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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Genetic toxicity: in vitro

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Administrative data

Endpoint:
in vitro gene mutation study in bacteria
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017-02-10 - 2017-05-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report date:
2017

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 471 (Bacterial Reverse Mutation Assay)
Version / remarks:
EC Guideline No. 440/2008. Part B: Methods for the Determination of Toxicity and
other health effects, Guideline B.13/14: "Mutagenicity: Reverse Mutation Test using
Bacteria”. Official Journal of the European Union No. L142, 31 May 2008
Deviations:
yes
Remarks:
Due to a calculation error not the correct composition of the S9-mix was prepared; this deviation in the composition of the S9-mix had no effect on the results of the study.
GLP compliance:
yes
Type of assay:
bacterial reverse mutation assay

Test material

Constituent 1
Chemical structure
Reference substance name:
Tributylphosphine
EC Number:
213-651-2
EC Name:
Tributylphosphine
Cas Number:
998-40-3
Molecular formula:
C12H27P
IUPAC Name:
tributylphosphane
Test material form:
not specified

Method

Species / strainopen allclose all
Species / strain / cell type:
S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
Species / strain / cell type:
E. coli WP2 uvr A
Metabolic activation:
with and without
Metabolic activation system:
Rat liver microsomal enzymes (S9 homogenate)
Test concentrations with justification for top dose:
Dose-range finding test: Eight concentrations, 1.7, 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate were tested in triplicate
Since the test item was cytotoxic in the dose range finding test/first mutation experiment, an additional dose range finding test was performed with the tester strains TA100 and WP2uvrA, both with and without S9-mix according to the pre-incubation method. Seven concentrations, 1.7, 5.4, 17, 52, 164, 512 and 1600 μg/plate and 5.4, 17, 52, 164, 512, 1600 and 5000 μg/plate were tested in triplicate in the tester strains TA100 and WP2uvrA, respectively.

Direct Plate Assay: Based on the results of the dose-range finding test, the following dose-range was selected for the mutation assay with the tester strains, TA1535, TA1537 and TA98 in the absence and presence of S9-mix: 5.4, 17, 52, 164, 512 and 1600 μg/plate.

Pre-Incubation Assay: Absence of S9-mix: 0.17, 0.54, 1.7, 5.4, 17 and 52 μg/plate; Presence of S9-mix: 1.7, 5.4, 17, 52, 164 and 512 μg/plate.
Vehicle / solvent:
- solvent used: Acetone
Controlsopen allclose all
Negative solvent / vehicle controls:
yes
Positive controls:
yes

Results and discussion

Test results
Species / strain:
other: All strains
Metabolic activation:
with and without
Genotoxicity:
negative
Cytotoxicity / choice of top concentrations:
cytotoxicity
Vehicle controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Conclusions:
Based on the results of this study it is concluded that Tri-n-butyl phosphine is not mutagenic in the Salmonella typhimurium reverse mutation assay and in the Escherichia coli reverse mutation assay.
Executive summary:

In this study, acceptable responses were obtained for the negative and strain-specific positive control items indicating that the test conditions were adequate and that the metabolic activation system functioned properly. The test item did not induce a significant dose-related increase in the number of revertant (His+) colonies in each of the four tester strains (TA1535, TA1537, TA98 and TA100) and in the number of revertant (Trp+) colonies in tester strain WP2uvrA both in the absence and presence of S9-metabolic activation. These results were confirmed in a follow-up experiment.