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EC number: 433-180-8 | 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
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1999-02-17-1999-03-26
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to GLP and guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guidelineopen allclose all
- 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:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
-Name of test material (as cited in study report): Reaktiv-Orange DYPR934
Constituent 1
Method
- Target gene:
- Test organism:
Salmonella typhinium strains:
TA98 hisD3052 rfa uvrB + R
TA 100 hisG46 rfa uvrB +R
TA 1535 hisG46 rfa uvrB,
TA 1537 hisC3076 rfa uvrB
and
E. coli WP2 uvrA pkm101
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Details on mammalian cell type (if applicable):
- Bacteria:
The strains of Salmonella typhimurium were obtained from professor B.N. Ames, University of California, U.S.A. The strain of E. coli was obtained from the national Collection of Industrial Bacteria, Aberdeen, Scotland.
Bacteria were grown overnight in nutrient broth (25 g Oxid Nutrient Broth No. 2 /liter) at approx. 37 °C. The amount of bacteria in the cell suspension was checked by nephelometry. Inoculation was performed with stock cultures which had been stored at approx. -80 °C. The different bacterial strains are checked half-yearly with regard to their respective biotin, histidine requirements, membrane permeability, ampicillin resistance, crystal violet sensitivity, UV resistance and response to diagnostic mutagens. All criteria for a valid assay were fulfilled.
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-Mix aus Rattenleber und Hamsterleber Mix
- Test concentrations with justification for top dose:
- Concentration range in the main test (with metabolic activation): 50 ... 5000 µg/plate
Concentration range in the main test (without metabolic activation): 50 ... 5000 µg/plate - Vehicle / solvent:
- Solvent: d. Wasser
Controlsopen allclose all
- Untreated negative controls:
- yes
- Remarks:
- See under " details on test system and conditions"
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- Without metabolic activation
- Positive control substance:
- sodium azide
- Remarks:
- Used with tester strains TA100 and TA1535
- Untreated negative controls:
- yes
- Remarks:
- See under " details on test system and conditions"
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- Used with tester Strain TA 1537
Migrated to IUCLID6: Without metabolic activation
- Untreated negative controls:
- yes
- Remarks:
- See under " details on test system and conditions"
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- Without metabolic activation
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- Used with tester strain TA 98
- Untreated negative controls:
- yes
- Remarks:
- See under " details on test system and conditions"
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- Without metabolic activation
- Positive control substance:
- other: MNNG( N-methyl-N-nitro-N-nitrosoguanidine
- Remarks:
- Used with tester strain WP2uvrA
- Untreated negative controls:
- yes
- Remarks:
- See under " details on test system and conditions"
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- Without metabolic activation
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- Used with tester strain WP2uvrA
- Untreated negative controls:
- yes
- Remarks:
- See under " details on test system and conditions"
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- with metabolic activatiobn (10% rat liver)
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- Used with all tester strains
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Remarks:
- with metabolic activation (30% Syrian golden hamster liver and preincubation)
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- Used with tester Strains TA 100, TA 1535 and TA 1537
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation; in suspension;
Test System:
Test Groups: PLATE INCORPORATION TEST
a) Without metabolic activation: 50; 160, 500, 1600 and 5000 µg/plate
b) With metabolic activation (10 % rat liver):
50, 160, 500, 1600 and 5000 µg/plate
PREINCUBATION TEST
a) Without metabolic activation:
50; 160, 500, 1600 and 5000 µg/plate
b) With metabolic activation (30 % rat liver)
50, 160, 500, 1600 and 5000 µg/plate
CONTROL GROUPS:
Negative controls:
a) Untreated control
b: solvent control
Positive controls:
a) without metabolic activation (Sodium-azide for Strain TA 100 and TA 1535, 9 aminoacridine for strain TA 1537, 2-Nitrofluorene for strain 98, MNNG for strain WP2uvrA and 4-NQO for strain WP2uvrA
b): with metabolic activation (10 % rat liver)
2-aminoanthracene for all tester strains
c)-with metabolic activation (30 % Syrian golden hamster liver and preincubation)
2-aminoanthracene for strain TA 100, TA 1535 and TA 1537
Congo red for Strain TA98
Formulation of test compound: dissolved in deionized water at appropriate concentrations immediately before use.
DURATION
- Preincubation period: 30 min preincubation in the presence of 30 % (v/v) Syrian golden hamster S9-mix.
Three volumes of S9 fraction was mixed with 7 volumes of the S9 cofactor solution. - Evaluation criteria:
- Assay considered valid if:
-Solvent control data are within the laboratory´s normal control range for the spontaneous mutant frequency
-Positive controls induced increases in the mutation frequency which were both statistically significant and within the laboratory´s normal range
Test compound is classified as mutagenic if has either following effects:
-it produces at least a 2-fold increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control at complete bacterial background lawn
-it induces a dose-related increase in the mean number of revertants per plate of at least one of the tester strains over the mean number of revertants per plate of the appropriate vehicle control in at least two to three concentrations of the test compound at complete bacterial background lawn If test substance does not achieve either of the above criteria, it is considered to show no evidence of mutagenic activity in this system Sterility of S9-mix and the test compound were indicated by the absence of contamination on the test material and S9-mix sterility check plates. Control plates (background control and positive controls) gave the expected number of colonies, i.e. values were within the laboratories control range. Test compound proved to be not toxic to the bacterial strains. In all independent mutation tests Reaktiv-Orange DYPR 934 was tested for mutagenicity with concentrations as described in table above. Number of colonies per plate with each strain as well as mean values of 3 plates is given.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Test compound proved to be not toxic to the bacterial strains
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Remarks:
- Test compound proved to be not toxic to the bacterial strains
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: NA
- Water solubility:
The test compound did not precipitate on the plates until the highest investigated dose of 5000 µg/plate
The test substance proved to be not toxic to the bacterial strains.
HISTORICAL CONTROL DATA (see table under "overall remarks”) - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
RESULTS AND COMMENTS:
RESULTS:
STERILITY CHECKS AND CONTROL PLATES
Sterility of S9-mix and the test material and S9-mix sterility check plates. Control plates gave the expected number of colonies, i.e. values were within the laboratory's historical range.
SOLUBILITY AND TOXICITY
The test compound was dissolved in deionized water and a stock solution of 50 mg/mL was prepared for the highest concentration, which provided a final concentration of 5000 µg/plate. Further dilutions of 1600, 500, 160 and 50 µg/plate were used in all experiments.
The test compound proves to be not toxic to the bacterial strains.
MUTAGENICITY:
In all independent mutation tests Reaktiv-Orange DYPR 934 was tested for mutagenicity with the same concentration.
AMES TEST:
Reaktiv-Orange DYPR 934 did not cause a significant increase in the number of revertant colonies at any dose level with any of the tester strains either in the absence or in the presence of rat liver S9-mix in either mutation test. No dose dependant effect was obtained.
PRIVAL TEST:
In the presence of hamster liver S9-mix (30 % (v/v)) using the preincubation method according to prival the test compound did not cause a significant increase in the number of revertant colonies under the experimental conditions described.
All positive controls produced significant increases in the number of revertant colonies. Thus the sensitivity of the assay and the efficacy of the exogenous metabolic activation system were demonstrated.
Table I: AMES TEST RESULTS Controls Study ZR0611 Date tested: 1999-02-17 Date counted: 1999-02-19 Positive controls: QN0073/87 Solvent Controls: QN0076/40 Negative Controls: QN0078/84 Solvent Control comments: none Negative control comments: none Positive control comments: none
|
||||||||
STRAIN |
Dose levels (µg/plate) |
Mean |
Standard deviation |
Ratio: BL Test/ Control |
No Revertants/plate
Plate 1 |
No Revertants/plate
Plate 2 |
No Revertants/plate
Plate 3 |
|
Ta 100 (+S9) |
Solvent controls |
116.0 |
13.7 |
|
|
131 |
104 |
113 |
Negative controls |
104.3 |
14.2 |
0.9 |
88 |
113 |
112 |
||
Positive controls 0.5 |
P00001/001/001 |
2-Aminoanthracene |
||||||
1464.0 |
21.9 |
12.0 |
1448 |
1489 |
1455 |
|||
Ta 100 (-S9) |
Solvent controls |
109.3 |
6.5 |
|
103 |
116 |
109 |
|
Negative controls |
113.0 |
27.9 |
1.0 |
105 |
144 |
90 |
||
Positive controls 1 |
P00002/001/001 |
Sodium-Azide |
||||||
|
453.7 |
38.4 |
4.2 |
498 |
432 |
431 |
||
Ta 1535 (+S9) |
Solvent controls |
10.0 |
3.0 |
|
7 |
10 |
13 |
|
Negative controls |
6.3 |
2.5 |
0.6 |
9 |
6 |
4 |
||
Positive controls 1 |
P00001/001/001 |
2-Aminoanthracene |
||||||
165.0 |
13.1 |
16.5 |
151 |
177 |
167 |
|||
Ta 1535 (-S9) |
Solvent controls |
8.7 |
4.0 |
|
5 |
8 |
13 |
|
Negative controls |
7.7 |
3.5 |
0.9 |
8 |
11 |
4 |
||
Positive controls 1 |
P00002/001/001 |
Sodium-Azide |
||||||
|
321.7 |
45.2 |
37.0 |
341 |
354 |
270 |
||
Ta 1537 (+S9) |
Solvent controls |
7.7 |
2.1 |
|
6 |
7 |
10 |
|
Negative controls |
7.3 |
1.2 |
0.9 |
8 |
8 |
6 |
||
Positive controls 1 |
P00001/001/001 |
2-Aminoanthracene |
||||||
200.0 |
16.5 |
26.0 |
191 |
190 |
219 |
|||
Ta 1537 (-S9) |
Solvent controls |
10.3 |
3.8 |
|
13 |
12 |
6 |
|
Negative controls |
|
|
|
4 |
7 |
8 |
||
Positive controls 50 |
P00003/001/001 |
9-Aminoacridine |
||||||
|
119.0 |
25.0 |
11.6 |
91 |
127 |
139 |
||
TA 98 (+S) |
Solvent controls |
24.3 |
2.5 |
|
22 |
24 |
27 |
|
|
Negative controls |
|
|
|
25 |
20 |
28 |
|
|
Positive controls 0.5 |
P00001/001/001 |
2-Aminoanthracene |
|||||
|
1042.7 |
118.5 |
42.9 |
1161 |
924 |
1043 |
||
TA 98 (-S) |
Solvent controls |
18.7 |
4.5 |
|
14 |
19 |
23 |
|
|
Negative controls |
17.0 |
2.0 |
0.9 |
15 |
19 |
17 |
|
|
Positive controls 2.5 |
P00004/001/001 |
2-Nitrofluorene |
|||||
|
420 |
56.7 |
22.5 |
479 |
366 |
415 |
||
Wp2uvrA (+S9) |
Solvent controls |
24.0 |
7.8 |
|
28 |
29 |
15 |
|
|
Negative controls |
22.3 |
4.0 |
0.9 |
26 |
23 |
18 |
|
|
Positive controls 30 |
P00001/001/001 |
2-Aminoanthracene |
|||||
|
98.3 |
9.0 |
4.1 |
103 |
88 |
104 |
||
Wp2uvrA (-S9) |
Solvent controls |
21.7 |
5.0 |
|
27 |
21 |
17 |
|
|
Negative controls |
17.3 |
5.1 |
0.8 |
|
13 |
23 |
16 |
|
Positive controls 4 |
P00005/001/001 |
|
MNNG (N-Methyl-N-nitro-N-nitrosoguanine) |
||||
|
|
109.0 |
16.7 |
5.0 |
|
91 |
112 |
124 |
Table II: AMES TEST RESULTS Study ZR0611 Date tested: 1999-02-17 Date counted: 1999-02-19 Compound D00897/001/001 Reaktiv Orange DYPR 934 Batch: DYPR 934 Comments: Votox 99.0014 All sterility control plates were steriled |
||||||||
STRAIN |
Dose levels (µg/plate) |
Mean |
Standard deviation |
Ratio: BL Test/ Control |
No Revertants/plate
Plate 1 |
No Revertants/plate
Plate 2 |
No Revertants/plate
Plate 3 |
|
Ta 100 (+S9)
|
0. |
116.0 |
13.7 |
|
|
131 |
104 |
113 |
50. |
104.3 |
14.2 |
1.1 |
140 |
120 |
122 |
||
160. |
|
|
||||||
113.7 |
26.4 |
1.0 |
106 |
92 |
143 |
|||
500. |
119.3 |
5.9 |
1.0 |
126 |
115 |
117 |
||
1600 |
116.0 |
14.5 |
1.0 |
102 |
131 |
115 |
||
5000. |
|
|
||||||
|
105.0 |
20.1 |
0.9 |
126 |
86 |
103 |
||
Ta 100 (-S9)
|
0. |
109.3 |
6.5 |
|
103 |
116 |
109 |
|
50. |
109.7 |
13.3 |
1.0 |
121 |
113 |
95 |
||
160. |
|
|
||||||
92.7 |
17.1 |
0.8 |
104 |
101 |
73 |
|||
500. |
92.7 |
28.1 |
0.8 |
66 |
122 |
90 |
||
1600 |
94.7 |
18.6 |
0.9 |
75 |
112 |
97 |
||
5000. |
|
|
||||||
79.3 |
4.0 |
0.7 |
84 |
77 |
77 |
|||
Ta 1535 (+S9)
|
0. |
10.0 |
3.0 |
|
7 |
10 |
13 |
|
50. |
9.3 |
0.6 |
0.9 |
10 |
9 |
9 |
||
160. |
|
|
||||||
10.0 |
0.0 |
1.0 |
10 |
10 |
10 |
|||
500. |
9.3 |
2.3 |
0.9 |
8 |
12 |
8 |
||
1600 |
12.0 |
2.0 |
1.2 |
12 |
14 |
10 |
||
5000. |
|
|
||||||
11.3 |
1.2 |
1.1 |
10 |
12 |
12 |
|||
Ta 1535 (-S9)
|
0 |
8.7 |
4.0 |
|
5 |
8 |
13 |
|
50. |
7.7 |
2.5 |
0.9 |
8 |
10 |
5 |
||
160. |
|
|
||||||
8.7 |
2.5 |
1.0 |
11 |
6 |
9 |
|||
500. |
11.0 |
2.0 |
1.3 |
9 |
11 |
13 |
||
1600 |
7.0 |
1.0 |
0.8 |
6 |
7 |
8 |
||
5000. |
|
|
||||||
8.3 |
5.1 |
1.0 |
7 |
4 |
14 |
|||
Ta 1537 (+S9)
|
0. |
7.7 |
2.1 |
|
6 |
7 |
10 |
|
50. |
6.0 |
1.7 |
0.8 |
7 |
7 |
4 |
||
160. |
|
|
||||||
6.7 |
2.1 |
0.9 |
9 |
6 |
5 |
|||
500. |
6.0 |
1.0 |
0.8 |
5 |
6 |
7 |
||
1600 |
5.7 |
2.1 |
0.7 |
|
5 |
4 |
8 |
|
5000. |
|
|
|
|||||
|
|
9.3 |
2.9 |
1.2 |
|
6 |
11 |
11 |
Table II: AMES TEST RESULTS TEST Study ZR0611 Date tested: 1999-02-17 Date counted: 1999-02-19 Compound D00897/001/001 Reaktiv Orange DYPR 934 Batch: DYPR 934 Comments: Votox 99.0014 All sterility control plates were sterile |
||||||||
STRAIN |
Dose levels (µg/plate) |
Mean |
Standard deviation |
Ratio: BL Test/ Control |
No Revertants/plate
Plate 1 |
No Revertants/plate
Plate 2 |
No Revertants/plate
Plate 3 |
|
Ta 1537 (-S9)
|
0. |
10.3 |
3.8 |
|
|
13 |
12 |
6 |
50. |
7.3 |
1.5 |
0.7 |
9 |
7 |
6 |
||
160. |
|
|
||||||
5.3 |
2.1 |
0.5 |
6 |
3 |
7 |
|||
500. |
8.3 |
4.9 |
0.8 |
14 |
5 |
6 |
||
1600 |
7.7 |
1.2 |
0.7 |
7 |
7 |
9 |
||
5000. |
|
|
||||||
|
8.3 |
0.6 |
0.8 |
8 |
9 |
8 |
||
Ta 98 (+S9)
|
0. |
24.3 |
2.5 |
|
22 |
24 |
27 |
|
50. |
26.0 |
1.7 |
1.1 |
27 |
24 |
27 |
||
160. |
|
|
||||||
18.3 |
2.3 |
0.8 |
17 |
21 |
17 |
|||
500. |
19.0 |
4.0 |
0.8 |
15 |
19 |
23 |
||
1600 |
18.3 |
3.6 |
0.7 |
22 |
15 |
17 |
||
5000. |
|
|
||||||
15.3 |
7.2 |
0.6 |
20 |
7 |
19 |
|||
Ta 98 (-S9)
|
0. |
18.7 |
4.5 |
|
14 |
19 |
23 |
|
50. |
22.7 |
8.1 |
1.2 |
32 |
25 |
17 |
||
160. |
|
|
||||||
22.3 |
2.3 |
1.2 |
21 |
25 |
21 |
|||
500. |
24.3 |
2.9 |
1.3 |
21 |
26 |
26 |
||
1600 |
21.7 |
0.6 |
1.2 |
22 |
22 |
21 |
||
5000. |
|
|
||||||
17.7 |
2.1 |
0.9 |
17 |
20 |
16 |
|||
WP2uvrA (+S9) |
0 |
24.0 |
7.8 |
|
28 |
29 |
15 |
|
50. |
24.0 |
7.2 |
1.0 |
16 |
30 |
26 |
||
160. |
|
|
||||||
22.3 |
3.2 |
0.9 |
26 |
21 |
20 |
|||
500. |
25.0 |
2.0 |
1.0 |
27 |
23 |
25 |
||
1600 |
22.0 |
5.3 |
0.9 |
28 |
20 |
18 |
||
5000. |
|
|
||||||
26.7 |
0.6 |
1.1 |
27 |
27 |
26 |
|||
WP2uvrA (-S9) |
0. |
21.7 |
5.0 |
|
27 |
21 |
17 |
|
50. |
20.0 |
1.0 |
0.9 |
24 |
16 |
20 |
||
160. |
|
|
||||||
20.0 |
1.0 |
0.9 |
24 |
16 |
20 |
|||
500. |
18.3 |
2.9 |
0.8 |
20 |
20 |
15 |
||
1600 |
19.3 |
1.5 |
0.9 |
|
19 |
18 |
21 |
|
5000. |
|
|
|
|||||
|
|
22.7 |
4.2 |
1.0 |
|
16 |
24 |
26 |
|
|
|
|
|
|
|
|
|
(to be continued)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation
negative without metabolic activation
Summarizing, it can be assumed that Reaktiv-Orange DYPR 934 is not mutagenic in the standard plate test; Ames Test as well as in the preincubation method according to Prival in the investigated dose levels.
- Executive summary:
Reaktiv-Orange DYPR 934 was tested for mutagenicity with the strains TA 100, TA 1535, TA 1537 and TA 98 of Salmonella typhimurium and Escherichia coli WP2uvrA.
Two independent mutagenicity studies were conducted one standard plate test ( Ames Test) and a modified preincubation test (Prival Test). The studies were performed in the absence and in the presence of a metabolizing system derived from a rat liver homogenate or a hamster liver homogenate. Additionally a repeat of the preincubation test was performed with the strain WP2uvrA in the absence of S9 -mix.
For all studies, the compound was dissolved in deionized water, and each bacterial strain was exposed to 5 dose levels. Doses for all studies ranged from 50 to 5000 µg/plate.
Control plates without mutagen showed that the number of spontaneous revertant colonies was within the laboratory's historical control range and similar to that described in the literature. All the positive control compounds gave the expected increase in the number of revertant colonies. Except in the first preincubation test with the strain WP2uvrA in the absence of S9 -mix, the positive control showed not the expected increase in the number of revertant colonies, this doubtful effect is caused by a decompose of N-Methyl-N-nitrosoguanidine (MNNG). In a repeat of this strain with an alternative positive compound 4 -Nitroquinoline-N-Oxide (4 -NQO) the sensitivity of the assay was demonstrated.
Toxicity: In the plate incorporation test and also in the preincubation test toxicity was not observed either with or without metabolic activation.
Ames Test:
Mutagenicity: in the absence of the metabolic activation system the test compound did not result in relevant increases in the number of revertants in any of the bacterial strains. Also in the presence of rat liver activation system (10 % (v/v)), treatment of the cells with Reaktiv-Orange DYPR 934 did not result in relevant increases in the number of revertant colonies.
Prival Test:
In the presence of hamster liver S9-mix (30 % (v/v)) using preincubation method according to Prival the test compound did not cause a significant increases in the number of revertant colonies with any of the tester strains under experimental conditions described.
Therefore, it can be assumed that Reaktiv-Orange DYPR 934 is not mutagenic in the standard plate test; Ames Test as well as in the preincubation method according to Prival in the investigated dose levels.
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