Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 924-669-1 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 2016-03-08 to 2016-06-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Version / remarks:
- 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: ICH Guideline S2 (R1): Genotoxicity testing and data interpretation for pharmaceuticals intended for human use, June 2012
- Version / remarks:
- 2012
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction product of Hexamethylene diisocyanate, oligomers with Mercaptopropyltrimethoxysilane
- EC Number:
- 924-669-1
- Molecular formula:
- No data available
- IUPAC Name:
- Reaction product of Hexamethylene diisocyanate, oligomers with Mercaptopropyltrimethoxysilane
- Test material form:
- liquid
Constituent 1
Method
- Target gene:
- The Salmonella typhimurium histidine (his) reversion system measures his- → his+ reversions. The Salmonella typhimurium strains are constructed to differentiate between base pair (TA1535, TA100) and frameshift (TA1537, TA98) mutations. The Escherichia coli WP2 uvrA (trp) reversion system measures trp– → trp+ reversions. The Escherichia coli WP2 uvrA strain detects mutagens that cause other base-pair substitutions (AT to GC).
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:
- S9 fraction of Phenobarbital (PB) and β-naphthoflavone (BNF) induced rat liver
- Test concentrations with justification for top dose:
- Selection of the concentrations was done on the basis of a Solubility Test and a concentration range finding test (Informatory Toxicity Test).
The highest dose was 1600 μg test item/plate in absence (-S9 Mix) and 5000 μg/plate in the presence of exogenous metabolic activation (+S9 Mix) in the final treatment mixture under the actual conditions of the test at the start of the experiments for all test strains used.
The following seven concentrations of the test item were tested in the main experiments:
-S9 Mix: 1600, 500; 160; 50; 16; 5 and 1.6 μg/plate;
+S9 Mix: 5000; 1600; 500; 160; 50; 16 and 5 μg/plate. - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-1,2-phenylene-diamine (NPD)
- Remarks:
- without S9; vehicle: DMSO; strain: Salmonella TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9; vehicle: ultrapure water; strains: Salmonella TA100, TA1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9; vehicle: DMSO; strain: Salmonella TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9; vehicle: ultrapure water; strain: E. coli WP2 uvr A
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene (2AA)
- Remarks:
- with S9; vehicle: DMSO; strains: all of Salmonella strains and E. coli WP2 uvrA
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) and preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: revertant colony numbers, background lawn development
- Any supplementary information relevant to cytotoxicity: The toxicity of the test item was determined with strains Salmonella typhimurium TA98 and TA100 in a pre-experiment. 7 concentrations were tested for toxicity and mutation induction with 3 plates each. The experimental conditions in this pre-experiment were the same as described below for the main experiment I (plate incorporation test) and included non-activated and S9 activated test conditions with appropriate positive and negative controls. The test item concentrations, including the controls (untreated, vehicle and positive reference) were tested in triplicate. In the toxicity test the concentrations examined were: 5000, 1600, 500, 160, 50, 16 and 5 μg/plate. - Rationale for test conditions:
- Selection of the concentrations was done on the basis of a Solubility Test and a concentration range finding test (Informatory Toxicity Test).
- 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.
An increase is considered biologically relevant if:
- in strain TA100 the number of reversions is at least twice as high as the reversion rate of the vehicle control.
- in strain TA98, TA1535, TA1537 and Escherichia coli WP2 uvrA the number of reversions is at least three times higher than the reversion rate of the vehicle control.
According to the guidelines, the biological relevance of the results was the criterion for the interpretation of results, a statistical evaluation of the results was not regarded as necessary.
Criteria for a Negative Response:
A test article is considered non-mutagenic in this bacterial reverse mutation assay if it produces neither a dose-related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups, 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:
- cytotoxicity
- Remarks:
- at 160 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 160 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 500 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- 500 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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:
- cytotoxicity
- Remarks:
- 1600 µg/plate and above
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: Test item was dissolved, suspended in anhydrous dimethyl sulfoxide (DMSO).
- Precipitation: In the performed experiments the test item solution precipitated in a form of drops (“microdrops”) on the plates; in all examined strains at the concentration of 5000 μg/plate, with addition of metabolic activation (+S9 Mix) following the plate incorporation and pre-incubation procedures (Initial and Confirmatory Mutation Tests).
RANGE-FINDING/SCREENING STUDIES: The toxicity of the test item was determined with strains Salmonella typhimurium TA98 and TA100 in a pre-experiment. 7 concentrations were tested for toxicity and mutation induction with 3 plates each. The experimental conditions in this pre-experiment were the same as described below for the main experiment I (plate incorporation test) and included non-activated and S9 activated test conditions with appropriate positive and negative controls. The test item concentrations, including the controls (untreated, vehicle and positive reference) were tested in triplicate. In the toxicity test the concentrations examined were: 5000, 1600, 500, 160, 50, 16 and 5 μg/plate. In the Informatory Toxicity Test inhibitory effect of the test item was observed; that was indicated by lower revertant colony numbers (compared to that of the vehicle and historical control data ranges) and/or reduced or slightly reduced background lawn development. The inhibitory, cytotoxic effect of the test item was observed in both strains at the concentrations of 5000 and 1600 μg/plate in the absence and also in the presence of exogenous metabolic activation (±S9 Mix). The slightly lower revertant colony numbers in S. typhimurium TA98 at 500 μg/plate (-S9 Mix) as well as the slightly higher revertant colony numbers in S. typhimurium TA100 at 50 μg/plate (-S9 Mix) remained in the corresponding historical control data ranges, and were considered as reflecting the biological variability of the applied test system. Microdrops (colloid-chemical phenomenon) were noticed in both strains at the highest examined concentration of 5000 μg/plate, without and with addition of exogenous metabolic activation (±S9 Mix).
HISTORICAL CONTROL DATA
Mutation frequencies were within historical control data (see "Any other information on results" table 1).
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Signs of cytotoxicity has been observed in all tested strains with and/or without metabolic activation. The 160 μg/plate was found to be the lowest cytotoxic concentration, observed in the case of Salmonella typhimurium TA1535 and TA1537 strains, following the pre-incubation procedure, in absence of exogenous metabolic activation (-S9 Mix).
Any other information on results incl. tables
Table 1 Historical control values for revertants/plate (for the period of 2008-2015)
|
|
Bacterial strains |
|||||
Historical control data of DMSO control |
-S9 |
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli |
Average |
20.9 |
101.4 |
10.3 |
7.9 |
24.9 |
||
SD |
3.5 |
26.2 |
1.4 |
2.5 |
4.9 |
||
Minimum |
10 |
65 |
3. |
2 |
11 |
||
Maximum |
39 |
150 |
23 |
20 |
44 |
||
|
|
|
|
|
|
|
|
+S9 |
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli |
|
Average |
27.1 |
114.7 |
12.0 |
8.8 |
34.2 |
||
SD |
4.0 |
19.3 |
1.5 |
2.1 |
5.2 |
||
Minimum |
15 |
71 |
4. |
3 |
16 |
||
Maximum |
48 |
161 |
24 |
20 |
56 |
||
|
|
|
|
|
|
|
|
Historical control data of water control |
-S9 |
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli |
Average |
22.4 |
150.5 |
10.4 |
7.5 |
26.3 |
||
SD |
3.6 |
27.6 |
1.6 |
2.3 |
5.9 |
||
Minimum |
12 |
67 |
3. |
2 |
13 |
||
Maximum |
36 |
156 |
24 |
15 |
47 |
||
|
|
|
|
|
|
|
|
+S9 |
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli |
|
Average |
28.0 |
117.4 |
11.5 |
8.7 |
35.2 |
||
SD |
4.0 |
19.8 |
1.4 |
2.3 |
5.2 |
||
Minimum |
15 |
83 |
4. |
4. |
18 |
||
Maximum |
43 |
166 |
22 |
16 |
56 |
||
|
|
|
|
|
|
|
|
Historical control data of positive control |
-S9 |
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli |
Average |
255.6 |
958.9 |
842.1 |
467.4 |
712.3 |
||
SD |
30.7 |
149.9 |
134.0 |
105.7 |
57.5 |
||
Minimum |
123 |
522 |
354 |
109 |
320 |
||
Maximum |
647 |
1927 |
1871 |
1498 |
1283 |
||
|
|
|
|
|
|
|
|
+S9 |
|
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
E. coli |
|
Average |
1224.8 |
1431.9 |
165.4 |
148.0 |
264.7 |
||
SD |
293.8 |
399.9 |
35.1 |
21.3 |
74.2 |
||
Minimum |
409 |
581 |
85 |
68 |
141 |
||
Maximum |
2587 |
2923 |
507 |
407 |
487 |
Table 2. Summary of the results of the Range Finding Test
Range Finding Test (Informatory Toxicity Test) |
||||||||
Concentrations (mg/plate) |
Salmonella typhimurium tester strains |
|||||||
TA 98 |
TA 100 |
|||||||
-S9 |
+S9 |
-S9 |
+S9 |
|||||
Mean values of revertants per plate and |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Untreated Control |
19.0 |
1.14 |
33.0 |
1.39 |
85.7 |
1.00 |
109.3 |
1.10 |
DMSO Control |
19.3 |
1.00 |
21.3 |
1.00 |
– |
– |
104.0 |
1.00 |
Ultrapure Water Control |
– |
– |
– |
– |
76.3 |
1.00 |
– |
– |
DMSO (Anhydrous) Control |
16.7 |
1.00 |
23.7 |
1.00 |
85.7 |
1.00 |
99.0 |
1.00 |
5000 |
3.0 |
0.18 |
7.7 |
0.32 |
0.3 |
0.00 |
58.3 |
0.59 |
1600 |
7.7 |
0.46 |
8.0 |
0.34 |
59.0 |
0.69 |
82.3 |
0.83 |
500 |
13.0 |
0.78 |
21.0 |
0.89 |
91.3 |
1.07 |
90.3 |
0.91 |
160 |
14.0 |
0.84 |
25.7 |
1.08 |
84.0 |
0.98 |
109.0 |
1.10 |
50 |
14.3 |
0.86 |
25.0 |
1.06 |
107.7 |
1.26 |
101.0 |
1.02 |
16 |
19.0 |
1.14 |
21.7 |
0.92 |
99.7 |
1.16 |
101.0 |
1.02 |
5 |
17.7 |
1.06 |
20.7 |
0.87 |
94.0 |
1.10 |
109.7 |
1.11 |
NPD (4mg) |
269.7 |
13.95 |
– |
– |
– |
– |
– |
– |
SAZ (2mg) |
– |
– |
– |
– |
1337.3 |
17.52 |
– |
– |
2AA (2mg) |
– |
– |
1170.7 |
54.88 |
– |
– |
1392.0 |
13.38 |
Table 3. Summary of the results of the Initial Mutation Test
Initial Mutation Test (Plate Incorporation Test) |
||||||||||||||||||||
Concentrations (mg/plate) |
Salmonella typhimurium tester strains |
Escherichia coli |
||||||||||||||||||
TA 98 |
TA 100 |
TA 1535 |
TA 1537 |
WP2 uvrA |
||||||||||||||||
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
-S9 |
+S9 |
|||||||||||
Mean values of revertants per plate Mutation rate (MR) |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Mean |
MR |
Untreated Control |
20.7 |
1.22 |
24.0 |
1.16 |
94.0 |
0.96 |
118.7 |
1.03 |
7.7 |
0.92 |
8.7 |
0.87 |
7.0 |
0.88 |
8.0 |
1.00 |
16.0 |
0.94 |
17.7 |
0.88 |
DMSO Control |
17.0 |
1.00 |
22.3 |
1.00 |
– |
– |
119.7 |
1.00 |
– |
– |
5.3 |
1.00 |
8.0 |
1.00 |
8.3 |
1.00 |
– |
– |
21.0 |
1.00 |
Ultrapure Water Control |
– |
– |
– |
– |
98.3 |
1.00 |
– |
– |
8.7 |
1.00 |
– |
– |
– |
– |
– |
– |
18.0 |
1.00 |
– |
– |
DMSO (Anhydrous) Control |
17.0 |
1.00 |
20.7 |
1.00 |
98.3 |
1.00 |
114.7 |
1.00 |
8.3 |
1.00 |
10.0 |
1.00 |
8.0 |
1.00 |
8.0 |
1.00 |
17.0 |
1.00 |
20.0 |
1.00 |
5000 |
– |
– |
17.0 |
0.82 |
– |
– |
52.0 |
0.45 |
– |
– |
2.7 |
0.27 |
– |
– |
0.7 |
0.08 |
– |
– |
10.3 |
0.52 |
1600 |
5.7 |
0.33 |
15.0 |
0.73 |
50.3 |
0.51 |
72.7 |
0.63 |
1.3 |
0.16 |
9.3 |
0.93 |
0.7 |
0.08 |
4.3 |
0.54 |
9.3 |
0.55 |
21.7 |
1.08 |
500 |
13.3 |
0.78 |
17.7 |
0.85 |
62.3 |
0.63 |
82.7 |
0.72 |
5.3 |
0.64 |
8.3 |
0.83 |
3.3 |
0.42 |
8.3 |
1.04 |
19.7 |
1.16 |
21.0 |
1.05 |
160 |
15.3 |
0.90 |
18.0 |
0.87 |
78.0 |
0.79 |
99.0 |
0.86 |
8.0 |
0.96 |
8.0 |
0.80 |
6.0 |
0.75 |
11.0 |
1.38 |
17.3 |
1.02 |
19.3 |
0.97 |
50 |
19.3 |
1.14 |
16.0 |
0.77 |
89.7 |
0.91 |
93.3 |
0.81 |
9.3 |
1.12 |
8.0 |
0.80 |
10.0 |
1.25 |
7.0 |
0.88 |
19.7 |
1.16 |
18.7 |
0.93 |
16 |
20.7 |
1.22 |
18.7 |
0.90 |
86.3 |
0.88 |
113.7 |
0.99 |
11.0 |
1.32 |
8.0 |
0.80 |
10.7 |
1.33 |
11.7 |
1.46 |
18.3 |
1.08 |
16.7 |
0.83 |
5 |
15.3 |
0.90 |
16.7 |
0.81 |
82.0 |
0.83 |
102.3 |
0.89 |
11.7 |
1.40 |
9.7 |
0.97 |
12.3 |
1.54 |
10.0 |
1.25 |
18.0 |
1.06 |
18.0 |
0.90 |
1.6 |
16.0 |
0.94 |
– |
– |
75.7 |
0.77 |
– |
– |
7.3 |
0.88 |
– |
– |
11.0 |
1.38 |
– |
– |
19.0 |
1.12 |
– |
– |
NPD (4mg) |
279.0 |
16.41 |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
SAZ (2mg) |
– |
– |
– |
– |
1066.7 |
10.85 |
– |
– |
809.3 |
93.38 |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
9AA (50mg) |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
804.0 |
100.50 |
– |
– |
– |
– |
– |
– |
MMS (2mL) |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
382.7 |
21.26 |
– |
– |
2AA (2mg) |
– |
– |
1156.0 |
51.76 |
– |
– |
1474.7 |
12.32 |
– |
– |
162.0 |
30.38 |
– |
– |
177.0 |
21.24 |
– |
– |
– |
– |
2AA (50mg) |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
– |
194.7 |
9.27 |
Applicant's summary and conclusion
- Conclusions:
- The reported data of this mutagenicity assay shows, that under the experimental conditions reported, the test item did not induce gene mutations by frameshift or base-pair substitution in the genome of the tester strains used. Therefore, the test item is considered non-mutagenic in this bacterial reverse mutation assay.
- Executive summary:
The test item was dissolved in anhydrous dimethyl sulfoxide (DMSO). In the Initial and Confirmatory Mutation Tests the following concentrations were examined: -S9 Mix: 1600; 500; 160; 50; 16; 5 and 1.6 μg/plate; +S9 Mix: 5000; 1600; 500; 160; 50; 16 and 5 μg/plate. In the Initial and Confirmatory Mutation Tests Salmonella typhimurium TA98, TA1537, TA1535 and TA100 strains and Escherichia coli WP2 uvrA were investigated. Five bacterial strains were used to investigate the mutagenic potential of the test item in two independent experiments, in a plate incorporation test (experiment I, Initial Mutation Test) and in a pre-incubation test (experiment II, Confirmatory Mutation Test). Each assay was conducted with and without metabolic activation (±S9 Mix). The concentrations, including the controls, were tested in triplicate. In the performed experiments positive and negative (vehicle) controls were run concurrently. In the performed experiments all of the validity criteria, regarding the investigated strains, negative and positive controls, S9 activity and number of investigated analyzable concentration levels were fulfilled. No substantial increases were observed in revertant colony numbers of any of the five test strains following treatment with the test item at any concentration level, either in the presence or absence of metabolic activation (S9 Mix) in the performed experiments. Sporadic increases in revertant colony numbers compared to the vehicle control values within the actual historical control data ranges were observed in both independently performed main experiments. However, there was no tendency of higher mutation rates with increasing concentrations beyond the generally acknowledged border of biological relevance in the performed experiments. In the performed experiments inhibitory effect of the test item (decreased number of revertant colony numbers and/or affected background lawn development) was observed in all examined bacterial strains. The 160 μg/plate was found to be the lowest cytotoxic concentration, observed in the case of Salmonella typhimurium TA1535 and TA1537 strains, in the absence of exogenous metabolic activation (-S9 Mix). Microdrops (as colloid-chemical phenomenon) was observed on the plates in the above bacterial strains at the concentration of 5000 μg/plate with addition of exogenous metabolic activation, following the plate incorporation and pre-incubation procedures (Initial and Confirmatory Mutation Tests).
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.