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EC number: 800-003-4 | CAS number: 1415316-96-9
- 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 mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- July 2016
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- May 2008
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5300 - In vitro Mammalian Cell Gene Mutation Test
- Version / remarks:
- August 1998
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell transformation assay
Test material
- Reference substance name:
- Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine
- EC Number:
- 800-003-4
- Cas Number:
- 1415316-96-9
- IUPAC Name:
- Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Test material form:
- liquid
Constituent 1
Constituent 2
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0012652167 (BASF SE)
- Expiration date of the lot/batch: September 24, 2017
- Purity test date: 2016-09-13
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Stability under test conditions: guaranteed by sponsor
- Solubility and stability of the test substance in the solvent/vehicle: no vehicle used
Method
- Target gene:
- HPRT
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- CELLS USED
- Modal number of chromosomes: 20
- Normal (negative control) cell cycle time: 12-16h
MEDIA USED
- Type and identity of media including CO2 concentration if applicable:
Ham's F12 supplemented with 10% FCS except during treatment. All media were supplemented with 1% (v/v) penicillin/streptomycin and 1% (v/v) amphotericine B. CO2 concentration was 5%
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital and β-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Starting at 285.94µg/mL test substance concentration (corrected for purity) and emulsion was prepared.
After 4 hours treatment in the absence of S9 mix, cytotoxicity was observed as indicated by a reduced RS of about or below 20% of control at 1143.75 μg/mL and above. In addition, in the presence of S9 mix, a clearly reduced relative RS (to 14.2%) was observed after treatment with 571.88 μg/mL. No viable cells were detected at higher concentrations.
Consequently, the following doses were tested in the main experiments:
1st and 2nd experiment:
w/S9: 7.81 (first exp. only), 15.63, 31.25, 62.5, 125, 250, 500, 1000µg/mL
w/out S9: 15.63, 31.25, 62.5, 125, 250, 500, 1000, 1500µg/mL
3rd experiment:
w/out S9: 25, 50, 100, 200, 300, 500, 600, 800, 1000µg/mL - Vehicle / solvent:
- Culture medium
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
- Cell density at seeding: 20x10^6 cells /40mL
DURATION
- Preincubation period: 1 day
- Exposure duration: 4h
- Expression time (cells in growth medium):7-9 days
- Selection time (if incubation with a selection agent): 6-7 days
- Fixation time (start of exposure up to fixation or harvest of cells): 16
SELECTION AGENT (mutation assays): 6-thioguanine
NUMBER OF REPLICATIONS:
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- Acceptance criteria
The HPRT assay is considered valid if:
• The absolute cloning efficiencies of the negative/vehicle controls should not be less than 50% (with and without S9 mix).
• The background mutant frequency in the negative/vehicle controls should be within our historical negative control data range (95% control limit).
• The positive controls both with and without S9 mix should induce a distinct, statistically significant increase in mutant frequencies in the expected range
Assessment criteria
A test substance is considered to be clearly positive if:
• A statistically significant increase in mutant frequencies is obtained.
• A dose-related increase in mutant frequencies is observed.
And
• The corrected mutation frequencies (MFcorr.) exceeds both the concurrent negative/vehicle control value and the range of our laboratory’s historical negative control data (95% control limit)
Isolated increases of mutant frequencies above our historical negative control range or isolated statistically significant increases without a dose-response relationship may indicate a biological effect but are not regarded as sufficient evidence of mutagenicity.
A test substance is considered to be clearly negative if:
• Neither a statistically significant nor dose-related increase in the corrected mutation frequencies is observed under any experimental condition.
• The corrected mutation frequencies in all treated test groups is close to the concurrent vehicle control value and within the range of our laboratory’s historical negative control data (95% control limit)
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No change in pH value was observed up to 5000µg/mL of test compound (corrected for purity).
In the absence and presence of S9 mix, test substance precipitation was observed macroscopically in culture medium at the end of treatment at 125.00 μg/mL onward in the 1st Experiment, at 1000.00 μg/mL in the 2nd Experiment and at 600μg/mL in the 3rd Experiment.
Any other information on results incl. tables
All provided concentrations have been adjusted to the purity of the test substance.
Exp. 1 | Exp. 2 | Exp.3 | |||||
Conc. | Met. Act. | Mutant Frequ. (%) | RS(%) | Mutant Frequ. (%) | RS(%) | Mutant Frequ. (%) | RS(%) |
0 | - | 1 | 100 | 5.3 | 100 | 2 | 100 |
15.63 | - | 3 | 81 | 1 | 82 | ||
31.25 | - | 7.2 | 91 | 3.9 | 85 | ||
62.5 | - | 7.1 | 81 | 0.3 | 80 | ||
125 | - | 2.7 | 76 | 4.6 | 80 | ||
200 | - | 3.8 | 103 | ||||
250 | - | 6 | 79 | 1 | 87 | ||
300 | - | 1.1 | 108 | ||||
500 | - | 13.3 | 76 | 0.4 | 77 | 0.6 | 103 |
600 | - | 0 | 103 | ||||
750 | - | 2.1 | 75 | ||||
1000 | - | not scored | 5 | not scored | 0 | not scored | 2 |
0 | + | 8.9 | 100 | 6.4 | 100 | ||
7.81 | + | 9.2 | 114 | ||||
15.63 | + | 8.1 | 108 | 3.5 | 107 | ||
31.25 | + | 5.8 | 89 | 1.5 | 102 | ||
62.5 | + | 5.4 | 102 | 4 | 98 | ||
125 | + | 3.5 | 94 | 1.5 | 93 | ||
250 | + | 2.3 | 123 | 0.3 | 102 | ||
500 | + | 4.2 | 53 | 0.6 | 47 | ||
1000 | + | not scored | 0 | not scored | 0 |
Bold values indicate significant differences
Applicant's summary and conclusion
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.
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