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EC number: 701-249-4 | 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:
- 18th September to 1st December 1996
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study following GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- UV sensitivity of cultures not verified in all experiments; this deviation from the guideline shown (by historical repeatability of results using the same frozen stock cultures) not to affect the validity of the study.
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Phenol, paraalkylation products with C10-15 branched olefins ( C12 rich) derived from propene oligomerization, calcium salts, sulfurized, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalyc dewaxed, light or heavy paraffinic C15-C50
- EC Number:
- 701-249-4
- Molecular formula:
- A molecular formula for this substance does not exist because it is a UVCB. The molecular formula for a theoretical representative structure is C36H58Ca2O4Sx where x = 1-3.
- IUPAC Name:
- Phenol, paraalkylation products with C10-15 branched olefins ( C12 rich) derived from propene oligomerization, calcium salts, sulfurized, including distillates (petroleum), hydrotreated, solvent-refined, solvent-dewaxed, or catalyc dewaxed, light or heavy paraffinic C15-C50
- Details on test material:
Phenol, dodecyl-, sulfurized, calcium salts
Testing was performed on a commercial sample of this material. Typical purity of this material as distributed in commerce is 60% alkyl phenol sulfide and 40% highly refined lubricant base oil.
Constituent 1
Method
- Target gene:
- no data
Species / strain
- Species / strain / cell type:
- other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvrA
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix
- Test concentrations with justification for top dose:
- 100, 250, 500, 1000, 5000 and 10000 µg/plate, with and without S-9
- Vehicle / solvent:
- 25% w/w Pluronic F127 (surfactant, CAS # 9003-11-6) in ethanol
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- other: Vehicle was tested as negative control
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: See table below.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: Bottom agar (25 ml per 15 x 100 mm petri dish) was Vogel-Bonner minimal medium E (Vogel and Bonner, 1956), supplemented with 1.5% (w/v) agar and 0.2% (w/v) glucose.
DURATION
- Preincubation period:
Overnight cultures for use in all testing procedures, will be inoculated by transferring a colony from the appropriate master plate to a flask containing culture medium. Inoculated flasks will be placed in a shaker/incubator which will be programmed to begin operation (shaking, 125 ± 25 rpm; incubation, 37 ± 2°C) so that the overnight cultures are in log phase or late log phase when turbidity monitoring begins.
- Exposure duration:
In the plate incorporation methodology, the test article, the tester strain and the S9 mix (where appropriate) were combined in molten agar which was overlaid onto a minimal agar plate. Following incubation at 37 ± 2 °C for 48 ± 8 hr, revertant colonies were counted. All doses of test article, vehicle controls, and positive controls were plated in triplicate.
DETERMINATION OF CYTOTOXICITY
- Method: The growth inhibitory effect (cytotoxicity) of the test article to the test system will be determined in order to allow the selection of appropriate doses to be tested in the mutagenicity assay. - Evaluation criteria:
- The following criteria will be used to determine a valid assay:
1.Tester Strain Integrity: Salmonella typhimurium
a. uvrB Excision Repair Deletion: To demonstrate the presence of the ma B excision repair deletion, tester strain cultures must exhibit sensitivity to UV light.
b. rfa Wall Mutation: To demonstrate the presence of the rfa wall mutation, tester strain cultures must exhibit sensitivity to crystal violet.
c. pKM 101 Plasmid: To demonstrate the presence of the R-factor plasmid, pKM101, cultures of tester strains TA98 and TA100 must exhibit resistance to ampicillin.
d. Characteristic Number of Spontaneous Revertants: To demonstrate the requirement for histidine, the tester strain cultures must exhibit a characteristic number of spontaneous revertants per plate when plated along with the vehicle under selective conditions.
2. Tester Strain Integrity: Escherichia coli
a. uvrA Excision Repair Deletion: To demonstrate the presence of the uvrA excision repair deletion, tester strains must exhibit sensitivity to UV light.
b. Characteristic Number of Spontaneous Revertants: To demonstrate the requirement for tryptophan, the tester strain culture must exhibit a characteristic number of spontaneous revertants per plate when plated along with the vehicle under selective conditions. The acceptable range for the WP2uvrA mean vehicle control is 5 to 40 revertants per plate.
3. Tester Strain Culture Density: To demonstrate that appropriate numbers of bacteria are plated, the density of tester strain cultures must be greater than or equal to 0.5 x 10ˆ9 bacteria per ml and/or have reached a target level of turbidity demonstrated to produce cultures with a density greater than or equal to 0.5 x 10ˆ9 bacteria per ml.
4. Positive Control Values
a. Positive Control Values in the Absence of S9 Mix
b. Positive Control Values in the Presence of S9 Mix (S9 Mix Integrity)
5. Cytotoxicity
A minimum of three non-toxic dose levels will be required to evaluate assay data - Statistics:
- no data
Results and discussion
Test results
- Species / strain:
- other: S. typhimurium TA 98, TA 100, TA 1535, TA 1537 and E. coli WP2 uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- - Precipitation: Test article precipitate was observed on the plates at 5.00 µg/plate.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Cytotoxic concentration:
With metabolic activation: > 10,000 µg/plate
Without metabolic activation > 10,000 µg/plate
RANGE-FINDING/SCREENING STUDIES:
Doses to be tested in the mutagenicity assay were selected based on the results of the dose rangefinding study conducted on the test article using tester strains TA 100 and WP2uvrA in both the presence and absence of a 10% S9 mix (one plate per dose). Ten doses of test article, from 5,000 to 6.67 µg per plate, were tested. These data were generated in Experiment 17865-Al. No cytotoxicity was observed up to 5,000 µg per plate in the dose rangefinding study with tester strains TA100 and WP2uvrA in either the presence or absence of S9 mix as evidenced by a normal background lawn and no reduction in the number of revertants per plate. Test article precipitate was observed on the plates at 33.3 µg per plate and above with both tester strains in both the presence and absence of S9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
All test validity criteria were satisfied. There was no evidence of cytotoxicity based on condition of the background lawn or revertants/plate data at doses up to 10,000 µg/plate. The greatest mean number of revertants/plate over concurrent controls among all test doses, all strains and for both assays was 100% (TA 1537, next highest 81%) with S-9 and 100% (TA 1535 and 1537, next highest 47%) without S-9. There was no indication of a dose-related decrease or increase of mean revertants/plate.
Applicant's summary and conclusion
- Conclusions:
- Not mutagenic with or without metabolic activation
- Executive summary:
The mutagenic potential of the substance was assessed in an "Ames" test conducted under conditions of GLP and in accordance with OECD guideline 471. The results of the Salmonella - Escherichia coli/Mammalian-Microsome Reverse Mutation Assay with a Confirmatory Assay indicate that, under the conditions of this study, in both an initial and a confirmatory assay, the test article did not cause a positive increase in the number of revertants per plate of any of the tester strains either in the presence or absence of microsomal enzymes prepared from AroclorTM-induced rat liver (S9). No cytotoxicity was observed up to 10,000 µg/plate with the Salmonella tester strains or with WP2uvrA in either the presence or absence of S9 mix. Test article precipitate was observed on the plates at 5.00 µg/plate. The test is therefore considered to have a negative result and the substance is considered non-mutagenic under the conditions of teh test in both the presence and absence of metabolic activation.
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