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EC number: 947-684-5 | CAS number: -
- 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:
- key study
- Study period:
- September 30, 2015 to January 22, 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 73138-58-6,73138-59-7,73138-60-0
- IUPAC Name:
- 73138-58-6,73138-59-7,73138-60-0
- Test material form:
- solid: flakes
- Details on test material:
- - Name of test material (as cited in study report): Licowax R 21 S FL
- CAS Number : 73138-58-6,73138-59-7,73138-60-0
- Molecular weight (if other than submission substance): Guerbet reaction Products: 505.6,
Fatty acids, tallow, Guerbet reaction Products, Ca salts: 1049.33, Fatty acids, tallow, Guerbet reaction Products, Na salts: 527.6
- Structural formula attached as image file (if other than submission substance): see attach-1
- Substance type: Fatty acids, tallow, Guerbet reaction Products,
- Physical state:Slightly yellow flakes
- Analytical purity: 99.6 % (w/w)
- Lot/batch No.: DEF2084336
- Expiration date of the lot/batch: November 13, 2018
- Stability under test conditions: Unknown
- Storage condition of test material: Room Temperature (20 to 30oC)
Constituent 1
Method
- Target gene:
- Histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 0.0050, 0.0158, 0.0501, 0.1582 and 0.5 mg/plate both with and without metabolic activation
Controls
- Untreated negative controls:
- yes
- Remarks:
- RO water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethyl Alcohol
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-Nitro-o-phenylenediamine -4-NOPD, 2-Aminoanthracene, 2-AA
- Details on test system and experimental conditions:
- please refer to "Any other information on materials and methods"
- Rationale for test conditions:
- Conditions were chosen based on the results of the pre test.
- Evaluation criteria:
- A test item is considered as a mutagen, if a biologically relevant increase in the number of revertants exceeding the htreshold of twice (strains TA 98, TA 100 and TA 102) or thrice (strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an second experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of solvent control such an increase is not considered biologically relevant. - Statistics:
- none
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Remarks:
- test item Licowax R 21 S FL did not induce gene mutations either by base pair substitution or by frame shifts in the genome of the strains used under the conditions of the assay, with and without metabolic activation
- 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
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Additional information on results
SOLUBILITY AND PRECIPITATION CHECK
To select an appropriate solvent and dose concentration range of the test item to be tested in pre-experiment, solubility and precipitation test were performed.Summary of solubility and precipitation check is as follows:
Solubility Record |
||||
Solvent used |
RO (reverse osmosis) Water |
Dimethyl sulfoxide |
Acetone |
Ethyl alcohol |
Quantity of test item |
50 mg |
50 mg |
50 mg |
50 mg |
Volume of vehicle added |
1mL |
1mL |
1mL |
1mL |
Final Concentration |
50 mg /mL |
50 mg /mL |
50 mg /mL |
50 mg /mL |
Solubility status |
Insoluble |
Insoluble |
Insoluble |
Soluble |
As mentioned in the above table, solubility of test item was checked in RO water, Dimethyl sulfoxide (DMSO), Acetone and found insoluble. So the solubility was checked in Ethyl alcohol. The test item was found soluble in Ethyl alcohol at 50 mg/ml to give final treatment concentration of 5 mg/plate (recommended maximum test concentration for soluble non-cytotoxic substances). Therefore, Ethyl alcohol was chosen as solvent for the study.
Precipitation was checked as insolubility to assess precipitation in the final mixture under the actual test conditions and evident to the unaided eye. Test item dissolved inEthyl alcoholat 50 mg/mL concentration was checked for precipitation. Details are given in table below:
Precipitation Record |
|||
Overlay agar volume |
Test item preparation volume |
Concentration/Plate |
Result |
2 mL |
100 µL |
5 mg |
Precipitation |
2 mL |
75 µL |
3.75 mg |
Precipitation |
2 mL |
50 µL |
2.5 mg |
Precipitation |
2 mL |
25 µL |
1.25 mg |
Precipitation |
2 mL |
12.5 µL |
0.625 mg |
Precipitation |
2 mL |
10 µL |
0.5 mg |
Slight Precipitation |
Different amounts of formulated test item (50 mg/ml) were added to overlay agar (top agar) in test tubes to give various test item concentrations (maximum 5 mg/plate) and plated on minimal glucose agar (MGA) plates. Precipitation was noticed at 5 mg/plate, 3.75 mg/plate, 2.5 mg/plate, 1.25mg/plate and 0.625mg/plate concentration which were assumed to interfere with the scoring. At treatment concentration 0.5 mg/plate slight precipitation was observed which was assumed non-interfering with the scoring. Therefore 0.5 mg/plate selected as highest concentration for pre-experiment
Range finding/Screening
In the pre-experiment, the concentration range of the test item was 0.0002 to 0.5 mg/plate based on the solubility and precipitation test.
No reduction in colony count as well as background lawn in any of the following concentrations tested; 0.0002, 0.0005, 0.0016, 0.0050, 0.0158, 0.0501, 0.1582 and 0.5 mg/plate both in absence and in the presence of metabolic activation, when compared to that of the vehicle control group.
Based on the results of pre-experiment, following doses were selected for the main study trials: 0.0050, 0.0158, 0.0501, 0.1582 and 0.5 mg/plate, both in absence (-S9) and in the presence (+S9) of metabolic activation
Applicant's summary and conclusion
- Conclusions:
- It is concluded that the test item Licowax R 21 S FL did not induce gene mutations either by base pair substitution or by frame shifts in the genome of the strains used under the conditions of the assay, with and without metabolic activation
- Executive summary:
Summary
This study was performed to assess the mutagenic potential of Licowax R 21 S FL to induce gene mutations in comparison to vehicle (solvent) control according to the plate incorporation method (Trial-I) and the pre-incubation method (Trial-II) using the Salmonella typhimurium strains TA 1535, TA 1537, TA 98, TA 100 and TA 102.
The assay was performed in two independent experiments both with and without liver microsomal activation. Each concentration, including the negative, vehicle and positive controls was tested in triplicates. The test item was tested at the following concentrations i.e., 0.0050, 0.0158, 0.0501, 0.1582 and 0.5 mg/plate, both in presence (+S9) and in absence (-S9) of metabolic activation.
No significant increase in revertant colony numbers in any of the tester strains were observed following treatment with Licowax R 21 S FL at any dose level in both the confirmatory trials, neither in the presence nor in the absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
The spontaneous reversion rates in the negative, vehicle and positive controls were within the range of in house historical data.
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