Registration Dossier
Registration Dossier
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EC number: 947-756-6 | CAS number: -
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 05, 2017 to December 14, 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- The Ames test was undertaken as a bridging study to demonstrate equivalence between the Target substance (XP 453) and the Source Substance (MOL-LUB) for the read-across of other data. Both Target and Source Substances conform to EC 303-385-6 (previously 272-365-6); CAS 94166-87-7 (previously 68815-27-0), but differ in method of manufacture and ratio of components.
A full discussion of read-across and supporting data is given in the attached justification in the endpoint for acute toxicity: oral for XP 453.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22 August 2012 and 21 September 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant, guideline study, available as an unpublished report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- Meets the requirements of the Japanese Regulatory Authorities including METI, MHLW and MAFF, OECD Guidelines for Testing of Chemicals No. 471 "and the USA, EPA (TSCA) OPPTS harmonised guidelines.
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- +Histidine for Salmonella.
Tryptophan for E.Coli - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- not applicable
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- Not applicable.
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbitone/betanaphthoflavone induced rat liver, S9
- Test concentrations with justification for top dose:
- Preliminary Toxicity Test: 0, 0.15, 0.5, 1.5, 5, 15, 50, 150, 500, 1500 and 5000 µg/plate
main test:
Experiment one: 50, 150, 500, 1500 and 5000 µg/plate
Experiment two: 50, 150, 500, 1500 and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Sterile distilled water
- Justification for choice of solvent/vehicle: The test item was insoluble in sterile distilled water (25 and 50 mg/ml), dimethyl sulphoxide, dimethyl formamide and acetonitrile (50 mg/ml), acetone (100 mg/ml) and tetrahydrofuran (200 mg/ml) in solubility checks performed in-house. The test item formed the best doseable suspension in sterile distilled water at 25 mg/ml; therefore, this solvent was selected as the vehicle. - Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA100
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene: 1 µg/plate
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA1535
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene: 2 µg/plate
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA1537
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene: 2 µg/plate
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of WP2uvrA
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene: 10 µg/plate
- Remarks:
- With S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA98
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- With S9 mix
Migrated to IUCLID6: Benzo(a)pyrene: 5 µg/plate - Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA98
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-Nitroquinoline-1-oxide: 0.2 µg/plate
- Remarks:
- without S9 mix
- Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA1537
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 mix
Migrated to IUCLID6: 9-Aminoacridine: 80 µg/plate - Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA100
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without S9 mix
Migrated to IUCLID6: N-ethyl-N'-nitro-N-nitrosoguanidine: 3 µg/plate - Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of TA1535
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Without S9 mix
Migrated to IUCLID6: N-ethyl-N'-nitro-N-nitrosoguanidine: 5 µg/plate - Untreated negative controls:
- yes
- Remarks:
- Spontaneous mutation rates of WP2uvrA
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Sterile distilled water
- True negative controls:
- not specified
- Positive controls:
- yes
- Positive control substance:
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Without S9 mix
Migrated to IUCLID6: N-ethyl-N'-nitro-N-nitrosoguanidine: 2 µg/plate - Details on test system and experimental conditions:
- METHODS OF APPLICATION: in agar (plate incorporation) - Experiment 1 and pre-incubation - Experiment 2
DURATION
- Preincubation period for bacterial strains: 10h
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): Not applicable
- Selection time (if incubation with a selection agent): Not applicable
NUMBER OF REPLICATIONS: Triplicate plating.
DETERMINATION OF CYTOTOXICITY
- Method: plates were assessed for numbers of revertant colonies using a colony counter and examined for effects on the growth of the bacterial background lawn. Manual counts were performed at 5000 µg/plate because of excessive test item precipitation. - Evaluation criteria:
- Acceptance Criteria:
The reverse mutation assay may be considered valid if the following criteria are met:
All tester strain cultures exhibit a characteristic number of spontaneous revertants per plate in the vehicle and untreated controls.
The appropriate characteristics for each tester strain have been confirmed, eg rfa cell-wall mutation and pKM101 plasmid R-factor etc.
All tester strain cultures should be in the approximate range of 1 to 9.0 x 10+9 bacteria per ml.
Diagnostic mutagens (positive control chemicals) must be included to demonstrate both the intrinsic sensitivity of the tester strains to mutagen exposure and the integrity of the S9-mix. All of the positive control chemicals used in the study should induce marked increases in the frequency of revertant colonies, both with or without metabolic activation.
There should be a minimum of four non-toxic test material dose levels.
There should not be an excessive loss of plates due to contamination.
Evaluation criteria:
There are several criteria for determining a positive result, such as a dose-related increase in revertant frequency over the dose range tested and/or a reproducible increase at one or more concentrations in at least one bacterial strain with or without metabolic activation. Biological relevance of the results will be considered first, statistical methods, as recommended by the UKEMS can also be used as an aid to evaluation, however, statistical significance will not be the only determining factor for a positive response.
A test material will be considered non-mutagenic (negative) in the test system if the above criteria are not met.
Although most experiments will give clear positive or negative results, in some instances the data generated will prohibit a definitive judgement about the test material activity. Results of this type will be reported as equivocal. - Statistics:
- Standard deviation
- 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
- Remarks:
- Tested up to maximum recommended dose of 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and 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
- Remarks:
- Tested up to maximum recommended dose of 5000 µg/plate
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Solubility: The test item was insoluble in sterile distilled water (25 and 50 mg/ml), dimethyl sulphoxide, dimethyl formamide and acetonitrile (50 mg/ml), acetone (100 mg/ml) and tetrahydrofuran (200 mg/ml) in solubility checks performed in-house.
The test item formed the best doseable suspension in sterile distilled water at 25 mg/ml; therefore, this solvent was selected as the vehicle.
- Precipitation: A test item precipitate (particulate in appearance) was noted at and above 1500 µg/plate, this observation did not prevent the scoring of revertant colonies.
RANGE-FINDING/SCREENING STUDIES:
Preliminary Toxicity Test:
The test item was non-toxic to the strains of bacteria used (TA100 and WP2uvrA). The test item formulation and S9-mix used in this experiment
were both shown to be sterile.
COMPARISON WITH HISTORICAL CONTROL DATA:
Prior to use, the master strains were checked for characteristics, viability and spontaneous reversion rate (all were found to be satisfactory).
Results for the negative controls (spontaneous mutation rates) were considered to be acceptable.
All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains.
ADDITIONAL INFORMATION ON CYTOTOXICITY: None - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
The test item, aluminum, aluminum, benzoate C16-18-fatty acids complexes, was considered to be non-mutagenic under the conditions of this test. - Executive summary:
Introduction.
The method was designed to conform to the guidelines for bacterial mutagenicity testing published by the major Japanese Regulatory Authorities including METI, MHLW and MAFF. It also meets the requirements of the OECD Guidelines for Testing of Chemicals No. 471 "Bacterial Reverse Mutation Test", Method B13/14 of Commission Directive 2000/32/EC and the, EPA (TSCA) OPPTS harmonised guidelines.
Method.
Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and Escherichia coli strain WP2uvrA were treated with suspensions of the test item, Aluminium, benzoate iso-Pr alc.stearate complexes, using both the Ames plate incorporation and pre-incubation methods at five dose levels, in triplicate, both with and without the addition of a rat liver homogenate metabolising system (10% liver S9 in standard co-factors). The dose range was determined in a preliminary toxicity assay and was 50 to 5000 µg/plate in the first experiment. The experiment was repeated on a separate day (pre-incubation method) using the same dose range as Experiment 1, fresh cultures of the bacterial strains and fresh test item formulations.
Results.
The vehicle (sterile distilled water) control plates gave counts of revertant colonies within the normal range. All of the positive controls used in the test induced marked increases in the frequency of revertant colonies, both with or without metabolic activation. Thus, the sensitivity of the assay and the efficacy of the S9-mix were validated.
The test item caused no visible reduction in the growth of the bacterial background lawn at any dose level and was, therefore, tested up to the maximum recommended dose level of 5000 µg/plate. A test item precipitate (particulate in appearance) was noted at and above 1500 µg/plate, this observation did not prevent the scoring of revertant colonies.
No significant increases in the frequency of revertant colonies were recorded for any of the strains of bacteria, at any dose level either with or without metabolic activation or exposure method.
All of the positive control chemicals used in the test induced marked increases in the frequency of revertant colonies thus confirming the activity of the S9-mix and the sensitivity of the bacterial strains.
Conclusion.
The test item, aluminum, benzoate C16-18-fatty acids complexes, was considered to be non-mutagenic under the conditions of this test.
RESULTS
Preliminary ToxicityTest
The test item was non-toxic to the strains of bacteria used (TA100 and WP2uvrA). The test item formulation and S9-mix used in this experiment were both shown to be sterile.
The numbers of revertant colonies for the toxicity assay were:
With (+) or without (-) S9-mix |
Strain |
Dose (µg/plate) |
||||||||||
0 |
0.15 |
0.5 |
1.5 |
5 |
15 |
50 |
150 |
500 |
1500 |
5000 |
||
- |
TA100 |
89 |
84 |
85 |
98 |
91 |
98 |
94 |
94 |
116 |
99P |
81P |
+ |
TA100 |
89 |
95 |
85 |
93 |
87 |
73 |
110 |
94 |
102 |
88 |
91P |
- |
WP2uvrA |
24 |
31 |
28 |
27 |
18 |
21 |
30 |
19 |
29 |
31 |
39P |
+ |
WP2uvrA |
29 |
21 |
31 |
37 |
24 |
19 |
36 |
25 |
35 |
33P |
33P |
P: Precipitate
MutationTest
Prior to use, the master strains were checked for characteristics, viability and spontaneous reversion rate (all were found to be satisfactory). These data are not given in the report. The amino acid supplemented top agar and the S9-mix used in both experiments was shown to be sterile.
Results for the negative controls (spontaneous mutation rates) are presented in Table1(see below) and were considered to be acceptable. These data are for concurrent untreated control plates performed on the same day as the Mutation Test.
The individual plate counts, the mean number of revertant colonies and the standard deviations, for the test item, positive and vehicle controls, both with and without metabolic activation, are presented in Table 2 and Table 3 for Experiment 1 and Table 4 and Table 5 for Experiment 2.
No significant increases in the frequency of revertant colonies were recorded for any of the strains of bacteria, at any dose level either with or without metabolic activation or exposure method.
All
of the positive control chemicals used in the test induced
marked increases in the frequency of revertant colonies thus
confirming the activity of the S9-mix and the sensitivity of
the bacterial strains.
Table1 Spontaneous Mutation Rates (Concurrent Negative Controls)
Experiment 1
Number of revertants (mean number of colonies per plate) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||
84 |
|
18 |
|
26 |
|
14 |
|
7 |
|
66 |
(77) |
12 |
(15) |
23 |
(23) |
19 |
(15) |
15 |
(10) |
81 |
|
14 |
|
21 |
|
13 |
|
9 |
|
Experiment 2
Number of revertants (mean number of colonies per plate) |
|||||||||
Base-pair substitution type |
Frameshift type |
||||||||
TA100 |
TA1535 |
WP2uvrA |
TA98 |
TA1537 |
|||||
93 |
|
29 |
|
18 |
|
12 |
|
11 |
|
103 |
(100) |
18 |
(25) |
21 |
(24) |
18 |
(18) |
10 |
(14) |
103 |
|
27 |
|
32 |
|
25 |
|
20 |
|
Table 2: Test Results: Experiment 1– Without Metabolic Activation
With or without S9-Mix |
Dose Level Per Plate |
Number of revertants (mean) ± SD |
|||||||||
Base-pair substitution strains |
Frameshift strains |
||||||||||
TA100 |
TA1535 |
WP2uvrA‑ |
TA98 |
TA1537 |
|||||||
S9-Mix (-) |
Solvent Control (Water) |
101 |
(90) 16.8# |
23 |
(190) 4.6 |
23 |
(26) 4.2 |
20 |
(22) 3.2 |
9 |
(9) 0.6 |
99 |
20 |
31 |
26 |
10 |
|||||||
71 |
14 |
25 |
21 |
9 |
|||||||
50 μg |
90 |
(85) 10.8 |
11 |
(16) 4.5 |
26 |
(20) 5.1 |
12 |
(21) 10.7 |
10 |
(13) 2.5 |
|
93 |
16 |
16 |
33 |
15 |
|||||||
73 |
20 |
19 |
19 |
13 |
|||||||
150 μg |
103 |
(81) 19.1 |
19 |
(18) 2.3 |
29 |
(25) 4.0 |
15 |
(17) 2.9 |
12 |
(12) 2.5 |
|
70 |
19 |
24 |
20 |
14 |
|||||||
70 |
15 |
21 |
15 |
9 |
|||||||
500 μg |
113 |
(103) 9.1 |
20 |
(20) 2.5 |
38 |
(31) 5.9 |
20 |
(21) 0.6 |
9 |
(10) 2.3 |
|
95 |
18 |
29 |
21 |
9 |
|||||||
102 |
23 |
27 |
21 |
13 |
|||||||
1500 μg |
106p |
(95) 10.6 |
24P |
(21) 4.2 |
25P |
(28) 4.6 |
19P |
(24) 6.4 |
9P |
(9) 2.5 |
|
93P |
16P |
25P |
31P |
12P |
|||||||
85P |
22P |
33P |
21P |
7P |
|||||||
5000 μg |
98P |
(86) 10.6 |
20P |
(21) 1.5 |
21P |
(24) 4.9 |
24p |
(24) 4.9 |
9P |
(11) 1.5 |
|
78P |
21P |
30P |
25P |
11P |
|||||||
82P |
23P |
22P |
23P |
12P |
|||||||
Positive controls S9-Mix (-) |
Name |
ENNG |
ENNG |
ENNG |
4NQO |
9AA |
|||||
Concentration (μg/plate) |
3 μg |
5 μg |
2 μg |
0.2 μg |
80 μg |
||||||
No. colonies per plate |
577 |
(560) 48.1 |
284 |
(304) 63.4 |
977 |
(807) 147.5 |
103 |
(107) 3.2 |
1054 |
(94.9) 183.9 |
|
629 |
253 |
713 |
108 |
737 |
|||||||
533 |
375 |
731 |
109 |
1057 |
|||||||
ENNG N-ethyl-N'-nitro-N-nitrosoguanidine
4NQO 4-Nitroquinoline-1-oxide
9AA 9-Aminoacridine
P Precipitate
# Standard deviation
Table 3 Test Results: Experiment 1 – With Metabolic Activation
With or without S9-Mix |
Dose Level Per Plate |
Number of revertants (mean) ± SD |
|||||||||
Base-pair substitution strains |
Frameshift strains |
||||||||||
TA100 |
TA1535 |
WP2uvrA‑ |
TA98 |
TA1537 |
|||||||
S9-Mix (+) |
Solvent Control (Water) |
106 |
(108) 11.6# |
12 |
(130)2.3 |
35 |
(38) 7.4 |
22 |
(25) 4.6 |
14 |
(12) 2.0 |
97 |
12 |
32 |
22 |
10 |
|||||||
120 |
16 |
46 |
30 |
12 |
|||||||
50 μg |
101 |
(96) 13.6 |
14 |
914) 0.6 |
38 |
(32) 10.1 |
29 |
(27) 2.5 |
13 |
(13) 1.5 |
|
107 |
14 |
37 |
27 |
15 |
|||||||
81 |
15 |
20 |
24 |
12 |
|||||||
150 μg |
111 |
(108) 14.2 |
14 |
(14) 0.6 |
34 |
(39) 6.4 |
23 |
(27) 4.7 |
12 |
(12) 3.0 |
|
121 |
14 |
46 |
25 |
15 |
|||||||
93 |
13 |
36 |
32 |
9 |
|||||||
500 μg |
118 |
(108) 20.3 |
19 |
(15) 5.1 |
29 |
(34) 5.7 |
14 |
(23) 8.3 |
11 |
(10) 3.1 |
|
122 |
16 |
32 |
26 |
13 |
|||||||
85 |
9 |
40 |
30 |
7 |
|||||||
1500 μg |
113P |
(111) 6.7 |
10p |
(12) 1.5 |
31P |
(32) 2.6 |
23P |
(26) 5.2 |
12P |
(12) 0.6 |
|
117P |
13P |
35P |
23P |
13P |
|||||||
104P |
12P |
30P |
32P |
12P |
|||||||
5000 μg |
113P |
(113) 3.0 |
12P |
(13) 4.6 |
36P |
(38) 5.3 |
31P |
(270) 4.0 |
7p |
(10) 3.0 |
|
110P |
9P |
34P |
23P |
13P |
|||||||
116P |
18P |
44P |
26P |
10P |
|||||||
Positive controls S9-Mix (+) |
Name |
2AA |
2AA |
2AA |
BP |
2AA |
|||||
Concentration (μg/plate) |
1 μg |
2 μg |
10 μg |
5 μg |
2 μg |
||||||
No. colonies per plate |
827 |
(817) 10.5 |
167 |
(161) 6.0 |
400 |
(400) 10.5 |
207 |
(246) 34.1 |
203 |
(212) 15.6 |
|
806 |
155 |
390 |
268 |
230 |
|||||||
818 |
162 |
411 |
264 |
203 |
|||||||
2AA 2-Aminoanthracene
BP Benzo(a)pyrene
P Precipitate
# Standard deviation
Tables 4 and 5 below
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21st July, 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- (benzoato-O,O')hydroxy(octadecanoato-O,O')aluminium
- EC Number:
- 259-105-7
- EC Name:
- (benzoato-O,O')hydroxy(octadecanoato-O,O')aluminium
- Cas Number:
- 54326-11-3
- Molecular formula:
- C25H41AlO5
- IUPAC Name:
- aluminum hydroxide benzoate stearate
- Reference substance name:
- aluminum hydroxide benzoate palmitate
- Molecular formula:
- C23H37AlO5
- IUPAC Name:
- aluminum hydroxide benzoate palmitate
- Reference substance name:
- Aluminium benzoate salts of other fatty acids
- IUPAC Name:
- Aluminium benzoate salts of other fatty acids
- Reference substance name:
- Aluminium fatty acid salts
- Cas Number:
- Not available.
- Molecular formula:
- Not available.
- IUPAC Name:
- Aluminium fatty acid salts
- Test material form:
- solid: particulate/powder
Constituent 1
Constituent 2
Constituent 3
Constituent 4
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat Liver S9 Fraction
- Test concentrations with justification for top dose:
- Selection of the concentration range was done on the basis of a Solubility Tests and a Concentration Range Finding Test (Informatory Toxicity Test).
The XP 453 concentrations investigated in the Initial and Confirmatory Mutation Tests:
±S9 Mix: 5000, 1600, 500, 160, 50 and 16 μg/plate.
The maximum test concentration was 5000 μg/plate (±S9 Mix). For the selected concentration range, the cytotoxicity and the solubility of the test item were taken into consideration. As indicated in section 6.1.1 and 6.1.2, at the planned whole concentration range test item particles (precipitate) were observed on the minimal glucose agar plates (following the plate incorporation method) and at the highest three concentrations in the test tubes. - Vehicle / solvent:
- Dimethyl sulfoxide (DMSO)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- methylmethanesulfonate
- other: 4-Nitro-1,2-phenylenediamine, NPD 2-aminoanthracene, 2AA
- Details on test system and experimental conditions:
- The study included a Preliminary Solubility Tests, a Preliminary Concentration Range Finding Test (Informatory Toxicity Test) an Initial Mutation Test (Plate Incorporation Test), and a Confirmatory Mutation Test (Pre-Incubation Test).
In the Preliminary Concentration Range Finding Test as well as in the Initial Mutation Test the plate incorporation method was used. - Evaluation criteria:
- A test item is considered mutagenic if:
- a dose–related increase in the number of revertants occurs and/or;
- a reproducible biologically relevant positive response for at least one of the dose groups occurs in at least one strain with or without metabolic activation.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle 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
- 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 nor precipitates, but tested up to recommended limit concentrations
- Vehicle 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
- 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
- Positive controls validity:
- valid
- Additional information on results:
- Test item particles (precipitate) were observed in dose-related manner on the plates in the examined strains, at all dose levels tested following the plate incorporation procedure and in the concentration rage of 5000-500 μg/plate following the pre-incubation procedure, in the absence and presence of exogenous metabolic activation (±S9 Mix).
In the Initial and Confirmatory Mutation Tests using plate incorporation and pre-incubation
methods no inhibitory effect of the test item was observed. The colony and background lawn development was not affected in any case; all of the obtained revertant mean colony number decreases (compared to the revertant colony numbers of the vehicle control) remained within the biological variability range of the applied test system. No biologically relevant increases were observed in revertant colony numbers for any of the five test strains following treatment with XP 453 at any concentration level, either in the presence or absence of metabolic activation (S9 Mix) in the performed experiments.
The reported data of this mutagenicity assay show that under the experimental conditions applied, the test item did not induce gene mutations in the genome of the strains of Salmonella typhimurium TA98, TA100, TA1535 and TA1537 and of Escherichia coli WP2 uvrA.
Applicant's summary and conclusion
- Conclusions:
- The test item XP 453 has no mutagenic activity to the bacterial tester strains under the test conditions used in this study.
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