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EC number: - | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- Particle size distribution (Granulometry)
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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:
- 2010-05-19 to 2010-05-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
Method
- Target gene:
- histidine operon (for the Salmonella strains), tryptophan operon (for the E.coli strain)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- phenobarbital/beta-napthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- 3, 10, 33, 100, 333, 1000, 2500, 5000 μg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: methanol
- Justification for choice of solvent/vehicle: solubility properties and relative nontoxicity to the bacteria
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- methanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 1535, TA 100 (without metabolic activation)
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- methanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine, 4-NOPD
- Remarks:
- TA 1537, TA 98 (without metabolic activation)
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- methanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- WP2 uvr A (without metabolic activation)
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene, 2-AA
- Remarks:
- all strains (with metabolic activation)
- Details on test system and experimental conditions:
- ACTIVATION: The amount of S9 supernatant was 10% v/v in the cultures. Cofactors were added to the S9 mix to reach the following concentrations in the S9 mix:
8 mM MgCl2
33 mM KCl
5 mM Glucose-6-phosphate
4 mM NADP
in 100 mM sodium-ortho-phosphate-buffer, pH 7.4
METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
-After solidification, the plates were incubated upside down for 48-72 hours at 37°C in the dark
SELECTION AGENT (mutation assays): histidine-deficient agar (Salmonella strains); tryptophan-deficient agar (E.coli strain)
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY: Toxicity of the test item results in a reduction in the mean number of spontaneous revertants (> 50% reduction) or a reduction of the bacterial background lawn, in comparison to the solvent control. - Evaluation criteria:
- A test item is considered as a mutagen is a biologically relevant increase in the mean number of revertants exceeding the threshold of twice (strains TA 98, TA 100 and WP2 uvr A) or thrice (strains TA 1535 and TA 1537) the mean colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent second experiment. - Statistics:
- No statistical evaluation of the data was required.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- bacteria, other: TA 1535, TA 100, WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- positive
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium, other: TA 1537, 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
Any other information on results incl. tables
Table 1: Plate incorporation test: Mean number of revertants per plate (3 plates)
Dose (µg/plate) |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2 uvr A |
|||||
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
- MA |
+ MA |
|
3 |
14 |
29 |
10 |
14 |
26 |
36 |
118 |
124 |
39 |
49 |
10 |
18 |
22 |
9 |
16 |
24 |
41 |
101 |
122 |
42 |
46 |
33 |
20 |
24 |
10 |
16 |
27 |
38 |
118 |
129 |
43 |
52 |
100 |
33 |
33* |
8 |
15* |
28 |
37 |
123 |
128 |
44 |
50 |
333 |
73 |
72* |
9 |
18* |
27 |
43* |
155 |
132* |
45 |
56* |
1000 |
133 |
151* |
14 |
18* |
25 |
37* |
214 |
193* |
63 |
57* |
2500 |
242 |
270* |
11 |
13* |
23 |
35* |
374 |
283* |
83 |
64* |
5000 |
404 |
407* |
14 |
15* |
25 |
38* |
662 |
511* |
129 |
105* |
Untreated |
16 |
19 |
9 |
19 |
27 |
45 |
121 |
127 |
44 |
55 |
Solvent control (methanol) |
14 |
17 |
9 |
19 |
28 |
40 |
117 |
126 |
40 |
48 |
Positive control (NaN3) - 10 |
1516 |
- |
- |
- |
- |
- |
1608 |
- |
- |
- |
Positive control (4-NOPD) - 10 |
- |
- |
- |
- |
336 |
- |
- |
- |
- |
- |
Positive control (4-NOPD) - 50 |
- |
- |
66 |
- |
- |
- |
- |
- |
- |
- |
Positive control (MMS) - 3 |
- |
- |
- |
- |
- |
- |
- |
- |
749 |
- |
Positive control (2-AA) - 2.5 |
- |
221 |
- |
455 |
- |
2224 |
- |
3198 |
- |
- |
Positive control (2-AA) - 10 |
- |
- |
- |
- |
- |
- |
- |
- |
- |
270 |
* Reduced background growth
NaN3 = sodium azide
2 -AA = 2 -aminoanthracene
4 -NOPD = 4 -nitro-o-phenylene-diamine
MMS = methyl methane sulfonate
Applicant's summary and conclusion
- Conclusions:
- In a valid bacterial reverse mutation assay, conducted according to OECD Test Guideline 471 and in compliance with GLP, reaction mass of 3-(2,3-epoxypropoxy)propyltrimethoxysilane and triacetoxyvinylsilane was tested using Salmonella typhimurium TTA 100, TA 1535, TA 98 or TA 1537 and E. coli WP2 uvr A. A substantial and dose dependent increase in the number of revertants was observed with or without metabolic activation in Salmonella typhimurium strains TA 100, TA 1535 an d E. coli WP2 uvr A when tested up to limit concentrations. No evidence of a test-substance related increase in the number of revertants was observed with or without metabolic activation in Salmonel la typhimurium strains TA 98 or TA 1537. Appropriate positive and solvent controls were included and gave the expected results. It is concluded that the test substance is positive for mutagenicity to bacteria under the conditions of the test.
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.
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