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EC number: 269-119-5 | CAS number: 68187-67-7
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- 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
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 25.11.1999 to 06.12.1999
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not effect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Qualifier:
- according to guideline
- Guideline:
- other: Japan Ministry of Agriculture, Forestry and Fisheries (1985) Notifcation of Director General, Agricultural Production Bureau. NohSan No. 4200
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- other: Joint Directives of J EPA, J MHW and J MITI (31 October 1997) Kanpoan No.287, Eisei No. 127 and Kikyoku No. 2 (31 October 1997)
- Deviations:
- not specified
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Amines, C12-14-alkyl, isooctyl phosphates
- EC Number:
- 269-119-5
- EC Name:
- Amines, C12-14-alkyl, isooctyl phosphates
- Cas Number:
- 68187-67-7
- Molecular formula:
- C19H42NPO4 - C29H63NPO4
- IUPAC Name:
- Amines, C12-14-tert-alkyl, isooctyl mono phosphates
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- Histidine for Salmonella. Tryptophan for E.coli
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 pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver, S9
- Test concentrations with justification for top dose:
- Test 1: 0, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
Test 2: :0, 5, 15, 50, 150, and 500 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: The solubility of the test item was assessed at 50mg/l in acetone, in which it was dissloved.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-(2-furyl)-3-(5-nitro-2-furyl) acrylamide
- Remarks:
- Without S9. : Sodium Azide 5μg/plate for TA1535 and TA100. 9-Aminoacridine 30μg/plate for TA1537. 2-Nitrofluorene 1μg/plate for TA98. 2-(2-furyl)-3-(5-nitro-2-furyl) acrylamide 0.05μg/plate for WP2uvrA/pKM101
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- other: 2-Aminoanthracene
- Remarks:
- with S9: 2-Aminoanthracene 2μg/plate for TA1535 and 10μg/plate for WP2uvrA/pKM101. Benzopyrene 5μg/plate for TA1537, TA98 and TA100
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) for Experiment 1 and pre-incubation for Experiment 2.
DURATION
- Preincubation period for bacterial strains: 10h
- Exposure duration: 72 hrs
NUMBER OF REPLICATIONS: Triplicate plating.
DETERMINATION OF CYTOTOXICITY
- Method: plates were assessed for numbers of revertant colonies and examined for effects on the growth of the bacterial background lawn. - Evaluation criteria:
- Evaluation Criteria:
The mutagenic activity was assessed by applying the following criteria:
1. If treatment with the test item produces an increase in revertant colony numbers of at least twice the concurrent control, with some evidence of a positive dose relationship, in two experiments, with any bacterial strain either in the presence or absence of S9 mix, the test item will be considered to show evidence of mutagenic activity in this test system..
2.If treatment with the test item does not produce reproducible increases of at least 1.5 times the concurrent control in either mutation test, the test item will be considered to show no evidence of mutagenic activity in this test system.
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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- The absence of colonies on sterility check plates confirmed the absence of microbial contamination.
The total colony counts on nutrient agar plates confirmed the viability and high cell density of the cultures of the individual organisms.
The mean revertant colony counts for the solvent controls were within 99% confidence limits of the current historical control range for the laboratory. Appropriate positive controls induced substantial increases in revertant colony numbers with all strains confirming the activity of the S9-mix and the sensitivity of the bacterial strains.
First Test (Range finding) - There were no substantial increases in revertant colony numbers over control counts in any of the tester strains following exposure to the test substance at any concentration in either the presence or absence of S9 mix.
Toxicity observed as a thinning of the background lawn of non revertant cells and reduced revertant colony counts, ocurred in all strains following exposure to the the test substance at concentrations of 500µg/plate and above.
A top concentration of 500µg/plate was therefore selected for use in the second test.
Second Test - There were no substantial increases in revertant colony numbers over control counts in any of the tester strains following exposure to the test substance at any concentration in either the presence or absence of S9 mix.
Toxicity observed as a thinning of the background lawn of non revertant cells and reduced revertant colony counts, ocurred in all strains following exposure to the the test substance at concentrations of 500µg/plate and above.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
The test item was considered to be non-mutagenic under the conditions of this test. - Executive summary:
Introduction
The test method was designed to be compatible with the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including MITI, MHW and MAFF, the OECD Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test", EEC Annex to Directive 92/69/EEC Part B Method For Determination OfToxicity B13 and B14 and the USA, EPA (TSCA) OPPTS harmonized guidelines.
Methods
Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA/pKM101 were treated with the test item using both the Ames plate incorporation and pre-incubation methods at up to seven dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system. The dose range for the first test (range-finding) ranged between 5 and 5000µg/plate. The second test used a pre-incubation method and a dose range 5 to 500µg/plate.
Results
The vehicle (acetone) control plates gave counts of revertant colonies within the normal range. All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
The test item caused a visible reduction in the growth of the bacterial background lawns and/or a substantial reduction in the frequency of revertant colonies in the absence and presenc of S9-mix at concentrations of 500µg/plate and above.
No significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test item, either with or without metabolic activation or exposure method.
Conclusion
The test item was considered to be non-mutagenic under the conditions of this test.
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