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EC number: 268-594-6 | CAS number: 68130-51-8
- Life Cycle description
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- Endpoint summary
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- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Bacterial Reverse Mutation Test
Not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation.
Chromosome Abberation Test and Mammalian Cell Gene Mutation Test
The substance, CAS 68130-51-8; EC 268-594-6, is analogous to the substances to be read across to, in terms of basic form, and the degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of mutagenicity. The substance is not considered to be mutagenic on the basis of read across.
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:
- 26. Sep. 2017 to 06. Oct. 2017
- 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:
- OECD Guidelines for the Testing of Chemicals Part 471, adopted 21. Jul. 1997 “Bacterial Reverse Mutation Test“
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- Commission Regulation (EC) No. 440/2008, EU-Method B.13/14 adopted 30. May 2008 “Mutagenicity –Reverse mutation test using bacteria”
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- No further details specified in the study report.
- Target gene:
- Histidine
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98, TA100, TA102 and TA1535
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- The following nominal concentrations were prepared for the first experiment: 5 μL/plate, 1.5 μL/plate, 0.5 μL/plate, 0.15 μL/plate and 0.05 μL/plate
The following nominal concentrations were prepared for the second experiment: 5 μL/plate, 2.5 μL/plate, 1.25 μL/plate, 0.63 μL/plate, 0.31 μL/plate, 0.16 μL/plate and 0.08 μL/plate
Justifcation not specified in the study report. - Vehicle / solvent:
- Ethanol was chosen as vehicle, because the test item was sufficiently soluble, and this solvent does not have any effects on the viability of the bacteria or the number of spontaneous revertants in the tested concentrations.
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethylsulfoxide (DMSO), Demineralised water and Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- benzo(a)pyrene
- other: 4-Nitro-1,2-phenylene Diamine; 2-Amino-Anthracene
- Details on test system and experimental conditions:
- Description of the Method
General preparation
Per bacteria strain and concentration, three plates with and three plates without metabolic activation (-S9) were used.
For the top agar 100 mL agar basis was melted in a microwave oven, 10 mL of the histidine-biotin-solution 0.5 mM was added, then the mixture was placed in the water bath at 43 ±1 °C.
Plate incorporation method
The following materials were gently vortexed in a test tube and poured onto the selective agar plates:
-100 μL test solution at each dose level, solvent (negative control) or reference mutagen solution (positive control)
-500 μL S9 mix or phosphate buffer (for test without metabolic activation).
-100 μL bacteria suspension
-2000 μL overlay agar (top agar)
The plates were closed and left to solidify for a few minutes, then inverted and placed in the dark incubator at 37 ±1 °C.
Pre-incubation method
The following materials were gently vortexed in a test tube and incubated at 37 ±1°C for 20 minutes:
-100 μL test solution at each dose level, solvent (negative control) or reference mutagen solution (positive control)
-500 μL S9 mix or phosphate buffer (for test without metabolic activation).
-100 μL bacteria suspension. After the pre-incubation for 20 minutes, 2000 μL top agar was added and the tube was gently vortexed. The mixture was poured onto the selective agar plate.
The plates were closed and left to solidify for a few minutes, then inverted and placed in the incubator at 37 ±1 °C.
References and Validity
Genotype Confirmation
Genotype confirmation is performed for each batch of lyophilized bacteria before stock culture preparation.
Histidine requirement
Each strain was streaked on a biotin and a histidine-biotin-plate, using a sterilized wire loop. The plates were incubated for 24 hours at 37 ±1 °C.
Ampicillin/Tetracycline-Resistance (pKM 101, pAQ1)
Each strain was streaked on an ampicillin agar plate and on an ampicillin-tetracycline agar plate. TA1535 was used as control strain, since it is not ampicillin resistant. The plates were incubated for 24 hours at 37 ±1 °C.
UV-sensitivity (uvrB)
Each strain was streaked on a plate, and one half of the plate covered with aluminium foil so that one half of each streak was protected against light. The plates for the strain TA97a, TA100 and TA102 were irradiated for 8 seconds, the plates for the strain TA 98 were irradiated for 10 seconds and the plates for the strain TA1535 were irradiated for 6 seconds with a germicidal lamp (254 nm, 30W).
Keeping a distance of 33 cm for the strains TA97a, TA102 and TA1535.
Keeping a distance of 66 cm for the following strains: TA98, TA100.
Incubation for 24 hours at 37 ±1 °C followed.
Crystal violet sensitivity (deep rough/rfa)
For each strain, two plates were used. 0.1 mL of bacteria suspension were mixed with 2 mL Top-Agar and poured on nutrient agar. Sterile paper discs ( 9 mm), each soaked with 10 μL of crystal violet solution (0.1%) were placed into the middle of each plate, followed by incubation for 24 hours at 37 ±1°C.
Spontaneous Revertants
Three replicates, with/without S9, for each solvent which was used in the test, incubation for 48 hours at 37 ±1°C.
Determination of Titre
The titre was determined by dilution of the overnight culture using sodium chloride solution and placing 0.1 mL on maximal-soft agar. Incubation for 48 hours at 37 ±1 °C followed. It should give a density of 109 cells/mL (at the least), two replicates with and without metabolic activation.
Toxicity Control
Performed in experiment 1 only analogously to the titre control with the maximum dose of test item on maximal-soft agar, two replicates with and without metabolic activation, incubation for 48 hours at 37 ±1°C.
Sterility Control
Performed analogously to the test with solvent only and S9 (without adding bacteria) on top agar, incubation for 48 hours at 37 ±1°C, four replicates.
Solubility
Plates were checked for precipitation of test item at the end of the incubation by visual inspection.
Positive Controls
Using diagnostic mutagens, three replicates were prepared.
The stock solutions of the substances were diluted to achieve an application volume of 0.1 mL/plate, incubation for 48 hours at 37 ±1°C. - Rationale for test conditions:
- In accordance with the test guidelines.
- Evaluation criteria:
- The colonies were counted visually and the numbers were recorded. A validated spreadsheet software (Microsoft Excel®) was used to calculate mean values and standard deviations of each treatment, solvent control and positive control.
The mean values and standard deviations of each threefold determination was calculated as well as the increase factor f(l) of revertant induction (mean revertants divided by mean spontaneous revertants) of the test item solutions and the positive controls. Additionally, the absolute number of revertants (Rev. Abs.) (mean revertants minus mean spontaneous revertants) was given.
A substance is considered to have mutagenic potential, if a reproducible increase of revertant colonies per plate exceeding an increase factor of 2 in at least one strain can be observed. A concentration-related increase over the range tested is also taken as a sign of mutagenic activity. - Statistics:
- Not specified.
- Key result
- Species / strain:
- S. typhimurium, other: TA97a
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- 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:
- not applicable
- 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:
- not applicable
- 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:
- not applicable
- Positive controls validity:
- valid
- Key result
- 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:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- First Experiment
Confirmation of the Criteria and Validity
All strains met the criterion of at least 109 bacteria/mL, and no inconsistencies were found in the sterility control. All determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory. All positive controls (diagnostic mutagens) showed mutagenic effects with and without metabolic activation and were within the historical control data ranges.
Solubility and Toxicity
In the first experiment, the test item showed no precipitates on the plates in all tested concentrations.
No signs of toxicity towards the bacteria strains could be observed. The bacterial background lawn was visible and not affected. The number of revertant colonies was not reduced.
Mutagenicity
No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.
Therefore, the test item is stated as not mutagenic under the test conditions.To verify this result, a further experiment was performed.
Second Experiment
Confirmation of the Criteria and Validity
All strains met the criterion of at least 109 bacteria/mL, and no inconsistencies were found in the sterility control. Nearly all determined values for the spontaneous revertants of the negative controls were in the normal range of the test laboratory. All positive controls (diagnostic mutagens) showed mutagenic effects with and without metabolic activation and were within the historical control data ranges.
Solubility and Toxicity
In the second experiment, the test item showed no precipitates on the plates in all tested concentrations.
No signs of toxicity towards the bacteria strains could be observed. The bacterial background lawn was visible and not affected. The number of revertant colonies was not reduced.
Mutagenicity
No significant increase of the number of revertant colonies in the treatments with and without metabolic activation could be observed. No concentration-related increase over the tested range was found.
Therefore, the test item is stated as not mutagenic under the test conditions.
Mutagenicity of Test Item
The test item Hatcol 1570 showed no increase in the number of revertants in all bacteria strains in both experiments.
Nearly all negative and all strain-specific positive control values were within the laboratory historical control data ranges indicating that the test conditions were adequate and that the metabolic activation system functioned properly.
Based on the results of this study it is concluded that Hatcol 1570 is not mutagenic in the Salmonella typhimurium test strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in the present study.
Acceptability of Study, Discussion
In all experiments, no precipitation of the test item Hatcol 1570 was observed at any of the tested concentrations up to 5 μL/plate.
In both experiments, the test item caused no cytotoxicity towards all bacteria strains
The confirmation tests of the genotype did not show any irregularities. The control of the titre was above the demanded value of 109 bacteria/mL.
Nearly all of the means of all replicates of the spontaneous revertants (in negative and solvent controls) were within the range of the historical data of the test facility. All numbers of revertant colonies of the positive controls were within the range of the historical data of the laboratory, but all were increased in comparison with the negative controls, which demonstrated the mutagenic potential of the diagnostic mutagens.
Since all criteria for acceptability have been met, the study is considered valid. - Conclusions:
- Based on the results of the study it is concluded that Hatcol 1570 is not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in the study.
- Executive summary:
Determination of the mutagenic potential of Hatcol 1570 with the Bacterial Reverse Mutation Test following OECD 471 and EU B.13/14
Findings and Results:
Two valid experiments were performed.
The study procedures described in this report were based on the most recent OECD and EC guidelines.
The test item Hatcol 1570 was tested in the Salmonella typhimurium reverse mutation assay with five strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 and TA1535).
The test was performed in two experiments in the presence and absence of metabolic activation, with +S9 standing for presence of metabolic activation, and –S9 standing for absence of metabolic activation.
In the first experiment, the test item (dissolved in ethanol) was tested up to concentrations of 5 μL/plate in the absence and presence of S9-mix in the strains TA97a, TA98, TA100, TA102 and TA1535 using the plate incorporation method.
The test item showed no precipitates on the plates at any of the concentrations.
The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test item showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation.
The results of this experiment showed that none of the tested concentrations showed a significant increase in the number of revertants in all tested strains, in the presence and the absence of metabolic activation.
Based on the first experiment, the test item was tested up to concentrations of 5 μL/plate in the absence and presence of S9-mix in all bacteria strains using the pre-incubation method.
The test item showed no precipitates on the plates at any of the concentrations.
The bacterial background lawn was not reduced at any of the concentrations and no relevant decrease in the number of revertants was observed in all bacteria strains. The test item showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation.
The results of this experiments showed that the test item caused no increase in the number of revertants in all bacteria strains compared to the solvent control, in both the absence and presence of metabolic activation. The test item did not induce a dose-related increase in the number of revertants colonies in all strains, in the presence and absence of metabolic activation.
Based on the results of the study it is concluded that Hatcol 1570 is not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in the study.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 May - 28 Oct 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study. For read-across, maximum reliability score is 2.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- adpoted in 1995
- Deviations:
- yes
- Remarks:
- Only basic data on test substance given
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Target gene:
- not applicable
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: McCoy´s 5A medium supplemented with 10% FBS, 100 units penicillin and 100 µg streptomycin/ml and 2 mM L-glutamine
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S9-mix (Spraque-Dawley)
- Test concentrations with justification for top dose:
- Preliminary cytotoxicity test: 0.5, 1.5, 5, 15, 50, 150, 500, 1500, 5000 µg/mL
Chromosomal abberation assay: (157, 313), 625, 1250, 2500, 5000 µg/mL. Concentrations 157 and 313 µg/mL were not evaluated for CA - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Ethanol
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: mitomycin C, 0.08 and 0.15 µg/mL, -S9; mitomycin C 10 µg/mL, +S9
- Remarks:
- 0.08 and 0.15 µg/mL
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 and 20 h without S9 activation and 4 h with activation.
STAIN (for cytogenetic assays): 5% Giemsa
NUMBER OF CELLS EVALUATED: A minimum of 200 metaphase spreads (100 per duplicate flask) at each concentration used. - Rationale for test conditions:
- In accordance with test guidelines.
- Evaluation criteria:
- Criteria for cytotoxicity of the test substance: (1) cell growth inhibition relative to the solvent control
Criteria for chromosomal damage: (1) Number and types of aberrations found, the percentage of structurally and numerically damaged cells in the total population were counted. - Statistics:
- The frequency of structural aberrations per cell was calculated. The statistical analysis of the percent aberrant cells was performed with Fisher´s Exact Test. It was used to compare pair wise the percent aberrant cells of each treatment group with that of the solvent control. In the event of positive control, the Cochran-Armitage test was used to measure dose- responsiveness.
The dose response was estimated by linear regression curves. Difference in the sensitivity of mutagenic compounds was established by comparing the slopes of corresponding dose-response regression curves. For a comparison of mean values, Student's t test was used. - Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 48% in the highest dose for treatment of 4 h without metabolic activation, 33% with metabolic activation and 3% for 20 h exposure without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: 8 in the highest dose
- Effects of osmolality: 285 in the highest dose
RANGE-FINDING/SCREENING STUDIES: Yes, cell growth inhibition of 83% without and 3% with metabolic activation at the highest dose tested (5000 µg/mL).
COMPARISON WITH HISTORICAL CONTROL DATA: Yes - Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- Interpretation of results:
negative - Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Remarks:
- 2 substances available for read across
- Adequacy of study:
- weight of evidence
- Justification for type of information:
- See the full attached justification in section 13 for details.
- Reason / purpose for cross-reference:
- read-across source
- Reason / purpose for cross-reference:
- read-across source
- Key result
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 48% in the highest dose for treatment of 4 h without metabolic activation, 33% with metabolic activation and 3% for 20 h exposure without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- at and above 333 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks:
- CAS 85186-89-6
- Conclusions:
- The substance, CAS 68130-51-8; EC 268-594-6, is analogous to the substances to be read across to, in terms of basic form, and the degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of mutagenicity. The substance is not considered to be mutagenic on the basis of read across.
- 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:
- 26 Mar - 08 June 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP-Guideline study.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 476 (In Vitro Mammalian Cell Gene Mutation Test)
- Version / remarks:
- adopted in 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.17 (Mutagenicity - In Vitro Mammalian Cell Gene Mutation Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- mammalian cell gene mutation assay
- Target gene:
- TK locus
- Species / strain / cell type:
- mouse lymphoma L5178Y cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI 1640 supplemented with 5% (v/v) heat-inactivated horse serum
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: yes
- Periodically "cleansed" against high spontaneous background: yes - Metabolic activation:
- with and without
- Metabolic activation system:
- co-factor supplemented post-mitochondrial fraction (S9-mix), prepared from rats pretreated with phenobarbital and ß-naphthoflavone
- Test concentrations with justification for top dose:
- First experiment: 0.3, 1, 3, 10, 33, 100, 333 and 750 µg/mL (with and without metabolic activation (8%, v/v))
Second experiment: 0.3, 1, 3, 10, 33, 100, 333 and 750 µg/mL (with and without metabolic activation (12%, v/v)) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- + S9: cyclophosphamide, 15 and 5 µg/mL for 3 and 24 h treatment, respectively; - S9: methylmethanesulfonate, 7.5 µg/mL
- Positive control substance:
- cyclophosphamide
- methylmethanesulfonate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension
DURATION
- Preincubation period: No
- Exposure duration: cells were exposed to the test material for 3 h and 24 h in the presence and absence of S9-mix, respectively.
- Expression time (cells in growth medium): For the expression of the mutant phenotype, the cells were separated by 2 centrifugation steps and cultures for 48 h after the treatment period. For determination of the mutation frequency cells were plated and incubated for 11-12 days. After that, cells were stained for 2 h by adding 0.5 mg/mL MTT (Sigma) to each well. The plates were scored for cloning efficiency and mutation frequency with the naked eye or with the microscope.
SELECTION AGENT (mutation assays): RPMI 1640 supplemented with 20% (v/v) heat-inactivated horse serum and 5 µg/mL trifluorothymidine (TFT).
DETERMINATION OF CYTOTOXICITY
- Method: relative total growth - Rationale for test conditions:
- In naccordance with test guidelines.
- Evaluation criteria:
- Several criteria including a concentration-related, or a reproducible increase in mutation frequencies determined a positive result.
- Key result
- Species / strain:
- mouse lymphoma L5178Y cells
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Remarks:
- at and above 333 µg/mL
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: at and above 333 µg/mL
RANGE-FINDING/SCREENING STUDIES: Yes, cytotoxicity data was obtained by treating cells for 3 h and 24 h respectively with a number of increasing test substance concentrations. The highest concentration tested was 750 µg/ml due to poor solubility of the test substance. No toxicity was observed with and without metabolic activation up to and at the maximum dose level tested with 3 h or 24 h incubation.
COMPARISON WITH HISTORICAL CONTROL DATA: Yes, all controls were in the range of the historical controls - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
Referenceopen allclose all
Mean Revertants First Experiment
Strain |
|
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
|||||
Induction |
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Demin. Water |
Mean |
74 |
73 |
35 |
38 |
94 |
108 |
291 |
288 |
19 |
20 |
sd |
12.4 |
7.5 |
2.0 |
8.6 |
22.5 |
12.2 |
39.5 |
10.6 |
2.0 |
3.5 |
|
DMSO |
Mean |
83 |
81 |
35 |
37 |
83 |
86 |
248 |
225 |
20 |
15 |
sd |
22.7 |
18.5 |
3.2 |
4.0 |
1.2 |
7.5 |
24.0 |
97.9 |
2.5 |
3.6 |
|
Ethanol |
Mean |
79 |
83 |
35 |
43 |
98 |
93 |
211 |
225 |
15 |
16 |
sd |
9.2 |
22.3 |
4.0 |
9.1 |
12.4 |
2.5 |
62.0 |
66.3 |
4.6 |
4.6 |
|
Positive Controls* |
Mean |
587 |
1001 |
493 |
299 |
327 |
557 |
668 |
1488 |
219 |
144 |
sd |
86.3 |
0.0 |
69.0 |
18.5 |
39.3 |
12.2 |
34.9 |
34.9 |
68.0 |
17.8 |
|
f(l) |
7.07 |
12.36 |
14.09 |
8.08 |
3.48 |
6.48 |
2.69 |
6.61 |
11.53 |
9.60 |
|
5 μL/plate |
Mean |
96 |
76 |
38 |
39 |
79 |
113 |
271 |
297 |
24 |
23 |
sd |
12.9 |
4.6 |
7.0 |
7.0 |
13.1 |
15.5 |
28.1 |
24.1 |
4.4 |
2.6 |
|
f(l) |
1.22 |
0.92 |
1.09 |
0.91 |
0.81 |
1.22 |
1.28 |
1.32 |
1.60 |
1.44 |
|
1.5 μL/plate |
Mean |
88 |
73 |
39 |
39 |
107 |
103 |
261 |
315 |
21 |
20 |
sd |
32.1 |
8.0 |
7.2 |
2.1 |
6.4 |
15.1 |
50.0 |
37.0 |
3.1 |
4.5 |
|
f(l) |
1.11 |
0.88 |
1.11 |
0.91 |
1.09 |
1.11 |
1.24 |
1.40 |
1.40 |
1.25 |
|
0.5 μL/plate |
Mean |
96 |
85 |
60 |
68 |
99 |
81 |
244 |
319 |
19 |
23 |
sd |
12.2 |
10.5 |
2.3 |
8.9 |
7.8 |
6.1 |
54.1 |
68.0 |
2.1 |
7.2 |
|
f(l) |
1.22 |
1.02 |
1.71 |
0.88 |
1.01 |
0.87 |
1.16 |
1.42 |
1.27 |
1.44 |
|
0.15 μL/plate |
Mean |
90 |
82 |
38 |
34 |
83 |
92 |
332 |
271 |
17 |
17 |
sd |
15.0 |
16.1 |
1.2 |
3.2 |
16.5 |
19.1 |
27.7 |
44.1 |
4.2 |
3.0 |
|
f(l) |
1.14 |
0.99 |
1.09 |
0.79 |
0.85 |
0.99 |
1.57 |
1.20 |
1.13 |
1.06 |
|
0.05 μL/plate |
Mean |
74 |
77 |
33 |
36 |
86 |
112 |
181 |
209 |
18 |
16 |
sd |
1.5 |
6.5 |
2.1 |
3.1 |
7.2 |
22.7 |
8.1 |
15.1 |
4.5 |
5.0 |
|
f(l) |
0.94 |
0.93 |
0.94 |
0.84 |
0.88 |
1.20 |
0.86 |
0.93 |
1.20 |
1.00 |
f(l) = increase factor
* Different positive controls were used
Mean Revertants Second Experiment
Strain |
|
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
|||||
Induction |
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Demin. Water |
Mean |
90 |
79 |
35 |
37 |
114 |
100 |
307 |
356 |
22 |
23 |
sd |
9.0 |
7.6 |
6.9 |
5.3 |
18.7 |
16.4 |
10.1 |
10.6 |
3.5 |
2.9 |
|
DMSO |
Mean |
88 |
83 |
40 |
39 |
114 |
109 |
291 |
329 |
20 |
21 |
sd |
4.0 |
10.4 |
11.8 |
4.0 |
3.5 |
8.1 |
11.5 |
39.3 |
0.6 |
1.2 |
|
Ethanol |
Mean |
80 |
81 |
38 |
38 |
109 |
96 |
260 |
363 |
15 |
17 |
sd |
9.8 |
8.7 |
9.9 |
3.0 |
5.0 |
15.9 |
65.5 |
41.1 |
5.0 |
4.0 |
|
Positive Controls* |
Mean |
365 |
915 |
685 |
188 |
341 |
816 |
1235 |
1235 |
346 |
153 |
sd |
14.7 |
28.1 |
92.4 |
38.0 |
20.1 |
83.1 |
119.8 |
180.0 |
50.3 |
12.9 |
|
f(l) |
4.15 |
11.02 |
17.13 |
4.82 |
2.99 |
7.49 |
4.24 |
3.75 |
15.73 |
7.29 |
|
5 μL/plate |
Mean |
80 |
100 |
36 |
33 |
114 |
115 |
385 |
392 |
21 |
23 |
sd |
16.2 |
11.0 |
5.0 |
3.1 |
8.1 |
36.3 |
34.9 |
60.5 |
2.9 |
2.5 |
|
f(l) |
1.00 |
1.23 |
0.95 |
0.87 |
1.05 |
1.20 |
1.48 |
1.08 |
1.40 |
1.35 |
|
2.5 μL/plate |
Mean |
100 |
72 |
41 |
34 |
101 |
97 |
325 |
287 |
20 |
19 |
sd |
9.5 |
6.0 |
2.0 |
10.1 |
18.1 |
21.7 |
50.3 |
4.6 |
1.2 |
4.0 |
|
f(l) |
1.25 |
0.89 |
1.08 |
0.89 |
0.93 |
1.01 |
1.25 |
0.79 |
1.33 |
1.12 |
|
1.25 μL/plate |
Mean |
96 |
101 |
36 |
39 |
78 |
96 |
257 |
233 |
18 |
20 |
sd |
18.2 |
11.5 |
4.7 |
3.2 |
3.8 |
20.6 |
77.6 |
37.2 |
2.9 |
3.5 |
|
f(l) |
1.20 |
1.25 |
0.95 |
1.03 |
0.72 |
1.00 |
0.99 |
0.64 |
1.20 |
1.18 |
|
0.63 μL/plate |
Mean |
100 |
83 |
35 |
30 |
122 |
114 |
268 |
257 |
22 |
14 |
sd |
10.1 |
7.2 |
7.2 |
9.5 |
1.2 |
2.0 |
46.1 |
55.6 |
1.5 |
2.1 |
|
f(l) |
1.25 |
1.02 |
0.92 |
0.79 |
1.12 |
1.19 |
1.03 |
0.71 |
1.47 |
0.82 |
|
0.31 μL/plate |
Mean |
67 |
83 |
33 |
31 |
107 |
97 |
347 |
276 |
19 |
19 |
sd |
10.4 |
5.2 |
6.0 |
5.5 |
5.0 |
21.9 |
8.3 |
14.4 |
5.3 |
1.2 |
|
f(l) |
0.84 |
1.02 |
0.87 |
0.82 |
0.98 |
1.01 |
1.33 |
0.76 |
1.27 |
1.12 |
|
0.16 μL/plate |
Mean |
77 |
99 |
36 |
41 |
108 |
114 |
333 |
355 |
20 |
19 |
sd |
9.0 |
27.5 |
3.5 |
2.5 |
8.1 |
2.0 |
16.2 |
31.1 |
3.2 |
1.5 |
|
f(l) |
0.96 |
1.22 |
0.95 |
1.08 |
0.99 |
1.19 |
1.28 |
0.98 |
1.33 |
1.12 |
|
0.08 μL/plate |
Mean |
84 |
91 |
39 |
35 |
115 |
108 |
290 |
344 |
20 |
18 |
sd |
7.0 |
13.2 |
10.4 |
5.1 |
10.1 |
3.2 |
93.6 |
48.7 |
2.9 |
3.2 |
|
f(l) |
1.05 |
1.12 |
1.03 |
0.92 |
1.06 |
1.13 |
1.12 |
0.95 |
1.33 |
1.06 |
f(l) = increase factor
* Different positive controls were used
Historical Data of Spontaneous Revertants
Strain |
|
TA97a |
TA98 |
TA100 |
TA102 |
TA1535 |
|||||
Induction |
|
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
Demin. H2O |
Mean |
91 |
96 |
17 |
19 |
92 |
97 |
280 |
298 |
17 |
17 |
Min |
60 |
63 |
6 |
8 |
51 |
64 |
85 |
67 |
6 |
7 |
|
Max |
144 |
138 |
52 |
50 |
141 |
141 |
425 |
511 |
31 |
33 |
|
SD |
19 |
16 |
9 |
8 |
16 |
15 |
62 |
74 |
6 |
6 |
|
Exp 1 |
74 |
73 |
35 |
38 |
94 |
108 |
291 |
288 |
19 |
23 |
|
Exp 2 |
90 |
79 |
35 |
37 |
114 |
100 |
307 |
356 |
22 |
23 |
|
DMSO |
Mean |
90 |
100 |
17 |
18 |
90 |
92 |
279 |
294 |
17 |
17 |
Min |
58 |
67 |
7 |
8 |
44 |
62 |
79 |
80 |
8 |
6 |
|
Max |
135 |
144 |
46 |
41 |
136 |
199 |
393 |
459 |
33 |
32 |
|
SD |
18 |
17 |
9 |
9 |
16 |
18 |
59 |
66 |
7 |
6 |
|
Exp 1 |
83 |
81 |
35 |
37 |
83 |
86 |
248 |
225 |
20 |
15 |
|
Exp 2 |
88 |
83 |
40 |
39 |
114 |
109 |
291 |
329 |
20 |
21 |
|
Ethanol |
Mean |
88 |
99 |
19 |
20 |
86 |
91 |
287 |
276 |
17 |
17 |
Min |
57 |
65 |
8 |
9 |
61 |
69 |
111 |
141 |
9 |
9 |
|
Max |
181 |
205 |
47 |
45 |
116 |
129 |
368 |
339 |
29 |
36 |
|
SD |
23 |
28 |
11 |
10 |
13 |
16 |
50 |
44 |
6 |
7 |
|
Exp 1 |
79 |
83 |
35 |
43 |
98 |
93 |
211 |
225 |
15 |
16 |
|
Exp 2 |
80 |
81 |
38 |
38 |
109 |
96 |
260 |
363 |
15 |
17 |
|
Positive Controls* |
Mean |
552 |
506 |
397 |
95 |
512 |
736 |
1142 |
1232 |
257 |
119 |
Min |
264 |
237 |
100 |
39 |
223 |
273 |
491 |
408 |
55 |
45 |
|
Max |
1152 |
1181 |
793 |
487 |
984 |
1912 |
2331 |
6083 |
484 |
712 |
|
SD |
165 |
148 |
139 |
74 |
151 |
300 |
443 |
636 |
86 |
77 |
|
Exp 1 |
587 |
1001 |
493 |
299 |
327 |
557 |
668 |
1488 |
219 |
144 |
|
Exp 2 |
365 |
915 |
685 |
188 |
341 |
816 |
1235 |
1235 |
346 |
153 |
*Different positive controls were used
Table 1: Chromosomal aberration – Summary
Treatment [µg/ml] |
S9 activation |
Treatment/ harvest time [h] |
Mitotic index |
Cells scored |
Aberrations/cell (mean±SD) |
Cells with aberrations [%] |
|
numerical |
structural |
||||||
Vehicle (Ethanol) |
- |
4/20 |
6.9 |
200 |
0.005±0.071 |
2.5 |
0.5 |
625 |
- |
4/20 |
5.9 |
200 |
0.000±0.000 |
2.0 |
0.0 |
1250 |
- |
4/20 |
5.9 |
200 |
0.025±0.186 |
4.0 |
2.0 |
2500 |
- |
4/20 |
6.5 |
200 |
0.025±0.186 |
2.5 |
2.0 |
5000 |
- |
4/20 |
4.4 |
200 |
0.000±0.000 |
0.5 |
0.0 |
MMC (0.08) |
- |
4/20 |
6.1 |
200 |
0.150±0.788 |
3.5 |
9.0* |
Vehicle (Ethanol) |
+ |
4/20 |
7.8 |
200 |
0.025±0.157 |
2.0 |
2.5 |
625 |
+ |
4/20 |
7.0 |
200 |
0.020±0.140 |
1.0 |
2.0 |
1250 |
+ |
4/20 |
6.9 |
200 |
0.035±0.184 |
3.0 |
3.5 |
2500 |
+ |
4/20 |
7.4 |
200 |
0.030±0.222 |
2.0 |
2.0 |
5000 |
+ |
4/20 |
7.7 |
200 |
0.010±0.100 |
2.5 |
1.0 |
CP (10) |
+ |
4/20 |
2.3 |
200 |
0.950±1.591 |
2.5 |
45.5* |
Vehicle (Ethanol) |
- |
20/20 |
7.6 |
200 |
0.020±0.140 |
1.0 |
2.0 |
625 |
- |
20/20 |
6.4 |
200 |
0.015±0.158 |
1.5 |
1.0 |
1250 |
- |
20/20 |
5.5 |
200 |
0.025±0.186 |
2.0 |
2.0 |
2500 |
- |
20/20 |
6.0 |
200 |
0.025±0.157 |
2.5 |
2.5 |
5000 |
- |
20/20 |
6.2 |
200 |
0.020±0.172 |
2.0 |
1.5 |
MMC (0.08) |
- |
20/20 |
5.8 |
200 |
0.220±0.513 |
1.0 |
18.0* |
MMC = Mitomycine C
CP = Cyclophosphamide
* = p≤0.01; Fisher´s exact test
Table 1: Results of experiment 1
Dose (µg/ml) |
RSG (%) |
CE day2 (%) |
RS day2 (%) |
RTG (%) |
mutation frequency x 10E6 |
|
|
|
|
|
total |
Without metabolic activation, 3 h treatment |
|||||
SC1 |
100 |
104 |
100 |
100 |
74 |
SC2 |
85 |
97 |
|||
0.3 |
99 |
98 |
104 |
102 |
74 |
1 |
101 |
102 |
108 |
109 |
71 |
3 |
100 |
101 |
107 |
107 |
94 |
10 |
93 |
98 |
104 |
97 |
67 |
33 |
120 |
94 |
100 |
120 |
63 |
100 |
113 |
101 |
107 |
121 |
61 |
333* |
104 |
113 |
120 |
124 |
64 |
750* |
405 |
101 |
107 |
112 |
74 |
MMS |
71 |
68 |
72 |
51 |
835 |
With 8% (v/v) metabolic activation, 3 h treatment |
|||||
SC1 |
100 |
70 |
100 |
100 |
65 |
SC2 |
69 |
64 |
|||
0.3 |
96 |
60 |
86 |
83 |
74 |
1 |
115 |
68 |
98 |
113 |
60 |
3 |
109 |
40 |
57 |
62 |
84 |
10 |
127 |
72 |
104 |
132 |
52 |
33 |
114 |
46 |
66 |
75 |
84 |
100 |
122 |
76 |
108 |
133 |
63 |
333* |
115 |
62 |
89 |
102 |
72 |
750* |
104 |
58 |
84 |
87 |
53 |
CP |
50 |
32 |
45 |
22 |
1617 |
Table 2: Results of experiment 2
Dose (µg/ml) |
RSG (%) |
CE day2 (%) |
RS day2 (%) |
RTG (%) |
mutation frequency x 10E6 |
|
|
|
|
|
total |
Without metabolic activation, 24 h treatment |
|||||
SC1 |
100 |
66 |
100 |
100 |
90 |
SC2 |
79 |
75 |
|||
0.3 |
112 |
77 |
106 |
119 |
88 |
1 |
116 |
80 |
110 |
128 |
82 |
3 |
117 |
72 |
100 |
117 |
79 |
10 |
120 |
85 |
117 |
140 |
66 |
33 |
114 |
74 |
101 |
116 |
83 |
100 |
121 |
69 |
95 |
115 |
83 |
333* |
116 |
70 |
97 |
112 |
70 |
750* |
116 |
66 |
91 |
106 |
71 |
MMS |
101 |
49 |
67 |
68 |
1502 |
With 12% (v/v) metabolic activation, 3 h treatment |
|||||
SC1 |
100 |
93 |
100 |
100 |
80 |
SC2 |
93 |
76 |
|||
0.3 |
103 |
84 |
90 |
93 |
74 |
1 |
113 |
83 |
89 |
101 |
81 |
3 |
107 |
97 |
104 |
112 |
60 |
10 |
105 |
94 |
101 |
107 |
80 |
33 |
103 |
93 |
100 |
103 |
67 |
100 |
102 |
105 |
114 |
116 |
57 |
333* |
106 |
91 |
99 |
104 |
74 |
750* |
103 |
93 |
100 |
103 |
73 |
CP |
72 |
75 |
81 |
58 |
1082 |
RSG: Relative Suspension Growth; CE: Cloning efficiency; RS: Relative Survival; RTG: Relative Total Growth; SC: Solvent Control (DMSO); MMS: Methylmethansulfonate; CP: Cyclophosphamide
*: Precipitation of test substance
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Bacterial Reverse Mutation Test
The test item Hatcol 1570 was tested in the Salmonella typhimurium reverse mutation assay with five strains of Salmonella typhimurium (TA97a, TA98, TA100, TA102 and TA1535).
The test was performed in two experiments in the presence and absence of metabolic activation, with +S9 standing for presence of metabolic activation, and –S9 standing for absence of metabolic activation.
In the first experiment, the test item (dissolved in ethanol) was tested up to concentrations of 5 μL/plate in the absence and presence of S9-mix in the strains TA97a, TA98, TA100, TA102 and TA1535 using the plate incorporation method.
The test item showed no precipitates on the plates at any of the concentrations.
The test item showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation.
The results of this experiment showed that none of the tested concentrations showed a significant increase in the number of revertants in all tested strains, in the presence and the absence of metabolic activation.
Based on the first experiment, the test item was tested up to concentrations of 5 μL/plate in the absence and presence of S9-mix in all bacteria strains using the pre-incubation method.
The test item showed no precipitates on the plates at any of the concentrations.
The test item showed no signs of toxicity towards the bacteria strains in both the absence and presence of metabolic activation.
The test item did not induce a dose-related increase in the number of revertants colonies in all strains, in the presence and absence of metabolic activation.
Based on the results of the study it is concluded that Hatcol 1570 is not mutagenic in the Salmonella typhimurium strains TA97a, TA98, TA100, TA102 and TA1535 in the absence and presence of metabolic activation under the experimental conditions in the study.
Chromosome abberation test
In an in vitro chromosome aberration test with read-across substance, decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate (CAS 11138-60-6), was not mutagenic with or without metabolic activation. Substance was not clastogenic in the CHO cell culture test system, with or without metabolic activation. Regardless of dose level (from 625 g/ml to as high as 5000 g/ml) and dosing regimen, the test substance was concluded to be negative for structural and numerical chromosome aberrations, with or without metabolic activation.
In vitro Mammalian Cell Gene Mutation Test
An in vitro Mammalian Cell Gene Mutation Test was conducted with the structural analogue substance with CAS No. 85186-89-6 (Fatty acids, C8-18 and C18-unsatd., esters with trimethylolpropane) according to OECD Guideline 476. Mouse lymphoma L5178Y cells were dosed with 0.3, 1, 3, 10, 33, 100, 333 and 750 µg/ml with and without metabolic activation. No signs of toxicity were observed, DMSO was used as vehicle, precipitation was observed at and above 100 µg/ml. There was no significant increase in the number of forward mutations at the thymidine kinase locus of L5178Y mouse lymphoma cells treated with the test material, indicated by the total number of colonies per plate.
Justification for classification or non-classification
Based on the available in vitro ames test conducted on the substance and utilising the read across approach with a closely related structural analogue, the substance does not need to be classified according to the CLP Regulation (EC) 1272/2008.
A report justifying the read-across approach is included in IUCLID Chapter 13.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.