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EC number: 208-686-5 | CAS number: 538-23-8
- 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:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Remarks:
- Acceptable, well documented study report which meets basic scientific principles.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 989
- Reference Type:
- publication
- Title:
- Prediction of Salmonella mutagenicity
- Author:
- Zeiger, E. et al.
- Year:
- 1 996
- Bibliographic source:
- Mutagenesis Vol. 11, No. 5: 471-484
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 994
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1981
- Deviations:
- yes
- Remarks:
- S9 mix from hamster used
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1997
- Deviations:
- yes
- Remarks:
- 2-Aminoanthracene was used as the sole indicator of the efficacy of the S9-mix; only four strains were tested and no strain was included to cross-linking mutagens (e.g. TA102 or E.coli); lack of cytotoxicity data.
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Glycerol trioctanoate
- EC Number:
- 208-686-5
- EC Name:
- Glycerol trioctanoate
- Cas Number:
- 538-23-8
- Molecular formula:
- C27H50O6
- IUPAC Name:
- 1,3-bis(octanoyloxy)propan-2-yl octanoate
Constituent 1
Method
- Target gene:
- his operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 97, 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 and hamsters treated with Aroclor 1254
- Test concentrations with justification for top dose:
- TA100 / TA97/ TA 98: 100, 333, 1000, 3333, 10000 µg/plate with and without S9 mix
TA 1535: 100, 333, 1000, 3333, 6666, 10000, 16666 µg/plate with and without S9 mix - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: 2-nitrofluorene (TA98), sodium azide (TA100 and TA1535), 9-aminoacridine (TA97); +S9: 2-aminoanthracene or occasionally sterigmatocystin (all strains)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation, agar plates
DURATION
- Preincubation period: 20 min. at 37°C
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: triplicates
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- If the test chemical was mutagenic to any particular strain of bacterium, the number of histidine-independent colonies arising on those plates must be significantly greater than the corresponding control plates for that strain of bacteria. The positive control plates were also counted, and the number of mutant colonies appearing on them must be significantly increased over the spontaneous control number for the test to be considered valid. Failure of the positive control chemical to induce mutation is reason to discard the experiment.
In analyzing the data, the pattern and the strength of the mutant response are taken into account in determining the mutagenicity of a chemical. If no increase in mutant colonies is seen after testing several strains under several different culture conditions, the test chemical is considered to be nonmutagenic in the Ames test.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium, other: TA 97, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Remarks:
- but tested up to limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with
- Genotoxicity:
- positive
- Remarks:
- at concentrations >= 6666 µg/plate
- Cytotoxicity / choice of top concentrations:
- not specified
- Remarks:
- but tested up to limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Remarks:
- but tested up to limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other:
- Remarks:
- in the presence of hamster or rat S9 mix
Any other information on results incl. tables
Table 1: Mutant frequency (revertants per plate ± standard error from 3 plates) in TA1535, TA97, TA98, TA100 after treatment with the test substance.
Strain | Dose (µg/plate) | -S9 | +30% Hamster S9 | +30% rat S9 | |||||||||||
Trial 1 | Trial 2 | Trial 3 | Trial 1 | Trial 2 | Trial 3 | ||||||||||
Mean | ± SEM | Mean | ± SEM | - | - | - | - | Mean | ± SEM | - | - | - | - | ||
TA100 | 0 | 144 | 17.7 | 137 | 7 | - | - | - | - | 193 | 8.5 | - | - | - | - |
100 | 169 | 5.2 | 135 | 4.9 | - | - | - | - | 197 | 4.8 | - | - | - | - | |
333 | 134 | 17 | 142 | 6.2 | - | - | - | - | 189 | 6.5 | - | - | - | - | |
1000 | 108 | 1.9 | 147 | 5.7 | - | - | - | - | 190 | 3.8 | - | - | - | - | |
3333 | 112 | 1 | 137 | 5 | - | - | - | - | 176 | 4.5 | - | - | - | - | |
10000 | 131 | 5.2 | 176 | 2.2 | - | - | - | - | 188 | 9.5 | - | - | - | - | |
Positive Control* | 955 | 37.8 | 837 | 39.5 | - | - | - | - | 440 | 26.1 | - | - | - | - | |
Strain | Dose (µg/plate) | -S9 | +30% Hamster S9 | +30% rat S9 | |||||||||||
Trial 1 | Trial 2 | Trial 3 | Trial 1 | Trial 2 | Trial 3 | ||||||||||
Mean | ± SEM | Mean | ± SEM | Mean | ± SEM | Mean | ± SEM | Mean | ± SEM | Mean | ± SEM | Mean | ± SEM | ||
TA1535 | 0 | 12 | 0.9 | 15 | 0.9 | 11 | 0 | 13 | 2.6 | 18 | 3.8 | 15 | 1.2 | 20 | 3.8 |
100 | 14 | 0.9 | 11 | 2.3 | - | - | - | - | 16 | 3.8 | - | - | - | - | |
333 | 13 | 3.4 | 14 | 2 | - | - | - | - | 17 | 1.2 | - | - | - | - | |
1000 | 15 | 2.6 | 12 | 0.9 | 12 | 2.9 | 24 | 1.2 | 17 | 2.3 | 15 | 1.5 | 28 | 5.1 | |
3333 | 14 | 1.3 | 15 | 0.3 | 18 | 1.5 | 45 | 4.5 | 20 | 2.6 | 19 | 1.7 | 37 | 1.5 | |
6666 | - | - | - | - | 50 | 6 | 42 | 1.9 | - | - | 37 | 2.2 | 39 | 3.4 | |
10000 | 17 | 1.8 | 44 | 9.1 | 52 | 2.8 | 55 | 1.9 | 42 | 1.5 | 49 | 5.5 | 54 | 3.8 | |
16666 | - | - | - | - | 85 | 2.8 | 107 | 10.7 | - | - | 76 | 2.4 | 95 | 3.2 | |
Positive Control | 958 | 34.3 | 607 | 16.8 | 408 | 39.8 | 351 | 8.9 | 105 | 3.6 | 91 | 9.1 | 90 | 10.5 | |
Strain | Dose (µg/plate) | -S9 | +30% Hamster S9 | +30% rat S9 | |||||||||||
Trial 1 | Trial 2 | Trial 3 | Trial 1 | Trial 2 | Trial 3 | ||||||||||
Mean | ± SEM | Mean | ± SEM | - | - | - | - | Mean | ± SEM | - | - | - | - | ||
TA97 | 0 | 222 | 6.9 | 185 | 6.9 | - | - | - | - | 216 | 5.3 | - | - | - | - |
100 | 228 | 3.8 | 198 | 7.3 | - | - | - | - | 205 | 20.4 | - | - | - | - | |
333 | 223 | 6.3 | 210 | 7.6 | - | - | - | - | 224 | 11.9 | - | - | - | - | |
1000 | 210 | 2.6 | 216 | 1.8 | - | - | - | - | 184 | 6.5 | - | - | - | - | |
3333 | 212 | 7.6 | 203 | 21.5 | - | - | - | - | 168 | 3.7 | - | - | - | - | |
10000 | 225 | 4 | 197 | 19.4 | - | - | - | - | 152 | 10.4 | - | - | - | - | |
Positive Control | 742 | 42.2 | 436 | 2.2 | - | - | - | - | 442 | 3.5 | - | - | - | - | |
Strain | Dose (µg/plate) | -S9 | +30% Hamster S9 | +30% rat S9 | |||||||||||
Trial 1 | Trial 2 | Trial 3 | Trial 1 | Trial 2 | Trial 3 | ||||||||||
Mean | ± SEM | Mean | ± SEM | - | - | - | - | Mean | ± SEM | - | - | - | - | ||
TA98 | 0 | 30 | 4.7 | 35 | 4 | - | - | - | - | 38 | 1.9 | - | - | - | - |
100 | 27 | 1.5 | 34 | 2.4 | - | - | - | - | 41 | 0.6 | - | - | - | - | |
333 | 27 | 0.9 | 33 | 6.7 | - | - | - | - | 36 | 3.8 | - | - | - | - | |
1000 | 28 | 4.6 | 29 | 1.7 | - | - | - | - | 31 | 3.7 | - | - | - | - | |
3333 | 28 | 1.5 | 28 | 3.4 | - | - | - | - | 34 | 1.7 | - | - | - | - | |
10000 | 28 | 2 | 31 | 4.3 | - | - | - | - | 28 | 1.5 | - | - | - | - | |
Positive Control | 677 | 20.6 | 770 | 11.3 | - | - | - | - | 168 | 3.5 | - | - | - | - |
* The positive controls in the absence of metabolic activation were sodium azide (TA100 and TA1535), 9-aminoacridine (TA97), and 4-nitro-o-phenylenediamine (TA98). The positive control for metabolic activation with all strains was 2-aminoanthracene.
Applicant's summary and conclusion
- Conclusions:
- Negative in TA 97, TA98 and TA 100 with and without metabolic activation (hamster S9 mix or rat S9 mix).
Positive with metabolic activation in TA1535, but only at very high concentrations of 6666 to 16666 µg/plate, which is above the required limit concentration of 5000 µg/plate.
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