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EC number: 241-646-5 | CAS number: 17671-27-1
- 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
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:
- 30 Nov - 13 Dec 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted in 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Hessisches Ministerium für Umwelt, ländlichen Raum und Verbraucherschutz, Wiesbaden, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Docosyl docosanoate
- EC Number:
- 241-646-5
- EC Name:
- Docosyl docosanoate
- Cas Number:
- 17671-27-1
- Molecular formula:
- C44H88O2
- IUPAC Name:
- docosyl docosanoate
- Test material form:
- solid
Constituent 1
Method
- Target gene:
- his operon (for S. typhimurium strains) and 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
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source: Trinova Biochem GmbH, Giessen, Germany
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source: Trinova Biochem GmbH, Giessen, Germany
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- Type: Cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with 80 mg/kg bw phenobarbital i.p. (Desitin, Hamburg, Germany) and 13-naphthoflavone p.o. (Aldrich, Steinheim, Germany) each on three consecutive days
- source of S9 : male Wistar Hanlbm rats, 8 - 12 weeks old, approx. 220 - 320 g
- quality controls of S9: checked regularly - Test concentrations with justification for top dose:
- Experiment I: 3, 10, 33, 100, 333, 1000, 2500 and 5000 µg/plate
Experiment II: 33, 100, 333, 1000, 2500 and 5000 µg/plate
Concentrations in Experiment II were chosen as no toxic effects were observed at 5000 µg/plate in Experiment I. - Vehicle / solvent:
- - Vehicle used: acetone (MERCK, Darmstadt, Germany, purity > 99%)
- Justification for choice of solvent/vehicle: Chosen based on solubility properties and its relative non-toxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration: triplicate
- Number of independent experiments : two
METHOD OF TREATMENT/ EXPOSURE:
- Test substance added in medium; in agar (plate incorporation, Experiment I) and preincubation (Experiment II)
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period: 1 h at 37 °C (Experiment II)
- Exposure duration/duration of treatment: 48 h at 37 °C
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Method: Inspection of the bacterial background lawn - Evaluation criteria:
- The test material may be considered positive in this test system if the following criteria are met.
For the test item to be considered mutagenic, two-fold (or more) increases in mean revertant numbers must be observed at two consecutive dose levels or at the highest practicable dose level only. In addition, there must be evidence of a dose-response relationship showing increasing numbers of mutant colonies with increasing dose levels. An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment. All cultures must demonstrate the characteristic mean number of spontaneous revertants in the vehicle controls. - Statistics:
- Mean values and standard deviation were calculated.
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:
- Precipitation at and above 333 µg/plate in experiment I and at and above 33 µg/plate in experiment II, each +/- S9.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In experiment II at and above 1000 µg/plate, with and without S9 mix; precipitation at and above 333 µg/plate in experiment I and at and above 33 µg/plate in experiment II, each +/- S9.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- In experiment II at and above 2500 µg/plate, without S9 mix; precipitation at and above 333 µg/plate in experiment I and at and above 33 µg/plate in experiment II, each +/- S9.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- 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:
- Precipitation at and above 333 µg/plate in experiment I and at and above 33 µg/plate in experiment II, each +/- S9.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- 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
- Remarks:
- Precipitation at and above 333 µg/plate in experiment I and at and above 33 µg/plate in experiment II, each +/- S9.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: The test item is poorly soluble in water; hence, DMSO was chosen to prepare the dosing suspensions.
- Precipitation and time of the determination: The test item precipitated in the overlay agar in the test tubes at and above 1000 µg/plate in Experiment I and at and above 2500 µg/plate in Experiment II. Precipitation of the test item was observed on the incubated agar plates at and above 333 µg/plate in Experiment I and at and above 33 µg/plate in experiment II with and without metabolic activation. The undissolved particles had no effect on the data recording.
RANGE-FINDING/SCREENING STUDIES:
In the range finding test, the substance was tested up to 5000 µg/plate in the absence and presence of S9 mix in all S. typhimurium and E. coli strains. No reduction of the bacterial lawn and no biologically relevant decrease in the number of revertants were observed. The highest concentration analysed was selected based on the solubility of the test substance in the cell culture medium. Since the range finding experiment was conducted using the acutal experimental conditions and fulfilled all acceptability and evaluation criteria, it was considered as Experiment I.
STUDY RESULTS
- Concurrent vehicle negative and positive control data are reported in a separate pdf document attached under 'Attached background material'.
Ames test:
- Individual plate counts and mean number of revertant colonies per plate and standard deviations are reported in a separate pdf document attached under 'Attached background material'.
HISTORICAL CONTROL DATA
- Positive and negative (solvent/vehicle) historical control data are reported in Table 1 under 'Any other information on results incl. tables'.
Any other information on results incl. tables
Table 1: Historical control data
Strain | Control | without S9 mix | with S9 mix | ||||||
Mean | SD | Min | Max | Mean | SD | Min | Max | ||
TA 1535 | Solvent control | 17 | 4.51 | 7 | 40 | 21 | 4.95 | 8 | 41 |
Negative control | 17 | 4.57 | 9 | 34 | 21 | 5.55 | 9 | 42 | |
Positive control | 1878 | 203.83 | 852 | 2347 | 270 | 83.95 | 98 | 636 | |
TA1537 | Solvent control | 11 | 2.91 | 6 | 23 | 16 | 4.19 | 6 | 35 |
Negative control | 11 | 2.97 | 6 | 24 | 17 | 4.97 | 7 | 37 | |
Positive control | 125 | 41.01 | 75 | 424 | 180 | 64.61 | 73 | 475 | |
TA98 | Solvent control | 32 | 6.78 | 18 | 66 | 40 | 6.24 | 24 | 64 |
Negative control | 35 | 6.67 | 17 | 62 | 41 | 6.56 | 23 | 67 | |
Positive control | S-34 | 163.95 | 172 | 1916 | 1193 | 491.42 | 184 | 2759 | |
TA 100 | Solvent control | 138 | 25.59 | 84 | 213 | 157 | 27.89 | 94 | 254 |
Negative control | 145 | 21.66 | 97 | 210 | 161 | 25.76 | 94 | 217 | |
Positive control | 1953 | 492.35 | 572 | 2943 | 1763 | 713.99 | 542 | 3886 | |
WP2uvrA | Solvent control | 50 | 8.32 | 32 | 82 | 63 | 8.86 | 39 | 90 |
Negative control | 50 | 7 .89 | 34 | 76 | 63 | 8.53 | 44 | 89 | |
Positive control | 913 | 460.35 | 191 | 2023 | 327 | 128.21 | 161 | 1345 |
Mean: mean value of revertants/plate
SD: standard deviation
Min: minimal value
Max: maximal value
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
A reliable study conducted in accordance with OECD guideline 471 and GLP found the test material not to induce gene mutation in bacteria. No base substitution or frame shift mutations were detected in S. typhimurium and E. coli strains.
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