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EC number: 234-398-4 | CAS number: 11140-04-8
- 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:
- 17 Apr -21 Apr 1997
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study with acceptable restrictions. Only 4 S. typhimurium strains used instead of 5 as required according to the current criteria. Only one concentration (5000 µg/plate) tested due to insolubility of the test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1983
- Deviations:
- yes
- Remarks:
- only 4 S. typhimurium strains used instead of 5 as required according to the current criteria. Only one concentration (5000 µg/plate) tested due to insolubility of the test substance.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Ministerium für Umwelt, Raumordnung und Landwirtschaft des Landes Nordrhein-Westfalen, Düsseldorf, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Glycerol tristearate
- EC Number:
- 209-097-6
- EC Name:
- Glycerol tristearate
- Cas Number:
- 555-43-1
- Molecular formula:
- C57H110O6
- IUPAC Name:
- propane-1,2,3-triyl trioctadecanoate
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Phenobarbital/β-Naphthoflavone
- Test concentrations with justification for top dose:
- 5000 µg/plate with and without metabolic activation
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: 95% ethanol (100 and 50 µL/plate in the plate incorporation and preincubation tests, respectively).
- Justification for choice of solvent/vehicle: in a preliminary test, the solubility of the test compound was determined in a number of solvents suitable for the Ames test, namely water, dimethylsulfoxide, glycerol, dimethyl formamide, formamide, ethanol, acetone, dioxane, tetrahydrofuran and tetrahydrofurfuryl alcohol. In all these solvents, the test compound could not be dissolved in appreciable amounts. Therefore, a suspension of the test material was prepared on the day of testing by mixing the test compound with 95% ethanol, stirring it on a magnetic stirrer and using samples of this stirred suspension for testing. No stability testing or composition analysis was performed on the dosing suspension.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: 2-nitrofluorene (2-NF; 2.5 µg/plate for TA98); sodium azide (SA; 5 and 2.5 µg/plate for TA100 and TA1535, respectively); 9-aminoacridine (9-AA; 40 µg/plate for TA1537; +S9: 2-aminoanthracene (2-AA; 2.5 µg/plate for all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
First experiment: in agar (plate incorporation)
Second experiment: preincubation
DURATION
- Preincubation period: 30 min (second experiment)
- Exposure duration: 72 h (first and second experiment)
NUMBER OF REPLICATIONS: 3 replications in the first and second experiment, respectively.
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency and relative total growth - Evaluation criteria:
- Criteria for determination of a valid test:
The following criteria had to be met for the mutagenicity assay to be considered valid:
- In the solvent control, each tester strain culture exhibited a characteristic mean number of spontaneous revertants.
- To ensure that appropriate numbers of bacteria were plated, overnight culture titers had to be in excess of 1E08 bacteria/mL.
- The mean of each positive control exhibited a significant increase in the number of revertants over the mean value of the respective vehicle control.
- In a standard Ames test, at least four non-toxic dose levels were required to evaluate the assay data. In the current test, due to non-solubility of the test compound, only a limit dose was employed.
Criteria for evaluation of test results:
For a test compound to be considered positive, it had to (in two independent experiments) cause at least a doubling in the mean revertants per plate of at least one tester strain. In a standard Ames test, this increase had to be accompanied by a dose response towards increasing concentrations of the test article. In the current test, a reproducible caused by a treatment with the limit dose would have been sufficient. A test article that did not meet these criteria would be called non-mutagenic in bacteria. Single increases in revertant frequencies, which were not reproducible in two independent tests were considered non-relevant. - Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- at 5000 µg/plate
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- due to insolubility, the test mateial was tested as suspension at a single limit concentration of 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: the test substance is not soluble in water.
- Precipitation: due to non-solubility of the test susbtance in all solvents used routinely in the Ames test, the tester strains were exposed to a suspension of the test compound at a single limit concentration of 5000 µg/plate. Test compound-treated bacterial colonies were counted by hand, as the precipitate formed by the test compound prevented automatic counting. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Test Results of Experiment 1 (plate incorporation).
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
|||
Base-pair substitution type |
Frameshift type |
||||
TA 100 |
TA1535 |
TA98 |
TA1537 |
||
– |
untreated |
110 |
8 |
31 |
12 |
– |
Ethanol |
105 |
7 |
33 |
16 |
– |
5000 |
125P |
3P |
30P |
20P |
Positive controls, –S9 |
Name |
SA |
SA |
2-NF |
9-AA |
Concentrations (μg/plate) |
5 |
2.5 |
2.5 |
40 |
|
Mean No. of colonies/plate (average of 3) |
575 |
267 |
123 |
125 |
|
+ |
untreated |
126 |
11 |
25 |
12 |
+ |
Ethanol |
116 |
14 |
33 |
16 |
+ |
5000 |
136P |
8P |
29P |
10P |
Positive controls, + S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (μg/plate) |
2.5 |
2.5 |
2.5 |
2.5 |
|
Mean No. of colonies/plate (average of 3) |
1394 |
123 |
835 |
120 |
SA = sodium azide
2-NF = 2-nitrofluorene
9-AA = 9-aminoacridine
2-AA = 2-Aminoanthracene
P = Precipitate
Table 2. Test Results of Experiment 2 (preincubation).
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates) |
|||
Base-pair substitution type |
Frameshift type |
||||
TA 100 |
TA1535 |
TA98 |
TA1537 |
||
– |
untreated |
142 |
13 |
30 |
14 |
– |
Ethanol |
126 |
9 |
28 |
11 |
– |
5000 |
127P |
8P |
24P |
12P |
Positive controls, –S9 |
Name |
SA |
SA |
2-NF |
9-AA |
Concentrations (μg/plate) |
5 |
2.5 |
2.5 |
40 |
|
Mean No. of colonies/plate (average of 3) |
575 |
267 |
123 |
125 |
|
+ |
untreated |
134 |
7 |
26 |
13 |
+ |
Ethanol |
155 |
11 |
27 |
10 |
+ |
5000 |
128P |
10P |
31P |
13P |
Positive controls, + S9 |
Name |
2-AA |
2-AA |
2-AA |
2-AA |
Concentrations (μg/plate) |
2.5 |
2.5 |
2.5 |
2.5 |
|
Mean No. of colonies/plate (average of 3) |
839 |
126 |
657 |
76 |
SA = sodium azide
2-NF = 2-nitrofluorene
9-AA = 9-aminoacridine
2-AA = 2-Aminoanthracene
P = Precipitate
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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