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Registration Dossier
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EC number: 942-520-9 | CAS number: -
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
The substance Guerbet alcohols, C24-26, branched and cyclic did not cause gene mutations in bacteria or in Chinese hamster V79 cells (CHO/HPRT), nor
induced micronuclei in human lymphocytes
All studies were performed in the absence and presence of metabolic activation, according to OECD Guidelines. Thus, Guerbet alcohols, C24-26, branched and cyclic is not considered to be genotoxic.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July to September 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- 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
- Species / strain / cell type:
- S. typhimurium, other: TA97a
- Species / strain / cell type:
- S. typhimurium TA 98
- Species / strain / cell type:
- S. typhimurium TA 100
- Species / strain / cell type:
- S. typhimurium TA 102
- Species / strain / cell type:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 from the livers male Sprague-Dawley rats, treated with 500 mg Aroclor 1254/kg bw
- Test concentrations with justification for top dose:
- First experiment: 5000 /1500 / 500 / 150 / 50 µg/plate
second experiment: 5000 / 2500 / 1250 / 625 / 312 / 156 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: In a preliminary test, the solubility of the test item was determined in demineralised water, DMSO and ethanol. The test item is only soluble in ethanol in a concentration of 50 g/L. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO and ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitro-1,2-phenylene Diamine, 20 µg/plate, with strains TA97a, TA98 and TA102; Sodium Azide, 1 µg/plate with strains TA100 and TA1535
- Remarks:
- without metabolic activation
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO and ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Amino-anthracene, 1 µg/plate, with strains TA97a, TA100, TA102 and TA1535; Benzo-a-pyrene, 20 µg/plyte with strain TA98
- Remarks:
- with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation in the first experiment; preincubation in the second experiment
DURATION
- Preincubation period: 20 min (only in the second experiment)
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY:
- Method:in the main experiments: evaluation of background lawn, reduction in number of revertants in comparison to negativ/solvents control
OTHER EXAMINATIONS:
- Visual counting of mutant colonies, a spreadsheet software (Microsoft Excel) was used to calculate mean values and standard deviations.
- Quality control of bacterial strains: genotype confirmation for each batch of bacteria before stock culture preparation: all bacterial strains were tested for histidine requirement, ampicillin resistence, crystal violet sensitivity, UV sensitivity and spontaneous revertants, furthermore the following examinations were performed: determination of titre, toxicity control, sterility control and positive control - Evaluation criteria:
- The colonies were counted visually, the numbers were recorded. A spreadsheet software (Microsoft Excel®) was used to calculate mean values and standard deviations of each treatment, solvent control and positive control. The increase factor f(I) of revertant induction (mean revertants divided by mean spontaneous revertants) and the absolute number of revertants (revertants less mean spontaneous revertants) were also calculated.
A substance is considered to have mutagenic potential, if a reproducible increase of revertant colonies per plate in at least one strain exceeding an increase factor of 2 (in tester strains TA 97a, TA98, TA100 and TA102) and an increase factor of 3 (in tester strain TA1535) as compared to the reversion rate of the solvent control can be observed. A concentration-related increase over the range tested can also be taken as a sign of mutagenic activity. - Statistics:
- not performed
- Key result
- Species / strain:
- S. typhimurium, other: TA 97a
- 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
- Key result
- Species / strain:
- S. typhimurium TA 98
- 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
- Key result
- Species / strain:
- S. typhimurium TA 100
- 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
- Key result
- Species / strain:
- S. typhimurium TA 102
- 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
- Species / strain:
- S. typhimurium TA 1535
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: not soluble in water
- Precipitation: Precipitated/undissolved test item was not observed at any of the concentrations tested.
- Other confounding effects: nothing mentioned
COMPARISON WITH HISTORICAL CONTROL DATA: Nearly all determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory, differences were only marginal and no critical impact on the outcome of the study was expected. All positive control showed mutagenic effects with and without metabolic activation. - Conclusions:
- The test item did not show mutagenic effects towards Salmonella typhimurium, strains TA97a, TA98, TA100, TA102 and TA1535. Therefore, no concentration-effect relationship could be determined. The test item is considered as not mutagenic under the conditions of the test:
- Executive summary:
Two valid experiments were performed following OECD 471 and EU B.13/14 under the conditions of GLP.
First Experiment: Five concentrations of the test item, dissolved in Ethanol (ranging from 50 to 5000 μg/plate) were used. Five genetically changed strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 (genetically manipulated) and TA1535) were exposed to the test item both in the presence and in the absence of a metabolic activation system (liver S9-mix of rats induced by Aroclor 1254) for 48 hours, using the plate incorporation method. None of the concentrations caused a significant increase in the number of revertant colonies in the tested strains. The test item did not show any mutagenic effects in the first experiment. The test item showed no precipitates on the plates in all tested concentrations. No signs of toxicity towards the bacteria could be observed. The background lawn was visible and the number of revertant colonies was not reduced. The sterility control and the determination of the titre did not show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range. All positive controls showed mutagenic effects with and without metabolic activation.
Second Experiment: To verify the results of the first experiment, a second experiment was performed, using six concentrations of the test item (ranging from 156 to 5000 μg/plate) and a modification in study performance (pre-incubation method). No significant inrease of the number of revertant colonies in the treatments with and without metabolic activation was observed. No concentration-related increase over the tested range was found. In the highest concentration with metabolic activation (5000 µg/plate) the number of revertant coloies of the stzrain TA98 showed an increase (2.08 fold). But this can be seen as uncritical, because the difference is marginal and no concentration-related increase over the tested range was found
The test item showed no precipitates on the plates in all tested concentrations. No signs of toxicity towards the tested strains cold be observed. The background lawn was visible and the number of revertant colonies was not significantly reduced. The sterility control and the determination of the titre did not show any inconsistencies. The determined values for the spontaneous revertants of the negative controls were in the normal range. All positive controls showed mutagenic effects with and without metabolic activation.
Under the conditions of the test, the test item did not show mutagenic effects towards Salmonella typhimurium, strains TA97a, TA98, TA100, TA102 and TA1535. Therefore, no concentration-effect relationship could be determined. The test item is considered as not mutagenic under the conditions of the test.
- Endpoint:
- in vitro gene mutation study in mammalian cells
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- May to December 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- hypoxanthine-guaninphosphoribosyl-transferase (HPRT) locus
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- CELLS USED
- Type and source of cells: Chinese hamster V79 cells from Dr. J. Thacker, MRC Radiobiology Unit, Harwell, UK. - Metabolic activation:
- with and without
- Metabolic activation system:
- mammalian liver post-mitrochondrial fraction (S9) from male Sprague Dawley rats, dosed with Phenobarbital and 5,6-Benzoflavone
- Test concentrations with justification for top dose:
- Without metabolic activation: 0.625, 0.313, 0.156, 0.0781, 0.0391 and 0.0195 µg/ml
With metabolic activation: 5.00, 2.50, 1.25, 0.625 and 0.313 µg/ml - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 7,12-dimethylbenzanthracene
- ethylmethanesulphonate
- Details on test system and experimental conditions:
- DURATION
- Exposure duration: 3 hours
- Expression time (cells in growth medium): 8 days (subcultured after 2 and 5 days)
SELECTION AGENT (mutation assays): 7.5 μg/mL 6-thioguanine (6-TG)
NUMBER OF REPLICATIONS: 2 (two treatments assays in separate runs), duplicate cultures (except positive control)
NUMBER OF CELLS EVALUATED: 2x10(exp5)
DETERMINATION OF CYTOTOXICITY
- Method: cloning efficiency - Evaluation criteria:
- A test item is considered to be clearly positive if:
– At least one of the test concentrations exhibits a statistically significant increase, compared with the concurrent solvent/vehicle control.
– The increase is concentration-related.
– Any of the results are outside the distribution of the historical negative control data (95% confidence limits).
A test item is considered to be clearly negative if:
– None of the test concentrations exhibits a statistically significant increase, compared with the concurrent solvent/vehicle control.
– There is no concentration-related increase.
– All results are inside the distribution of the historical negative control data (95% confidence limits). Historical control data are used to demonstrate biological relevance of the results obtained. - Statistics:
- The individual mutation frequency values at each test point were transformed to induce homogeneous variance and normal distribution. The appropriate transformation was estimated using the procedure of Snee and Irr (1981), and was found to be
y = (x +a)b where a = 0 and b = 0.275.
The mutant frequency in the solvent control and treated cultures was compared using the Dunnett’s test (one-tailed).
For each experimental point, the corrected sum of squares of transformed mutation frequencies was calculated.
The error mean square (EMS) was calculated as the sum of SSy values divided by the sum of degrees of freedom. For each experimental point the t value was calculated.
For each comparison of treatment with control, the calculated t value was compared with tabulated critical values for the one tailed Dunnett’s test.
The results of the experiment were subjected to an Analysis of Variance in which the effect of replicate culture and dose level in explaining the observed variation were examined. For each experiment, a two way analysis of variance was performed (without interaction) fitting to two factors:
– Replicate culture: to identify differences between the replicate cultures treated.
– Dose level: to identify dose-related increases (or decreases) in response, after allowing for the effects of replicate cultures and expression time.
The analysis was performed separately with the sets of data obtained in the absence and presence of S9 metabolism. - Key result
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH and osmollity: The addition of the test item solution did not have any obvious effect on the osmolality or pH of the treatment medium.
- Precipitation: By the end of treatment in the absence of S9 metabolism, precipitation of the test item was noted from 0.156 μL/mL onwards. In the presence of S9 metabolism, precipitation was observed at the highest concentration tested.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
A preliminary cytotoxicity assay was performed. Both in the absence and presence of S9 metabolic activation, the test item, was assayed at a maximum dose level of 5.00 μL/mL and at a wide range of lower dose levels: 2.50, 1.25, 0.625, 0.313, 0.156, 0.0781, 0.0391 and 0.0195 μL/mL. In the absence of S9 metabolic activation, dose related toxicity was observed reducing Relative Survival (RS) to 16% of the concurrent negative control at the highest dose level tested. Following treatment in the presence of S9 metabolic activation, moderate toxicity was observed at 5.00 and 2.50 μL/mL, reducing RS to 35% and 41%, respectively. Mild or no toxicity was observed over the remaining dose levels tested. - Conclusions:
- The test substance does not induce gene mutation in Chinese hamster V79 cells after in vitro treatment in the absence or presence of S9 metabolic activation, under the reported experimental conditions.
- Executive summary:
The test item was examined for mutagenic activity by assaying for the induction of 6-thioguanine resistant mutants in Chinese hamster V79 cells after in vitro treatment. A Main Assay was performed both in the absence and presence of metabolic activation, using liver S9 fraction from rats pre-treated with phenobarbital and 5,6-benzoflavone. Test item solutions were prepared using dimethylsulfoxide (DMSO).
A Main Assay for mutation to 6-thioguanine resistance was performed. Cells were treated for 3 hours, both in the absence and presence of S9 metabolism and maintained in growth medium for 8 days to allow phenotypic expression of induced mutation. In the absence of S9 metabolism, selection of dose levels was performed based on the observed precipitation, even if cytotoxicity occurred at higher concentrations.
No statistically significant and biologically relevant increases in mutant frequency were observed following treatment with the test item at any dose level, in the absence or presence of S9 metabolism. It is concluded that the test substance does not induce gene mutation in Chinese hamster V79 cells after in vitro treatment in the absence or presence of S9 metabolic activation, under the reported experimental conditions.
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- March to July 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 487 (In vitro Mammalian Cell Micronucleus Test)
- Version / remarks:
- 29 July 2016
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
- Species / strain / cell type:
- lymphocytes: human
- Details on mammalian cell type (if applicable):
- CELLS USED
- Type and source of cells: human lymphocytes from peripheral blood
For lymphocytes:
- Sex, age and number of blood donors: female, 35 and 28 years old
- Whether blood from different donors were pooled or not: pooled - Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : Trinova Biochem GmbH
- method of preparation of S9 mix (for 10 ml): S9 tissue fraction 1.0 mL; NADP (100 mM) 0.4mL; G-6-P (100 mM) 0.5mL; MgCl2 (100 mM) 0.2 mL; Phosphate buffer (pH 7.4, 200 mM) 5.0 mL; Distilled Water 2.9 mL - Test concentrations with justification for top dose:
- 5.00, 3.33 and 2.22 μL/mL (for 3 h treatment; with and without S9)
5.00, 2.22 and 0.990 μL/mL (for 31 h treatment; without S9) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: solubility of test item - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- colchicine
- cyclophosphamide
- Details on test system and experimental conditions:
- DURATION
- Exposure duration: Experiment I: 3 h (with and without S9)
Experiment II: 31 h (without S9)
- Recovery time: Experiment I and II: 28 h
- Harvest time: Experiment I: 32.5 h (with and without S9), Experiment II: 31 h (without S9)
SPINDLE INHIBITOR (cytogenetic assays): Cytochalasin B (final concentration: 6 µg/ml in DMSO
STAIN: Acridine Orange in PBS (12.5 mg per 100 mL PBS)
NUMBER OF REPLICATIONS: Two
METHODS OF SLIDE PREPARATION AND STAINING TECHNIQUE USED:
The lymphocyte cultures were centrifuged for 10 minutes at 1000 rpm and the supernatant was removed.
The cells were resuspended in hypotonic solution. Fresh methanol/acetic acid fixative was then added. After centrifugation and removal of this solution, the fixative was changed several times by centrifugation and resuspension.
A few drops of the cell suspension obtained in this way were dropped onto clean, wet, greasefree glass slides. Three slides were prepared for each test point and each was labelled with the identity of the culture. The slides were allowed to air dry and kept at room temperature prior to staining with a solution of Acridine Orange in PBS.
NUMBER OF CELLS EVALUATED: 1000 mononucleated cells per cell culture were scored. As Colchicine as mitotic spindle poison induces mitotic slippage and cytokinesis block, a greater magnitude of response is observed in mononucleated cells.
CRITERIA FOR MICRONUCLEUS IDENTIFICATION:
1. The micronucleus diameter was less than 1/3 of the nucleus diameter
2. The micronucleus diameter was greater than 1/16 of the nucleus diameter
3. No overlapping with the nucleus was observed
4. The aspect was the same as the chromatin
DETERMINATION OF CYTOTOXICITY
- Method: Cytokinesis-block proliferation index (CBPI)
OTHER EXAMINATIONS:
- pH value, osmolality, solubility
TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not influenced by test substance
- Effects of osmolality: not influenced by test substance
- Precipitation: no
HISTORICAL CONTROL DATA (with ranges)
- Positive historical control data:
mean incidence (%) of binucleated dells with micronuclei:
0.95 -7.65 % (Cyclophosphamide)
1.10 – 8.05 % (Colchicine)
- Negative (solvent/vehicle) historical control data:
0.00 – 0.75 % (absence of S9 metabolism, 3 h)
0.00 – 0.96 % (absence of S9 metabolism, 31-32 h)
0.00 – 0.85 % (presence of S9 metabolism, 3 h) - Evaluation criteria:
- The test item is considered as clearly positive if the following criteria are met:
– Significant increases in the proportion of micronucleated cells over the concurrent controls occur at one or more concentrations.
– The proportion of micronucleated cells at such data points exceeds the normal range based on historical control values (95% control limits).
– There is a significant dose effect relationship.
The test item is considered clearly negative if the following criteria are met:
– None of the dose levels shows a statistically significant increase in the incidence of micronucleated cells.
– There is no concentration related increasewhenevaluated with theCochran-Armitage trend test.
– All the results are inside the distribution of the historical control data (95% control limits). - Statistics:
- For the statistical analysis, a modified χ2 test was used to compare the number of cells with micronuclei in control and treated cultures.
Cochran-Armitage Trend Test (one-sided) was performed to aid determination of concentration response relationship. - Key result
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- True negative controls validity:
- not examined
- Positive controls validity:
- valid
- Conclusions:
- It is concluded that Guerbet alcohols, C24-26, branched and cyclic, does not induce micronuclei in human lymphocytes afterin vitro treatment, under the reported experimental conditions.
- Executive summary:
The test item Guerbet alcohols, C24-26, branched and cyclic, was assayed for the ability to induce micronuclei in human lymphocytes, following in vitro treatment in the presence and absence of S9 metabolic activation.
Three treatment series were performed. A short term treatment, where the cells were treated for 3 hours, was performed in the absence and presence of S9 metabolism. The harvest time of approximately 32 hours, corresponding to approximately two cell cycle lengths, was used. A long term(continuous) treatment was also performed only in the absence of S9 metabolism, until harvest at 31 hours.
For the 3-hour treatment series, both in the absence and presence of S9 metabolism, the test item was assayed at the maximum concentration of 5.00μL/mL and at the following dose levels:
3.33, 2.22, 1.48, 0.987, 0.658, 0.439, 0.293 and 0.195μL/mL.
For the continuous treatment in the absence of S9 metabolism, the following lower dose levels were employed:
3.34, 2.22, 1.48, 0.990, 0.658, 0.440, 0.293, 0.196 and 0.130μL/mL.
All treatments were performed using the test item as a solution/suspension in dimethylsulfoxide (DMSO) with the exception of the continuous treatment in the absence of S9 at the highest dose level where, in order to reach the maximum concentration of 5.00μL/mL, the test item was used as supplied.
The actin polymerisation inhibitor Cytochalasin B was added prior to the targeted mitosis to allow the selective analysis of micronucleus frequency in binucleated cells. The cytokinesis block proliferation index CBPI was calculated in order to evaluate cytotoxicity.
One thousand binucleated cells per culture were scored to assess the frequency of micronucleated
cells. Following treatment with the test item, no statistically significant increase in the incidence of micronucleated cells over the concurrent solvent control value was observed at any dose level, in any treatment series. All incidences were within the distribution of historical negative control values and no concentration related increase was seen.
It is concluded that Guerbet alcohols, C24-26, branched and cyclic, does not induce micronuclei in human lymphocytes afterin vitrotreatment, under the reported experimental conditions.
Referenceopen allclose all
Table #1: First Mutation Assay (Direct Plate Incorporation Method)
| TA 97a | TA 98 | TA 100 | ||||||||||
| - S9 mix | + S9 mix | - S9 mix | + S9 mix | - S9 mix | + S9 mix | |||||||
| Dose level[µg/plate] | Mean revertants per plate ± SD | f (I) | Mean revertants per plate ± SD | f (I) | Mean revertants per plate ± SD | f (I) | Mean revertantsper plate± SD | f (I) | Mean revertants per plate ± SD | f (I) | Mean revertants per plate ± SD | f (I) |
| H2O | 106 ± 12.7 | - | 112 ± 19.6 | - | 12 ± 4.0 | - | 14 ± 5.6 | - | 101 ± 15.1 | - | 117 ± 10.4 | - |
| DMSO | 114 ± 9.0 | - | 98 ± 10.0 | - | 11 ± 2.6 | - | 14 ± 1.7 | - | 117 ± 5.5 | - | 115 ± 3.0 | - |
| 5000 | 116 ± 11.4 | 1.05 | 121 ± 4.0 | 1.21 | 12 ± 2.1 | 0.86 | 14 ± 0.6 | 1.00 | 113 ± 4.0 | 0.97 | 108 ± 12.2 | 0.95 |
| 1500 | 118 ± 5.0 | 1.06 | 121 ± 8.0 | 1.21 | 12 ± 2.5 | 0.86 | 11 ± 1.2 | 0.79 | 113 ± 5.1 | 0.97 | 109 ± 13.2 | 0.96 |
| 500 | 126 ± 1.5 | 1.14 | 125 ± 8.5 | 1.25 | 10 ± 0.6 | 0.71 | 10 ± 1.5 | 0.71 | 112 ± 1.5 | 0.97 | 118 ± 5.0 | 1.04 |
| 150 | 118 ± 7.4 | 1.06 | 121 ± 6.2 | 1.21 | 12 ± 3.2 | 0.86 | 14 ± 0.6 | 1.00 | 115 ± 9.3 | 0.99 | 111 ± 10.4 | 0.97 |
| 50 | 102 ± 9.0 | 0.92 | 130 ± 28.4 | 1.30 | 10 ± 0.6 | 0.71 | 12 ± 2.1 | 0.86 | 103 ± 6.1 | 0.89 | 99 ± 9.0 | 0.87 |
| Positive controls | 1107 ± 80.5 | 9.71 | 733 ± 95.4 | 7.48 | 333 ± 78.9 | 30.3 | 53 ± 12.2 | 3.79 | 588 ± 143.2 | 5.82 | 660 ± 123.2 | 5.80 |
| Ethanol | 111 ± 2.6 | - | 100 ± 8.7 | - | 14 ± 0.6 | - | 14 ± 2.6 | 116 ± 4.9 | 114 ± 4.0 | |||
f (I) = increase factor of revertant induction (mean revertants divided by mean spontaneous revertants)
Table #1 (continued): First Mutation Assay (Direct Plate Incorporation Method)
| TA 102 | TA 1535 | |||||||
| - S9 mix | + S9 mix | - S9 mix | + S9 mix | |||||
| Dose level [µg/plate] | Mean revertants per plate ± SD | f (I) | Mean revertants per plate ± SD | f (I) | Mean revertants per plate ± SD | f (I) | Mean revertants per plate ± SD | f (I) |
| H2O | 265 ± 45.5 | - | 400 ± 66.6 | - | 12 ± 1.7 | - | 12 ± 2.6 | - |
| DMSO | 288 ± 67.3 | - | 247 ± 36.1 | - | 12 ± 3.1 | - | 11 ± 2 .6 | - |
| 5000 | 200 ± 14.4 | 0.77 | 284 ± 20.0 | 1.12 | 13 ± 3.1 | 1.30 | 11 ± 1.7 | 0.92 |
| 1500 | 263 ± 58.3 | 1.02 | 268 ± 24.0 | 1.06 | 11 ± 0.6 | 1.10 | 10 ± 1.2 | 0.83 |
| 500 | 333 ± 101.5 | 1.29 | 283 ± 10.1 | 1.12 | 9 ± 1.2 | 0.90 | 12 ± 4.4 | 1.00 |
| 150 | 349 ± 36.1 | 1.35 | 253 ± 26.0 | 1.00 | 9 ± 0.6 | 0.9 | 12 ± 2.5 | 0.1.00 |
| 50 | 257 ± 92.7 | 0.99 | 308 ± 55.0 | 1.22 | 11 ± 3.2 | 1.10 | 12 ± 2.5 | 1.00 |
| Positiv controls | 1051 ± 179 | 3.65 | 1020 ± 179.6 | 4.13 | 113 ± 35.1 | 9.42 | 280 ± 49.2 | 25.45 |
| Ethanol | 259 ± 24.4 | - | 253 ± 41.1 | - | 10 ± 1.5 | - | 12 ± 3.8 | - |
f (I) = increase factor of revertant induction (mean revertants divided by mean spontaneous revertants)
Table #2: Second Mutation Assay (Pre-incubation Method)
| TA 97a | TA 98 | TA 100 | ||||||||||
| - S9 mix | + S9 mix | - S9 mix | + S9 mix | - S9 mix | + S9 mix | |||||||
| Dose level [µg/plate] | Mean revertants per plate ± SD | f (I) | Mean revertants per plate ± SD | f (I) | Mean revertants per plate ± SD | f (I) | Mean revertants per plate ± SD | f (I) | Mean revertants per plate ± SD | f (I) | Mean revertants per plate ± SD | f (I) |
| H2O | 105 ± 5.5 | - | 138 ± 42.0 | - | 11 ± 1.2 | - | 15 ± 2.5 | - | 109 ± 19.7 | - | 96 ± 3.8 | - |
| DMSO | 135 ± 36.4 | - | 144 ± 25.0 | - | 10 ± 0.6 | - | 11 ± 2.0 | - | 114 ± 14.6 | - | 110 ± 22.3 | - |
| 5000 | 157 ± 4.6 | 0.87 | 193 ± 34.5 | 0.94 | 22 ± 5.2 | 1.62 | 27 ± 7.6 | 2.08 | 95 ± 5.0 | 1.01 | 123 ± 6.4 | 1.12 |
| 2500 | 191 ± 22.3 | 1.06 | 240 ± 24.3 | 1.17 | 12 ± 1.2 | 0.92 | 20 ± 0.0 | 1.54 | 108 ± 5.6 | 1.15 | 107 ± 10.5 | 0.97 |
| 1250 | 157 ± 18.9 | 0.87 | 193 ± 14.0 | 0.94 | 14 ± 1.5 | 1.08 | 16 ± 6.5 | 1.23 | 102 ± 6.7 | 1.09 | 108 ± 23.1 | 0.98 |
| 625 | 132 ± 33.7 | 0.73 | 162 ± 24.3 | 0.79 | 17 ± 0.6 | 1.31 | 17 ± 1.5 | 1.31 | 119 ± 24.3 | 1.27 | 105 ± 30.6 | 0.95 |
| 312 | 139 ± 18.0 | 0.77 | 162 ± 29.9 | 0.79 | 14 ± 1.2 | 1.08 | 11 ± 0.85 | 1.20 | 106± 19.3 | 1.13 | 105 ± 12.7 | 0.95 |
| 156 | 196 ± 72.5 | 1.08 | 273 ± 75.1 | 1.33 | 14 ± 4.6 | 1.08 | 15 ± 4.6 | 1.15 | 117 ± 12.5 | 1.24 | 108 ± 7.0 | 0.98 |
| Ethanol | 181 ± 25.3 | - | 205 ± 62.1 | - | 13 ± 1.2 | - | 13 ± 3.1 | - | 94 ± 2.0 | - | 110 ± 12.7 | - |
| Positive controls | 639 ± 48.9 | 4.73 | 661 ± 108.9 | 4.59 | 227 ± 40.5 | 22.70 | 48 ± 13.5 | 4.36 | 696 ± 30.2 | 6.39 | 729 ± 37.0 | 6.63 |
f (I) = increase factor of revertant induction (mean revertants divided by mean spontaneous revertants)
Table #3 (continued): Second Mutation Assay (Pre-incubation Method)
| TA 102 | TA 1535 | |||||||
| - S9 mix | + S9 mix | - S9 mix | + S9 mix | |||||
| Dose level [µg/plate] | Mean revertants per plate ± SD | f (I) | Mean revertants per plate ± SD | f (I) | Mean revertants per plate ± SD | f (I) | Mean revertants per plate ± SD | f (I) |
| H2O | 284 ± 10.6 | - | 236 ± 13.9 | - | 15 ± 1.0 | - | 11 ± 0.6 | - |
| DMSO | 229 ± 53.3 | - | 271 ± 37.0 | - | 10 ± 0.6 | - | 12 ± 1.5 | - |
| 5000 | 285 ± 55.2 | 0.97 | 277 ± 40.5 | 1.19 | 10 ± 0.0 | 0.83 | 10 ± 0.0 | 0.71 |
| 2500 | 295 ± 26.0 | 1.00 | 271 ± 46.9 | 1.16 | 13 ± 1.5 | 1.08 | 13 ± 1.0 | 0.93 |
| 1250 | 273 ± 16.7 | 0.93 | 229 ± 40.1 | 0.98 | 12 ± 1.5 | 1.00 | 10 ± 0.0 | 0.71 |
| 625 | 249 ± 33.5 | 0.84 | 237 ± 8.3 | 1.02 | 10 ± 1.0 | 0.83 | 12 ± 2.1 | 0.86 |
| 312 | 259 ± 12.9 | 0.88 | 313 ± 25.7 | 1.34 | 10 ± 2.5 | 0.83 | 10 ± 1.5 | 0.71 |
| 156 | 208 ± 114.8 | 0.71 | 272 ± 97.1 | 1.17 | 10 ± 2.0 | 0.83 | 10 ± 1.5 | 0.71 |
| Ethanol | 295 ± 15.0 | - | 233 ± 20.5 | - | 12 ± 3.5 | - | 14 ± 3.0 | - |
Positive controls |
1065 ± 69.0 |
4.65 |
1033 ± 64.8 |
3.81 |
384 ± 186.0 |
25 .6 |
115 ± 17.0 |
9.58 |
f (I) = increase factor of revertant induction (mean revertants divided by mean spontaneous revertants)
| Table 1: Preliminary toxicity test, 3 h, relative survival, in the absence of S9 mix | ||||
| Concentration µg/ml) |
relative survival (%) |
|||
| 0 | 100 | |||
| 0.0195 | 88 | |||
| 0.0391 | 101 | |||
| 0.0781 | 95 | |||
| 0.156 | 78 | |||
| 0.313 | 70 | |||
| 0.625 | 59 | |||
| 1.25 | 45 | |||
| 2.50 | 46 | |||
| 5.00 | 16 | |||
| Table 2: Preliminary toxicity test, 3 h, relative survival, in the presence of S9 mix | ||||
| Concentration µg/ml) |
relative survival (%) | |||
| 0 | 100 | |||
| 0.313 | 94 | |||
| 0.625 | 82 | |||
| 1.25 | 76 | |||
| 2.50 | 71 | |||
| 5.00 | 71 | |||
| Table 3: 3 hour treatment in the absence of S9 mix, Day 8 | ||||
| Concentration µg/ml) |
mean relative cloning efficienty (%) | mean mutant frequency |
||
| 0 | 77 | 12.40 | ||
| 0.0195 | 70 | 11.05 | ||
| 0.0391 | 57 | 11.86 | ||
| 0.0781 | 55 | 12.25 | ||
| 0.156 | 55 | 9.63 | ||
| 0.313 | 45 | 9.38 | ||
| 0.625 | 47 | 7.96 | ||
| positive control EMS | 31 | 19.206** | ||
| ** p< 0.01, statistically significant | ||||
| Table 4: 3 hour treatment in the presence of S9 mix, Day 8 | ||||
| Concentration µg/ml) |
mean relative cloning efficienty (%) |
mean mutant frequency |
||
0 |
83 | 11.48 | ||
| 0.313 | 82 | 6.69 | ||
| 0.625 | 77 | 7.76 | ||
| 1.25 | 82 | 6.67 | ||
| 2.50 | 83 | 3.32 | ||
| 5.00 | 91 | 4.41 | ||
| positive control DMBA | 83 | 11.827** | ||
| ** p< 0.01, statistically significant | ||||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Avalaible data are conclusive but not sufficient for classification of Guerbet alcohols, C24-26, branched and linear with regard to mutagenicity / genotoxicity.
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