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EC number: 701-160-0 | 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
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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:
- march 2008
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study (OECD 471)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2008
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)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- GRAPHISTRENGTH C100
- IUPAC Name:
- GRAPHISTRENGTH C100
- Reference substance name:
- Tangled Multi-Walled Carbon Nanotubes
- EC Number:
- 701-160-0
- Cas Number:
- 7782-42-5
- Molecular formula:
- Hollow tubular carbon, 1-dimensional nano structures with hexagonal arrangement of carbon atoms
- IUPAC Name:
- Tangled Multi-Walled Carbon Nanotubes
- Test material form:
- solid: nanoform
Constituent 1
Constituent 2
Method
- Target gene:
- Histidine operon
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100, TA 102
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix from Arochlor1254-induced liver rats
- Test concentrations with justification for top dose:
- 1, 10, 50, 100, 250 and 500 µg/plate for the preliminary toxicity test.
15.6, 31.3, 62.5, 125, 250 and 500 µg/plate for both mutagenicity experiments - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used:ethanol
- Justification for choice of solvent/vehicle:
The test item was found not soluble in the vehicles usually used for this type of assay.
Consequently, a suspension was selected for the treatment. An homogenous suspension (to the naked eye) was obtained in ethanol at the concentration of 10 mg/mL.
For positive control : DMSO was used as solvent (except for Mitomycin C which was dissolved in distilled water)
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: azide de sodium, 9-Aminoacridine, 2-Nitrofluorène, Mitomycin C, 2-Anthramine, Benzo(a)pyrène
- Details on test system and experimental conditions:
- METHOD OF APPLICATION:
Both experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the preincubation method (60 minutes, 37°C).
DURATION
- Preincubation period: During the preincubation method, test item solution, S9 mix and the bacterial suspension were incubated for 60 minutes at 37°C, under shaking.
- Exposure duration: 48 to 72 hours of incubation at 37°C
NUMBER OF REPLICATIONS: Each strain was exposed to at least five dose-levels of the test item (three plates/dose-level).
DETERMINATION OF CYTOTOXICITY
- Method: The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn.
The test item did not induce any noteworthy increase in the number of revertants, either with or without S9 mix, in any of the five strains. - Evaluation criteria:
- A reproducible 2-fold increase (for the TA 98, TA 100 and TA 102 strains) or 3-fold increase (for the TA 1535 and TA 1537 strains) in the number of revertants compared with the vehicle controls, in any strain at any dose-level and/or evidence of a dose-relationship was considered as
a positive result. Reference to historical data, or other considerations of biological relevance may also be taken into account in the evaluation of the data obtained. - Statistics:
- no
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 the dose-level of 500 µg/plate in the five strains used without S9
- 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 the dose-level of 500 µg/plate in the five strains used without S9
- 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:
- at the dose-level of 500 µg/plate in the five strains used without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at the dose-level of 500 µg/plate in the five strains used without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at the dose-level of 500 µg/plate in the five strains used without S9
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- See tables 1, 2.
Any other information on results incl. tables
Table 1: First experiment
Direct plate incorporation method
Strain |
Compound |
Dose level per plate (µg) |
S9 mix |
Mean revertant colony counts |
SD |
Ration treated / solvent |
TA 1535 |
ETHANOL |
- |
16 |
5 |
||
TEST ITEM |
15.6 |
- |
12 |
5 |
0.8 |
|
31.3 |
- |
21 |
7 |
1.3 |
||
62.5 |
- |
21 |
8 |
1.4 |
||
125 |
- |
11 |
3 |
0.7 |
||
250 |
- |
15 |
6 |
1.0 |
||
500 |
- |
0 |
1 |
0.0 |
||
NAN3 |
1 |
- |
610 |
39 |
38.9 |
|
ETHANOL |
+ |
19 |
3 |
|||
TEST ITEM |
15.6 |
+ |
12 |
2 |
0.6 |
|
31.3 |
+ |
16 |
3 |
0.8 |
||
62.5 |
+ |
16 |
2 |
0.8 |
||
125 |
+ |
20 |
7 |
1.1 |
||
250 |
+ |
16 |
8 |
0.8 |
||
500 |
+ |
16 |
6 |
0.8 |
||
2AM |
2 |
+ |
286 |
16 |
14.8 |
|
TA 1537 |
ETHANOL |
- |
6 |
1 |
||
TEST ITEM |
15.6 |
- |
9 |
8 |
1.6 |
|
31.3 |
- |
9 |
3 |
1.4 |
||
62.5 |
- |
12 |
3 |
2.1 |
||
125 |
- |
9 |
3 |
1.4 |
||
250 |
- |
10 |
6 |
1.6 |
||
500 |
- |
0 |
0 |
0.0 |
||
9AA |
50 |
- |
1168 |
324 |
194.7 |
|
ETHANOL |
+ |
8 |
2 |
|||
TEST ITEM |
15.6 |
+ |
10 |
4 |
1.2 |
|
31.3 |
+ |
9 |
5 |
1.1 |
||
62.5 |
+ |
9 |
4 |
1.0 |
||
125 |
+ |
10 |
2 |
1.2 |
||
250 |
+ |
8 |
5 |
1.0 |
||
500 |
+ |
5 |
5 |
0.6 |
||
2AM |
2 |
+ |
144 |
15 |
17.3 |
|
TA 98 |
ETHANOL |
- |
30 |
4 |
||
TEST ITEM |
15.6 |
- |
36 |
6 |
1.2 |
|
31.3 |
- |
28 |
5 |
0.9 |
||
62.5 |
- |
27 |
8 |
0.9 |
||
125 |
- |
31 |
7 |
1.0 |
||
250 |
- |
30 |
1 |
1.0 |
||
500 |
- |
1 |
2 |
0.0 |
||
2NF |
0.5 |
- |
248 |
16 |
8.3 |
|
ETHANOL |
+ |
35 |
6 |
|||
TEST ITEM |
15.6 |
+ |
38 |
4 |
1.1 |
|
31.3 |
+ |
40 |
11 |
1.1 |
||
62.5 |
+ |
36 |
2 |
1.0 |
||
125 |
+ |
43 |
5 |
1.2 |
||
250 |
+ |
40 |
4 |
1.1 |
||
500 |
+ |
35 |
7 |
1.0 |
||
2AM |
2 |
+ |
1462 |
112 |
41.4 |
|
TA 100 |
ETHANOL |
- |
95 |
19 |
||
TEST ITEM |
15.6 |
- |
125 |
22 |
1.3 |
|
31.3 |
- |
120 |
10 |
1.3 |
||
62.5 |
- |
112 |
30 |
1.2 |
||
125 |
- |
132 |
14 |
1.4 |
||
250 |
- |
138 |
1 |
1.5 |
||
500 |
- |
36 |
52 |
0.4 |
||
NAN3 |
1 |
- |
744 |
82 |
7.8 |
|
ETHANOL |
+ |
106 |
16 |
|||
TEST ITEM |
15.6 |
+ |
117 |
8 |
1.1 |
|
31.3 |
+ |
118 |
22 |
1.1 |
||
62.5 |
+ |
119 |
8 |
1.1 |
||
125 |
+ |
117 |
10 |
1.1 |
||
250 |
+ |
122 |
6 |
1.2 |
||
500 |
+ |
129 |
15 |
1.2 |
||
BAP |
5 |
+ |
957 |
28 |
9.0 |
|
TA 102 |
ETHANOL |
- |
290 |
52 |
||
TEST ITEM |
15.6 |
- |
349 |
51 |
1.2 |
|
31.3 |
- |
241 |
34 |
0.8 |
||
62.5 |
- |
344 |
53 |
1.2 |
||
125 |
- |
345 |
16 |
1.2 |
||
250 |
- |
403 |
53 |
1.4 |
||
500 |
- |
12 |
5 |
0.0 |
||
MMC |
0.5 |
- |
2764 |
159 |
9.5 |
|
ETHANOL |
+ |
382 |
41 |
|||
TEST ITEM |
15.6 |
+ |
433 |
10 |
1.1 |
|
31.3 |
+ |
433 |
22 |
1.1 |
||
62.5 |
+ |
407 |
54 |
1.1 |
||
125 |
+ |
327 |
27 |
0.9 |
||
250 |
+ |
469 |
41 |
1.2 |
||
500 |
+ |
505 |
22 |
1.3 |
||
2AM |
10 |
+ |
2778 |
162 |
7.3 |
|
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
GRAPHISTRENGTH C100 MICRONISED did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium. - Executive summary:
The potential of the test item GRAPHISTRENGTH C100 MICRONISED to induce reverse mutation in Salmonella typhimurium was evaluated. The study was performed according to the international guidelines OECD 471 and Good Laboratory Practices.
A preliminary toxicity test was performed to define the dose-levels of GRAPHISTRENGTH C100 MICRONISED to be used for the mutagenicity study. The test item was then tested in two independent experiments, with and without a metabolic activation system, the S9 mix, prepared from a liver post-mitochondrial fraction (S9 fraction) of rats induced with Aroclor 1254. Both experiments were performed according to the direct plate incorporation method except for the second test with S9 mix, which was performed according to the preincubation method (60 minutes, 37°C). Five strains of bacteria Salmonella typhimurium: TA 1535, TA 1537, TA 98, TA 100 and TA 102 were used. Each strain was exposed to at least five dose-levels of the test item (three plates/dose-level). After 48 to 72 hours of incubation at 37°C, the revertant colonies were scored. The evaluation of the toxicity was performed on the basis of the observation of the decrease in the number of revertant colonies and/or a thinning of the bacterial lawn. The test item GRAPHISTRENGTH C100 MICRONISED was suspended in ethanol.
The test item was found not soluble in the vehicles usually used for this type of assay. Consequently, a suspension was selected for the treatments. An homogenous suspension (to the naked eye) was obtained in ethanol at the concentration of 10 mg/mL. Since the test item was not soluble and non-toxic in the preliminary test, the highest dose-level was selected on the basis of the precipitate observed in the Petri plates, according to the criteria specified in the international guidelines. The selected treatment-levels were 15.6, 31.3, 62.5, 125, 250 and 500 µg/plate, for both mutagenicity experiments with and without S9 mix.
A moderate to marked precipitate was observed in the Petri plates when scoring the revertants at all dose-levels. In the first experiment without S9 mix, a marked toxicity was noted at the dose-level of 500 µg/plate in the five strains used. The test item did not induce any noteworthy increase in the number of revertants, either with or without S9 mix, in any of the five strains. The number of revertants for the vehicle and positive controls was as specified in the acceptance criteria. The study was therefore considered valid.
GRAPHISTRENGTH C100 MICRONISED did not show any mutagenic activity in the bacterial reverse mutation test with Salmonella typhimurium.
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