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EC number: - | 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:
- 12 Oct - 25 Nov 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP - Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
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
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Landesamt für Umwelt, Wasserwirtschaft und Gewerbeaufsicht, Mainz, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
Method
- Target gene:
- his operon (S. thyphimurium)
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA97a, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- co-factor supplemented post-mitochondrial fraction (S9 mix) (Trinova Biochem, Gießen, Germany), prepared from the livers of male Sprague Dawley rats intraperitoneally treated with 500 mg/kg bw Aroclor 1254
- Test concentrations with justification for top dose:
- First experiment: 50, 150, 500, 1500 and 5001 µg/plate with and without metabolic activation
Second experiment: 313, 626, 1251, 2501 and 5001 µg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle/solvent used: DMSO (for the test substance and the positive control substances 4-nitro-1,2-phenylene diamine, 2-amino-anthracene and benzo-a-pyrene) or water (for the positive control substance sodium azide); 0.1 mL for the plate-incorporation and the preincubation treatment
- Justification for choice of solvent/vehicle: DMSO was chosen as vehicle, since the test substance was completely soluble, and this solvent did not have any effect on the viability of bacteria or the number of spontaneous revertants.
Controls
- 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 (20 µg/plate, -S9, TA 97a, TA98 and TA 102); sodium azide (1 µg/plate, -S9, TA100 and TA 1535); 2-amino-anthracene (1 µg/plate, +S9, TA 97a, TA100, TA 102 and TA 1535); benzo-a-pyrene (20 µg/plate, +S9, TA98)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION 1: in agar (plate incorporation) for first experiment
DURATION
- Exposure duration: 48 h
METHOD OF APPLICATION 2: preincubation method for the second experiment
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: quadruplicate each in both experiments
DETERMINATION OF CYTOTOXICITY
- Method: determination of titre (cytotoxicity test) and observation of background lawn (plate incorporation and preincubation experiment) - Evaluation criteria:
- The test substance was considered to have mutagenic potential, if a significant, reproducible increase in revertant colonies per plate (increase factor ≥ 2) in at least one of the test strains was observed. A concentration-dependent increase over a range of test concentrations was considered to be a sign of mutagenic activity.
- Statistics:
- Mean values and standard deviations of revertant colonies from each test group were calculated.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA97a, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- COMPARISON WITH HISTORICAL CONTROL DATA:
The mean numbers of spontaneous revertants in the solvent/vehicle controls of the strains used were all within the normal historical ranges.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In a preliminary study using the plate incorporation method, each strain was incubated with 1500 and 5001 µg/plate of the test substance. Two replicates for each concentration were performed both in the presence or absence of metabolic activation. For the determination of toxicity, the titre (colonies/plate) was determined in control and treated cultures. In control culture, the titre should give a number of at least 1E+9 cells/mL, correlating to 100 colonies/plate after dilution. A substance is considered non-toxic, if the quotient control titre/treatment titre is below 2. This criterion was fulfilled after treatment with 1500 and 5001 µg/plate of the test substance. In the main study, no signs of toxicity were observed in any strain and at any concentration tested in both experiments. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Test results of experiment 1 (plate incorporation)
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate |
|||||
(μg/plate) |
(Average of 4 plates ± standard deviation) |
||||||
|
Base-pair substitution type |
Frameshift type |
|||||
|
TA 100 |
TA102 |
TA1535 |
TA 97a |
TA 98 |
||
– |
water |
105 ± 5 |
151 ± 24 |
22 ± 4 |
97 ± 3 |
11 ± 3 |
|
– |
DMSO |
88 ± 5 |
171 ± 9 |
16 ± 1 |
108 ± 3 |
10 ± 2 |
|
– |
50 |
79 ± 10 |
146 ± 9 |
15 ± 2 |
108 ± 3 |
13 ± 1 |
|
– |
150 |
81 ± 9 |
147 ± 17 |
13 ± 3 |
110 ± 8 |
11 ± 1 |
|
– |
500 |
96 ± 2 |
142 ± 9 |
14 ± 1 |
132 ± 9 |
17 ± 3 |
|
|
1500 |
90 ± 8 |
148 ± 9 |
14 ± 3 |
104 ± 14 |
10 ± 2 |
|
– |
5001 |
90 ± 10 |
145 ± 6 |
14 ± 2 |
106 ± 9 |
14 ± 4 |
|
Positive controls, -S9 |
Name |
NaN3 |
4NOPD |
NaN3 |
4NOPD |
4NOPD |
|
Concentrations (μg/plate) |
1 |
20 |
1 |
20 |
20 |
||
Mean No. of colonies/plate (average of 4 ± SD) |
495 ± 60 |
604 ± 99 |
201 ± 18 |
456 ± 18 |
240 ± 19 |
||
+ |
water |
128 ± 19 |
176 ± 17 |
15 ± 2 |
108 ± 8 |
13 ± 6 |
|
+ |
DMSO |
112 ± 9 |
171 ± 4 |
14 ± 2 |
115 ± 2 |
14 ± 3 |
|
+ |
50 |
86 ± 11 |
154 ± 5 |
14 ± 3 |
102 ± 8 |
12 ± 2 |
|
+ |
150 |
80 ± 16 |
150 ± 8 |
14 ± 3 |
101 ± 3 |
13 ± 2 |
|
+ |
500 |
91 ± 12 |
146 ± 8 |
20 ± 2 |
105 ± 6 |
10 ± 3 |
|
+ |
1500 |
91 ± 15 |
154 ± 34 |
16 ± 3 |
108 ± 5 |
10 ± 2 |
|
+ |
5001 |
92 ± 5 |
149 ± 9 |
16 ± 4 |
92 ± 4 |
14 ± 1 |
|
Positive controls, +S9 |
Name |
AAN |
AAN |
AAN |
AAN |
BP |
|
Concentrations (μg/plate) |
1 |
1 |
1 |
1 |
20 |
||
Mean No. of colonies/plate (average of 4 ± SD) |
446 ± 63 |
594 ± 88 |
201 ± 11 |
499 ± 22 |
202 ± 13 |
Table 2. Test results of experiment 2 (preincubation)
With or without S9-Mix |
Test substance concentration |
Mean number of revertant colonies per plate |
|||||
(μg/plate) |
(Average of 4 plates ± standard deviation) |
||||||
|
Base-pair substitution type |
Frameshift type |
|||||
|
TA 100 |
TA102 |
TA1535 |
TA 97a |
TA 98 |
||
– |
water |
114 ± 23 |
162 ± 7 |
23 ± 6 |
115 ± 5 |
17 ± 4 |
|
– |
DMSO |
124 ± 4 |
153 ± 12 |
21 ± 3 |
113 ± 4 |
10 ± 3 |
|
– |
313 |
115 ± 21 |
154 ± 4 |
22 ± 2 |
115 ± 1 |
11 ± 1 |
|
– |
626 |
126 ± 16 |
148 ± 3 |
18 ± 3 |
113 ± 10 |
10 ± 3 |
|
– |
1251 |
123 ± 11 |
141 ± 15 |
20 ± 3 |
109 ± 6 |
11 ± 3 |
|
– |
2501 |
117 ± 8 |
160 ± 13 |
19 ± 4 |
114 ± 1 |
13 ± 2 |
|
– |
5001 |
130 ± 21 |
150 ± 7 |
20 ± 1 |
118 ± 6 |
10 ± 3 |
|
Positive controls, –S9 |
Name |
NaN3 |
4NOPD |
NaN3 |
4NOPD |
4NOPD |
|
Concentrations (μg/plate) |
1 |
20 |
1 |
20 |
20 |
||
Mean No. of colonies/plate (average of 4 ± SD) |
487 ± 35 |
657 ± 40 |
122 ± 8 |
488 ± 56 |
192 ± 30 |
||
+ |
water |
143 ± 11 |
141 ± 17 |
17 ± 4 |
117 ± 5 |
17 ± 3 |
|
+ |
DMSO |
111 ± 15 |
165 ± 6 |
22 ± 2 |
115 ± 12 |
15 ± 3 |
|
+ |
313 |
127 ± 23 |
148 ± 9 |
19 ± 4 |
116 ± 4 |
14 ± 1 |
|
+ |
626 |
147 ± 8 |
144 ± 4 |
14 ± 3 |
106 ± 4 |
10 ± 2 |
|
+ |
1251 |
126 ± 9 |
143 ± 2 |
17 ± 2 |
116 ± 5 |
11 ± 1 |
|
+ |
2501 |
134 ± 25 |
154 ± 13 |
17 ± 3 |
118 ± 6 |
11 ± 3 |
|
+ |
5001 |
130 ± 7 |
152 ± 2 |
15 ± 2 |
116 ± 6 |
12 ± 2 |
|
Positive controls, +S9 |
Name |
AAN |
AAN |
AAN |
AAN |
BP |
|
Concentrations (μg/plate) |
1 |
1 |
1 |
1 |
20 |
||
Mean No. of colonies/plate (average of 4 ± SD) |
618 ± 164 |
516 ± 60 |
131 ± 15 |
460 ± 24 |
236 ± 26 |
NaN3 = sodium azide
4NOPD = 4-nitro-1,2-phenylene diamine
AAN = 2-aminoanthracene
BP = benzo-a-pyrene
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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.
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