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EC number: - | CAS number: -
- 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
- Study period:
- 28 Jul - 16 Oct 2017
- 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 490 (In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene)
- Version / remarks:
- adopted in 2016
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayerirsches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
- Type of assay:
- in vitro mammalian cell gene mutation tests using the thymidine kinase gene
Test material
- Reference substance name:
- Fatty acids C16-18 (even numbered), mono, di and triesters with sucrose, UVCB
- Molecular formula:
- not applicable, substance is UVCB
- IUPAC Name:
- Fatty acids C16-18 (even numbered), mono, di and triesters with sucrose, UVCB
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature protected from light
- Solubility and stability of the test substance in the solvent/vehicle: 5 mg/mL in 0.25% THF
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: A stock solution of the test item was made with 0.25% THF. This stock solution was then diluted in RPMI and 5% HS.
- Final preparation of a solid: The test solution was then soniticated for 10 minutes at 37 degree C.
FORM AS APPLIED IN THE TEST (if different from that of starting material): Solution
Method
- Target gene:
- TK locus
Species / strain
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Eurofins Munich cell bank
- Cell cycle length, doubling time or proliferation index: 10-12 hr doubling time
- Whether whole blood or separated lymphocytes were used if applicable: lymphoma cells
- Methods for maintenance in cell culture if applicable: Thawed stock cultures are maintained in RPMI 1640 complete medium.
- Modal number of chromosomes: 40
MEDIA USED
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 10, 20, 50, 100, 200, and 300 µg/mL.
Top dose based on results of toxicity pre-experiment which found precipitation at concentrations of 400 µg/mL and above. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: THF
- Justification for choice of solvent/vehicle: THF was chosen due to the solubility of the test item in that solvent as compared to other solvents.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- ethylmethanesulphonate
- methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension of 11 mL RPMI medium and 5% horse serum
- Cell density at seeding (if applicable): 1 x 10E+07
DURATION
- Preincubation period: 1-3 days
- Exposure duration: 4 hrs
- Expression time (cells in growth medium): 2 days
- Selection time (if incubation with a selection agent): 12 days
- Fixation time (start of exposure up to fixation or harvest of cells): 14 days (8 days for cloning efficiency experiment)
SELECTION AGENT (mutation assays): RPMI with 20% horse serum, 100 U/100 µg/mL penicillin/streptomycin, 1 mM sodium pyruvate, 2 mM L-glutamine, 25 mM HEPES, 2.5 µg/mL amphotericin B, 5 µg/mL TFT
NUMBER OF REPLICATIONS: 4
NUMBER OF CELLS EVALUATED: all
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- The test substance is considered mutagenic if the following criteria were met:
induced mutant frequency of >= 126 mutants per 10E06 cells
dose-dependent increase in mutant frequency
increased occurrence of small colonies >= 40% of all colonies - Statistics:
- Mean mutant frequency
Mean induced mutant frequency
p-value
Results and discussion
Test results
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: yes, at highest dose level of 300 µg/mL
RANGE-FINDING/SCREENING STUDIES: A range-finding study was performed at concentrations of 10, 30, 100, 200, 400, and 1000 µg/mL with and without metabolic activation. Precipitation was seen at the 400 and 1000 µg/mL concentrations both with and without metabolic activation.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data:
Ethylmethanesulfonate (300 µg/mL): range - 318.7-2919.0, mean - 726.5, standard deviation - 203.5
Methylmethanesulfonate (10 µg/mL): range - 376.4-2416.1, mean - 763.4, standard deviation - 421.6
Benzo[a]pyrene (2.5 µg/mL): range - 303.6-1267.2, mean - 635.9, standard deviation - 167.8
- Negative (solvent/vehicle) historical control data:
Negative without S9: range - 50.1-170.3, mean - 87.9, standard deviation - 25.5
Negative with S9: range - 50.1-165.9, mean 85.1, standard deviation - 24.3
Any other information on results incl. tables
Mouse Lymphoma Assay Results – Without Metabolic Activation
Concentration |
Relative Cloning Efficiency (%) |
Relative Total Growth (%) |
Mutant Frequency (mutants/10E+06 cells) |
Induced Mutant Frequency (mutants/10E+06 cells) |
Control 1 |
102.9 |
106.4 |
69.5 |
-- |
Control 2 |
98.0 |
100.3 |
69.5 |
-- |
Solvent Control |
100.0 |
100.0 |
64.9 |
-- |
10 µg/mL |
106.5 |
109.8 |
71.8 |
6.9 |
25 µg/mL |
85.1 |
86.7 |
64.6 |
-0.3 |
50 µg/mL |
102.9 |
97.3 |
86.5 |
21.6 |
100 µg/mL |
87.7 |
81.2 |
73.9 |
9.0 |
200 µg/mL |
104.7 |
86.6 |
69.0 |
4.2 |
300 µg/mL (Precipitate observed) |
93.4 |
84.1 |
61.6 |
-3.3 |
Ethylmethanesulfonate* |
91.9 |
73.0 |
649.0 |
584.2 |
Methylmethanesulfonate* |
62.8 |
46.6 |
631.5 |
566.7 |
* Global Evaluation Factor exceeded and statistically significant increase in mutant frequency seen
Mouse Lymphoma Assay Results – With Metabolic Activation
Concentration |
Relative Cloning Efficiency (%) |
Relative Total Growth (%) |
Mutant Frequency (mutants/10E+06 cells) |
Induced Mutant Frequency (mutants/10E+06 cells) |
Control 1 |
94.4 |
89.4 |
63.7 |
-- |
Control 2 |
107.0 |
105.6 |
63.7 |
-- |
Solvent Control |
100.0 |
100.0 |
80.2 |
-- |
10 µg/mL |
89.0 |
96.6 |
91.8 |
11.6 |
25 µg/mL |
112.3 |
119.5 |
71.2 |
-8.9 |
50 µg/mL |
91.6 |
84.8 |
68.4 |
-11.8 |
100 µg/mL |
100.4 |
95.5 |
49.6 |
-30.6 |
200 µg/mL |
98.9 |
96.2 |
72.7 |
-7.4 |
300 µg/mL (Precipitate observed) |
114.2 |
102.7 |
60.4 |
-19.8 |
Benzo[a]pyrene* |
90.3 |
64.4 |
702.5 |
622.4 |
* Global Evaluation Factor exceeded and statistically significant increase in mutant frequency seen
Applicant's summary and conclusion
- Conclusions:
- The test substance is non-mutagenic.
- Executive summary:
The mutagenicity of the test substance was determined in an OECD Guideline 490 study. The mutagenicity of the test substance was determined at concentrations of 10, 20, 50, 100, 200, and 300 µg/mL both with and without metabolic activation. Tetrahydrofuran was used as solvent. Negative, solvent, and positive controls were used. Precipitation was seen at the highest test concentration of 300 µg/mL. The test substance was not cytotoxic, nor was it mutagenic.
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