Registration Dossier
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EC number: 609-080-7 | CAS number: 35160-38-4
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid: compact
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Remarks:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- For both experiments the following concentrations were used:
31.6, 100, 316, 1000, 2500 and 5000 µg/plate.
based on solubility and cytotoxicity tests - Vehicle / solvent:
- Distilled water
Controls
- Untreated negative controls:
- yes
- Remarks:
- distilled water
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation; experiment I) and preincubation (experiment II)
DURATION
- Preincubation period: 60 min
- Exposure duration: 48 h
SELECTION AGENT (mutation assays): his
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Rationale for test conditions:
- according to guideline
- Evaluation criteria:
- Validity:
A test ist considered acceptable if for each strain:
- the bacteria demonstrate their typical responses to ampicillin (TA 98, TA 100)
- the control plates with and without S9 mix are within the historical control ranges
- the positive controls show a distinct enhacement of revertant tates over the control plate
Evaluation of Mutagenicity:
A test item is mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with or without metabolic activation - Statistics:
- not mandatory
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No precipitation of the test item was observed in any tester strain used in experiment I and II (with and without metabolic activation).
Applicant's summary and conclusion
- Conclusions:
- During the described mutagenicity test and the experimental conditions reported, the source substance diethylphosphinic acid, did not cause gene mutations by base pair changes or frameshifts in the genome of the tester strains used. Therefore the substance is considered to be non-mutagenic in this bacterial reverse mutation assay.
- Executive summary:
The source substance, diethyl phosphinic acid, was investigated for its potential to induce gene mutations according to the plate incorporation test and the pre-incubation test using Salmonella th. TA 98, TA 100, TA 1535, TA 1537 and tester strain E. coli WP2 uvrA.
In two independent experiments several concentrations of the test item were used. Each assay was conducted with and without metabolic activation. The concentrations, including the controls were tested in triplicate. The following concentrations were prepared and used in the experiments: 31.6, 100, 316, 1000, 2500 and 5000 µg/plate.
No preciptitation of the test item was observed in any tester strain used in exp. I and II (with and without metabolic activation).
No toxic effects of the test item were noted in any of the five tester strains up to the highest dose with and without metabolic activation.
No biologically relevant increases in revertant colony numbers of any of the five tester strains were observed folling the treatment at any concentration level, neither in the presence nor absence of the metabolic activation in experiment I and II.
The reference mutagens induced a distinct increase of revertant colonies indicating the validity of the experiments.
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