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EC number: 701-026-1 | 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:
- 2012-09-17 to 2012-12-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- 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)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- carbon
- EC Number:
- 701-026-1
- Cas Number:
- 7440-44-0
- Molecular formula:
- C up to (C80N5H16O)n
- IUPAC Name:
- carbon
- Test material form:
- solid: fibres
- Details on test material:
- - milled carbonised PAN based fibre (Sigrafil C30 M150 UNS)
- for further details on the test material, see section 1.4, endpoint "Non-graphitic carbon fibre (carbonised PAN based fibre, milled)", attached document "Analytics_milled_carbonised_PAN_based_fibre.pdf"
Constituent 1
Method
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Details on mammalian cell type (if applicable):
- - Type and identity of media: overlay agar (for S. typhimurium strains consisting of 0.6% agar, 0.5% NaCl and 10% 0.5 mM histidine/biotin solution)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: not reported
- Periodically checked for karyotype stability: The test strains were checked at regular intervals for their genetic markers, according to the methods by MARON and AMES (1983):
- Amino acid requirement (histidine for S. typhimurium strains)
- rfa mutation where appropriate: crystal violet sensitivity
- uvrB/uvrA mutation: sensibility to ultraviolet (UV) radiation
- Presence of R-factor plasmids where appropriate: ampicilline resistance of strains TA98, TA100
- Periodically "cleansed" against high spontaneous background: no - Additional strain / cell type characteristics:
- other: see section "any other information on materials and methods incl. tables"
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Details on mammalian cell type (if applicable):
- - Type and identity of media: overlay agar (for E.coli strain consisting of 0.6% agar, 0.5% NaCl and 10% 0.25 mM tryptophane solution)
- Properly maintained: yes
- Periodically checked for Mycoplasma contamination: not known
- Periodically checked for karyotype stability:
The test strains were checked at regular intervals for their genetic markers, according to the methods by MARON and AMES (1983):
- amino acid requirement (tryptophan for E.coli WP2 strain)
- uvrB/uvrA mutation: sensibility to ultraviolet (UV) radiation
- Presence of R-factor plasmids where appropriate: ampicilline resistance of E.coli WP2 uvrA (pKM101)
- Periodically "cleansed" against high spontaneous background: no - Additional strain / cell type characteristics:
- other: see section "any other information on materials and methods incl. tables"
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (S9 fraction from phenobarbital / ß-naphthoflavone induced rat liver + co-factors)
- Test concentrations with justification for top dose:
- 5.0 μg/plate, 50 μg/plate, 150 μg/plate, 500 μg/plate, 1500 μg/plate, 2500 μg/plate, 5000 μg/plate (with and without S9 mix)
- Vehicle / solvent:
- DMSO or H20 (for strain specific control experiments) served as negative (vehicle) controls
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO or H20
- True negative controls:
- yes
- Remarks:
- Phosphate buffer (pH 7.4)
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-Amino-anthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 12 hrs
- Exposure duration: 48 hrs
- Expression time (cells in growth medium): not applicable
- Selection time (if incubation with a selection agent): not applicable
- Fixation time (start of exposure up to fixation or harvest of cells): not applicable
SELECTION AGENT (mutation assays): not applicable
SPINDLE INHIBITOR (cytogenetic assays): not applicable
STAIN (for cytogenetic assays): not applicable
NUMBER OF REPLICATIONS: not applicable
NUMBER OF CELLS EVALUATED: not applicable
DETERMINATION OF CYTOTOXICITY
- Method: the cytotoxicity of a substance is shown by reduction in the number of revertant colonies and/or inhibition (clearing or diminution) of the background lawn or the degree of survival of treated cultures - Evaluation criteria:
- - the study is considered as valid if the background growth of the test organisms in the negative control plates is close and the mean colony counts of the control values of the strains (spontaneous reversion rates of the control plates without S9 mix) are within the historical control data range
- positive reference items should induce a distinct enhancement of revertant rates over the control plates
- slight toxicity or precipitates in the treatment groups will not invalidate the experiments or the doses at which they are found
-a test item is considered to show a positive response in this test system if there is a reproducible demonstration in two independent assays of a
dose-effect relation with a strain dependent increase in the mean number of revertants per plate compared to the vehicle control in at least one
strain with or without metabolic activation
- in the strains TA98, TA100 and WP2uvra the increase should be at least 2-fold, for tester strains TA1535 and TA 1537 this increase should be at least 3-fold
- a test item is considered to show a negative response if no dose-related increase in the mean number of revertant colonies is observed nor a
reproducible positive response at any of the test points in at least two independent experiments
- if there is a clear positive response the test is not repeated
- in case of a negative or equivocal result the test is repeated using different exposure conditions (concentration spacing and/or amount of S9 mix used)
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
Any other information on results incl. tables
Table 2a.: Results of the follow-up experiments with different concentrations of the milled PAN based carbon fibre (trade name: Sigrafil C30 M150 UNS) in Salmonella TA 98
Study: 16G12025 Experiment: Follow-Up Experiment Test strain: TA 98 |
|||||||||
revertants/plate | revertants/plate | ||||||||
Plate lD | dose/plate | -S9 | Mean | ± SD | Q | +S9 | Mean | ± SD | Q |
25 | 45 | ||||||||
Spontaneous rate | 41 | 35 | 9 | 46 | 44 | 3 | |||
38 | 41 | ||||||||
24 | 38 | ||||||||
DMSO | 100 µL/plate | 28 | 28 | 5 | 0,8 | 48 | 40 | 7 | 0,9 |
33 | 34 | ||||||||
32 | 51 | ||||||||
Sigrafil | 50 µg/plate | 33 | 34 | 3 | 1 | 57 | 49 | 10 | 1,1 |
37 | 38 | ||||||||
52 | 40 | ||||||||
Sigrafil | 150 µg/plate | 30 | 37 | 13 | 1,1 | 40 | 40 | 1 | 0,9 |
30 | 41 | ||||||||
53 | 49 | ||||||||
Sigrafil | 500 µg/plate | 39 | 41 | 11 | 1,2 | 46 | 41 | 12 | 0,9 |
32 | 27 | ||||||||
26 | 41 | ||||||||
Sigrafil | 1500 µg/plate | 26 | 26 | 1 | 0,7 | 67 | 48 | 17 | 1,1 |
27 | 36 | ||||||||
35 | 51 | ||||||||
Sigrafil | 5000 µg/plate | 43 | 42 | 6 | 1,2 | 26 | 47 | 19 | 1,1 |
47 | 64 | ||||||||
1012 | |||||||||
2-NF | 5 µg/plate | 809 | 824 | 180 | 29,4 | * | |||
652 | |||||||||
56 | 1864 | ||||||||
2-AA | 1 µg/plate | 56 | 56 | 1 | 2,0 | 1488 | 1654 | 192 | 41,4 |
57 | 1611 |
Table 2b: Results of the follow-up experiments with different concentrations of the milled PAN based carbon fibre (trade name: Sigrafil
C30 M150 UNS) in Salmonella TA 100
Study: 16G12025 Experiment: Follow-Up Experiment Test strain: TA 100 |
|||||||||
revertants/plate |
revertants/plate |
||||||||
Plate lD |
dose/plate |
-S9 |
Mean |
± SD |
Q |
+S9 |
Mean |
± SD |
Q |
143 |
|
|
|
129 |
|
|
|
||
Spontaneous rate |
150 |
151 |
9 |
139 |
139 |
11 |
|||
160 |
150 |
||||||||
193 |
173 |
||||||||
DMSO |
100 µL/plate |
178 |
182 |
9 |
1,2 |
130 |
160 |
26 |
1,2 |
176 |
176 |
||||||||
151 |
171 |
||||||||
Sigrafil |
50 µg/plate |
177 |
158 |
17 |
1,0 |
184 |
189 |
21 |
1,4 |
145 |
212 |
||||||||
185 |
175 |
||||||||
Sigrafil |
150 µg/plate |
194 |
185 |
10 |
1,2 |
163 |
175 |
12 |
1,3 |
175 |
186 |
||||||||
189 |
209 |
||||||||
Sigrafil |
500 µg/plate |
175 |
189 |
14 |
1,3 |
150 |
180 |
30 |
1,3 |
202 |
182 |
||||||||
176 |
149 |
||||||||
Sigrafil |
1500 µg/plate |
187 |
179 |
7 |
1,2 |
156 |
162 |
17 |
1,2 |
175 |
181 |
||||||||
192 |
175 |
||||||||
Sigrafil |
5000 µg/plate |
173 |
178 |
13 |
1,2 |
208 |
194 |
17 |
1,4 |
168 |
198 |
||||||||
1249 |
|
||||||||
2-NF |
5 µg/plate |
1512 |
1331 |
157 |
7,3 |
* |
|||
1231 |
|||||||||
177 |
2946 |
||||||||
2-AA |
1 µg/plate |
199 |
196 |
17 |
1,1 |
2883 |
2876 |
74 |
18,0 |
211 |
|
|
|
2799 |
|
|
|
Table 2c: Results of the follow-up experiments with different concentrations of the milled PAN based carbon fibre (trade name: Sigrafil C30 M150 UNS) in Salmonella TA 1535
Study: 16G12025 Test strain: TA 1535 |
|||||||||
revertants/plate |
revertants/plate |
||||||||
Plate lD |
dose/plate |
-S9 |
Mean |
± SD |
Q |
+S9 |
Mean |
± SD |
Q |
12 |
|
|
|
21 |
|
|
|
||
Spontaneous rate |
18 |
18 |
6 |
20 |
19 |
2 |
|||
23 |
17 |
||||||||
19 |
15 |
||||||||
DMSO |
100 µL/plate |
15 |
20 |
6 |
1,1 |
11 |
15 |
4 |
0,8 |
26 |
19 |
||||||||
16 |
16 |
||||||||
H2O |
100 µg/plate |
12 |
25 |
19 |
1,4 |
10 |
12 |
3 |
0,6 |
46 |
11 |
||||||||
14 |
18 |
||||||||
Sigrafil |
50 µg/plate |
20 |
17 |
3 |
0,9 |
21 |
16 |
6 |
0,8 |
17 |
10 |
||||||||
16 |
18 |
||||||||
Sigrafil |
150 µg/plate |
15 |
19 |
6 |
1,1 |
12 |
20 |
9 |
1,1 |
25 |
30 |
||||||||
24 |
26 |
||||||||
Sigrafil |
500 µg/plate |
14 |
16 |
7 |
0,9 |
25 | 24 | 3 | 1,3 |
10 | 21 | ||||||||
15 | 23 | ||||||||
Sigrafil | 1500 µg/plate | 18 | 17 | 2 | 0,9 | 19 | 18 | 6 | 0,9 |
17 | 11 | ||||||||
14 | 22 | ||||||||
Sigrafil | 5000 µg/plate | 22 | 16 | 5 | 0,9 | 22 | 23 | 2 | 1,2 |
13 | 26 | ||||||||
386 | |||||||||
NaN3 | 1 µg/plate | 543 | 463 | 79 | 18,5 | * | |||
459 | |||||||||
26 | 305 | ||||||||
2-AA | 1 µg/plate | 10 | 15 | 10 | 0,8 | 603 | 402 | 174 | 26,8 |
9 | 298 |
Table 2d: Results of the follow-up experiments with different concentrations of the milled PAN based carbon fibre (trade name: Sigrafil C30 M150 UNS) in Salmonella TA 1537
Study: 16G12025 Test strain: TA 1537 |
|||||||||
revertants/plate | revertants/plate | ||||||||
Plate lD | dose/plate | -S9 | Mean | ± SD | Q | +S9 | Mean | ± SD | Q |
10 | 4 | ||||||||
Spontaneous rate | 5 | 8 | 3 | 15 | 9 | 6 | |||
10 | 9 | ||||||||
7 | 13 | ||||||||
DMSO | 100 µL/plate | 9 | 8 | 1 | 1,0 | 5 | 9 | 4 | 1,0 |
7 | 8 | ||||||||
26 | 12 | ||||||||
Sigrafil | 50 µg/plate | 12 | 17 | 8 | 2,1 | 5 | 11 | 5 | 1,2 |
13 | 15 | ||||||||
22 | 26 | ||||||||
Sigrafil | 150 µg/plate | 12 | 15 | 6 | 1,9 | 16 | 19 | 6 | 2,1 |
12 | 16 | ||||||||
17 | 12 | ||||||||
Sigrafil | 500 µg/plate | 11 | 13 | 3 | 1,6 | 17 | 12 | 6 | 1,3 |
12 | 6 | ||||||||
15 | 15 | ||||||||
Sigrafil | 1500 µg/plate | 11 | 12 | 2 | 1,5 | 14 | 17 | 4 | 1,9 |
11 | 21 | ||||||||
29 | 11 | ||||||||
Sigrafil | 5000 µg/plate | 14 | 19 | 8 | 2,4 | 11 | 15 | 7 | 1,7 |
15 | 23 | ||||||||
526 | |||||||||
9 -Aminoacridine | 50 µg/plate | 1204 | 763 | 383 | 95,4 | * | |||
558 | |||||||||
22 | 129 | ||||||||
2-AA | 1 µg/plate | 13 | 15 | 7 | 1,9 | 131 | 129 | 2 | 14,3 |
9 | 127 |
Table 2e: Results of the follow-up experiments with different concentrations of the milled PAN based carbon fibre (trade name: Sigrafil C30 M150 UNS) in Ecoli WP2 uvrA pKM101
Study: 16G12025 Experiment: Follow-Up Experiment Test strain: Ecoli WP2 uvrA pKM101 |
|||||||||
revertants/plate | revertants/plate | ||||||||
Plate lD | dose/plate | -S9 | Mean | ± SD | Q | +S9 | Mean | ± SD | Q |
193 | 222 | ||||||||
Spontaneous rate | 172 | 183 | 11 | 252 | 234 | 16 | |||
184 | 227 | ||||||||
162 | 220 | ||||||||
DMSO | 100 µL/plate | 153 | 155 | 6 | 0,8 | 226 | 226 | 6 | 1,0 |
150 | 232 | ||||||||
175 | 251 | ||||||||
Sigrafil | 50 µg/plate | 172 | 180 | 12 | 1,0 | 251 | 238 | 23 | 1,0 |
194 | 211 | ||||||||
173 | 239 | ||||||||
Sigrafil | 150 µg/plate | 163 | 165 | 7 | 0,9 | 254 | 247 | 8 | 1,1 |
160 | 247 | ||||||||
180 | 285 | ||||||||
Sigrafil | 500 µg/plate | 170 | 172 | 8 | 0,9 | 239 | 258 | 24 | 1,1 |
165 | 251 | ||||||||
207 | 257 | ||||||||
Sigrafil | 1500 µg/plate | 160 | 169 | 34 | 0,9 | 217 | 238 | 20 | 1,0 |
140 | 241 | ||||||||
173 | 226 | ||||||||
Sigrafil | 5000 µg/plate | 156 | 166 | 9 | 0,9 | 212 | 227 | 15 | 1,0 |
169 | 242 | ||||||||
3269 | |||||||||
MMS | 2 µL/plate | 3300 | 3344 | 104 | 21,6 | * | |||
3462 | |||||||||
179 | 942 | ||||||||
2-AA | 1 µg/plate | 143 | 170 | 24 | 1,1 | 886 | 925 | 34 | 4,1 |
188 | 948 |
± SD: Standard Deviation
Q: Quotient of mean revertants (test item) / mean revertants (concurrent negative reference item)
-S9: without S9 mix
+S9: with S9 mix
DMSO: dimethyl sulfoxide
H2O: water
2-NF: 2-nitrofluorene
2-AA: 2-aminoanthracene
9-AA: 9-aminoacridine
MMS: methyl methanesulfonate
NaN3: sodium azide
* not tested
Applicant's summary and conclusion
- Conclusions:
- The study is regarded as valid because there were no deviations from the test protocols, the study has been performed according to the principles of Good Laboratory Practice, and all validity criteria are fulfilled. Under the test conditions (both with and without metabolic activation) and with the bacterial strains used the test item (milled carbonised PAN based fibre) is considered not to induce a mutagenic effect (induction of gene mutation).
- Executive summary:
At a maximum concentration of 5000 μg test substance/plate the test substance (milled carbonised PAN based fibre) did not show any cytotoxic effects in the preliminary experiment. This concentration was therefore chosen as the maximum test substance concentration for the mutagenicity experiments (initial and follow-up experiments). All experiments are regarded as valid. The mean numbers of the revertant colonies of the negative controls were within the acceptable ranges. The mean number of revertants induced by the positive control items was adequately enhanced in all bacterial strains compared to the spontaneous reversion rate. In all experiments the test item (milled carbonised PAN based fibre) did not induce any responses, neither a positive nor ar dose-related response.
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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.