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EC number: 222-079-2 | CAS number: 3338-24-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
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- Endpoint summary
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Toxicological Summary
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- Additional toxicological data

Genetic toxicity: in vitro
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
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Sodium O,O-diisobutyl dithiophosphate
- EC Number:
- 258-508-5
- EC Name:
- Sodium O,O-diisobutyl dithiophosphate
- Cas Number:
- 53378-51-1
- Molecular formula:
- C8H18NaO2PS2
- IUPAC Name:
- Sodium O,O-diisobutyl phosphorodithioate
- Test material form:
- other: aqueous solution
- Details on test material:
- - Substance type: Liquid
- Physical state: Light brown liquid
- Molecular formula (if other than submission substance): C8H18NaO2PS2
- Molecular weight (if other than submission substance): 264
- Smiles notation (if other than submission substance): CC(C)COP(=S)([S-])OCC(C)C.[Na+]
- InChl (if other than submission substance): InChI=1/C8H19O2PS2.Na/c1-7(2)5-9-11(12,13)10-6-8(3)4;/h7-8H,5-6H2,1-4H3,(H,12,13);/q;+1/p-1
- Stability under test conditions: Stable
- Storage condition of test material: ambient
Constituent 1
Method
- Target gene:
- Strain Designation Histidine Gene Locus Affected Additional Mutations Type of Mutation Detected
Repair LPS Plasmids
TA 98#1 his D 3052 uvr B- rfa- pKM 101 Frameshift
TA 100#1 his G 46 uvr B- rfa- pKM 101 Base-pair substitution
TA 102#1 his G 428 wild-type rfa- pKM 101 / pAQ1 Base-pair substitution
TA 1535#2 his G 46 uvr B- rfa- none Base-pair substitution
TA 1537#2 his C 3076 uvr B- rfa- none Frameshift
rfa-: partial loss of lipopolysaccharide (LPS) barrier that causes increased permeability to macromolecules
uvr B-: loss of DNA excision repair system
pKM 101: R-factor plasmid, thought to cause an increased error-prone DNA repair
pAQ1: plasmid, carrier of tetracycline resistance
#1 resistance to Ampicillin
#2 non-resistance to Ampicillin
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:
- a microsomal preparation derived from Aroclor 1254-induced rat liver.
- Test concentrations with justification for top dose:
- 31.6, 100, 316, 1000, 3160 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: aqua ad iniectabilia ( Batch no. 123618002; B. Braun Melsungen AG, 34212 Melsungen, Germany)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- aqua ad iniectabilia
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- in aqua ad iniectabilia (10 µg/plate) : TA 1535, TA 100
- Untreated negative controls:
- yes
- Remarks:
- aqua ad iniectabilia
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- in DMSO (10 µg/plate) : TA 98
- Untreated negative controls:
- yes
- Remarks:
- aqua ad iniectabilia
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- in ethanol, abs. (100 µg/plate) : TA 1537
- Untreated negative controls:
- yes
- Remarks:
- aqua ad iniectabilia
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- in DMSO (10 µg/plate) : TA 102
- Untreated negative controls:
- yes
- Remarks:
- aqua ad iniectabilia
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- in DMSO (10 µg/plate) : TA 98, TA 102, TA 1537
- Untreated negative controls:
- yes
- Remarks:
- aqua ad iniectabilia
- Positive controls:
- yes
- Positive control substance:
- other: 2-amino-anthracene
- Remarks:
- in DMSO (2 µg/plate) : TA 100, TA 1535
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 20 minutes at 37°C
- Exposure duration: 48-72 hours at 37°C - Evaluation criteria:
- A test item is considered to show a positive response if
- the number of revertants is significantly increased (p ≤ 0.05, U-test according to MANN and WHITNEY, see COLQUHOUN, D.: Lectures on Biostatistics, Clarendon Press, Oxford (1971)) compared with the solvent control to at least 2-fold of the solvent control for TA 98, TA 100 and TA 102 and 3-fold of the solvent control for TA 1535 and TA 1537 in both independent experiments;
- in addition, a significant (p ≤ 0.05) concentration (log value)-related effect (Spearman’s rank correlation coefficient, see COLQUHOUN, D.: Lectures on Biostatistics, Clarendon Press, Oxford (1971)) is observed;
- positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking random samples on histidine-free agar plates.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- 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
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results:
negative with metabolic activation
negative without metabolic activation
Under the present test conditions the substance, IBP1-Na, tested up to a concentration of 5000 µg i-Butyl-dtp-Na/plate, caused no mutagenic effect in the Salmonella typhimurium strains TA 98, TA 100, TA 102, TA 1535 and TA 1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
Remark: the test solution contains NaOH due to the production method.
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