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EC number: 268-776-5 | CAS number: 68140-14-7
- 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:
- 18 March 2015 to 13 April 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Tall oil, reaction products with diethylenetriamine
- EC Number:
- 268-776-5
- EC Name:
- Tall oil, reaction products with diethylenetriamine
- Cas Number:
- 68140-14-7
- Molecular formula:
- UVCB substance - not applicable
- IUPAC Name:
- Tall Oil, reaction products with diethylenetriamine
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: the test material (tall oil reaction products with diethylenetriamine) was provided by Baker Hughes Ltd., no batch number was available
- Expiration date of the lot/batch: 31 January 2016
- Purity test date: not supplied; purity >95%
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature in the dark
- Stability under test conditions: assumed stable for the study duration
- Solubility and stability of the test substance in the solvent/vehicle: the test material was not miscible in DMSO at 50 mg/mL, but was fully miscible in acetone at 100 mg/mL and dimethyl formamide at 50 mg/mL. Acetone was therefore selected as the vehicle.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: None, but acetone is toxic to bacterial cells at 0.1 mL (see further information below)
OTHER SPECIFICS: Formulated concentrations were adjusted to allow for the stated water/impurity content (5%) of the test item
Method
- Target gene:
- Point mutation - reversion to histidine dependence
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 Microsomal fraction prepared from homogenised livers of male rats induced with Phenobarbitone/β-Naphthoflavone
- Test concentrations with justification for top dose:
- Experiment 1: 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate. Due to excessive toxicity observed in TA1535 and TA1537, an amended experiment was conducted in these strains at 0.15, 0.5, 1.5, 5, 15, 50, 150 and 500 µg/plate
Experiment 2: Salmonella strains: 0.05, 0.15, 0.5, 1.5, 5, 15, 50 and 150 µg/plate; E.coli strain 0.5, 1.5, 5, 15, 50, 1510, 500 and 1500 µg/plate
The maximum dose level in the first experiment was selected as the maximum recommended level - 5000 µg/plate. Excessive toxicity (evidenced by thinning of the background lawns) was observed in strains TA1535 and TA1537 therefore part of the test was repeated employing the toxic limit as the maximum dose (500 µg/plate). Weakened background lawns were observed in E. coli at 1500 µg/plate and above therefore this dose was employed as the highest dose in the second experiment. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
- Justification for choice of solvent/vehicle: the test material was not miscible in DMSO at 50 mg/mL, but was fully miscible in acetone at 100 mg/mL and dimethyl formamide at 50 mg/mL.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- Master strains were checked for characteristics, viability and spontaneous reversion rate (all found to be satisfactory) before the start of the study.
Test item preparation:
Experiment 1 - plate incorporation method.
0.1 mL of the appropriate test item concentration, vehicle or positive control was added to 2 mL of molten trace amino acid supplemented media containing 0.1 mL of the bacterial strain culture and 0.5 mL of phosphate buffer (without metabolic activation) or S9 mix (with metabolic activation). The items were mixed and overlayed on a Vogel-Bonner agar plate. Negative controls were performed on the same day as the mutation test. Each test concentration and control was tested in triplicate. All plates were incubated at 37±3°C for approx. 48 hours and scored for the presence of revertant colonies using an automated colony counting system. The plates were viewed microscopically for evidence of thinning (toxicity). Several manual counts were performed due to interference and bubbles in the base agar.
Experiment 2 - pre-incubation method
0.1 mL of the bacterial strain culture, 0.5 mL of phosphate buffer (without metabolic activation) or S9 mix (with metabolic activation) and 0.05 mL of the test item concentration, vehicle or 0.1 mL positive control were incubated at 37±3°C for 20 minutes with shaking prior to addition of 2 mL molten amino acid supplemented media and subsequent plating onto Vogel-Bonner plates. Negative controls were performed on the same day as the mutation test. Each test concentration and control was tested in triplicate. All of the plates were incubated at 37±3°C for approximately 48 hours and scored for the presence of revertant colonies using an automated colony counting system. The plates were viewed microscopically for evidence of thinning (toxicity). Several manual counts were required, predominantly due to revertant colonies spreading slightly, thus distorting the actual plate count. - Rationale for test conditions:
- As specified by the OECD guideline
- Evaluation criteria:
- A dose-related increase in mutant frequency over the dose range tested; a reproducible increase at one or more concentrations; biological relevance against in-house historical control ranges; statistical analysis of data as determined by UKEMS; fold increase greater than two times the concurrent solvent control for any tester strain (especially if accompanied by an out-of-historical range response). A test item will be considered non-mutagenic (negative) if the criteria are not met.
- Statistics:
- Not required.
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:
- 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:
- cytotoxicity
- 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:
- cytotoxicity
- 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:
- cytotoxicity
- 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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- The maximum dose level in the first experiment was selected as the maximum recommended level - 5000 µg/plate. Excessive toxicity (evidenced by thinning of the background lawns) was observed in strains TA1535 and TA1537 therefore part of the test was repeated employing the toxic limit as the maximum dose (500 µg/plate). Weakened background lawns were observed in E. coli at 1500 µg/plate and above therefore this dose was employed as the highest dose in the second experiment. In the second experiment, toxicity (weakened background lawn) was observed in the absence of S9 mix from 5 µg/plate (TA100 and TA1537) and 50 µg/plate (TA1535, TA98 and WP2uvrA). In the presence of S9 toxicity was observed from 15 µg/plate (TA100 and TA1537), 50 µg/plate (TA1535 and TA98) and 150 µg/plate (WP2uvrA). A test item film (cream coloured in appearance) was noted at 5000 µg/plate, this observation did not prevent colony scoring.
There was no significant increase in the frequency of revertant colonies for any of the bacterial strains at any dose level, with or without S9 mix in either of two independent experiments.
All positive controls induced marked increases in the frequency of revertant colonies.
Any other information on results incl. tables
There was no significant increase in the frequency of revertant colonies for any of the bacterial strains at any dose level, with or without S9 mix in either of two independent experiments. All positive controls induced marked increases in the frequency of revertant colonies.
Applicant's summary and conclusion
- Conclusions:
- DTO_DETA was considered to be non-mutagenic in the bacterial reverse mutation assay (Ames test).
- Executive summary:
The mutagenic potential of 'Tall oil reaction products with diethylenetriamine' was evaluated in a bacterial reverse mutation assay (Ames test) according to OECD 471. Salmonella typhimurium strains TA1535, TA1537, TA98 and TA100 and Escherichia coli strain WP2uvrA were exposed to the test substance in two independent assays, according to the plate incorporation and pre-incubation methods. Eight concentrations were tested up to the maximum 5000 µg/plate, both in the presence and absence of metabolic activation (S9 mix). The test substance induced excessive toxicity in TA1535 and TA1537 in the first experiment, therefore part of the experiment was repeated using an amended dose range (0.15 to 500 µg/plate). Based on the results observed in experiment 1, the dose range was amended for experiment 2 and ranged between 0.05 and 1500 µg/plate.
The vehicle (acetone) control plate gave revertant colony counts within the normal range. All of the positive controls induced marked increases in the frequency of revertant colonies, both with and without metabolic activation. The maximum dose level in the first experiment was selected as the maximum recommended level - 5000 µg/plate. Excessive toxicity (evidenced by thinning of the background lawns) was observed in strains TA1535 and TA1537 therefore part of the test was repeated employing the toxic limit as the maximum dose (500 µg/plate). Weakened background lawns were observed in E. coli at 1500 µg/plate and above therefore this dose was employed as the highest dose in the second experiment. In the second experiment, toxicity (weakened background lawn) was observed in the absence of S9 mix from 5 µg/plate (TA100 and TA1537) and 50 µg/plate (TA1535, TA98 and WP2uvrA). In the presence of S9 toxicity was observed from 15 µg/plate (TA100 and TA1537), 50 µg/plate (TA1535 and TA98) and 150 µg/plate (WP2uvrA). A test item film (cream coloured in appearance) was noted at 5000 µg/plate, this observation did not prevent colony scoring.
There was no significant increase in the frequency of revertant colonies for any of the bacterial strains at any dose level, with or without S9 mix in either of two independent experiments. The test substance is therefore considered to be non-mutagenic under the conditions of this test.
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