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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: the chemical was tested within the National toxicology program (NTP)

Data source

Reference
Reference Type:
publication
Title:
Salmonella Mutagenicity tests: III. Results from the testing of 255 chemicals
Author:
Zeiger E, Anderson B, Haworth S, Lawlor T, Mortelmans K, Speck W
Year:
1987
Bibliographic source:
Environ Mol Mutagen 9, Suppl 9: 1-110

Materials and methods

Principles of method if other than guideline:
The preincubation method was used. The test chemical, Salmonella culture, and S-9 mix or buffer were incubated at 37°C, 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. The histidine-revertant (his+) colonies arising on these plates were counted following 2 days incubation at 37°C. The plates were hand-counted when a precipitate was present; otherwise automatie colony counters were used.
All chemicals were tested initially in a toxicity assay to determine the appropriate dose range. Toxic concentrations were those at which a decrease in the number of his+ colonies was seen or at which there was a clearing in the density of the background lawn. At least five doses of the chemical were tested in triplicate. Each chemical was tested initially at half-log doses up to a dose that elicited toxicity; subsequent trials occasionally used narrower dose increments. Chemicals that were not toxic were tested to a maximum dose of 10 mg/plate. Chemicals that were poorly soluble were tested up to a dose defined by their solubility.
Concurrent solvent and positive controls were run with each trial. The positive controls in the absence of metabolie activation were sodium azide (TA1535 and TA100), 9-aminoacridine (TA97 and TAI537), and 4-nitro-o-phenylenediamine (TA98). The positive control for metabolic activation was 2-aminoanthracene for all strains.
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
purity: 98%

Method

Target gene:
no data
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 mix
Test concentrations with justification for top dose:
0, 100, 333, 1000, 3333, 10000 µg/plate
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: sodium azide, 9-aminoacridine, 4-nitro-o-phenylenediamine, mitomycon C, sodium azide, 9-aminoacridine, 4-nitro-o-phenylenediamine, 2-aminoanthracene

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:
no cytotoxicity
Vehicle controls validity:
valid
Untreated negative 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

Ames test was negative (-) at SRI

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information):
negative
Executive summary:

An Ames test was conducted using a preincubation protocol in the absence of exogenous metabolic activation, and in the presence of liver S-9.

Result: triethyl phosphate was negative in the test with and without metabolic activation.