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EC number: 298-680-9 | CAS number: 93820-97-4
- 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
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- Endpoint summary
- Stability
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- 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
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- 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:
- 26 Sep - 18 Oct 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- National Institute of Pharmacy, Budapest, Hungary
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Docosyl stearate
- EC Number:
- 244-971-0
- EC Name:
- Docosyl stearate
- Cas Number:
- 22413-03-2
- Molecular formula:
- C40H80O2
- IUPAC Name:
- docosyl octadecanoate
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium strains), trp operon (for E. coli strains)
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 phenobarbital and β-naphthoflavone
- Test concentrations with justification for top dose:
- Pre-experiment for toxicity:
10, 31.6, 100, 316, 1000, 2500 and 5000 µg/plate with and without metabolic activation for TA98 and TA100
Based on the results of the pre-experiment the following concentrations were chosen for the main experiment for all strains:
First experiment: 5, 15.81, 50, 158.1, 500, 1581 and 5000 µg/plate with and without metabolic activation
Second experiment: 1.581, 5, 15.81, 50, 158.1, 500, 1581 and 5000 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Solvents used: DMF
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-1,2-phenylene-diamine: -S9: 4 µg/plate for TA98; 2-aminoanthracene: +S9: 2 µg/plate for all S. typhimurium strains and 50 µg/plate for WP2uvrA
- Remarks:
- The biological activity in the Salmonella assay of S9 was characterized using the two mutagens 2-Aminoanthracene and Benzo(a)pyrene, that requires metabolic activation by microsomal enzymes. The batch of S9 used in this study functioned appropriately.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation, 1st experiment); preincubation (2nd experiment)
DURATION
- Preincubation period: 20 min (preincubation method)
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: Triplicates each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: number of revertant colonies - Evaluation criteria:
- The colony numbers on the untreated / negative (vehicle/solvent) / positive control and test item treated plates were determined by manual counting. Visual examination of the plates was also performed; precipitation or signs of growth inhibition (if any) were recorded and reported. The mean number of revertants per plate, the standard deviation and the mutation factor (mean number of revertants on the test item plate / mean number of revertants on the vehicle control plate) values were calculated for each concentration level of the test item and for the controls using Microsoft ExcelTM software.
Criteria for Validity:
The study was considered valid if:
- the number of revertant colonies of the negative (vehicle/solvent) and positive controls were in the historical control range in all strains of the main tests;
- at least five analyzable concentrations were presented in all strains of the main tests.
Criteria for a Positive Response:
A test item was considered mutagenic if:
- a dose–related increase in the number of revertants occurred and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurred in at least one strain with or without metabolic activation.
An increase was considered biologically relevant if:
- in all strains: the number of reversion was more than two times higher than the reversion rate of the negative (solvent) control.
According to the guidelines, statistical method may be used as an aid in evaluating the test results. However, statistical significance should not be the only determining factor for a positive response.
Criteria for a Negative Response:
A test article was considered non-mutagenic if it produced neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups, with or without metabolic activation.
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
- Remarks:
- Reduced background lawn was observed at 1581 µg/plate without metabolic activation in the pre-incubation method.
- Vehicle controls validity:
- valid
- 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
- Remarks:
- Slightly reduced and reduced background lawn was observed at 1581 and 5000 µg/plate without metabolic activation in the pre-incubation method, respectively.
- Vehicle controls validity:
- valid
- 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
- Remarks:
- Reduced background lawn was observed at 5000 µg/plate without metabolic activation in the pre-incubation method.
- Vehicle controls validity:
- valid
- 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
- Remarks:
- Slightly reduced background lawn was observed at 158.1 µg/plate and higher without metabolic activation in the pre-incubation method.
- Vehicle controls validity:
- valid
- 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:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: Precipitate or slight precipitate was observed in all tester strains at 1581 and 5000 µg/plate with and without metabolic activation.
RANGE-FINDING/SCREENING STUDIES: Lower or slightly reduced numbers of revertant colonies (compared to the solvent control plates) were observed in Salmonella typhimurium TA98 bacterial strain with metabolic activation, although no effect on the background lawn was observed. However, they had no biological significance, and this fact did not affect the proper dose selection.
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 and therefore considered to be valid (please refer to table 1 under "any other information on materials and methods incl. tables").
- Negative (solvent/vehicle) historical control data: The negative control values were within the range of the historical control data and therefore considered to be valid (please refer to table 1 under "any other information on materials and methods incl. tables").
Any other information on results incl. tables
Table 2: Results of the pre-experiment for toxicity
Concentrations (µg/plate) | Mean values of revertants / Mutation factor (MF) | Salmonella typhimuriumtester strains | |||
TA98 | TA100 | ||||
-S9 | +S9 | -S9 | +S9 | ||
Untreated control | Mean | 17.0 | 20.3 | 121.0 | 125.3 |
MF | 0.98 | 0.51 | 1.08 | 0.87 | |
Distilled water control | Mean | - | - | 114.7 | - |
MF | - | - | 1.02 | - | |
DMSO control |
Mean | 19.7 | 19.7 | - | 153.0 |
MF | 1.13 | 0.49 | - | 1.06 | |
DMF control |
Mean | 17.3 | 40.0 | 112.3 | 143.7 |
MF | 1.00 | 1.00 | 1.00 | 1.00 | |
5000 | Mean | 15.0 | 25.7 | 96.0 | 103.3 |
MF | 0.87 | 0.64 | 0.85 | 0.72 | |
2500 | Mean | 17.3 | 18.3 | 122.0 | 117.7 |
MF | 1.00 | 0.46 | 1.09 | 0.82 | |
1000 | Mean | 15.0 | 17.7 | 115.0 | 124.7 |
MF | 0.87 | 0.44 | 1.02 | 0.87 | |
316 | Mean | 15.0 | 18.3 | 123.0 | 141.0 |
MF | 0.87 | 0.46 | 1.09 | 0.98 | |
100 | Mean | 15.7 | 17.0 | 134.0 | 149.3 |
MF | 0.90 | 0.43 | 1.19 | 1.04 | |
31.6 | Mean | 14.0 | 21.7 | 121.0 | 130.7 |
MF | 0.81 | 0.54 | 1.08 | 0.91 | |
10 | Mean | 17.0 | 24.0 | 134.3 | 123.7 |
MF | 0.98 | 0.60 | 1.20 | 0.86 | |
NPD (4 µg) | Mean | 235.3 | - | - | - |
MF | 11.97 | - | - | - | |
2AA (2 µg) | Mean | - | 2444.0 | - | 2794.7 |
MF | - | 124.27 | - | 18.27 | |
SA (2 µg) | Mean | - | - | 1273.3 | - |
MF | - | - | 11.10 | - |
NPD: 4-nitro-1,2-phenylene-diamine
2AA: 2-aminoanthracene
SA: sodium azide
MF: mutation factor
Table 3: Summary of Experiment I (plate incorporation)
Concentrations (µg/plate) | Mean values of revertants / Mutation factor (MF) | Salmonella typhimuriumtester strains | Escherichia coli | ||||||||
TA98 | TA100 | TA1535 | TA1537 | WP2uvrA | |||||||
-S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | ||
Untreated control | Mean | 25.7 | 29.3 | 111.0 | 127.3 | 9.0 | 10.0 | 8.0 | 9.7 | 25.7 | 39.0 |
MF | 1.60 | 1.06 | 0.89 | 0.91 | 0.87 | 1.20 | 0.75 | 1.21 | 1.40 | 1.27 | |
Distilled water control | Mean | - | - | 124.0 | - | 7.3 | - | - | - | 25.3 | - |
MF | - | - | 0.99 | - | 0.71 | - | - | - | 1.38 | - | |
DMSO control |
Mean | 21.0 | 36.3 | - | 210.7 | - | 7.7 | 8.0 | 8.3 | - | 46.7 |
MF | 1.31 | 1.31 | - | 1.50 | - | 0.92 | 0.75 | 1.04 | - | 1.52 | |
DMF control |
Mean | 16.0 | 27.7 | 125.3 | 140.3 | 10.3 | 8.3 | 10.7 | 8.0 | 18.3 | 30.7 |
MF | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | |
5000 | Mean | 21.0 | 26.3 | 104.7 | 123.3 | 8.3 | 11.3 | 9.7 | 7.7 | 23.0 | 41.3 |
MF | 1.31 | 0.95 | 0.84 | 0.88 | 0.81 | 1.36 | 0.91 | 0.96 | 1.25 | 1.35 | |
1581 | Mean | 29.3 | 26.3 | 115.3 | 126.0 | 11.7 | 11.0 | 7.0 | 8.7 | 27.0 | 33.7 |
MF | 1.83 | 0.95 | 0.92 | 0.90 | 1.13 | 1.32 | 0.66 | 1.08 | 1.47 | 1.10 | |
500 | Mean | 22.3 | 26.0 | 123.0 | 151.7 | 7.7 | 6.0 | 11.7 | 9.0 | 27.7 | 39.7 |
MF | 1.40 | 0.94 | 0.98 | 1.08 | 0.74 | 0.72 | 1.09 | 1.13 | 1.51 | 1.29 | |
158.1 | Mean | 25.3 | 30.0 | 133.0 | 151.0 | 7.3 | 7.0 | 7.7 | 8.3 | 24.3 | 36.3 |
MF | 1.58 | 1.08 | 1.06 | 1.08 | 0.71 | 0.84 | 0.72 | 1.04 | 1.33 | 1.18 | |
50 | Mean | 23.7 | 26.0 | 130.0 | 151.7 | 6.7 | 8.3 | 8.0 | 8.0 | 29.3 | 33.0 |
MF | 1.48 | 0.94 | 1.04 | 1.08 | 0.65 | 1.00 | 0.75 | 1.00 | 1.60 | 1.08 | |
15.81 | Mean | 21.0 | 22.0 | 122.7 | 134.7 | 5.3 | 10.0 | 7.3 | 10.3 | 30.7 | 39.3 |
MF | 1.31 | 0.80 | 0.98 | 0.96 | 0.52 | 1.20 | 0.69 | 1.29 | 1.67 | 1.28 | |
5 | Mean | 19.3 | 25.3 | 119.3 | 139.0 | 4.7 | 9.3 | 8.3 | 5.3 | 28.7 | 32.7 |
MF | 1.21 | 0.92 | 0.95 | 0.99 | 0.45 | 1.12 | 0.78 | 0.67 | 1.56 | 1.07 | |
NPD (4 µg) | Mean | 289.3 | - | - | - | - | - | - | - | - | - |
MF | 13.78 | - | - | - | - | - | - | - | - | - | |
2AA (2 µg) | Mean | - | 2400.0 | - | 2273.3 | - | 214.0 | - | 125.3 | - | - |
MF | - | 66.06 | - | 10.79 | - | 27.91 | - | 15.04 | - | - | |
2AA (50 µg) | Mean | - | - | - | - | - | - | - | - | - | 253.3 |
MF | - | - | - | - | - | - | - | - | - | 5.43 | |
SA (2 µg) | Mean | - | - | 1244.0 | - | 1101.3 | - | - | - | - | - |
MF | - | - | 10.03 | - | 150.18 | - | - | - | - | - | |
9AA (50 µg) | Mean | - | - | - | - | - | - | 509.3 | - | - | - |
MF | - | - | - | - | - | - | 63.67 | - | - | - | |
MMS (2 µL) | Mean | - | - | - | - | - | - | - | - | 1037.3 | - |
MF | - | - | - | - | - | - | - | - | 40.95 | - |
NPD: 4-nitro-1,2-phenylene-diamine
9AA: 9-aminoacridine
2AA: 2-aminoanthracene
SA: sodium azide
MMS: methylmethanesulfonate
MF: mutation factor
Table 4: Summary of Experiment II (pre-incubation method)
Concentrations (µg/plate) | Mean values of revertants / Mutation factor (MF) | Salmonella typhimuriumtester strains | Escherichia coli | ||||||||
TA98 | TA100 | TA1535 | TA1537 | WP2uvrA | |||||||
-S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | ||
Untreated control | Mean | 22.0 | 26.7 | 110.0 | 122.3 | 7.0 | 11.0 | 5.7 | 12.0 | 34.0 | 38.3 |
MF | 1.10 | 1.10 | 1.47 | 1.22 | 0.72 | 1.10 | 0.81 | 1.24 | 1.00 | 1.02 | |
Distilled water control | Mean | - | - | 119.0 | - | 7.0 | - | - | - | 44.3 | - |
MF | - | - | 1.59 | - | 0.72 | - | - | - | 1.30 | - | |
DMSO control |
Mean | 21.7 | 29.3 | - | 132.0 | - | 12.7 | 8.0 | 8.0 | - | 42.3 |
MF | 1.08 | 1.21 | - | 1.31 | - | 1.27 | 1.14 | 0.83 | - | 1.12 | |
DMF control |
Mean | 20.0 | 24.3 | 75.0 | 100.7 | 9.7 | 10.0 | 7.0 | 9.7 | 34.0 | 37.7 |
MF | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | 1.00 | |
5000 | Mean | 12.3 | 21.0 | 57.0 | 94.3 | 7.7 | 9.3 | 5.3 | 11.3 | 29.7 | 28.7 |
MF | 0.62 | 0.86 | 0.76 | 0.94 | 0.79 | 0.93 | 0.76 | 1.17 | 0.87 | 0.76 | |
1581 | Mean | 18.0 | 21.3 | 81.0 | 99.7 | 6.7 | 6.7 | 5.3 | 8.7 | 20.3 | 32.0 |
MF | 0.90 | 0.88 | 1.08 | 0.99 | 0.69 | 0.67 | 0.76 | 0.90 | 0.60 | 0.85 | |
500 | Mean | 14.3 | 20.3 | 76.3 | 99.7 | 7.7 | 9.0 | 8.0 | 8.0 | 30.0 | 30.3 |
MF | 0.72 | 0.84 | 1.02 | 0.99 | 0.79 | 0.90 | 1.14 | 0.83 | 0.88 | 0.81 | |
158.1 | Mean | 16.7 | 18.0 | 52.0 | 91.3 | 6.0 | 8.0 | 2.0 | 6.3 | 31.0 | 35.0 |
MF | 0.83 | 0.74 | 0.69 | 0.91 | 0.62 | 0.80 | 0.29 | 0.66 | 0.91 | 0.93 | |
50 | Mean | 10.7 | 24.3 | 83.0 | 93.0 | 4.3 | 7.7 | 2.7 | 9.3 | 22.3 | 36.3 |
MF | 0.53 | 1.00 | 1.11 | 0.92 | 0.45 | 0.77 | 0.38 | 0.97 | 0.66 | 0.96 | |
15.81 | Mean | 16.0 | 23.7 | 58.3 | 101.3 | 7.0 | 10.3 | 5.7 | 7.3 | 27.0 | 36.7 |
MF | 0.80 | 0.97 | 0.78 | 1.01 | 0.72 | 1.03 | 0.81 | 0.76 | 0.79 | 0.97 | |
5 | Mean | 14.7 | 17.7 | 80.7 | 91.0 | 5.3 | 7.3 | 6.3 | 7.7 | 24.3 | 32.3 |
MF | 0.73 | 0.73 | 1.08 | 0.90 | 0.55 | 0.73 | 0.90 | 0.79 | 0.72 | 0.86 | |
1.581 | Mean | 15.3 | 23.7 | 63.3 | 97.0 | 5.3 | 7.3 | 7.0 | 5.7 | 23.0 | 32.7 |
MF | 0.77 | 0.97 | 0.84 | 0.96 | 0.55 | 0.73 | 1.00 | 0.59 | 0.68 | 0.87 | |
NPD (4 µg) | Mean | 298.7 | - | - | - | - | - | - | - | - | - |
MF | 13.78 | - | - | - | - | - | - | - | - | - | |
2AA (2 µg) | Mean | - | 2374.7 | - | 2468.0 | - | 192.3 | - | 207.3 | - | - |
MF | - | 80.95 | - | 18.70 | - | 15.18 | - | 25.92 | - | - | |
2AA (50 µg) | Mean | - | - | - | - | - | - | - | - | - | 235.3 |
MF | - | - | - | - | - | - | - | - | - | 5.56 | |
SAZ (2 µg) | Mean | - | - | 1202.7 | - | 1134.7 | - | - | - | - | - |
MF | - | - | 10.11 | - | 162.10 | - | - | - | - | - | |
9AA (50 µg) | Mean | - | - | - | - | - | - | 364.0 | - | - | - |
MF | - | - | - | - | - | - | 45.50 | - | - | - | |
MMS (2 µL) | Mean | - | - | - | - | - | - | - | - | 1102.7 | - |
MF | - | - | - | - | - | - | - | - | 24.87 | - |
NPD: 4-nitro-1,2-phenylene-diamine
9AA: 9-aminoacridine
2AA: 2-aminoanthracene
SA: sodium azide
MMS: methylmethanesulfonate
MF: mutation factor
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the conducted study, the test substance did not show mutagenic properties in S. typhimurium TA 1535, TA 1537, TA 100, TA 98 and E. coli WP2 uvrA with and without metabolic activation.
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