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EC number: 205-377-7 | CAS number: 139-85-5
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Genetic toxicity in vitro
Description of key information
In vitro gene mutation study in bacteria: Key study. Test method according to OECD 471, GLP study. The test item did not induce any mutagenic change in the bacterial reverse mutation test in any of the strains tested with and without metabolic activation up to 5000 μg/plate.
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:
- 4 July to 22 July 2022
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- yes
- Remarks:
- In test 1, error during preparation on Methyl methanesulfonate: 9.924 mg/mL instead of 10 mg/mL. In test 2, error during preparation on Amino 9: 1 mg/mL solution instead of 2.5 mg/mL. The results allow the test to be validated.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- his D (S. typhimurium TA 98); his C (S. typhimurium TA 1537); his G (S. typhimurium TA 100 and
TA1535); tryp E (E. coli WP2 uvrA pKM101) - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Additional strain / cell type characteristics:
- other: ΔuvrB and rfa mutated (TA 98 and TA 100: pKM 101)
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Metabolic activation system:
- Type and composition of metabolic activation system:
- source of S9 : S9 fraction prepared from Sprague Dawley rat liver homogenate and provided by MOLTOXTM (POB Box 1189 - 157 Industrial Park Dr - Boone, NC 28607 - USA).
- method of preparation of S9 mix : 10% S9 fraction, 8 mM MgCL2-6H2O, 33 mM KCl, 5 mM Glucose-6-Phosphate Na2, 4 mM NADP Na2 and 0.1 M Phosphate buffer pH 7.4.
- concentration or volume of S9 mix and S9 in the final culture medium: 500 μL of S9-mix.
- quality controls of S9 (e.g., enzymatic activity, sterility, metabolic capability): Sterility test: 500 μL of S9-mix were added to 2 mL of top agar maintained at 45ºC, and poured after homogenization on the bottom agar (20 ml) onto a Petri plate (90 mm in diameter) (n = 3). Plates were incubated for 48 - 72 hours at 37°C and then examined. - Test concentrations with justification for top dose:
- Initial mutation test (plate incorporation) / Confirmatory mutation test (pre-incubation +S9): 50, 150,
500, 1500 and 5000 μg/plate.
In the preliminary cytotoxicity test (strain TA100) no toxicity was found for doses up to 5000 μg/plate. Therefore, the test item was tested at the recommended maximum test concentration of 5000 μg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: the test item was found soluble in DMSO at the highest
tested concentration. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Dimethyl sulfoxide (DMSO), acetone, NaCl 0.15M
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other:
- Details on test system and experimental conditions:
- NUMBER OF REPLICATIONS:
- Number of cultures per concentration (single, duplicate, triplicate): triplicate
- Number of independent experiments: 2
METHOD OF TREATMENT/ EXPOSURE:
1. Plate incorporation (initial mutation test): In a test tube, 0.1 mL of the bacterial suspension containing 1-9 E09 bacteria/mL and 0.1 mL of each dilution of the original solution and 0.5 mL of sterile phosphate buffer are successively added to 2 mL of overlay agar maintained super cooled at 45ºC containing 10% (v/v) of a L-Histidine-D-Biotine solution (0.5 mM) for Salmonella Typhimurium strains, or containing 5% (v/v) of nutrient broth nº2 to which are added 5 μL of a L-Tryptophane solution at 2 mg/mL for Escherichia coli strain. In the assay with metabolic activation, the protocol is similar to the described above, except that, 500 μL of S9-mix fraction is quickly added, before pouring the mixture onto the plates. After a 48-72 hour incubation period at 37ºC, revertant colonies are counted in each plate.
2. Pre-incubation (confirmatory mutation test +S9): The test item solution with the test strain, and 500μL of S9-mix fraction are preincubated with shaking for 30 min., at 37ºC prior to mixing with the overlay agar and pouring onto the minimal agar plate.. After a 48-72 hour incubation period at 37ºC, revertant colonies are counted in each plate.
TREATMENT AND HARVEST SCHEDULE:
- Preincubation period, if applicable: 30 minutes (confirmatory mutation test)
- Exposure duration/duration of treatment: 48-72 hours
METHODS FOR MEASUREMENT OF CYTOTOXICITY
- Preliminary cytotoxicity test (Strain TA100): In a test tube 0.1 mL of the bacterial suspension (1-9 E03 bacteria /mL) and 0.1 mL of the stock solution and dilutions were successively added to 2mL of top agar at 45ºC, containing 10 % (v/v) of a solution of L-Histidine-D-Biotine (2.5 mM). After homogenization, the content of the tube was poured onto a Petri plate (90 mm in diameter) containing minimal agar (20 mL). 3 plates per concentration were incubated for 48-72 h at 37ºC, and the colonies counted. A negative control containing the blank alone was run in parallel. In case of bacteriostatic activity is detected, the highest concentration to be retained is that exhibiting a bacteriostatic activity of 75% or less. The precipitate, if present, should not interfere with the scoring.
METHODS FOR MEASUREMENTS OF GENOTOXICIY
In the bacterial reverse mutation test, mutations are detected which revert mutations present in the test strains and restore the functional capability of the bacteria to synthesize an essential amino acid. The revertant bacteria are detected by their ability to grow in the absence of the amino acid required by the parent test strain. After a 48-72-hour incubation period at 37ºC, revertant colonies were manually counted in each plate.
The following ratio was calculated per plate: R = Number of revertant colonies in the presence of the test item / Number of revertant colonies in the absence of the test item.
- OTHER:
- Sterility test: Test item and the corresponding dilutions are added to 2 mL of top agar maintained at 45ºC, and poured after homogenization on the bottom agar (20 mL) onto a Petri plate (90 mm in diameter) (n=3). Plates are incubated for 48-72 hours at 37ºC and then examined. There should be no bacterial growth on any plate. S9-mix sterility is checked using the same protocol. - Rationale for test conditions:
- Results of sterility controls show the absence of any bacterial growth in the presence of test item and S9-mix. Results of the bacteriostatic activity control show a toxicity in presence of the test item at 5000μg/plate compatible with the maximum tolerate . Values and frequency are within the laboratory's historical control ranges.
- Evaluation criteria:
- The result of the test is considered as negative if the revertant number is below three fold the number of spontaneous reversions, for TA 1535 and TA 1537 strains, and below two fold the number of sp ontaneous reversions for TA 98, TA 100 and Escherichia coli WP2(uvrA-) (pKM 101) strains without and with metabolic activation.
The result of the test is considered positive if a dependent relationship concentration is obtained in one, or several of the 5 strains, without and/or with metabolic activation, a mutagenic effect being t
aken into account for a given dilution of test item if the number of revertant colonies is at least two fold that of spontaneous revertant colonies for TA 98, TA 100 and Escherichia coli WP2(uvrA-) (pKM 101), and three fold for TA 1535 and TA 1537. All results must be confirmed in an independent experiment. - Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- True negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- 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:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS : None observed.
RANGE-FINDING/SCREENING STUDIES: In the preliminary cytotoxicity test (strain TA100) no toxicity was found for doses up to 5000 μg/plate. Therefore, the test item was tested at the recommended maximum test concentration of 5000 μg/plate.
STUDY RESULTS
- Concurrent vehicle negative and positive control data: see tables below.
Ames test:
- Signs of toxicity: see table 5 below.
- Individual plate counts: see table 5 below.
- Mean number of revertant colonies per plate and standard deviation: see table 5 below.
HISTORICAL CONTROL DATA (with ranges, means and standard deviation, and 95% control limits for the distribution as well as the number of data)
- Positive historical control data: see table 6 below
- Negative (solvent/vehicle) historical control data: see table 6 below
- There is no significant difference between the number of spontaneous reversions, the number of
reversions obtained in the positive controls (without and with metabolic activation), and the mean of
corresponding experimental “historical” values obtained in the laboratory. - Conclusions:
- The test item did not induce any mutagenic change in the bacterial reverse mutation test in any of the strains tested with and without metabolic activation up to 5000 μg/plate.
- Executive summary:
A bacterial reverse mutation test was conducted on the test substance according to OECD guideline 471 under GLP conditions. Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli WP2 uvrA were exposed to concentrations of the test substance ranging from 50 to 5000 μg/plate in DMSO, with and without metabolic activation, based on preliminary solubility and cytotoxicity tests. The metabolic activation system (S9 fraction) was prepared from Sprague Dawley rat liver homogenate. Two independent assays were performed in all strains: an initial mutation test (plate incorporation method) and a confirmatory mutation test (plate incorporation method without S9 and pre-incubation method with S9). Untreated, solvent controls and strain specific positive controls were included in the assays and the values obtained were within ranges of the historical control values of the laboratory in all strains. All validity criteria were fulfilled. The test item did not induce any significant increase in the number of revertants in any of the strains tested, with and without metabolic activation, up to 5000 μg/plate. Based on these results, the test item can be considered as not mutagenic according to the OECD TG 471.
Reference
Table 3. Sterility control.
Serie |
Doses |
Colony number/plate | ||
Control n° 1 | 1 | 2 | 3 | |
Solution of
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 5000 µg /plate | 0 | 0 | 0 |
1500 µg /plate | 0 | 0 | 0 | |
500 µg /plate | 0 | 0 | 0 | |
150 µg /plate | 0 | 0 | 0 | |
50 µg /plate | 0 | 0 | 0 | |
S9-mix | 500 µL/plate | 0 | 0 | 0 |
Control n° 2 | 1 | 2 | 3 | |
Solution of
RFL-1 BATCH M21736C (Identification code: PH-22/0351)
| 5000 µg /plate | 0 | 0 | 0 |
1500 µg /plate | 0 | 0 | 0 | |
500 µg /plate | 0 | 0 | 0 | |
150 µg /plate | 0 | 0 | 0 | |
50 µg /plate | 0 | 0 | 0 | |
S9-mix | 500 µL/plate | 0 | 0 | 0 |
Table 4. Bacteriostatic activity controls.
| Doses (/plate) | |||||||||||||||||||
0 (negative control) |
DMSO |
50 µg |
150 µg |
500 µg |
1 500 µg |
5000 µg | ||||||||||||||
| N1 |
| 768 |
|
| 789 |
|
| 805 |
|
| 806 |
|
| 698 |
| 796 |
| 303 |
|
Solution of | N2 |
| 818 |
|
| 697 |
|
| 768 |
|
| 819 |
|
| 753 |
| 818 |
| 431 |
|
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | N3 |
| 740 |
|
| 766 |
|
| 746 |
|
| 780 |
|
| 760 |
| 813 |
| 330 |
|
N | 775 | ± | 40 | 751 | ± | 48 | 773 | ± | 30 | 802 | ± | 20 | 737 | ± | 34 | 778±16 | 355 | ± | 67 | |
% |
| - |
|
| 97% |
|
| 100% |
|
| 103% |
|
| 95% |
| 104% |
| 46% |
|
| Doses (/plate) | |||||||||||||||||||
0 (negative control) |
DMSO |
50 µg |
150 µg |
500 µg |
1 500 µg |
5 000 µg | ||||||||||||||
| N1 |
| 812 |
|
| 795 |
|
| 785 |
|
| 820 |
|
| 775 |
| 745 |
| 452 |
|
Solution of | N2 |
| 823 |
|
| 786 |
|
| 769 |
|
| 786 |
|
| 810 |
| 852 |
| 362 |
|
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | N3 |
| 825 |
|
| 796 |
|
| 845 |
|
| 810 |
|
| 753 |
| 793 |
| 398 |
|
N | 820 | ± | 7 | 792 | ± | 6 | 800 | ± | 40 | 805 | ± | 17 | 779 | ± | 29 | 797±54 | 404 | ± | 45 | |
% |
| - |
|
| 97% |
|
| 98% |
|
| 98% |
|
| 102% |
| 97% |
| 100% |
|
Table 5. Result tables.
TA1535 Assay n°1 – without metabolic activation (-S9-mix) | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 4 | 17 | 11 | 10.67 | 6.51 | _ |
Positive control solvent | 5 µL | 11 | 7 | 14 | 10.67 | 3.51 | _ |
Positive control : Sodium azide | 5 µg in 5 µL |
764 |
842 |
887 |
831.00 |
62.23 |
77.91 |
Vehicle | 50µL | 15 | 11 | 9 | 11.67 | 3.06 | _ |
| 5000 µg | 0 | 2 | 0 | 0.67 | 1.15 | 0.06 |
Solution of | 1500 µg | 11 | 5 | 13 | 9.67 | 4.16 | 0.83 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 16 | 11 | 10 | 12.33 | 3.21 | 1.06 |
150 µg | 5 | 15 | 11 | 10.33 | 5.03 | 0.89 | |
50 µg | 10 | 14 | 18 | 14.00 | 4.00 | 1.20 |
TA1535 Assay n°1 – with metabolic activation (10 % S9-mix) – without pre-incubation | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 13 | 7 | 10 | 10.00 | 3.00 | _ |
Positive control solvent | 20 µL | 7 | 12 | 6 | 8.33 | 3.21 | _ |
Positive control : 2-Anthramine | 2 µg in 20 µL |
43 |
63 |
48 |
51.33 |
10.41 |
6.16 |
Vehicle | 50µL | 15 | 13 | 12 | 13.33 | 1.53 | _ |
| 5000 µg | 1 | 3 | 2 | 2.00 | 1.00 | 0.15 |
Solution of | 1500 µg | 11 | 11 | 12 | 11.33 | 0.58 | 0.85 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 10 | 9 | 7 | 8.67 | 1.53 | 0.65 |
150 µg | 18 | 11 | 14 | 14.33 | 3.51 | 1.08 | |
50 µg | 13 | 19 | 11 | 14.33 | 4.16 | 1.08 |
TA1535 Assay n°2 – without metabolic activation (-S9 mix) | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 19 | 16 | 21 | 18.67 | 2.52 | _ |
Positive control solvent | 5 µL | 15 | 14 | 21 | 16.67 | 3.79 | _ |
Positive control : Sodium azide | 5 µg in 5 µL |
671 |
722 |
620 |
671.00 |
51.00 |
40.26 |
Vehicle | 50µL | 20 | 16 | 17 | 17.67 | 2.08 | _ |
| 5000 µg | 1 | 3 | 0 | 1.33 | 1.53 | 0.08 |
Solution of | 1500 µg | 8 | 11 | 10 | 9.67 | 1.53 | 0.55 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 13 | 12 | 8 | 11.00 | 2.65 | 0.62 |
150 µg | 18 | 15 | 16 | 16.33 | 1.53 | 0.92 | |
50 µg | 20 | 16 | 17 | 17.67 | 2.08 | 1.00 |
TA1535 Assay n°2 – with metabolic activation (10 % S9-mix) – with pre-incubation | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 7 | 16 | 13 | 12.00 | 4.58 | _ |
Positive control solvent | 10 µL | 10 | 8 | 10 | 9.33 | 1.15 | _ |
Positive control : 2-Anthramine | 1 µg in 10 µL |
105 |
112 |
92 |
103.00 |
10.15 |
11.04 |
Vehicle | 50µL | 15 | 12 | 18 | 15.00 | 3.00 | _ |
| 5000 µg | 1 | 2 | 1 | 1.33 | 0.58 | 0.09 |
Solution of | 1500 µg | 15 | 10 | 5 | 10.00 | 5.00 | 0.67 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 17 | 15 | 16 | 16.00 | 1.00 | 1.07 |
150 µg | 18 | 20 | 21 | 19.67 | 1.53 | 1.31 | |
50 µg | 24 | 15 | 20 | 19.67 | 4.51 | 1.31 |
TA1537 Assay n°1 – without metabolic activation (-S9-mix) | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 8 | 8 | 6 | 7.33 | 1.15 | _ |
Positive control solvent | 20 µL | 11 | 12 | 5 | 9.33 | 3.79 | _ |
Positive control : 9-Aminoacridine | 50 µg |
813 |
620 |
923 |
785.33 |
153.38 |
217.29 |
Vehicle | 50µL | 10 | 13 | 9 | 10.67 | 2.08 | _ |
| 5000 µg | 1 | 2 | 4 | 2.33 | 1.53 | 0.29 |
Solution of | 1500 µg | 10 | 10 | 8 | 9.33 | 1.15 | 0.67 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 8 | 8 | 6 | 7.33 | 1.15 | 0.75 |
150 µg | 7 | 7 | 14 | 9.33 | 4.04 | 0.67 | |
50 µg | 7 | 11 | 10 | 9.33 | 2.08 | 0.75 |
TA1537 Assay n°1 – with metabolic activation (10 % S9-mix) – without pre-incubation | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 8 | 11 | 5 | 8.00 | 3.00 | _ |
Positive control solvent | 20 µL | 8 | 16 | 13 | 9.00 | 3.61 | _ |
Positive control : 2-Anthramine | 2 µg |
531 |
603 |
432 |
522.00 |
85.85 |
58.00 |
Vehicle | 50µL | 7 | 6 | 811 | 8.00 | 2.65 | _ |
| 5000 µg | 5 | 1 | 3 | 3.00 | 2.00 | 0.38 |
Solution of | 1500 µg | 7 | 11 | 9 | 9.00 | 2.00 | 1.13 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 11 | 18 | 5 | 8.00 | 3.00 | 1.00 |
150 µg | 8 | 10 | 10 | 9.33 | 1.15 | 1.17 | |
50 µg | 9 | 8 | 141 | 9.33 | 1.53 | 1.17 |
TA1537 Assay n°2 – without metabolic activation (-S9-mix) | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 6 | 7 | 5 | 6.00 | 1.00 | _ |
Positive control solvent | 20 µL | 8 | 6 | 6 | 6.67 | 1.15 | _ |
Positive control : 9-Aminoacridine | 20 µL |
862 |
1280 |
1480 |
1207.33 |
315.34 |
181.10 |
Vehicle | 50µL | 7 | 5 | 9 | 7.00 | 2.00 | _ |
| 5000 µg | 3 | 2 | 2 | 2.33 | 0.58 | 0.33 |
Solution of | 1500 µg | 4 | 6 | 5 | 5.00 | 1.00 | 0.71 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 5 | 4 | 7 | 5.33 | 1.53 | 0.76 |
150 µg | 6 | 7 | 5 | 6.00 | 1.00 | 0.86 | |
50 µg | 5 | 3 | 6 | 4.67 | 1.53 | 0.67 |
TA1537 Assay n°2 – with metabolic activation (10% S9-mix) – with pre-incubation | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 10 | 12 | 10 | 10.67 | 1.15 | _ |
Positive control solvent | 10 µL | 12 | 8 | 11 | 10.33 | 2.08 | _ |
Positive control : 2-Anthramine | 1 µg
|
42 |
39 |
51 |
44.00 |
6.24 |
4.26 |
Vehicle | 50µL | 10 | 10 | 6 | 8.67 | 2.31 | _ |
| 5000 µg | 5 | 7 | 12 | 8.00 | 3.61 | 0.92 |
Solution of | 1500 µg | 9 | 9 | 8 | 8.67 | 0.58 | 1.00 |
RFL-1 BATCH (Identification code: PH-22/0351) | 500 µg | 13 | 10 | 10 | 11.00 | 1.73 | 1.27 |
| 150 µg | 12 | 16 | 12 | 13.33 | 2.31 | 1.54 |
LEMI code : 20/0151-250520-S1 | 50 µg | 14 | 16 | 10 | 13.33 | 3.06 | 1.54 |
TA98 Assay n°1 – without metabolic activation (-S9-mix) | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 25 | 23 | 21 | 23.00 | 2.00 | _ |
Positive control solvent | 20 µL | 18 | 19 | 20 | 19.00 | 1.00 | _ |
Positive control : 2-Nitrofluorene | 2 µg |
608 |
545 |
703 |
618.67 |
79.54 |
32.56 |
Vehicle | 50µL | 20 | 16 | 24 | 20.00 | 4.00 | _ |
| 5000 µg | 7 | 6 | 6 | 6.33 | 0.58 | 0.32 |
Solution of | 1500 µg | 17 | 22 | 21 | 20.00 | 2.65 | 1.00 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 23 | 16 | 14 | 17.67 | 4.73 | 0.88 |
150 µg | 17 | 19 | 25 | 20.33 | 4.16 | 1.02 | |
50 µg | 24 | 19 | 18 | 20.33 | 3.21 | 1.02 |
TA98 Assay n°1 – with metabolic activation (10 % S9-mix) – without pre-incubation | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 30 | 31 | 34 | 31.67 | 2.08 | _ |
Positive control solvent | 20 µL | 29 | 32 | 27 | 29.33 | 2.52 | _ |
Positive control : 2-Anthramine | 2 µg |
988 |
964 |
997 |
983.00 |
17.06 |
33.51 |
Vehicle | 50µL | 32 | 32 | 33 | 32.33 | 0.58 | _ |
| 5000 µg | 18 | 11 | 18 | 15.67 | 4.04 | 0.48 |
Solution of | 1500 µg | 23 | 32 | 18 | 24.33 | 7.09 | 0.75 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 24 | 34 | 33 | 30.33 | 5.51 | 0.94 |
150 µg | 22 | 29 | 23 | 24.67 | 3.79 | 0.76 | |
50 µg | 29 | 32 | 28 | 29.67 | 2.08 | 0.92 |
TA98 Assay n°2 – without metabolic activation (-S9-mix) | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 28 | 25 | 29 | 27.33 | 2.08 | _ |
Positive control solvent | 20 µL | 25 | 23 | 26 | 24.67 | 1.53 | _ |
Positive control : 2-Nitrofluorene | 2 µg |
575 |
336 |
436 |
449.00 |
120.03 |
18.20 |
Vehicle | 50µL | 24 | 22 | 24 | 23.33 | 1.15 | _ |
| 5000 µg | 10 | 10 | 8 | 9.33 | 1.15 | 0.40 |
Solution of | 1500 µg | 21 | 18 | 23 | 20.67 | 2.52 | 0.89 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 21 | 25 | 19 | 21.67 | 3.06 | 0.93 |
150 µg | 26 | 24 | 20 | 23.33 | 3.06 | 1.00 | |
50 µg | 19 | 20 | 25 | 21.33 | 3.21 | 0.91 |
TA98 Assay n°2 – with metabolic activation (10 % S9-mix) – with pre-incubation | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 34 | 36 | 31 | 33.67 | 2.52 | _ |
Positive control solvent | 10 µL | 35 | 25 | 28 | 29.33 | 5.13 | _ |
Positive control : 2-Anthramine | 1 µg
|
337 |
391 |
582 |
436.67 |
128.73 |
14.89 |
Vehicle | 50µL | 32 | 36 | 35 | 34.33 | 2.08 | _ |
| 5000 µg | 10 | 20 | 8 | 12.67 | 6.43 | 0.37 |
Solution of | 1500 µg | 26 | 28 | 30 | 28.00 | 2.00 | 0.82 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 30 | 34 | 28 | 30.67 | 3.06 | 0.89 |
150 µg | 37 | 33 | 30 | 33.33 | 3.51 | 0.97 | |
50 µg | 30 | 35 | 34 | 33.00 | 2.65 | 0.96 |
TA100 Assay n°1 – without metabolic activation (-S9-mix) | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 69 | 61 | 87 | 72.33 | 13.32 | _ |
Positive control solvent | 20 µL | 70 | 75 | 81 | 75.33 | 5.51 | _ |
Positive control : Sodium azide | 20 µg |
1603 |
1341 |
1350 |
1431.33 |
148.74 |
19.00 |
Vehicle | 50µL | 89 | 95 | 70 | 84.67 | 13.05 | _ |
| 5000 µg | 72 | 76 | 7 | 5.33 | 2.08 | 0.06 |
Solution of | 1500 µg | 93 | 75 | 65 | 65.67 | 4.04 | 0.78 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 73 | 79 | 96 | 75.67 | 17.79 | 0.89 |
150 µg | 71 | 85 | 89 | 87.33 | 6.66 | 1.03 | |
50 µg | 82 | 80 | 84 | 77.00 | 6.08 | 0.91 |
TA100 Assay n°1 – with metabolic activation (10 % S9-mix) – without pre-incubation | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 68 | 96 | 102 | 88.67 | 18.15 | _ |
Positive control solvent | 20 µL | 81 | 94 | 98 | 91.00 | 8.89 | _ |
Positive control : 2-Anthramine | 2 µg |
893 |
840 |
905 |
879.33 |
34.59 |
9.66 |
Vehicle | 50µL | 120 | 69 | 110 | 99.67 | 27.02 | _ |
| 5000 µg | 11 | 8 | 8 | 9.00 | 1.73 | 0.09 |
Solution of | 1500 µg | 57 | 57 | 55 | 56.33 | 1.15 | 0.57 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 57 | 63 | 62 | 60.67 | 3.21 | 0.61 |
150 µg | 72 | 77 | 80 | 76.33 | 4.04 | 0.77 | |
50 µg | 62 | 85 | 91 | 79.33 | 15.31 | 0.80 |
TA100 Assay n°2 – without metabolic activation (-S9-mix) | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 71 | 60 | 91 | 74.00 | 15.72 | _ |
Positive control solvent | 20 µL | 63 | 71 | 69 | 67.67 | 4.16 | _ |
Positive control : Sodium azide | 20 µg |
934 |
946 |
1045 |
975.00 |
60.92 |
14.41 |
Vehicle | 50µL | 61 | 59 | 70 | 63.33 | 5.86 | _ |
| 5000 µg | 5 | 8 | 9 | 7.33 | 2.08 | 0.12 |
Solution of | 1500 µg | 63 | 75 | 64 | 67.33 | 6.66 | 1.06 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 66 | 62 | 84 | 70.67 | 11.72 | 1.12 |
150 µg | 80 | 79 | 78 | 79.00 | 1.00 | 1.25 | |
50 µg | 73 | 75 | 83 | 77.00 | 5.29 | 1.22 |
TA100 Assay n°2 – with metabolic activation (10 % S9-mix) – with pre-incubation | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 68 | 72 | 65 | 68.33 | 3.51 | _ |
Positive control solvent | 10 µL | 52 | 52 | 51 | 51.67 | 0.58 | _ |
Positive control : 2-Anthramine | 1 µg |
570 |
507 |
599 |
558.67 |
47.04 |
10.81 |
Vehicle | 50µL | 63 | 57 | 77 | 65.67 | 10.26 | _ |
| 5000 µg | 9 | 21 | 1 | 10.33 | 10.07 | 0.16 |
Solution of | 1500 µg | 52 | 68 | 73 | 64.33 | 10.97 | 0.98 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 81 | 74 | 76 | 77.00 | 3.61 | 1.17 |
150 µg | 71 | 75 | 84 | 76.67 | 6.66 | 1.17 | |
50 µg | 99 | 96 | 80 | 91.67 | 10.21 | 1.40 |
E. COLI Assay n°1 – without metabolic activation (-S9-mix) | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 107 | 82 | 76 | 84.33 | 16.44 | _ |
Positive control solvent | 10 µL | 98 | 87 | 81 | 88.67 | 8.62 | _ |
Positive control : cis-Platinum (II) | 99.24 µg |
343 |
456 |
511 |
436.67 |
85.65 |
4.92 |
Vehicle | 50µL | 76 | 46 | 75 | 65.67 | 17.04 | _ |
| 5000 µg | 37 | 25 | 39 | 33.67 | 7.57 | 0.51 |
Solution of | 1500 µg | 60 | 47 | 59 | 55.33 | 7.23 | 0.84 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 65 | 81 | 80 | 75.33 | 8.96 | 1.15 |
150 µg | 87 | 70 | 81 | 79.33 | 8.62 | 1.21 | |
50 µg | 71 | 73 | 83 | 75.67 | 6.43 | 1.15 |
E. COLI Assay n°1 – with metabolic activation (10 % S9-mix) – without pre-incubation | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 91 | 101 | 95 | 95.67 | 5.03 | _ |
Positive control solvent | 5 µL | 97 | 119 | 96 | 104.00 | 13.00 | _ |
Positive control : 2-Anthramine | 50 µg
|
799 |
896 |
904 |
866.33 |
58.45 |
8.33 |
Vehicle | 50µL | 98 | 77 | 67 | 80.67 | 15.82 | _ |
| 5000 µg | 12 | 19 | 19 | 16.67 | 4.04 | 0.21 |
Solution of | 1500 µg | 45 | 42 | 42 | 43.00 | 1.73 | 0.53 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 65 | 63 | 74 | 67.33 | 5.86 | 0.83 |
150 µg | 71 | 98 | 110 | 93.00 | 19.97 | 1.15 | |
50 µg | 81 | 85 | 97 | 87.67 | 8.33 | 1.09 |
E. COLI Assay n°2 – without metabolic activation (-S9-mix) | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 83 | 66 | 86 | 78.33 | 10.79 | _ |
Positive control solvent | 10 µL | 88 | 81 | 74 | 81.00 | 7.00 | _ |
Positive control : MMS | 100 µg
|
476 |
518 |
486 |
493.33 |
21.94 |
6.09 |
Vehicle | 50µL | 70 | 79 | 71 | 73.33 | 4.93 | _ |
| 5000 µg | 25 | 31 | 26 | 27.33 | 3.21 | 0.37 |
Solution of | 1500 µg | 65 | 69 | 46 | 60.00 | 12.29 | 0.82 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 69 | 72 | 78 | 71.67 | 2.52 | 0.98 |
150 µg | 69 | 72 | 78 | 73.00 | 4.58 | 1.00 | |
50 µg | 68 | 70 | 82 | 73.33 | 7.57 | 1.00 |
E. COLI Assay n°2 – with metabolic activation (10 % S9-mix) – with pre-incubation | |||||||
Serie |
Dose/Plate | Plate |
Mean |
Standard deviation |
R | ||
n° 1 | n° 2 | n° 3 | |||||
Negative control | 100 µL | 95 | 91 | 81 | 89.00 | 7.21 | _ |
Positive control solvent | 12.5 µL | 97 | 101 | 91 | 96.33 | 5.03 | _ |
Positive control : 2-Anthramine | 12.5 µg
|
1001 |
965 |
1034 |
1000.00 |
34.51 |
10.38 |
Vehicle | 50µL | 105 | 97 | 76 | 92.67 | 14.98 | _ |
| 5000 µg | 13 | 22 | 15 | 16.67 | 4.73 | 0.18 |
Solution of | 1500 µg | 61 | 62 | 63 | 62.00 | 1.00 | 0.67 |
RFL-1 BATCH M21736C (Identification code: PH-22/0351) | 500 µg | 65 | 64 | 69 | 66.00 | 2.65 | 0.71 |
150 µg | 91 | 96 | 62 | 83.00 | 18.36 | 0.90 | |
50 µg | 98 | 91 | 90 | 93.00 | 4.36 | 1.00 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Justification for classification or non-classification
Based on the available data (negative Ames test), the test substance is not classified for mutagenecity in accordance with CLP Regulation (EC) No. 1272/2008.
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.
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