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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: No OECD guideline or GLP defined.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1985

Materials and methods

Principles of method if other than guideline:
other: Ames Test (Ames et al. 1973a, 1975)
GLP compliance:
not specified
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Tributyl phosphate
EC Number:
204-800-2
EC Name:
Tributyl phosphate
Cas Number:
126-73-8
Molecular formula:
C12H27O4P
IUPAC Name:
tributyl phosphate
Details on test material:
Purity: 99,8 %

Method

Target gene:
ames assay: detection of base pair substitutions and frameshift mutations
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:
S9 mix
Test concentrations with justification for top dose:
see: Any other information on materials and methods
Controls
Untreated negative controls:
yes
Negative solvent / vehicle controls:
yes
True negative controls:
not specified
Positive controls:
yes
Positive control substance:
other: see: any other information on materials and methods incl. tables
Details on test system and experimental conditions:
Ames test

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:
other: Doses up to and including 120 µg per plate did not cause any bacteriotoxic effects
Vehicle controls validity:
valid
Untreated negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
other: other: S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Remarks:
Migrated from field 'Test system'.

Any other information on results incl. tables

Genotoxicity: negative

Applicant's summary and conclusion

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

The test substance Tri-n-butylphosphate was investigated in the Salmonella/microsome test for point-mutagenic effects in doses up to 12500 µg per plate on four Salmonella typhimurium LT2 mutants. These were the histidine-auxotropic strains TA 1535, TA 100; TA 1537 and TA 98.

Doses up to and including 120 µg per plate did not cause any bacteriotoxic effects. The total bacteria counts remained unchanged. No inhibition of growth was observed. In doses above this the substance had a strong bacteriotoxic effect specific to strain, so that this range can only be used to a limited extent up to 500 µg per plate for evaluation purposes.

Evidence of mutagenic activity for the test substance was not found. Neither a dose-related doubling of the mutant count nor a biologically relevant increase in the same, in comparison with the negative controls, was observed.

The positive controls sodiumazide, nitrofurantoine, 4 -nitro-o-phenylenediamine and 2 -aminoanthracene had a marked mutagenic effect, as can be seen from the biologically relevant increase of mutant colonies, compared with the corresponding negative control.

The test substance was found to be negative for genotoxicity.

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