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EC number: 949-812-5 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Density
- Particle size distribution (Granulometry)
- Vapour pressure
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- Solubility in organic solvents / fat solubility
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- Stability in organic solvents and identity of relevant degradation products
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- Stability: thermal, sunlight, metals
- pH
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- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
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- Endpoint summary
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- 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:
- Experimental Starting Date (first day of data collection): 17 August 2018 and Experimental Start Date (first day test substance administered to test system): 21 August 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Alcohols, C12-14 (even numbered), propoxylated, aminated, ethoxylated
- EC Number:
- 949-812-5
- Molecular formula:
- C12H27N(C3H6O)n(C2H4O)m, C14H31N(C3H6O)n(C2H4O)m
- IUPAC Name:
- Alcohols, C12-14 (even numbered), propoxylated, aminated, ethoxylated
- Test material form:
- liquid
- Details on test material:
- Name: XTJ-785, experimental
Lot No.: 9570-2-6738
CAS No.: Not listed
Purity: >92% C1214 alcohol, propoxylated, aminated, ethyoxylated
Expiry Date: No date established
Constituent 1
Method
- Target gene:
- The tester strains used were the Salmonella typhimurium histidine auxotrophs TA98, TA100, TA1535 and TA1537 as described by Ames et al. (1975) and Escherichia coli WP2 uvrA as described by Green and Muriel (1976).
Tester strains TA98 and TA1537 are reverted from histidine dependence (auxotrophy) to histidine independence (prototrophy) by frameshift mutagens. Tester strain TA1535 is reverted by mutagens that cause basepair substitutions. Tester strain TA100 is reverted by mutagens that cause both frameshift and basepair substitution mutations. Specificity of the reversion mechanism in E. coli is sensitive to basepair substitution mutations, rather than frameshift mutations (Green and Muriel, 1976).
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):
- not applicable
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not applicable
- Cytokinesis block (if used):
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9 was used as the metabolic activation system.
- Test concentrations with justification for top dose:
- In the preliminary toxicity assay, the dose levels tested were 1.50, 5.00, 15.0, 50.0, 150, 500, 1500 and 5000 µg per plate. The top dose is determined per the guidelines and solubility of the test substance. Based upon these results, the maximum dose tested in the confirmatory mutagenicity assay was 500 or 1500 µg per plate. In the confirmatory mutagenicity assay, the dose levels tested were 1.50, 5.00, 15.0, 50.0, 150 and 500 µg per plate in the absence of S9 activation and 5.00, 15.0, 50.0, 150, 500 and 1500 µg per plate in the presence of S9 activation.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO (Dimethyl sulfoxide)
- Justification for choice of solvent/vehicle: DMSO was the vehicle of choice based on the solubility of the test substance and compatibility with the target cells. The test substance formed a clear solution in DMSO at a concentration of approximately 500 mg/mL in the solubility test conducted at BioReliance.
- Suplier: Sigma-Aldrich
- Lot number: SHBH9867
- Purity: 99.92%
- Expiration date: Aug 2021
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- vehicle control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- solvent used to prepare positive control (DMSO)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- 2-aminoanthracene: positive control for testing with S9 metabolic activation.
- Untreated negative controls:
- yes
- Remarks:
- vehicle control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- 2-nitrofluorene: positive control for testing of TA98 without metabolic activation.
- Untreated negative controls:
- yes
- Remarks:
- vehicle control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterile water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- sodium azide: positive control for testing of TA100 and TA1535 without metabolic activation.
- Untreated negative controls:
- yes
- Remarks:
- vehicle control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- 9-aminoacridine: positive control for testing of TA1537 without metabolic activation.
- Untreated negative controls:
- yes
- Remarks:
- vehicle control
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- methylmethanesulfonate: positive control for testing of WP2 uvra without metabolic activation.
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: In agar (plate incorporation)
- Cell density at seeding (if applicable): To ensure that appropriate numbers of bacteria are plated, tester strain culture titers must be greater than or equal to 0.3x10E9 cells/mL.
DURATION
- Exposure duration: 48 to 72 hours
NUMBER OF REPLICATIONS: 2 in the preliminary toxicity assay; 3 in the mutagenicity assay.
NUMBER OF CELLS EVALUATED: 1.6 to 3.9 x10E8 cells per plate.
DETERMINATION OF CYTOTOXICITY
- Method: The condition of the bacterial background lawn was evaluated for evidence of test substance toxicity by using a dissecting microscope. Precipitate was evaluated after the incubation period by visual examination without magnification. Toxicity and degree of precipitation were scored relative to the vehicle control plate using the codes shown in the following table. As appropriate, colonies were enumerated either by hand or by machine.
- Evaluation criteria:
- Evaluation of Test Results
For each replicate plating, the mean and standard deviation of the number of revertants per plate were calculated and are reported.
For the test substance 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 substance as specified below:
Strains TA1535 and TA1537
Data sets were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 3.0-times the mean vehicle control value and above the corresponding acceptable vehicle control range.
Strains TA98, TA100 and WP2 uvrA
Data sets were judged positive if the increase in mean revertants at the peak of the dose response was equal to or greater than 2.0-times the mean vehicle control value and above the corresponding acceptable vehicle control range.
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. - Statistics:
- According to the test guidelines, the biological relevance of the results is the criterion for the interpretation of the results, and a statistical evaluation of the results is not regarded as necessary.
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:
- cytotoxicity
- Remarks:
- toxicity observed at >= 50µg per plate w/o metabolic activation and toxicty observed at >= 500 µg per plate with metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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:
- toxicity observed at >= 150µg per plate w/o metabolic activation and toxicty observed at >= 500 µg per plate with metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- 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:
- toxicity observed at >= 150µg per plate w/o metabolic activation and toxicty observed at >= 500 µg per plate with metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- toxicity observed at >= 150µg per plate w/o metabolic activation and toxicty observed at >= 500 µg per plate with metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- 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:
- cytotoxicity
- Remarks:
- toxicity observed at >= 500µg per plate w/o metabolic activation and toxicty observed at 1500 µg per plate with metabolic activation.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: precipitate was observed at 1500 µg per plate.
Any other information on results incl. tables
Sterility Results
No contaminant colonies were observed on the sterility plates for the vehicle control, the test substance dilutions or the S9 and Sham mixes.
Tester Strain Titer Results
Experiment |
Tester Strain |
||||
TA98 |
TA100 |
TA1535 |
TA1537 |
WP2uvrA |
|
Titer Value (x 109cells per mL) |
|||||
B1 |
1.2 |
1.0 |
1.6 |
1.3 |
2.8 |
B2 |
1.3 |
1.1 |
1.5 |
1.3 |
2.7 |
Initial Toxicity-Mutation Assay
The maximum dose of 5000 µg per plate was achieved using a concentration of 100 mg/mL and a 50.0 µL plating aliquot. Precipitate was observed beginning at 1500 µg per plate with all conditions. Toxicity was observed as indicated in the following table:
Tester Strains |
Without metabolic activation (µg per plate) |
With metabolic activation (µg per plate) |
Toxicity |
Toxicity |
|
TA98 |
≥ 150 |
≥ 500 |
TA100 |
≥ 150 |
≥ 500 |
TA1535 |
≥ 50.0 |
≥ 500 |
TA1537 |
≥ 150 |
≥ 500 |
WP2uvrA |
≥ 500 |
≥ 1500 |
No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation.
Confirmatory Mutagenicity Assay
Based upon the results of the initial toxicity-mutation assay, the dose levels selected for the confirmatory mutagenicity assay were 1.50, 5.00, 15.0, 50.0, 150 and 500 µg per plate in the absence of S9 activation and 5.00, 15.0, 50.0, 150, 500 and 1500 µg per plate in the presence of S9 activation.
Precipitate was observed at 1500 µg per plate with all tester strains in the presence of S9 activation. Toxicity was observed as indicated in the following table:
Tester Strains |
Without metabolic activation (µg per plate) |
With metabolic activation (µg per plate) |
Toxicity |
Toxicity |
|
TA98 |
≥ 150 |
≥ 500 |
TA100 |
≥ 150 |
≥ 500 |
TA1535 |
≥ 50.0 |
≥ 500 |
TA1537 |
≥ 150 |
≥ 500 |
WP2uvrA |
≥ 500 |
1500 |
No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation.
Historical Negative and Positive Control Values 2016 revertants per plate |
||||||||||||
Strain |
Control |
Activation |
||||||||||
None |
Rat Liver |
|||||||||||
Mean |
SD |
Min |
Max |
95% CL |
Mean |
SD |
Min |
Max |
95% CL |
|||
TA98 |
Neg |
15 |
5 |
6 |
34 |
5-25 |
22 |
6 |
8 |
42 |
10-34 |
|
Pos |
198 |
174 |
36 |
1826 |
|
287 |
159 |
47 |
1916 |
|
||
TA100 |
Neg |
90 |
12 |
60 |
146 |
66-114 |
94 |
14 |
63 |
181 |
66-122 |
|
Pos |
629 |
159 |
186 |
1383 |
|
620 |
294 |
192 |
3483 |
|
||
TA1535 |
Neg |
12 |
4 |
3 |
31 |
4-20 |
12 |
4 |
3 |
26 |
4-20 |
|
Pos |
541 |
164 |
34 |
1082 |
|
150 |
122 |
27 |
1114 |
|
||
TA1537 |
Neg |
8 |
3 |
1 |
21 |
2-14 |
9 |
3 |
2 |
23 |
3-15 |
|
Pos |
368 |
227 |
21 |
1791 |
|
91 |
90 |
17 |
951 |
|
||
WP2uvrA |
Neg |
24 |
7 |
7 |
44 |
10-38 |
27 |
7 |
8 |
51 |
13-41 |
|
Pos |
336 |
119 |
25 |
876 |
|
300 |
111 |
41 |
1059 |
|
||
SD=standard deviation; Min=minimum value; Max=maximum value; 95% CL = Mean ±2 SD (but not less than zero); Neg=negative control (including but not limited to deionized water, dimethyl sulfoxide, ethanol and acetone); Pos=positive control |
Applicant's summary and conclusion
- Conclusions:
- 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, Alcohols, C12-14 alkyl ethers, propoxylated, aminated, ethoxylated 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.
- Executive summary:
The test substance, Alcohols, C12-14 alkyl ethers, propoxylated, aminated, ethoxylated, was tested to evaluate its mutagenic potential by measuring its ability to induce reverse mutations at selected loci of several strains ofSalmonella typhimuriumand at the tryptophan locus of Escherichia coli strain WP2 uvrA in the presence and absence of an exogenous metabolic activation system. Dimethyl sulfoxide (DMSO) was used as the vehicle.
In the initial toxicity-mutation assay, the dose levels tested were 1.50, 5.00, 15.0, 50.0, 150, 500, 1500 and 5000 µg per plate. Precipitate was observed beginning at 1500 µg per plate with all conditions. Toxicity was observed beginning at 50.0, 150, 500 or 1500 µg per plate with all conditions. No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation. Based upon these results, the maximum dose tested in the confirmatory mutagenicity assay was 500 or 1500 µg per plate.
In the confirmatory mutagenicity assay, the dose levels tested were 1.50, 5.00, 15.0, 50.0, 150 and 500 µg per plate in the absence of S9 activation and 5.00, 15.0, 50.0, 150, 500 and 1500 µg per plate in the presence of S9 activation. Precipitate was observed at 1500 µg per plate with all tester strains in the presence of S9 activation. Toxicity was observed beginning at 50.0, 150, 500 or 1500 µg per plate with all conditions. No positive mutagenic responses were observed with any of the tester strains in either the presence or absence of S9 activation.
These results indicate Alcohols, C12-14 alkyl ethers, propoxylated, aminated, ethoxylated was negative for the ability to induce reverse mutations at selected loci of several strains ofSalmonella typhimuriumand at the tryptophan locus ofEscherichia colistrain WP2 uvrA in the presence and absence of an exogenous metabolic activation system.
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