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Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide
EC number: 903-162-9 | 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:
- 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test conducted according to GLP and following OECD guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide
- EC Number:
- 903-162-9
- IUPAC Name:
- Phenol, paraalkylation products with C12-rich branched olefins derived from propene oligomerisation, reaction products with sulphur monochloride and decene, reaction products with Benzoic acid, 2-hydroxy-,C14-18 alkyl dervis., polybutenyl benzenesulphonic acid, carbon dioxide and calcium hydroxide
- Test material form:
- liquid: viscous
- Details on test material:
- - Material tested was a sample of EC-903-162-9 diluted in base oil. *
- Name of test material (as cited in study report): EC 903-162-9
- Physical state: Dark brown/black viscous liquid
- Lot/batch No.: LN07006926
- Expiration date of the lot/batch: 2013-12-19
- Storage condition of test material: Ambient temperature in the dark
*EC 903-162-9 is exclusively synthesised and handled in solvent oil. Therefore testing was conducted on a sample that contained 40.8% Base oil and 59.2% EC 903-162-9.
Constituent 1
Method
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:
- Aroclor 1254-induced rat liver S9
- Test concentrations with justification for top dose:
- Preliminary Toxicity Assay (with and without metabolic activation): 5000, 3333, 1000, 667, 333, 100, 67, 33, 10, 6.7 µg/plate
Mutagenicity Assay (with and without metabolic activation): 5000, 1500, 500, 150, 50, 25 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: THF (CAS No. 109-99-9, Lot Nos. 48347 and 51154)
Controls
- Negative solvent / vehicle controls:
- yes
- Remarks:
- THF
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Remarks:
- 2-aminoanthracene tested with metabolic activation.
- Details on test system and experimental conditions:
- Solubility Test
A solubility test was conducted to determine the vehicle. The test was conducted, using
water, DMSO, ethanol (EtOH), acetone and THF, to determine the vehicle, selected in order
of preference, that permitted preparation of the highest soluble or workable stock
concentration up to 50 mg/mL for aqueous solvents and up to 500 mg/mL for organic
solvents.
Preliminary Toxicity Assay
The preliminary toxicity assay was used to establish the dose-range over which the test article
would be assayed. Vehicle control and a minimum of eight dose levels of the test article were
plated, one plate per dose, with overnight cultures of TA98, TA100, TA1535, TA1537 and
WP2 uvrA on selective minimal agar in the presence and absence of Aroclor-induced rat
liver S9.
Mutagenicity Assay
The mutagenicity assay was used to evaluate the mutagenic potential of the test article. A
minimum of five dose levels of test article along with appropriate vehicle control and positive
controls were plated with overnight cultures of TA98, TA100, TA1535, TA1537 and WP2 uvrA
in the presence and absence of Aroclor-induced rat liver S9. All dose levels of test article,
vehicle control and positive controls were plated in triplicate.
Plating and Scoring Procedures
The test system was exposed to the test article via the plate incorporation methodology
originally described by Ames et al. (1975) and updated by Maron and Ames (1983).
On the day of its use, minimal top agar, containing 0.8 % agar (W/V) and 0.5 % NaCl (W/V),
was melted and supplemented with L-histidine, D-biotin and L-tryptophan solution to a final
concentration of 50 µM each. Top agar not used with S9 or Sham mix was supplemented with
25 mL of water for each 100 mL of minimal top agar. For the preparation of media and
reagents, all references to water imply sterile, deionized water. Bottom agar was Vogel-Bonner
minimal medium E (Vogel and Bonner, 1956) containing 1.5 % (W/V) agar. Nutrient bottom
agar was Vogel-Bonner minimal medium E containing 1.5 % (W/V) agar and supplemented
with 2.5 % (W/V) Oxoid Nutrient Broth No. 2 (dry powder). Nutrient Broth was Vogel-Bonner
salt solution supplemented with 2.5 % (W/V) Oxoid Nutrient Broth No. 2 (dry powder).
Each plate was labeled with a code system that identified the test article, test phase, dose level,
tester strain and activation, as described in detail in BioReliance's Standard Operating
Procedures.
One-half (0.5) milliliter of S9 or Sham mix, 100 µL of tester strain (cells seeded) and 25 µL of
vehicle or test article dilution were added to 2.0 mL of molten selective top agar at 45±2°C.
After vortexing, the mixture was overlaid onto the surface of 25 mL of minimal bottom agar.
When plating the positive controls, the test article aliquot was replaced by a 50 µL aliquot of
appropriate positive control. After the overlay had solidified, the plates were inverted and
incubated for approximately 48 to 72 hours at 37±2°C. Plates that were not counted
immediately following the incubation period were stored at 2-8°C until colony counting could
be conducted.
The condition of the bacterial background lawn was evaluated for evidence of test article
toxicity by using a dissecting microscope. Precipitate was evaluated by visual examination
without magnification. Toxicity and degree of precipitation were scored relative to the vehicle
control plate using the codes shown in attachment 1.
Revertant colonies for a given tester strain and activation condition, except for positive controls,
were counted either entirely by automated colony counter or entirely by hand unless the assay
was the preliminary toxicity assay or the plate exhibited toxicity. - Evaluation criteria:
- For each replicate plating, the mean and standard deviation of the number of revertants per plate
were calculated and are reported.
For the test article to be evaluated positive, it must cause a dose-related increase in the mean
revertants per plate of at least one tester strain over a minimum of two increasing concentrations
of test article.
Data sets for tester strains TA1535 and TA1537 were judged positive if the increase in mean
revertants at the peak of the dose response was greater than or equal to 3.0-times the mean
vehicle control value. Data sets for tester strains TA98, TA100 and WP2 uvrA were judged
positive if the increase in mean revertants at the peak of the dose response was greater than or
equal to 2.0-times the mean vehicle control value.
An equivocal response is a biologically relevant increase in a revertant count that partially meets
the criteria for evaluation as positive. This could be a dose-responsive increase that does not
achieve the respective threshold cited above or a non-dose responsive increase that is equal to or
greater than the respective threshold cited. A response was evaluated as negative, if it was
neither positive nor equivocal.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle 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
Solubility Test
THF was selected as the solvent of choice based on the solubility of the test article and
compatibility with the target cells. The test article formed a clear solution in THF at
approximately 500 mg/mL, the maximum concentration tested in the solubility test.
Sterility Results
No contaminant colonies were observed on the sterility plates for the vehicle control, the test
article dilutions and the S9 and Sham mixes.
Tester Strain Titer Results
Experiment | TA98 | TA100 | TA1535 | TA1537 | WP2 uvrA |
B1 | 1.6 | 0.8 | 1.0 | 0.7 | 1.5 |
Titer Value (x 109 cells per ml)
Preliminary Toxicity Assay
The results of the preliminary toxicity assay are presented in Tables 1 and 2 (attachment 2). In the preliminary
toxicity assay, the maximum dose tested was 5000 µg per plate; this dose was achieved using a
concentration of 200 mg/mL and a 25 µL plating aliquot. The dose levels tested were 6.7, 10,
33, 67, 100, 333, 667, 1000, 3333 and 5000 µg per plate. Precipitate was observed beginning at
333 µg per plate. No toxicity was observed. Based on the findings of the toxicity assay, the
maximum dose tested in the mutagenicity assay was 5000 µg per plate.
Mutagenicity Assay
The results of the mutagenicity assay are presented in Tables 3 and 4 (attachment 3). These data were
generated in Experiment B1.
In Experiment B1 (Mutagenicity Assay), no positive mutagenic responses were observed with
any of the tester strains in either the presence or absence of S9 activation. The dose levels tested
were 50, 150, 500, 1500 and 5000 µg per plate. Precipitate was observed beginning at 500 µg
per plate. No toxicity was observed.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
All criteria for a valid study were met as described in the protocol. The results of the Bacterial
Reverse Mutation Assay indicate that, under the conditions of this study, EC 903-162-9 did not
cause a positive mutagenic response with any of the tester strains in either the presence or absence
of Aroclor-induced rat liver S9. The study was concluded to be negative without conducting a confirmatory
(independent repeat) assay because no unique metabolism
requirements were known about the test article and because no equivocal responses were
observed in the assay that would suggest further testing was warranted.
At the request of the Sponsor, dosing formulation analysis for concentration and stability was
not conducted. Due to the lack of dose formulation analysis, the interpretation of the study
data was based on the nominal dose levels as documented in the study records and not on the
actual formulated test article concentrations as confirmed by analytical analysis.
Nevertheless, precipitate in the assay demonstrated that the test system was dosed up to the
regulatory-required level. - Executive summary:
An in vitro genetic toxicity study was conducted in accordance with OECD guidelines 471. All critieria for a valid study were met. Under the condition of this study EC 903-162-9 did not cause a positive mutagenic response with any of the tester strains in either the presence or absence of Aroclor-induced rat liver S9. The study was concluded to be negative. The interpretation of the study data was based on the nominal dose levels due to lack of dose formulation analysis for concentration and stability. Nevertheless, precipitate in the assay demonstrated the test system was dosed up to the regulatory-required level.
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