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EC number: 904-908-6 | CAS number: -
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Endpoint summary
Administrative data
Key value for chemical safety assessment
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 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 the available data, the test item is not mutagenic.
In vitro cytogenicity chromosome aberration study in mammalian cells:Weight of evidence. The genotoxic potential of the test substance methyl salicylate (99% purity) was studied under non-GLP conditions in an in vitro mammalian chromosomal aberration assay using Chinese hamster lung fibroblast cells in accordance with the publication by Ishidate and Odashima 1977). All tested doses were negative and did not produce a significant increase in the number of chromosomal aberrations.
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:
- From May 29th, 2018 to June 6th, 2018
- 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:
- no
- 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
- Additional strain / cell type characteristics:
- other: uvrA, pKM 101 mutated
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix of liver rats
- Test concentrations with justification for top dose:
- Initial mutation test (plate incorporation) / Confirmatory mutation test (pre-incubation): 50, 150, 500, 1500 and 5000 μg/plate. The maximum test concentration was 5000 μg test item/plate since in the preliminary test the numbers of revertant colonies were mostly in the normal range, no cytotoxicity was observed and there was no precipitation up to the highest dose tested (TA100 without metabolic activation).
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulfoxide (DMSO)
- Justification for choice of solvent/vehicle: the test item was found to be soluble in Dimethyl sulfoxide (DMSO) at 100 mg/mL. - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9,10-dimethylbenzanthracene
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- other: 2-Anthramine (1, 2 μg/plate; S. typhimurium strains, + S9), /cis-Platinum (II) Diammine D ichloride (1 μg/plate; E.coli, - S9)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
1.Plate incorporation (initial mutation test): A stock solution of the test item was prepared at 100 mg / mL. In a test tube, 0.1 mL of the bacterial suspension containing 1-9E09 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, either a standard plate incorporation method where 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 37 ºC, revertant colonies are counted in each plate.
2.Pre-incubation (confirmatory mutation test): Before the overlaying, the test item formulation (or vehicle/solvent or reference control), the bacterial culture and the S9 mix or phosphate buffer were added into appropriate tubes to provide direct contact between bacteria and the test item (in its vehicle/solvent). The tubes were gently mixed and incubated for 30 min at 37ºC in a shaking incubator. After the incubation period, molten top agar was added to the tubes; the content was mixed up and poured onto minimal glucose agar plates as described for the standard plate incorporation method. After preparation, the plates were incubated at 37ºC for 48 hours.
DURATION
- Preincubation period: 30 minutes (confirmatory mutation test)
- Exposure duration: 48 hours
SELECTION AGENT (mutation assays): The lack of amino-acid in the medium. Only the mutants can grow due to their capability to synthesize the essential amino acid.
NUMBER OF REPLICATIONS: 3 (test item, negative and positive controls).
DETERMINATION OF CYTOTOXICITY
- Method: other: relative total growth.
- Preliminary cytotoxicity test (Strain TA100): In a test tube 0.1 mL of the bacterial suspension (1-9E 03 bacteria /mL) and 0.1 mL of the stock solution of L-Histidine-D-Biotine (2.5 mM). After homogenization, the content of the tube is poured onto a Petri plate (90 mm in diameter) containing minimal agar (20 mL). 3 plates per concentration are incubated for 48-72 h at 37 ºC, and the colonies counted. A negative control containing the blank alone is 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. The following four dilutions studied are distributed according to a semi-logarithmic progression.
- 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.
- Preparation of the metabolic activation system (S9 fraction): Obtention of S9 fraction: S9 fraction, microsome fraction prepared from Sprague Dawley rat liver homogenate, is provided by MOLTOX (POB Box 1189 - 157 Industrial Park Dr - Boone, NC 28607 - USA) (S9 Moltox-11101-5-3805 validated on 5.2017 - expiry date: 25.05.2019). Preparation of S9-mix 10% (v/v): The final concentration of cofactors and salts is as follows: S9 fraction 10%; MgCl2-6H2O 8 mM; KCl 33 mM; Glucose-6-Phosphate Na2 5 mM; NADP Na2 4mM; Phosphate buffer pH 7.4 0.1 M. - Rationale for test conditions:
- Results of sterility controls show the absence of any bacterial growth in the presence of test item S9-mix. Results of the bacteriostatic activity control show no toxicity. 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 spontaneous 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 taken 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
- 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 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
- Key result
- Species / strain:
- S. typhimurium TA 1537
- 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:
- E. coli WP2 uvr A
- 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
- Precipitation: None observed
RANGE-FINDING/SCREENING STUDIES: No precipitate and no inhibitory, cytotoxic effect of the test item was observed up to the highest dose tested (5000 μg/plate).
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data (- S9): values for spontaneous revertants (revertants/plate) in the period of 2008 - 2017 were as follows:
Salmonella typhimurium TA98: 496.3 ± 219.9, TA100: 991.8 ± 331.2, TA1535: 731.5 ± 220.2, TA1537: 876.5 ± 448.3, Escherichia coli WP2 uvrA: 484.6 ± 168.2.
- Positive historical control data (+ S9): values with metabolic activation in the period of 2008 - 2017 were:
Salmonella typhimurium TA98: 572.9 ± 222.1, TA100: 846.8 ± 359.5, TA1535: 109.2 ± 56.0, TA1537: 55.1 ± 24.7, Escherichia coli WP2 uvrA: 686.5 ± 253.3.
- Negative (solvent/vehicle) historical control data (- S9): values for untreated control sample without metabolic activation in the period of 2008 - 2017 were as follows:
Salmonella typhimurium TA98: 16.0 ± 3.9, TA100: 59.8 ± 11.8, TA1535: 11.0 ± 3.6, TA1537: 6.0 ± 2.5, Escherichia coli WP2 uvrA: 48.8 ± 7.8.
- Negative (solvent/vehicle) historical control data (+ S9): values with metabolic activation in the period of 2008 - 2017 were:
Salmonella typhimurium TA98: 23.2 ± 5.0, TA100: 96.2 ± 22.3, TA1535: 12.2 ± 4.1, TA1537: 8.1 ± 3.5, Escherichia coli WP2 uvrA: 156.8 ± 34.6.
- 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.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
-- No toxic effects of the test item were observed in any of the five tested strains used up to the highest dose (with and without metabolic activation) in assays 1 and 2. - Conclusions:
- 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 the available data, the test item is not mutagenic.
- 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 five concentrations of the test substance ranging from 50 to 5000 μg/plate in DMSO, with and without metabolic activation, according to preliminary assays. The metabolic activation system (S9 fraction) prepared from Sprague Dawley rat liver homogenate was provided by MOLTOX. Two independent assays were performed: an initial mutation test (plate incorporation method) and a confirmatory mutation test (pre-incubation method) were carried out. Untreated, solvent controls and strain specific positive controls were included in the assays and were within the historical control range 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 the available data, the test item is not mutagenic.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Principles of method if other than guideline:
- Tests were performed according to Ishidate and Odashima (1977)
- GLP compliance:
- no
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- other: Chinese hamster lung fibroblast cells
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Minimum Essential Medium supplemented with 10% calf serum
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: no data
- Periodically checked for karyotype stability: no data
- Periodically "cleansed" against high spontaneous background: no data - Metabolic activation:
- without
- Test concentrations with justification for top dose:
- Three different doses up to 0.25 mg/mL were tested
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: dimethylsulphoxide (DMSO)
- Justification for choice of solvent/vehicle: no justification provided - Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- not specified
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium; in agar (plate incorporation); preincubation; in suspension; as impregnation on paper disk
DURATION
- Exposure duration: 24 or 48 hours
SPINDLE INHIBITOR (cytogenetic assays): colcemid
STAIN (for cytogenetic assays): Giemsa solution (1.5% at pH 6.8)
NUMBER OF REPLICATIONS: one for each exposure duration
NUMBER OF CELLS EVALUATED: 100 well-spread metaphases were observed
DETERMINATION OF CYTOTOXICITY
- Method: was determined in a pre-test in which the dose leading to 50% cell-growth inhibition was determined (this dose was used as maximum dose in the test)
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- The results were considered to be negative if the incidence of chromosome aberrations weas less than 4.9%.
- Statistics:
- Not reported
- Species / strain:
- other: Chinese hamster lung fibroblast cells
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- other: the maximum dose was established in a pre-test and defined as the dose leading to 50% growth inhibition
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- not specified
- Additional information on results:
- The incidence of polyploid cells was 4% and the incidence of structural aberrations was 1% after 48 hours of exposure.
- Remarks on result:
- other: all strains/cell types tested
- Conclusions:
- The substance (Methyl salicylate) was negative in an in vitro mammalian chromosomal aberration assay using Chinese hamster lung fibroblast cells in the absence of metabolic activation.
- Executive summary:
The genotoxic potential of the test substance methyl salicylate (99% purity) was studied under non-GLP conditions in an in vitro mammalian chromosomal aberration assay using Chinese hamster lung fibroblast cells in accordance with the publication by Ishidate and Odashima 1977). The cells were obtained from a cell line established from the lung of a newborn female at the Cancer Research Institute at Tokyo and was maintained by 4 -day passage in Minimum Essential Medium supplemented with 10% calf serum. The modal chromosome number was 25 and the doubling time was approximately 15 hours. Cells were exposed to the substance for 24 or 48 hours in the absence of metabolic activation. The substance was dissolved in DMSO and tested at three doses, whereby the highest dose was defined as the dose leading to 50% inhibition of cell growth (as determined in a preliminary test). Chromosome preparations were made by adding colcemid (at a concentration of 0.2 µg/mL) to the medium 2 hours before cell harvest. Cells were then trypsinised and suspended in a hypotonic KCl solution (0.075 M) for 13 minutes at room temperature, centrifuged and fixed with acetic acid-methanol (1:3, v:v) and spread on glass slides. After air-drying the slides were stained with Giemsa solution (1.5% at pH 6.8) for 12 to 15 minutes. A hundred well-spread metaphases were observed under the microscope. The incidence of polyploid cells and cells with structural chromosomal aberrations was recorded. Untreated cells and solvent controls served as negative controls. All tested doses were negative and did not produce a significant increase in the number of chromosomal aberrations.
Referenceopen allclose all
Table 3. Sterility control
Serie |
Doses |
Colony number/plate |
||
Control n° 1 |
1 |
2 |
3 |
|
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate
|
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 Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate BATCH: L4284945
(LEMI code : 18/0147-110618-S1) |
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 control nº1
|
Doses (/plate) |
||||||||
0 (negative control) |
DMSO |
50 µg |
150 µg |
500 µg |
1500 µg |
2500 µg |
5000 µg |
||
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
N1 |
849 |
900 |
789 |
856 |
630 |
405 |
445 |
221 |
N2 |
844 |
750 |
825 |
823 |
758 |
569 |
420 |
235 |
|
N3 |
674 |
715 |
819 |
869 |
789 |
589 |
439 |
132 |
|
N |
789 ± 100 |
788 ± 98 |
811 ± 19 |
849 ± 24 |
726 ± 84 |
521 ± 101 |
435 ± 13 |
196 ± 56 |
|
% |
- |
100% |
103% |
108% |
92% |
66% |
55% |
25% |
Table 5. Bacteriostatic activity control n° 2
|
Doses (/plate) |
|||||||
0 (negative control) |
DMSO |
50 µg |
150 µg |
500 µg |
1500 µg |
5000 µg |
||
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
N1 |
420 |
406 |
429 |
408 |
389 |
309 |
89 |
N2 |
396 |
386 |
435 |
389 |
401 |
245 |
121 |
|
N3 |
384 |
365 |
418 |
409 |
425 |
274 |
92 |
|
N |
400 ± 18 |
386 ± 21 |
427 ± 9 |
402 ± 11 |
405 ± 18 |
276 ± 32 |
101 ± 18 |
|
% |
- |
96% |
107% |
101% |
101% |
69% |
25% |
Table 6. Assays of metabolic activity without metabolic activation
TA 1535 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 |
14 |
9 |
6 |
9.67 |
4.04 |
- |
Positive control solvent |
5 µL |
13 |
9 |
7 |
9.67 |
3.06 |
- |
Positive control : Sodium azide |
5 µg in 5 µL |
878 |
948 |
980 |
935.33 |
52.37 |
96.76 |
Vehicle |
50 µL |
15 |
9 |
11 |
11.67 |
3.06 |
- |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
5000 µg* 1500 µg 500 µg 150 µg 50 µg |
10 4 16 8 7 |
4 10 9 14 13 |
6 7 9 4 7 |
6.67 7.00 11.33 8.67 9.00 |
3.06 3.00 4.04 5.03 3.46 |
0.57 0.60 0.97 0.74 0.77 |
TA 1535 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 |
11 |
13 |
18 |
14.00 |
3.61 |
- |
Positive control solvent |
5 µL |
12 |
14 |
10 |
12.00 |
2.00 |
- |
Positive control : Sodium azide |
5 µg in 5 µL |
844 |
814 |
883 |
847.00 |
34.60 |
70.58 |
Vehicle |
50 µL |
13 |
15 |
13 |
13.67 |
1.15 |
- |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
5000 µg* 1500 µg 500 µg 150 µg 50 µg |
9 3 7 14 6 |
5 9 10 7 15 |
7 8 6 17 14 |
7.00 6.67 7.67 12.67 11.67 |
2.00 3.21 2.08 5.13 4.93 |
0.51 0.49 0.56 0.93 0.85 |
TA 1537 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 |
4 |
7 |
6.33 |
2.08 |
- |
Positive control solvent |
20 µL |
12 |
4 |
10 |
8.67 |
4.16 |
- |
Positive control : 9-Aminoacridine |
50 µg in 20 µL |
1609 |
1978 |
1739 |
1775.33 |
187.16 |
204.85 |
Vehicle |
50 µL |
9 |
10 |
18 |
12.33 |
4.93 |
- |
|
5000 µg* |
10 |
5 |
7 |
7.33 |
2.52 |
0.59 |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
1500 µg 500 µg |
10 9 |
13 7 |
4 10 |
9.00 8.67 |
4.58 1.53 |
0.73 0.70 |
|
150 µg |
8 |
10 |
7 |
8.33 |
1.53 |
0.68 |
50 µg |
10 |
9 |
9 |
9.33 |
0.58 |
0.76 |
TA 1537 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 |
7 |
6 |
5 |
6.00 |
1.00 |
- |
Positive control solvent |
20 µL |
8 |
4 |
9 |
7.00 |
2.65 |
- |
Positive control : 9-Aminoacridine |
50 µg in 20 µL |
1209 |
869 |
841 |
873.00 |
204.86 |
139.00 |
Vehicle |
50 µL |
5 |
7 |
8 |
6.67 |
1.53 |
- |
|
5000 µg* |
8 |
6 |
6 |
6.67 |
1.15 |
1.00 |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
1500 µg 500 µg |
9 4 |
6 10 |
7 7 |
7.33 7.00 |
1.53 3.00 |
1.10 1.05 |
|
150 µg |
10 |
9 |
9 |
9.33 |
0.58 |
1.40 |
50 µg |
9 |
9 |
9 |
9.00 |
0.00 |
1.35 |
TA 98 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 |
12 |
17 |
20 |
16.33 |
4.04 |
- |
Positive control solvent |
20 µL |
19 |
23 |
17 |
19.67 |
3.06 |
- |
Positive control : 2-Nitrofluorene |
2 µg in 20 µL |
559 |
648 |
598 |
601.67 |
44.61 |
30.59 |
Vehicle |
50 µL |
17 |
11 |
19 |
15.67 |
4.16 |
- |
|
5000 µg* |
15 |
17 |
12 |
14.67 |
2.52 |
0.94 |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
1500 µg 500 µg |
23 19 |
20 14 |
19 18 |
20.67 17.00 |
2.08 2.65 |
1.32 1.09 |
|
150 µg |
29 |
17 |
19 |
21.67 |
6.43 |
1.38 |
50 µg |
19 |
26 |
21 |
22.00 |
3.61 |
1.40 |
TA 98 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 |
21 |
23 |
20 |
21.33 |
1.53 |
_ |
Positive control solvent |
20 µL |
25 |
27 |
25 |
25.67 |
1.15 |
_ |
Positive control : 2-Nitrofluorene |
2 µg in 20 µL |
494 |
689 |
563 |
582.00 |
98.88 |
22.68 |
Vehicle |
50 µL |
23 |
20 |
22 |
21.67 |
1.53 |
_ |
|
5000 µg* |
13 |
11 |
14 |
12.67 |
1.53 |
0.58 |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
1500 µg 500 µg |
12 17 |
15 13 |
15 15 |
14.00 15.00 |
1.73 2.00 |
0.65 0.69 |
|
150 µg |
17 |
19 |
17 |
17.67 |
1.15 |
0.82 |
50 µg |
20 |
22 |
23 |
21.67 |
1.53 |
1.00 |
TA 100 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 |
51 |
63 |
52 |
55.33 |
6.66 |
- |
Positive control solvent |
20 µL |
67 |
68 |
52 |
62.33 |
8.96 |
- |
Positive control : Sodium azide |
20 µg in 20 µL |
1346 |
1287 |
1293 |
1308.67 |
32.47 |
20.99 |
Vehicle |
50 µL |
59 |
56 |
68 |
61.00 |
6.24 |
- |
|
5000 µg** |
24 |
24 |
28 |
25.33 |
2.31 |
0.42 |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
1500 µg 500 µg |
62 58 |
63 69 |
59 60 |
61.33 62.33 |
2.08 5.86 |
1.01 1.02 |
|
150 µg |
55 |
64 |
57 |
58.67 |
4.73 |
0.96 |
50 µg |
48 |
58 |
58 |
54.67 |
5.77 |
0.90 |
TA 100 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 |
75 |
46 |
54 |
58.33 |
14.98 |
- |
Positive control solvent |
20 µL |
48 |
54 |
52 |
51.33 |
3.06 |
- |
Positive control : Sodium azide |
20 µg in 20 µL |
1512 |
1351 |
1441 |
1434.67 |
80.69 |
27.95 |
Vehicle |
50 µL |
55 |
69 |
62 |
62.00 |
7.00 |
- |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
5000 µg** 1500 µg 500 µg 150 µg 50 µg |
32 50 54 51 51 |
38 53 52 55 50 |
37 52 48 53 54 |
35.67 51.67 51.33 53.00 51.67 |
3.21 1.53 3.06 2.00 2.08 |
0.58 0.83 0.83 0.85 0.83 |
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 |
119 |
121 |
110 |
116.67 |
5.86 |
- |
Positive control solvent |
10 µL |
113 |
124 |
126 |
121.00 |
7.00 |
- |
Positive control : cis-Platinum (II) |
1 µg in 10 µL |
453 |
511 |
477 |
480.33 |
29.14 |
3.97 |
Vehicle |
50 µL |
107 |
104 |
132 |
114.33 |
15.37 |
- |
|
5000 µg** |
61 |
108 |
99 |
89.33 |
24.95 |
0.78 |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
1500 µg 500 µg |
99 114 |
109 106 |
107 116 |
105.00 112.00 |
5.29 5.29 |
0.92 0.98 |
|
150 µg |
104 |
102 |
105 |
103.67 |
1.53 |
0.91 |
50 µg |
101 |
105 |
109 |
105.00 |
4.00 |
0.92 |
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 |
177 |
167 |
174 |
172.67 |
5.13 |
- |
Positive control solvent |
10 µL |
172 |
177 |
181 |
176.67 |
4.51 |
- |
Positive control : cis-Platinum (II) |
1 µg in 10 µL |
577 |
610 |
554 |
580.33 |
28.15 |
3.28 |
Vehicle |
50 µL |
153 |
178 |
169 |
166.67 |
12.66 |
- |
|
5000 µg ** |
137 |
169 |
172 |
159.33 |
19.40 |
0.96 |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
1500 µg 500 µg |
147 151 |
160 157 |
146 144 |
151.00 150.67 |
7.81 6.51 |
0.91 0.90 |
|
150 µg |
152 |
181 |
178 |
170.33 |
15.95 |
1.02 |
50 µg |
162 |
167 |
176 |
168.33 |
7.09 |
1.01 |
Table 7. Assays with metabolic activation
TA 1535 -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 |
7 |
6 |
9 |
7.33 |
1.53 |
- |
Positive control solvent |
20 µL |
9 |
8 |
9 |
8.67 |
0.58 |
- |
Positive control : 2-Anthramine |
2 µg in 20 µL |
113 |
203 |
133 |
149.67 |
47.26 |
17.27 |
Vehicle |
50 µL |
7 |
10 |
16 |
11.00 |
4.58 |
- |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
5000 µg** 1500 µg 500 µg 150 µg 50 µg |
1 4 5 10 11 |
1 6 5 6 7 |
1 4 6 6 8 |
1.00 4.67 5.33 7.33 8.67 |
0.00 1.15 0.58 2.31 2.08 |
0.09 0.42 0.48 0.67 0.79 |
*light thinning of the bacterial lawn
**thinning of the bacterial lawn
TA 1535 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 |
9 |
14 |
15 |
12.67 |
3.21 |
- |
Positive control solvent |
10 µL |
13 |
10 |
12 |
11.67 |
1.53 |
- |
Positive control : 2-Anthramine |
1 µg in 10 µL |
88 |
116 |
93 |
99.00 |
14.93 |
8.49 |
Vehicle |
50 µL |
7 |
14 |
16 |
12.33 |
4.73 |
- |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
5000 µg** 1500 µg* 500 µg 150 µg 50 µg |
0 1 4 6 12 |
0 3 4 9 13 |
0 2 5 10 9 |
0.00 2.00 4.33 8.33 11.33 |
0.00 1.00 0.58 2.08 2.08 |
0.00 0.16 0.35 0.68 0.92 |
*light thinning of the bacterial lawn
**thinning of the bacterial lawn
TA 1537 -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 |
9 |
5 |
19 |
11.00 |
7.21 |
- |
Positive control solvent |
20 µL |
10 |
19 |
17 |
15.33 |
4.73 |
- |
Positive control : 2-Anthramine |
2 µg in 20 µL |
45 |
54 |
51 |
50.00 |
4.58 |
3.26 |
Vehicle |
50 µL |
18 |
18 |
10 |
15.33 |
4.62 |
- |
|
5000 µg** |
0 |
0 |
0 |
0.00 |
0.00 |
0.00 |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
1 500 µg** 500 µg |
1 5 |
6 3 |
6 6 |
4.33 4.67 |
2.89 1.53 |
0.28 0.30 |
|
150 µg |
11 |
13 |
10 |
11.33 |
1.53 |
0.74 |
50 µg |
11 |
9 |
14 |
11.33 |
2.52 |
0.74 |
*light thinning of the bacterial lawn
**thinning of the bacterial lawn
TA 1537 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 |
13 |
10 |
5 |
9.33 |
4.04 |
- |
Positive control solvent |
10 µL |
5 |
16 |
4 |
8.33 |
6.66 |
- |
Positive control : 2-Anthramine |
1 µg in 10 µL |
62 |
53 |
55 |
56.67 |
4.73 |
6.80 |
Vehicle |
50 µL |
8 |
13 |
11 |
10.67 |
2.52 |
- |
|
5000 µg** |
0 |
0 |
0 |
0.00 |
0.00 |
0.00 |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
1500 µg** 500 µg |
5 11 |
1 14 |
2 8 |
2.67 11.00 |
2.08 3.00 |
0.25 1.03 |
|
150 µg |
7 |
10 |
8 |
8.33 |
1.53 |
0.78 |
50 µg |
5 |
10 |
7 |
7.33 |
2.52 |
0.69 |
*light thinning of the bacterial lawn
**thinning of the bacterial lawn
TA 98 -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 |
27 |
31 |
26 |
28.00 |
2.65 |
- |
Positive control solvent |
20 µL |
19 |
20 |
26 |
21.67 |
3.79 |
- |
Positive control : 2-Anthramine |
2 µg in 20 µL |
807 |
645 |
907 |
786.33 |
132.22 |
36.29 |
Vehicle |
50 µL |
25 |
23 |
27 |
25.00 |
2.00 |
- |
|
5000 µg** |
5 |
7 |
16 |
9.33 |
5.86 |
0.37 |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
1500 µg* 500 µg |
17 8 |
18 16 |
14 18 |
16.33 14.00 |
2.08 5.29 |
0.65 0.56 |
|
150 µg |
23 |
20 |
23 |
22.00 |
1.73 |
0.88 |
50 µg |
32 |
24 |
26 |
27.33 |
4.16 |
1.09 |
*light thinning of the bacterial lawn
**thinning of the bacterial lawn
TA 98 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 |
22 |
25 |
23 |
23.33 |
1.53 |
- |
Positive control solvent |
10 µL |
26 |
29 |
23 |
26.00 |
3.00 |
- |
Positive control : 2-Anthramine |
1 µg in 10 µL |
622 |
739 |
603 |
654.67 |
73.65 |
25.18 |
Vehicle |
50 µL |
23 |
26 |
30 |
26.33 |
3.51 |
- |
|
5000 µg** |
6 |
2 |
4 |
4.00 |
2.00 |
0.15 |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
1500 µg** 500 µg |
1 23 |
7 21 |
6 15 |
4.67 19.67 |
3.21 4.16 |
0.18 0.75 |
|
150 µg |
20 |
21 |
25 |
22.00 |
2.65 |
0.84 |
50 µg |
26 |
27 |
29 |
27.33 |
1.53 |
1.04 |
*light thinning of the bacterial lawn
**thinning of the bacterial lawn
TA 100 -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 |
64 |
76 |
65 |
68.33 |
6.66 |
- |
Positive control solvent |
20 µL |
63 |
67 |
65 |
65.00 |
2.00 |
- |
Positive control : 2-Anthramine |
2 µg in 20 µL |
675 |
693 |
769 |
712.33 |
49.89 |
10.96 |
Vehicle |
50 µL |
50 |
59 |
65 |
58.00 |
7.55 |
- |
|
5000 µg** |
53 |
46 |
33 |
44.00 |
10.15 |
0.76 |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
1500 µg 500 µg |
58 71 |
60 66 |
54 55 |
57.33 64.00 |
3.06 8.19 |
0.99 1.10 |
150 µg |
51 |
70 |
69 |
63.33 |
10.69 |
1.09 |
|
50 µg |
65 |
69 |
71 |
68.33 |
3.06 |
1.18 |
*light thinning of the bacterial lawn
**thinning of the bacterial lawn
TA 100 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 |
67 |
70 |
65 |
67.33 |
2.52 |
- |
Positive control solvent |
10 µL |
74 |
84 |
87 |
81.67 |
6.81 |
- |
Positive control : 2-Anthramine |
1 µg in 10 µL |
724 |
760 |
655 |
713.00 |
53.36 |
8.73 |
Vehicle |
50 µL |
76 |
58 |
69 |
67.67 |
9.07 |
- |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
5000 µg** 1500 µg* 500 µg 150 µg 50 µg |
10 20 21 70 69 |
10 10 65 58 72 |
20 30 28 68 75 |
13.33 20.00 38.00 65.33 72.00 |
5.77 10.00 23.64 6.43 3.00 |
0.20 0.30 0.56 0.97 1.06 |
*light thinning of the bacterial lawn
**thinning of the bacterial lawn
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 |
167 |
192 |
176 |
178.33 |
12.66 |
- |
Positive control solvent |
5 µL |
212 |
207 |
184 |
201.00 |
14.93 |
- |
Positive control : Dimethylbenzanthracene |
5 µg in 5 µL |
709 |
690 |
740 |
713.00 |
25.24 |
3.55 |
Vehicle |
50 µL |
159 |
166 |
166 |
163.67 |
4.04 |
- |
|
5000 µg** |
113 |
136 |
76 |
108.33 |
30.27 |
0.66 |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
1500 µg* 500 µg |
122 152 |
121 139 |
146 158 |
129.67 149.67 |
14.15 9.71 |
0.79 0.91 |
|
150 µg |
161 |
133 |
144 |
146.00 |
14.11 |
0.89 |
50 µg |
146 |
152 |
155 |
151.00 |
4.58 |
0.92 |
*light thinning of the bacterial lawn
**thinning of the bacterial lawn
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 |
222 |
197 |
218 |
212.33 |
13.43 |
- |
Positive control solvent |
5 µL |
218 |
220 |
205 |
214.33 |
8.14 |
- |
Positive control : Dimethylbenzanthracene |
2.5 µg in 5 µL |
724 |
829 |
659 |
737.33 |
85.78 |
3.44 |
Vehicle |
50 µL |
181 |
177 |
197 |
185.00 |
10.58 |
- |
|
5000 µg** |
160 |
47 |
18 |
75.00 |
75.03 |
0.41 |
Solution of Reaction mass of isopentyl salicylate and 2-methylbutyl salicylate |
1500 µg* 500 µg |
106 223 |
97 166 |
111 176 |
104.67 188.33 |
7.09 30.44 |
0.57 1.02 |
|
150 µg |
213 |
201 |
192 |
202.00 |
10.54 |
1.09 |
50 µg |
208 |
213 |
183 |
201.33 |
16.07 |
1.09 |
*light thinning of the bacterial lawn
**thinning of the bacterial lawn
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Description of key information
In vivo mouse micronucleus test (Micronucleus):
Under the conditions of this study, the test substance did not show any evidence of mutagenic potential when administered orally.
Link to relevant study records
- Endpoint:
- in vivo mammalian somatic cell study: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- not applicable
- GLP compliance:
- yes
- Type of assay:
- micronucleus assay
- Species:
- mouse
- Strain:
- CF-1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Male mice were individually housed and females were housed 4/cage and given free access to rodent diet and drinking water except for 16 hours prior and 3 hours post dosing of the high-dose group and 4-6 prior to 3 hours post dosing of the other test groups. The animal room had a light photoperiod of 12 hours.
- Route of administration:
- oral: gavage
- Vehicle:
- Peanut Oil
- Details on exposure:
- 8-week-old CFW-1 (Winkelmann) albino mice (7/sex/group) weighing 20-30 g were gavaged with 3000 mg test substance/kg body weight in peanut oil at a dose volume of 10 ml/kg body weight and euthanized at 24, 48, or 72 hours post dosing.
- Duration of treatment / exposure:
- dose volume of 10 ml/kg body weight and euthanized at 24, 48, or 72 hours post dosing.
- Frequency of treatment:
- Once
- Post exposure period:
- 24, 48, or 72 hours
- Remarks:
- Doses / Concentrations:
300 mg/kg
Basis:
nominal conc. - Remarks:
- Doses / Concentrations:
1500 mg/kg
Basis:
nominal conc. - Remarks:
- Doses / Concentrations:
3000 mg/kg
Basis:
nominal conc. - No. of animals per sex per dose:
- 7/sex/group
- Positive control(s):
- Positive control (20 mg/kg body weight of Endoxan)
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- The smears were fixed in methanol, rinsed with distilled water 2x, stained in 10% Giemsa, rinsed with distilled water, and air-dried. The stained smears were examined by light microscopy to determine the incidence of micronucleated cells per 1000 polychromatic erythrocytes.
- Evaluation criteria:
- The proportion of polychromatic to normochromatic erythrocytes was assessed by examination of at least 1000 erythrocytes and the number of micronucleated normochromatic erythrocytes was recorded.
- Statistics:
- Statistical analyses were conducted using the tables of Kastenbaum and Bowman.
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Conclusions:
- Under the conditions of this study, the test substance did not show any evidence of mutagenic potential when administered orally.
- Executive summary:
- Under the conditions of this study, the test substance did not show any evidence of mutagenic potential when administered orally.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Short description of key information:
Ames test: non-mutagenic
In vitro cytogenicity (chromosome aberration on Methyl salicylate):
non-mutagenic with and without S9
In vitro gene mutation in mammalian cells: Data waived as reliable in
vivo data on structural analogue is available.
In vivo Mouse micronucleus (Cyclo hexyl salicylate): did not show any
evidence of mutagenic potential when administered orally.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
For classification and labelling purposes this indicates that the Source Substances are suitable structural analogues and based on the response seen for the above end points the Target substance is considered not to be mutagenic. Classification and labelling is therefore not required.
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.
