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EC number: 202-908-4 | CAS number: 101-02-0
Toxicological information
Genetic toxicity: in vitro
Currently viewing:
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Triphenyl phosphite
- EC Number:
- 202-908-4
- EC Name:
- Triphenyl phosphite
- Cas Number:
- 101-02-0
- Molecular formula:
- C18H15O3P
- IUPAC Name:
- triphenyl phosphite
- Reference substance name:
- Triphenyl phosphate
- EC Number:
- 204-112-2
- EC Name:
- Triphenyl phosphate
- Cas Number:
- 115-86-6
- Molecular formula:
- C18-H15-O4-P
- IUPAC Name:
- triphenyl phosphate
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- NAME OF TEST MATERIAL: Triphenyl Phosphite
- Purity: 99.48%
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: UPL Limited, Jhagadia, India. Batch No. CO05TPI078
- Expiration date of the lot/batch: February 2018
- Purity: 99.48%
- Purity test date: March 29, 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Under ambient conditions in original container
- Solubility and stability of the test substance in the solvent/vehicle: soluble in dimethyl sulfoxide at concentration of 50 µL/mL
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: Precipitation was not observed at the tested concentrations
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Arochlor 1254-induced rat liver S9 fraction
- Test concentrations with justification for top dose:
- 6 concentrations (three plates/concentration) between 0.15625 and 5 µL/plate both in the absence and presence (10 % v/v S9 mix) of metabolic activation.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility
Controls
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): approximately 1 - 2 x 10E9 bacteria/mL
DURATION
- Exposure duration: 48-hr incubation
SELECTION AGENT (mutation assays): histidine - Rationale for test conditions:
- Test guideline
- Evaluation criteria:
- Tester strain integrity, characteristic number of spontaneous revertants, tester strain density, positive control values with and without metabolic activation, cytoxicity, responses observed
- Statistics:
- Simple linear regression analysis was performed to assess the dose dependent nature of any increase in revertant colonies.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In a reliable OECD Guideline 471 GLP study, TPP was not mutagenic to any of 5 strains of S. typhimurium when tested in the absence and presence of an exogenous metabolic activation system (rat liver S9) at concentrations up the recommended maximum test concentration of 5 µL/plate.
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