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EC number: 700-839-9 | 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:
- 11 September - 14 October 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: study performed according GLP and protocol cmpliant with OECD Guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
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:
- 2-octyldodecan-1-ol; 2-octyldodecyl 2-[(2-hydroxypropanoyl)oxy]propanoate; 2-octyldodecyl 2-hydroxypropanoate
- EC Number:
- 700-839-9
- IUPAC Name:
- 2-octyldodecan-1-ol; 2-octyldodecyl 2-[(2-hydroxypropanoyl)oxy]propanoate; 2-octyldodecyl 2-hydroxypropanoate
- Details on test material:
- The test article below was received from the sponsor and assigned the test article number M08-4389.03.
It was stored as indicated by the client-supplied storage conditions until testing commenced. Test article derivation,
characterization and stability was the responsibility of the sponsor.
Name: Cosmol 13
Lot Number: 7-10-A
Storage Conditions: Room Temperature
CPTC ID No.: M08-4389.03
Constituent 1
- Specific details on test material used for the study:
- Lot-Nr. 7-10-A
Storage at room temperature
Method
- Target gene:
- his-
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254 induced rat liver microsomes (S9)
- Test concentrations with justification for top dose:
- 5.0, 1.0, 0.5, 0.1, 0.05 mg/plate
- Vehicle / solvent:
- Isopropyl Alcohol
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- Migrated to IUCLID6: Strain TA100 & 1535
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Migrated to IUCLID6: Strain TA98
- Positive controls:
- yes
- Positive control substance:
- other: ICR 191 Acridine: Strain TA1537
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- Migrated to IUCLID6: Strain E. coli WP2 uvrA
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene w/S9 all strains
- Details on test system and experimental conditions:
- Test Procedure
A Pre-test
Assemble the supplies and equipment needed to perform the test on the day before.
Remove the QUAD plates form the refrigerator, cut off the plastic sleeve and allow to dry upright at room temperature overnight.
Label Minimal Glucose Agar plates and Top Agar tubes with strain number, test identification adn dose, S9 (+/-) and date of test. Be sure to include the diagnostic positive and negative controls.
Adjust the temperature of your water bath or dry block heater to approximately 45 °C.
One Day Prior to the Assay
Label sterile flasks with the strain number (e.g., TA98, TA100, TA1535, TA1537, E.coli WP2 uvrA).
Using aseptic technique, carefully decant approximately 20-25 ml of Oxoid #2 nutrrient broth into Erlenmeyer flasks. To all flasks add ampicillin to final concentration of 25 pg/ml (to 25 ml nutrient broth, 78 µl of an 8 mg/ml solution ).
Remove the STDisc vials from the refrigerator and warm to room temperature before opening.
Remove the vial closure.
Using a sterile loop/needle, pick up one or more discs and drop intro the appropriately labeled flask containing nutient broth.
After the flasks are inoculated, place them on the shaker and incubate at 37°C with the shaker operating at approximately 150 rpm. Incubation must not exceed 16 hours.
After incubation (e.g. on the morning of the assay) remove the flask cultrues and place them in the refrigerator until needed.
The Day of the Assay
Melt the top atar. After melting, place the top agar bottles into a 45°C water bath allow at least 45 minutes for temperature equilibration.
Cultures and the S9 must be placed on ice prior to use and kept on ice throughout the assay.
Prepare the positive controls:
Add one ml of the appropriate solvent to each of the CONTROLCHEM tubes.
Mutagen Strain
Sodium Azide TA100 & 1535
2-Nitrofluorene TA98
ICR 191 Acridine TA1537
Methyl Methanesulfonate E. coli WP2uvrA
2-Aminoanthracene All strains
Perform the dilutions of your test article.
Load the 45°C heating block with sterile 13 *100 mm tubes with closures equal to the number of labeled minimal glucose agar plates. Pipette 2 ml of molten,
45°C, top agar into each tube (top agar containing histidine for all Salmonella strains; top agar with tryptophan for the E. coli strain).
Arrange your previously labeld Minimal Glucose Agar plates by strain and condition.
Decide which strain you are going to begin with. In the scheme shown below it is assumed that TA98 will be used first in a triplicate plate, + and - S9 assay. The S9 Concentration used in the assay will be 10 %.
Assay the test article:
Without S9
Begin with the solvent control; add 100 µl of water or DMSO (or other solvent used to solubilize the test article) to the first three tubes preheated to 37+-2°C. Then, in ascending sequence, add 100 µl of each test article dilution to each additional trio of preheated tubes. Add 500 µl of sterile buffer to each tube.
Add 100 µl of the TA98 culture to the first three tubes (solvent control tubes).
Without delay, gently mix the tube contents using a vortex mixer. Decant the mixture onto the surface of the appropriately labeled Minimal Glucose Agar plate. Do one tube at a time. Immediately upon decantation, gentrly tilt the plate and rotate so as to obtain an even distribution of the plating mixture over the surface of the bottom atar. Place onto a level surface and allow to harden.
Repeat the procedure for each dose of the test article.
With S9
Begin with the solvent control; add 100 µl of water or DMSO (or other solvent used to solubilize the test article) to the first three tubes preheated to 37+-2°C. Then, in ascending sequence, add 100 µl of each test article dilution to each additional trio of preheated tubes. Add 500 µl of sterile buffer to each tube.
Add 500 µl of the previously prepared S9 mix to the first three tubes (solvent control tubes).
Without delay, gently mix the tube contents using a vortex mixer. Decant the mixture onto the surface of the appropriately labeled Minimal Glucose Agar plate. Do one tube at a time. Immediately upon decantation, gentrly tilt the plate and rotate so as to obtain an even distribution of the plating mixture over the surface of the bottom atar. Place onto a level surface and allow to harden.
Repeat the procedure for each dose of the test article.
Repeat the above procedure for each strain
Inoculate the Quad Plates with the Salmonella strains and the Tri Plates with E. coli WP2 uvrA.
Using a sterile loop or swab, wet with the appropriate culture and inoculate each of the four sectors of a Quad PCTM plate using a "Z" inoculation pattern and Tri plate using a "Z" inoculation pattern.
Repeat for each strain. After all plates are inoculated, open the vial containing the crystal violet discs and using forceps or an inoculating loop, place a single disc on the atar surface in Sector II of each of the Quad plates.
Determine the Titer of the Strain Cultures
Arrange sets of 3 sterile tubes with closures for each strain. Pipette 4.95 ml sterile water into each strain.
Usinge your positive displacement pipette, inoculate the first tube with 50 µl of the appropriate strain culture. Mix thoroughly. This tube contains 1: 100 dilution of the sampled culture. Add 50 µl of the 1:100 dilution to the second tube containign 4.95 ml sterile water and mix. The second dilution is 1:10000. Complete the diltions by adding 50 µl of the 1:10000 dilution to the third 4.95 ml tube and mix. The final dilutio is 1:1000000.
Arrange sets of 2 sterile tubes with closures for each strain and place in 45°C water bath. Add 2 ml of molten top agar to each tube.
Using the positive displacement pipette, inoculate the top agar containing tubes with 50 µl of the 1:10000 and 1:000000 dilutions in water, respectively.
Incubate the Assay
Invert the plates and arrange in stacks correspongin to each experimental condition.
Place in a 37°C incubator and continue incubation for approximately 48 h.
Read the Assay
After the incubation period, remove the inverted plates and allow them to come to room temperature.
Colony counting can be performed manually with the aid of a magnifying counter or with an automatic colony counter. depending on the activity of your test, large numbers of colonies may develop in certain dose groups. In some cases, it may be desirable to utilize sector-counting techniques rather than full plate counts.
After counting and recording the results for the test treatments, the diagnostic positive control plates should be counted. Plates should also be examined for bacterial growth inhibition or cytotoxicity in the noted dose level producing the inhibition should be recorded. If any precipitation of the test article is noted in the plates, this information should also be recorded for each dose level.
Examine the cell titer plates. The 5*10^-6 plates should be too numerous to count. In contrast, the 5*10^-8 plates should contaoin approximately 25-100 colonies; - Evaluation criteria:
- Negative (solvent) control Counts
The colonies that grew o the Minimal Glucose Agar plates developed from single cells that had regained their ability to grow in the absence of added histidine. The genetic reversion, form histidine auxotrophy to prototrophy, that enabled those cells to grow in the absence of exogenous histidine might have arisen spontaneously or as the result of a mutation induced by the treatments.
Diagnosic Positive Control Counts
In general, the positive control frequencies should be at least 2.5 times the negative contol counts. Large deviations usually indicate problems with cell management; e.g., high spontaneous frequencies often are paralleled by low induced frequencies. Such eventualities reduce the resolving power of the assay and raise questions regarding the interpretation ot the results of the test treatments.
Phenotypic Confirmation
The Quad plates are prepared with fou different media that provide basic information concerning the genotypes of the strain provided in the kit. Tri plate are used for E. coli WP2 uvrA. By sector, the results should be:
Quad Plate
Sector Observation Genotype
I No growth (all strains) his-
II Zonal inhibition around CV disc (all) rfa
III Profuse growth (all) pKM101
IV No growth pAQ1
Triplate
Sector Observation Genotype
I No growth (all strains) trp-
II Luxuriant Growth trp-
III Inhibition R-factor
Test Article Results
In general, the 2 or 2.5 times over the background "rule-of-thumb" serves as a useful way of distinguishing active mutagens from non-mutagenic test articles. - Statistics:
- The mean and standard deviations will be calculated at each dose level of test article for each test organism.
Results and discussion
Test results
- Key result
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not determined
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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
Table #1: Number of revertants without S-9 activation
Test Strain # | Solvent Control | Positive Control | 5.0 mg sample | 1.0 mg sample | 0.5 mg sample | 0.1 mg sample | 0.05 mg sample |
TA 98 | 24 | 770 | 23 | 25 | 24 | 21 | 23 |
24 | 784 | 24 | 23 | 23 | 25 | 22 | |
23 | 798 | 23 | 23 | 22 | 24 | 25 | |
Average = | 23 | 784 | 23 | 24 | 23 | 23 | 23 |
Std. Deviation = | 1.15 | 14.00 | 0.58 | 1.15 | 1.00 | 2.08 | 1.53 |
Test Strain # | Solvent Control | Positive Control | 5.0 mg sample | 1.0 mg sample | 0.5 mg sample | 0.1 mg sample | 0.05 mg sample |
TA 100 | 88 | 1026 | 87 | 83 | 89 | 80 | 86 |
85 | 1040 | 81 | 84 | 85 | 82 | 82 | |
84 | 1069 | 84 | 83 | 81 | 85 | 84 | |
Average = | 86 | 1045 | 84 | 83 | 85 | 82 | 84 |
Std. Deviation = | 2.08 | 21.93 | 3.00 | 0.58 | 4.00 | 2.52 | 2.00 |
Test Strain # | Solvent Control | Positive Control | 5.0 mg sample | 1.0 mg sample | 0.5 mg sample | 0.1 mg sample | 0.05 mg sample |
TA 1535 | 9 | 456 | 9 | 10 | 12 | 9 | 12 |
10 | 499 | 9 | 9 | 10 | 12 | 10 | |
11 | 485 | 12 | 12 | 8 | 11 | 12 | |
Average = | 10 | 480 | 10 | 10 | 10 | 11 | 11 |
Std. Deviation = | 1.00 | 21.93 | 1.73 | 1.53 | 2.00 | 1.53 | 1.15 |
Test Strain # | Solvent Control | Positive Control | 5.0 mg sample | 1.0 mg sample | 0.5 mg sample | 0.1 mg sample | 0.05 mg sample |
TA 1537 | 9 | 399 | 7 | 8 | 9 | 9 | 7 |
9 | 385 | 9 | 8 | 8 | 9 | 10 | |
8 | 413 | 9 | 10 | 9 | 8 | 9 | |
Average = | 9 | 399 | 8 | 9 | 9 | 9 | 9 |
Std. Deviation = | 0.58 | 14.00 | 1.15 | 1.15 | 0.58 | 0.58 | 1.53 |
Test Strain # | Solvent Control | Positive Control | 5.0 mg sample | 1.0 mg sample | 0.5 mg sample | 0.1 mg sample | 0.05 mg sample |
WP2 uvrA | 27 | 698 | 28 | 25 | 26 | 27 | 25 |
25 | 670 | 26 | 29 | 28 | 24 | 26 | |
28 | 684 | 24 | 27 | 28 | 29 | 29 | |
Average = | 27 | 684 | 26 | 27 | 27 | 27 | 27 |
Std. Deviation = | 1.53 | 14.00 | 2.00 | 2.00 | 1.15 | 2.52 | 2.08 |
Table#2: Number of revertants with S-9 activation
Test Strain # | Solvent Control | Positive Control | 5.0 mg sample | 1.0 mg sample | 0.5 mg sample | 0.1 mg sample | 0.05 mg sample |
TA 98 | 26 | 877 | 28 | 28 | 26 | 27 | 29 |
29 | 869 | 26 | 27 | 26 | 28 | 30 | |
26 | 884 | 28 | 26 | 30 | 28 | 28 | |
Average = | 27 | 877 | 27 | 27 | 27 | 28 | 29 |
Std. Deviation = | 1.73 | 7.51 | 1.15 | 1.00 | 2.31 | 0.58 | 1.00 |
Test Strain # | Solvent Control | Positive Control | 5.0 mg sample | 1.0 mg sample | 0.5 mg sample | 0.1 mg sample | 0.05 mg sample |
TA 100 | 97 | 1083 | 97 | 96 | 98 | 94 | 96 |
94 | 1112 | 93 | 94 | 93 | 98 | 97 | |
93 | 1097 | 93 | 98 | 96 | 98 | 95 | |
Average = | 95 | 1097 | 94 | 96 | 96 | 97 | 96 |
Std. Deviation = | 2.08 | 14.50 | 2.31 | 2.00 | 2.52 | 2.31 | 1.00 |
Test Strain # | Solvent Control | Positive Control | 5.0 mg sample | 1.0 mg sample | 0.5 mg sample | 0.1 mg sample | 0.05 mg sample |
TA 1535 | 13 | 570 | 10 | 12 | 13 | 13 | 15 |
11 | 556 | 10 | 11 | 13 | 9 | 11 | |
11 | 542 | 13 | 10 | 10 | 14 | 14 | |
Average = | 12 | 556 | 11 | 11 | 12 | 12 | 13 |
Std. Deviation = | 1.15 | 14.00 | 1.73 | 1.00 | 1.73 | 2.65 | 2.08 |
Test Strain # | Solvent Control | Positive Control | 5.0 mg sample | 1.0 mg sample | 0.5 mg sample | 0.1 mg sample | 0.05 mg sample |
TA 1537 | 10 | 456 | 12 | 11 | 11 | 10 | 12 |
10 | 426 | 10 | 10 | 10 | 9 | 11 | |
11 | 485 | 9 | 10 | 11 | 13 | 10 | |
Average = | 10 | 456 | 10 | 10 | 11 | 11 | 11 |
Std. Deviation = | 0.58 | 29.50 | 1.53 | 0.58 | 0.58 | 2.08 | 1.00 |
Test Strain # | Solvent Control | Positive Control | 5.0 mg sample | 1.0 mg sample | 0.5 mg sample | 0.1 mg sample | 0.05 mg sample |
WP2 uvrA | 29 | 755 | 27 | 30 | 32 | 29 | 30 |
30 | 741 | 26 | 28 | 30 | 31 | 31 | |
28 | 770 | 31 | 27 | 28 | 27 | 29 | |
Average = | 29 | 755 | 28 | 28 | 30 | 29 | 30 |
Std. Deviation = | 1.00 | 14.50 | 2.65 | 1.53 | 2.00 | 2.00 | 1.00 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
The results in Tables 1 and 2 show that the test strains are sensitive to the positive control mutagens and showed the appropriate mutagenic response (i.e. positive control counts were greater than 2.5 times the negative solvent control). The spontaneous reversion rate was well within the accepted values of each strain, indicating that under the test conditions, the strains were sensitive to the detection of potentially genotoxic agents. the data in Tables 1 and 2 shows that the test article was not cytotoxic to the test system at 5.0, 1.0, 0.5, 0.1 and 0.05 mg. There was no precipitation of the test article noted at any test concentration either with or without S-9 for the test system.
The metabolic activation using the S9 activation mixture shows an active microsomal preparation.
Using the same test conditions, there was no detectable genotoxic activity at the concentrations shown above (i.e. the test article did not show a 2.5 fold increase in counts over the negative solvent control) associated with Cosmol 13 neither in the absence (Table 1) or presence (Table 2) of the S9 enzyme activation.
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