Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 272-905-0 | CAS number: 68919-79-9
- 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From March 04, 2015 to April 01, 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline 471 and EU Method B.13/14, in compliance with GLP
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)
- 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:
- Fatty acids, tall-oil, reaction products with triethylenetetramine
- EC Number:
- 272-905-0
- EC Name:
- Fatty acids, tall-oil, reaction products with triethylenetetramine
- Cas Number:
- 68919-79-9
- Molecular formula:
- Not applicable for this UVCB.
- IUPAC Name:
- Fatty acids, tall-oil, reaction products with triethylenetetramine
- Test material form:
- semi-solid (amorphous): gel
- Remarks:
- migrated information: paste
Constituent 1
Method
- Target gene:
- Strain Mutation name
TA97a hisD6610
TA98 hisD3052
TA100 hisG46
TA102 hisG428
TA1535 hisG46
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium, other: TA97a
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix, rat liver S9-mix induced by Aroclor 1254
- Test concentrations with justification for top dose:
- Nominal concentrations tested in the first experiment (1a and 1b): 500 μg/plate, 150 μg/plate, 50 μg/plate, 15 μg/plate and 5 μg/plate.
Nominal concentrations tested in the second experiment (2a and 2b): 500 μg/plate, 250 μg/plate, 125 μg/plate, 63 μg/plate, 31 μg/plate, 16 μg/plate and 8 μg/plate. - Vehicle / solvent:
- - Vehicle/solvent used: ethanol
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene Diamine
- Remarks:
- without metabolic activation for TA97a, TA98 and TA102
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without metabolic activation for TA100 and TA1535
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Amino-Anthracene
- Remarks:
- with metabolic activation for TA97a, TA100, TA102 and TA1535.
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- with metabolic activation for TA98
- Details on test system and experimental conditions:
- PERFORMANCE OF THE STUDY
Culture of Bacteria
8 h before the start of each experiment, the nutrient broth was inoculated. For the incubation of strains TA97a, TA98, TA100, TA102; ampicilline was added to the nutrient broth (25 mg/L), for the incubation of strain TA102, tetracycline was added (2 mg/L), too. TA1535 was incubated without the addition of antibiotics. The flasks were incubated at 37±1°C for 8 h.
Conduct of Experiment
Preparations
In the days before each test, the media and solutions were prepared.
On the day of the test, the overnight cultures were checked for growth. The incubation chambers were heated to 37±1°C. The water bath was turned to 43±1°C. The table surface was disinfected.
The S9 mix was freshly prepared and stored at 0±1°C.
Experimental Parameters
Experiment 1a
Concentrations tested: 500, 150, 50, 15 and 5 μg/plate
Incubation time: 48 h
Incubation temperature: 37±1°C
Bacteria strains: TA97a, TA102
Method: Plate incorporation method
Experiment 1b
Concentrations tested: 500, 150, 50, 15 and 5 μg/plate
Incubation time: 48 h
Incubation temperature: 37±1°C
Bacteria strains: TA98, TA100, TA1535
Method: Plate incorporation method
Experiment 2a
Concentrations tested: 500, 250, 125, 63, 31, 16 and 8 μg/plate
Incubation time: 48 h
Incubation temperature: 37±1°C
Bacteria strains: TA97a, TA98, TA102, TA1535
Method: Pre-incubation method
Experiment 2b
Concentrations tested: 500, 250, 125, 63, 31, 16 and 8 μg/plate
Incubation time: 48 h
Incubation temperature: 37±1°C
Bacteria strains: TA100
Method: Pre-incubation method
Description of the Method
General preparation
Per strain and dose, 3 plates with and 3 plates without S9 mix were used. Top agar basis was melted in a microwave oven, after melting, 10 mL of histidine-biotinsolution 0.5 mM per 100 mL basis was added and the bottle was placed in the water bath at 43±1°C.
Plate incorporation method
The following materials were gently vortexed in a test tube and poured onto the selective agar plates:
• 100 μL test solution at each dose level, solvent (negative control) or reference mutagen solution (positive control)
• 500 μL S9 mix or phosphate buffer (for test without metabolic activation).
• 100 μL bacteria suspension
• 2,000 μL overlay agar (top agar)
The plates were closed and left to harden for a few minutes, then inverted and placed in the dark incubator at 37±1°C.
Pre-incubation method
The following materials were gently vortexed in a test tube and incubated at 37±1°C for 20 minutes:
• 100 μL test solution at each dose level, solvent (negative control) or reference mutagen solution (positive control)
• 500 μL S9 mix or phosphate buffer (for test without metabolic activation).
• 100 μL bacteria suspension
After pre-incubation, 2,000 μL overlay agar (top agar) was added, the tube was gently vortexed and the mixture was poured onto the selective agar plate.
The plates were closed and left to harden for a few minutes, then inverted and placed in the dark incubator at 37±1°C. - Evaluation criteria:
- A test substance is considered to have mutagenic potential, if a significant, reproducible increase of revertant colonies per plate (increase factor >=2) in at least one strain can be observed.
A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium, other: TA97a
- 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
- 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
- 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
- Species / strain:
- S. typhimurium TA 102
- 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
- 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
- Additional information on results:
- FINDINGS
Confirmation of genotype is performed for each batch of lyophilized bacteria before stock culture preparation. The last performance showed no abnormalities.
Experiment 1a and 1b
Confirmation of the Criteria and Validity
The treatments for the sterility control and the determination of the titre did not show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory. All positive controls (diagnostic mutagenes) showed mutagenic effects with and without metabolic activation.
Solubility and Toxicity
The test substance was dissolved in ethanol. A stock solution containing 5 g/L was prepared. In both experiment, the test substance showed no precipitates on the plates in all tested concentrations. Signs of toxicity towards the bacteria strain TA100 could be observed in the highest concentration (500 μg/plate) with and without metabolic activation. In the next lower concentration (150 μg/plate) the test substance showed toxicity towards the strain TA100 only in the treatment without metabolic activation. The background lawn was visible, but the number of revertant colonies was clearly reduced.
Mutagenicity
No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.
Therefore, the test substance is stated as not mutagenic under these test conditions.
Experiment 2a and 2b
Confirmation of the Criteria and Validity
The treatments for the sterility control and the determination of the titre did not show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory. All positive controls (diagnostic mutagenes) showed mutagenic effects with and without metabolic activation.
Solubility and Toxicity
The test substance was dissolved in ethanol. A stock solution containing 5 g/L was prepared. In both experiment, the test substance showed no precipitates on the plates in all tested concentrations. Signs of toxicity towards all bacteria strains could be observed in the 2 highest concentrations (500 and 250 μg/plate) in the treatment with and without metabolic activation.
In these concentrations the background lawn was not visible and the number of revertant colonies was clearly reduced.
Mutagenicity
No significant increase of the number of revertant colonies in the treatments with and without metabolic activation was observed. No concentration-related increase over the tested range was found.
Therefore, the test substance is stated as not mutagenic under the test conditions.
RESULTS
Mutagenicity of Test substance
The test substance did not show mutagenic effects in all experiments. The number of revertant colonies was not increased in comparison with the spontaneous revertants (solvent only). In the experiment 1b cytotoxicity of the test substance was detected towards the strains TA100 in the highest concentration (500 μg/plate) in the treatment with and without metabolic activation. In the next lower concentration (150 μg/plate) the test substance showed toxicity towards the strain TA100 only in the treatment without metabolic activation.
In the experiment 2a and 2b signs of cytotoxicity towards all bacteria strains could be observed in the 2 highest concentrations (500 and 250 μg/plate) in the treatment with and without metabolic activation.
In these concentrations the bacterial background lawn was partly not visible and the number of revertants was clearly decreased.
On the base of these results, it can be stated, that under the test conditions, the test substance is not mutagenic in the Bacterial Reverse Mutation Test using Salmonella typhimurium, strains TA97a, TA98, TA100, TA102 and TA1535.
Acceptability of Study
All spontaneous revertants (except of 2 values in the first experiment) and all positive control values were within the range of the historical data. Difference of revertants lying outside the range is marginal. Therefore, the study is considered valid. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative without metabolic activation
negative with metabolic activation
The test substance was found to be non-mutagenic in the bacterial reverse mutation assay. - Executive summary:
An in vitro study was performed to investigate the potential of the test substance to induce gene mutations according to OECD Guideline 471 and EU Method B.13/14, in compliance with GLP. Two mutagenicity studies were conducted, one as the plate incorporation test (i.e., experiment 1a and 1b) and the other one as a preincubation test (i.e., experiment 2a and 2b). The studies were performed in the absence and in the presence of a metabolizing system derived from a rat liver homogenate. The test substance was tested for mutagenic effects without and with metabolic activation at concentrations in the range of 5 - 500 µg/plate in experiment 1a and 1b and 8 - 500 µg/plate in experiment 2a and 2b. In the plate incorporation test, the test substance did not result in relevant increases in the number of revertants in any of the bacterial strains in the absence and presence of the metabolic activation (rat liver S9-mix). Cytotoxicity was observed in the strains TA100 in experiment 1b at the highest concentration (500 μg/plate) with and without metabolic activation and at the next lower concentration (150 μg/plate) without metabolic activation. In the preincubation tests no relevant increase in the number of revertants was observed in any of the bacterial strains in the absence and presence of the metabolic activation (rat liver S9-mix). Further, cytotoxicity was observed in all bacteria strains in both the experiments i.e., 2a and 2b at the two highest concentrations (500 and 250 μg/plate) with and without metabolic activation. In addition, spontaneous revertants were within the normal range in comparison with the historical data. The reference mutagens also showed the expected increase in induced revertant colonies. Under the study conditions, the test substance was found to be non-mutagenic in the bacterial reverse mutation assay (Andres I, 2015c).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.