Registration Dossier

Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Remarks:
Type of genotoxicity: gene mutation
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Test within the National Toxicology Program’s mutagenicity testing program and according to GLP.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Deviations:
yes
Remarks:
(Only 4 strains were tested)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Specific details on test material used for the study:
Source: Fluka Chemical
Purity: 90%

Method

Species / strain
Species / strain / cell type:
other: TA 98, TA 100, TA 1535 and TA 97
Metabolic activation:
with and without
Metabolic activation system:
S-9 mix (fractions of Aroclor 1254-induced, male Sprague-Dawley rat and male Syrian hamster livers)
Test concentrations with justification for top dose:
33, 100, 333, 666, and 1000, 2000 µg/plate
Vehicle / solvent:
- Vehicle(s)/solvent(s) used: Distilled water
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Remarks:
(Distilled water)
Positive controls:
yes
Remarks:
(Without metabolic activation)
Positive control substance:
sodium azide
Remarks:
(For strains TA 1535 and TA 100)
Positive controls:
yes
Remarks:
(Without metabolic activation)
Positive control substance:
9-aminoacridine
Remarks:
(For strain TA 97)
Positive controls:
yes
Remarks:
(Without metabolic activation)
Positive control substance:
other: 4-nitro-o-phenylenediamine
Remarks:
(For strain TA 98)
Positive controls:
yes
Remarks:
(With metabolic activation)
Positive control substance:
other: 2-aminoanthracene
Remarks:
(For all strains)
Details on test system and experimental conditions:
The test chemical (0.05 mL), overnight culture of Salmonella (0.05 mL), and S-9 mix or buffer (0.5 mL), were incubated at 37 ºC, without shaking, for 20 min.
The top agar was added and the contents of the tubes were mixed and poured onto the surface of petri dishes containing Vogel-Bonner medium.

Histidine-independent colonies arising on these plates were counted following two days incubation at 37 ºC.

Number of replications: 3 plates/dose
Evaluation criteria:
Test substance was judged mutagenic or weakly mutagenic if it produced a reproducible, dose-related response over the solvent control, under a single metabolic activation condition, in replicate trials.
Test substance was judged questionable if the results of individual trials were not reproducible, if increases in his+ revertants did not meet the criteria for a weakly mutagenic response, or if only single doses produced increases in his+ revertants in repeat trials.
Test substance was judge nonmutagenic if it did not meet the criteria for a mutagenic or questionable response.

Results and discussion

Test results
Key result
Species / strain:
other: TA 98, TA 100, TA 1535, and TA 97
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Remarks:
(at 2000 µg/plate)
Vehicle controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: all strains/cell types tested
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

The test item did not show any mutagenic effect under test conditions, with and without metabolic activation.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative
The test item did not show any mutagenic effect under test conditions, with and without metabolic activation.
Executive summary:

A standard Ames test was carried out with the btest item using Salmonella typhimurium strains TA 98, TA 100, TA 1535, and TA 97. The test was performed with and without matabolic activation. The concentrations were 33, 100, 333, 666, 1000 and 2000 µg/plate.

The substance did not show any mutagenic effect under test conditions.