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Diss Factsheets
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EC number: 294-571-5 | CAS number: 91744-09-1
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well-documented publication meeting basic scientific principles. Test compound was a mixture of short- and long-chain acyl triglyceride.
Data source
Reference
- Reference Type:
- publication
- Title:
- Genetic Toxicology Studies of SALATRIM Structured Triacylglycerols. Lack of Genetic Damage in in Vitro Mammalian Cell Assays and the in Vivo Micronucleus Assay
- Author:
- Hayes, J.R. et al.
- Year:
- 1 994
- Bibliographic source:
- J. Agrlc. Food Chem. 42:521-527
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- , only 100 cells per dose scored.
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- short- and long-chain fatty acid triacylglycerols (SALATRIM 23CA)
- IUPAC Name:
- short- and long-chain fatty acid triacylglycerols (SALATRIM 23CA)
- Details on test material:
- - Name of test material (as cited in study report): SALATRIM 23CA lot A014 (Short- and long-chain acyl triglyceride molecules)
- Analytical purity: no data
- Other: The studies reported here used SALATRIM 23CA lot A014 in the in vitro mammalian cell studies as a representative of SALATRIM fats. SALATRIM 23CA lot A014 was produced from triacetin, tripropionin, and hydrogenated canola oil, with triacetin being the predominant source of the SCFA. As a result, acetic acid is the predominant short-chain fatty acid and occurs in the vast majority of triacylglycerols that comprise this fat.
Members of the SALATRIM family of structured triacylglycerols are typical triacylglycerols composed of fatty acids esterified to a glycerol backbone. The unique characteristic of this family of fats is the triacylglycerols contain a preponderance of stearic, acetic, propionic, and/
or butyric acids. Triacylglycerols that contain one stearic acid and two short-chain fatty acids (SCFA) predominate among the mixed triacylglycerols that comprise these fats. Because of the limited absorption of stearic acid compared to certain other fatty acids and the fewer carbons available for energy production from the SCFA, these fats have lower caloric availabilities (4.5-6 kcal/g) than fats such corn oil (9 kcal/g). SALATRIM fats are produced by interesterification among high-stearate fats, such as hydrogenated canola oil and hydrogenated soybean oil, and triacetin, tripropionin, and tributyrin. Because the natural precursor fats contain mixed triacylglycerols, SALATRIM fats contain small quantities of other fatty acids such as oleic and palmitic, among others. SALATRIM fats can have different physical and functional characteristics because the ratios of the SCFA can be varied.
Constituent 1
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- Chinese hamster ovary cells (CHO ETCC CCL 61 CHO-KL, proline-requiring)
- Type and identity of media: Cells were grown in a 5% C02 atmosphere at 37 "C in McCoy's 5a medium.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9
- Test concentrations with justification for top dose:
- 250, 500 and 1000 µg/mL.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
Controls
- Untreated negative controls:
- yes
- Remarks:
- Corn oil; 500, 750 and 1000 µg/mL
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: methylmethanesulfonate , 20 µg/mL, -S9; cyclophosphamide, 110 µg/mL, +S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium;
DURATION
- Exposure duration: 8h (-S9); 2h (+S9);
SPINDLE INHIBITOR (cytogenetic assays): colchicine 0.4 µg/mL
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: duplicates
NUMBER OF CELLS EVALUATED: 50 cells per flask were evaluated for chromosomal aberrations, resulting in a total of 100 cells evaluated per dose.
DETERMINATION OF CYTOTOXICITY
- Method: The mitotic index was evaluated on the basis of at least 1000 cells per flask.
OTHER:
- In the absence of metabolic activation, the fats and 0.01 mM deoxybromouridine (BrdU) were added to the cell culture and incubated at 37ºC for 8h. The cells were washed and then incubated in fresh medium containing 0.01 mM BrdU for 13.5 h.
When metabolic activation was used, the cultures were exposed to the fats for 2 h at 37ºC, washed, and then incubated in fresh medium containing
0.01 mM BrdU for 6-8 h.
After incubation in BrdU, colchicine was added to the cultures at 0.4 μg/mL followed by incubation for 2.5 h at 37 ºC. - Evaluation criteria:
- A test material would be considered positive if there was a statistically significant (p < 0.05) increase in the frequency of cells with chromosomal damage and if this increase was dose-dependent.
- Statistics:
- The number of cells with chromosomal damage in the test fat groups and positive control group were compared to the concurrent solvent control by Fischer's exact test (Gad and Weil, 1991).
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The SALATRIM fat appeared to be soluble in the culture medium for the chromosomal aberration assay at a concentration of 40 μg/mL but produced a suspension at higher concentrations.
The pH of the high dose in the medium was approximately 7.0. The preliminary dose range/cytotoxicity study used a dose range of 0-1000 μg/mL and was limited by the lack of solubility of the fat. Corn oil behaved in a manner similar to that of SALATRIM 23CA lot A014 and was tested using the same criteria. No significant cell cycle delay or reduction in the mitotic index was noted with either corn oil or the SALATRIM fat. There was a slight increase in the number of cells in metaphase 1 at a SALATRIM dose of 1000 μg/mL and at corn oil doses of 40 and 200 μg/mL, but these were not significant on the basis of assay criteria. Therefore, for the definitive assay, a dose range of 0 (solvent control), 250, 500, and 1000 μg/mL was chosen for the SALATRIM and 500,750, and 1000 μg/mL for corn oil.
RANGE-FINDING/SCREENING STUDIES:
A preliminary dose range study to determine cytotoxicity and optimal cell fixation time was done before the definitive study was performed. Doses of 8.0, 40.0, 200.0, 500.0, and 1000 μg/mL were tested.
On the basis of the results of the range-finding study, doses of 250,500, and 1000 μg/mL for the SALATRIM fat and 500,750, and 1000 μg/mL for corn oil were used for the definitive study and a harvest time of 8-10 h was selected.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In the absence of metabolic activation, no major changes were noted in the mitotic index with either SALATRIM 23CA lot A014 or corn oil, indicating a lack of cytotoxicity. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1:Summary of results of the chromosome aberration study in CHO cells treated with SALATRIM 23CA Lot A014
|
S9 |
Conc. in μg/mL |
Cells scored |
mitotic index (%) |
cells with abnormal chromosomes (%) |
cells with chromatid deletions /exchanges (%) |
structural aberrations per cell |
corn oil** |
- |
1000 |
100 |
9.6 |
2 |
2/0 |
0.02 |
MMS |
- |
20 |
100 |
4.7 |
18* |
13/5 |
0.22 |
Acetone |
- |
0 |
100 |
5.9 |
4 |
3/0 |
0.04 |
Test item |
- |
250 |
100 |
4.8 |
2 |
1/0 |
0.01 |
Test item |
- |
500 |
100 |
5.0 |
4 |
3/0 |
0.06 |
Test item |
- |
1000 |
100 |
4.4 |
4 |
3/0 |
0.05 |
corn oil** |
+ |
1000 |
100 |
4.7 |
5 |
4/0 |
0.05 |
CP |
+ |
50 |
100 |
0.4 |
26* |
16.2/6.1 |
0.42 |
Acetone |
+ |
0 |
100 |
3.6 |
4 |
3/0 |
0.06 |
Test item |
+ |
250 |
100 |
3.9 |
0 |
0/0 |
0.00 |
Test item |
+ |
500 |
100 |
3.9 |
2 |
2/0 |
0.03 |
Test item |
+ |
1000 |
100 |
5.1 |
3 |
3/0 |
0.03 |
*p<0.05
**corn oil was tested in an independent experiment
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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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