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EC number: 204-110-1 | CAS number: 115-83-3
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 Nov - 17 Dec 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- No test substance purity reported
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted Jul 1997
- Deviations:
- yes
- Remarks:
- no purity of test substance
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Department of the Government of the United Kingdom
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 2,2-bis[[(1-oxodocosyl)oxy]methyl]propane-1,3-diyl didocosanoate
- EC Number:
- 262-895-6
- EC Name:
- 2,2-bis[[(1-oxodocosyl)oxy]methyl]propane-1,3-diyl didocosanoate
- Cas Number:
- 61682-73-3
- Molecular formula:
- C93H180O8
- IUPAC Name:
- 3-(docosanoyloxy)-2,2-bis[(docosanoyloxy)methyl]propyl docosanoate (non-preferred name)
Constituent 1
Method
- Target gene:
- his operon, trp operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbitone and β-naphthoflavone
- Test concentrations with justification for top dose:
- First experiment (served as range finding study):
5, 15, 50, 150, 500, 1500 and 5000 µg/plate without metabolic activation (TA 1535, TA 1537, TA 98 and TA 100)
50, 150, 500, 1500 and 5000 µg/plate without metabolic activation (WP2uvrA)
50, 150, 500, 1500 and 5000 µg/plate with metabolic activation (all strains)
Second experiment:
50, 150, 500, 1500 and 5000 µg/plate with and without metabolic activation (all strains) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: none
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- no
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- N-ethyl-N-nitro-N-nitrosoguanidine
- benzo(a)pyrene
- other: 2-Aminoanthracene: +S9: 1 ,2 or 10 µg/plate for TA 1535, TA 1537, TA 100 and WP2uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3 replicates each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: growth of bacterial background lawn - Evaluation criteria:
- The test material may be considered positive in this test system if the following criteria are met:
The test material should have induced a reproducible, dose-related and statistically (Dunnett's method of linear regression(S)) significant increase in the revertant count in at least one strain of bacteria.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- not applicable
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitation of the test substance was observed at 500 µg/plate and higher for all tester strains with and without metabolic activation
RANGE-FINDING/SCREENING STUDIES: In order to select appropriate dose levels for use in the main study, a preliminary test was carried out to determine the toxicity of the test material. The dose range of the test material was 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 pg/plate. The test material exhibited toxicity at and above 500 µg/plate to tester strain TA 100 (without S9-mix only). This response however, was not observed in either the range-finding or main studies and was therefore considered artefactual and of no toxicological significance.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data: The positive control values were within the range of the historical control data (please refer to Table 1 under "any other information on material and methods incl. tables") except of all three values for TA 98 and a single value for TA100 and TA 1535, respectively, in Experiment I without metabolic activation, a single value for TA 98 in Experiment I with metabolic activation, and all three values for TA 98 in Experiment II with metabolic activation. These deviations were not considered to invalid the test since a distinct increase of the number of revertants was seen when compared with the control values.
- Negative historical control data: The negative control values were within the range of the historical control data (please refer to Table 1 under "any other information on material and methods incl. tables") except of a single value for TA 1535 in Experiment II with metabolic activation, which was not considered to influence the validity of the test.
Any other information on results incl. tables
Table 2: Summar of Results of Experiment I
Test substance concentration (µg/plate) | Number of revertants (mean number of colonies per plate) | Number of revertants (mean number of colonies per plate) | ||||||||
TA 100 | TA 1535 | WP2uvrA | TA 98 | TA 1537 | TA 100 | TA 1535 | WP2uvrA | TA 98 | TA 1537 | |
Without metabolic activation | With metabolic activation | |||||||||
0 | 117 | 24 | 24 | 27 | 13 | 90 | 20 | 15 | 24 | 14 |
73 | 15 | 18 | 18 | 8 | 82 | 14 | 11 | 24 | 20 | |
95 | 12 | 14 | 19 | 6 | 72 | 18 | 15 | 22 | 14 | |
5 | 76 | 28 | nt | 28 | 9 | nt | ||||
73 | 11 | 15 | 11 | |||||||
82 | 22 | 24 | 8 | |||||||
15 | 86 | 18 | nt | 20 | 12 | |||||
63 | 25 | 21 | 11 | |||||||
79 | 9 | 26 | 10 | |||||||
50 | 89 | 16 | 14 | 19 | 10 | 72 | 15 | 15 | 20 | 24 |
101 | 21 | 9 | 17 | 9 | 80 | 22 | 20 | 27 | 7 | |
85 | 15 | 13 | 18 | 18 | 90 | 20 | 23 | 18 | 22 | |
150 | 80 | 15 | 10 | 17 | 11 | 82 | 18 | 17 | 23 | 20 |
95 | 22 | 11 | 22 | 8 | 101 | 24 | 13 | 21 | 18 | |
91 | 22 | 13 | 17 | 15 | 102 | 25 | 17 | 16 | 15 | |
500 P | 99 | 16 | 14 | 28 | 16 | 95 | 18 | 16 | 21 | 22 |
90 | 22 | 10 | 15 | 13 | 81 | 17 | 20 | 23 | 12 | |
94 | 13 | 17 | 18 | 12 | 88 | 25 | 21 | 24 | 10 | |
1500 P | 104 | 19 | 9 | 30 | 13 | 77 | 35 | 10 | 30 | 33 |
115 | 25 | 15 | 21 | 16 | 66 | 13 | 12 | 35 | 12 | |
96 | 21 | 14 | 26 | 14 | 91 | 21 | 21 | 16 | 15 | |
5000 P | 106 | 17 | 19 | 36 | 7 | 114 | 14 | 16 | 33 | 20 |
105 | 15 | 23 | 23 | 14 | 93 | 21 | 13 | 33 | 23 | |
115 | 14 | 28 | 30 | 11 | 89 | 12 | 13 | 26 | 12 | |
Positive controls | ENNG | ENNG | ENNG | 4NQO | 9AA | 2AA | 2AA | 2AA | BP | 2AA |
Concentration (µg/plate) | 3 | 5 | 2 | 0.2 | 80 | 1 | 2 | 10 | 5 | 2 |
No. Colonies | 307 | 158 | 411 | 98 | 584 | 507 | 401 | 788 | 242 | 333 |
297 | 190 | 362 | 101 | 586 | 518 | 292 | 680 | 263 | 373 | |
274 | 182 | 618 | 93 | 769 | 824 | 308 | 716 | 167 | 284 |
ENNG: N-ethyl-N`-nitro-N-nitrosoguanidine
9AA: 9-Aminoacridine
4NQO: 4-Nitroquinoline-1-oxide
BP: Benzo(a)pyrene
2AA: 2-Aminoanthracene
P: Precipitation
Table 3: Summary of results of Experiment II
Test substance concentration (µg/plate) | Number of revertants (mean number of colonies per plate) | Number of revertants (mean number of colonies per plate) | ||||||||
TA 100 | TA 1535 | WP2uvrA | TA 98 | TA 1537 | TA 100 | TA 1535 | WP2uvrA | TA 98 | TA 1537 | |
Without metabolic activation | With metabolic activation | |||||||||
0 | 136 | 14 | 23 | 28 | 11 | 108 | 14 | 24 | 28 | 12 |
130 | 22 | 27 | 23 | 11 | 96 | 9 | 31 | 33 | 8 | |
133 | 18 | 27 | 33 | 8 | 109 | 12 | 30 | 39 | 7 | |
50 | 142 | 14 | 27 | 26 | 5 | 112 | 18 | 19 | 21 | 13 |
140 | 16 | 19 | 23 | 9 | 99 | 16 | 23 | 26 | 9 | |
130 | 18 | 18 | 20 | 10 | 123 | 12 | 26 | 27 | 23 | |
150 | 131 | 13 | 22 | 25 | 6 | 79 | 18 | 26 | 14 | 9 |
156 | 21 | 23 | 23 | 14 | 91 | 5 | 24 | 21 | 4 | |
118 | 20 | 28 | 23 | 6 | 81 | 6 | 24 | 15 | 13 | |
500 P | 157 | 20 | 22 | 17 | 9 | 93 | 14 | 16 | 13 | 13 |
100 | 17 | 19 | 17 | 15 | 92 | 7 | 42 | 17 | 11 | |
103 | 19 | 16 | 25 | 7 | 89 | 20 | 28 | 10 | 10 | |
1500 P | 106 | 13 | 23 | 29 | 8 | 100 | 20 | 24 | 17 | 11 |
91 | 15 | 27 | 16 | 11 | 78 | 21 | 29 | 15 | 16 | |
121 | 21 | 22 | 22 | 22 | 114 | 11 | 26 | 15 | 6 | |
5000 P | 150 | 17 | 35 | 25 | 15 | 104 | 17 | 40 | 27 | 11 |
116 | 15 | 37 | 20 | 6 | 119 | 20 | 39 | 28 | 11 | |
107 | 14 | 37 | 20 | 6 | 90 | 9 | 35 | 18 | 15 | |
Positive controls | ENNG | ENNG | ENNG | 4NQO | 9AA | 2AA | 2AA | 2AA | BP | 2AA |
Concentration (µg/plate) | 3 | 5 | 2 | 0.2 | 80 | 1 | 2 | 10 | 5 | 2 |
No. Colonies | 734 | 215 | 878 | 140 | 980 | 832 | 188 | 260 | 156 | 321 |
589 | 276 | 727 | 159 | 983 | 917 | 186 | 318 | 161 | 310 | |
676 | 248 | 891 | 163 | 926 | 909 | 188 | 336 | 158 | 269 |
ENNG: N-ethyl-N`-nitro-N-nitrosoguanidine
9AA: 9-Aminoacridine
4NQO: 4-Nitroquinoline-1-oxide
BP: Benzo(a)pyrene
2AA: 2-Aminoanthracene
P: Precipitation
Applicant's summary and conclusion
- Conclusions:
- CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008.
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