presence of 10% rat or hamster liver S-9. All positive controls induced at least a 2-fold increase in the number of mutants with respect to the vehicle control.