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EC number: 614-074-2 | CAS number: 675106-31-7
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- Endpoint:
- in vitro cytogenicity / micronucleus study
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Simple protocol study except that a particulate was tested causing the appearance of a precipitate on the slides. No studies were carried out on the homogeneity of the test item or its solubility, however it did not effect pH or osmolality of culture medium at concentrations up to 1mg/ml.
- Qualifier:
- according to guideline
- Guideline:
- other: Draft OECD 487
- Deviations:
- yes
- Remarks:
- Test article was particulate inorganic solid
- Principles of method if other than guideline:
- Cultures of human lymphocytes evaluated for the presence of micronuclei in binucleate cells at 3 dose levels.
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian cell micronucleus test
- Target gene:
- None
- Species / strain / cell type:
- lymphocytes:
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- without
- Test concentrations with justification for top dose:
- 31.88 - 1020 mg/ml
- Vehicle / solvent:
- Minimum essential medium (MEM)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- medium
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- Migrated to IUCLID6: & Cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in suspension
DURATION
- Preincubation period: 48 hours
- Exposure duration: 4 & 20 hours
- Fixation time (start of exposure up to fixation or harvest of cells): 48 hours & 32 hours
NUMBER OF CELLS EVALUATED: 2000 binucleated cells per concentration of test substance
DETERMINATION OF CYTOTOXICITY
- Method: Cytokinesis block proliferation index - Evaluation criteria:
- Criteria for identifying micronuclei was that they were round or oval, non refractile not linked to the main nucleus and were less than a third of the diameter of the main nucleus.
- Statistics:
- The frequency of cells with micronuclei was compared with the concurrent control value using a chi squared test. A significant result was recorded if the p value was less than 0.05 with a dose reponse relationship.
- Species / strain:
- lymphocytes:
- Metabolic activation:
- with
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: no significant effect of test article on pH
- Effects of osmolality: no significant effect of test article on osmolality
- Precipitation: Material was an insoluble inorganic solid - Remarks on result:
- other: other: Micronucleus induction in human lyphocytes
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative with metabolic activation & negative without metabolic activation
Polycrystalline wools are not genotoxic to human lymphocytes in vitro. - Executive summary:
In a well conducted trial with and without metabolic activation and using 2 positive control substances polycrystalline wools are not genotoxic to human lymphocytes in vitro.
Reference
Results tables for theIn vitroMN test in Human Lymphocytes on Crushed Polycrystalline Wool
Study number 3016/0003
Table 1 - CBPI - Preliminary Toxicity Test
4-hour exposure without S9 |
4-hour exposure with S9 |
20-hour exposure without S9 |
|||||||||||||||
Dose Level (μg/ml) |
Nucleate Cells/ 500 Cells |
CBPI |
% Control CBPI |
Dose Level (μg/ml) |
Nucleate Cells/ 500 Cells |
CBPI |
% Control CBPI |
Dose Level (μg/ml) |
Nucleate Cells/ 500 Cells |
CBPI |
% Control CBPI |
||||||
Mono |
Bi |
Multi |
Mono |
Bi |
Multi |
Mono |
Bi |
Multi |
|||||||||
0 |
146 |
218 |
136 |
1.98 |
100 |
0 |
172 |
207 |
121 |
1.90 |
100 |
0 |
82 |
256 |
162 |
2.16 |
100 |
3.98 |
NS |
NS |
NS |
NS |
3.98 |
NS |
NS |
NS |
NS |
3.98 |
NS |
NS |
NS |
NS |
|||
7.97 |
NS |
NS |
NS |
NS |
7.97 |
NS |
NS |
NS |
NS |
7.97 |
NS |
NS |
NS |
NS |
|||
15.94 |
NS |
NS |
NS |
NS |
15.94 |
NS |
NS |
NS |
NS |
15.94 |
NS |
NS |
NS |
NS |
|||
31.88 |
NS |
NS |
NS |
NS |
31.88 |
NS |
NS |
NS |
NS |
31.88 |
NS |
NS |
NS |
NS |
|||
63.75 |
NS |
NS |
NS |
NS |
63.75 P |
NS |
NS |
NS |
NS |
63.75 |
NS |
NS |
NS |
NS |
|||
127.5 P |
179 |
228 |
94 |
1.83 |
85 |
127.5 P |
188 |
225 |
87 |
1.80 |
89 |
127.5 P |
77 |
253 |
170 |
2.19 |
102 |
255 P |
130 |
240 |
130 |
2.00 |
102 |
255 P |
161 |
224 |
115 |
1.91 |
101 |
255 P |
74 |
259 |
167 |
2.19 |
102 |
510 P* |
155 |
226 |
119 |
1.93 |
95 |
510 P* |
198 |
220 |
82 |
1.77 |
86 |
510 P* |
72 |
269 |
159 |
2.17 |
101 |
1020 P* |
167 |
222 |
111 |
1.89 |
91 |
1020 P* |
208 |
194 |
98 |
1.78 |
87 |
1020 P* |
86 |
251 |
163 |
2.15 |
99 |
NS - = Not selected for CBPI analysis
P= Undissolved solid material of the test item observed at end of exposure period in blood-free cultures
P*= Undissolved solid material of the test item observed on slides and at end of exposure period in blood-free cultures
Table 2 - CBPI and Micronucleus Data – Experiment 1 without Metabolic Activation (S9)
Dose level (μg/ml) |
Exposure Time +/-S9 |
Replicate |
Nucleate cells /500 cells |
CBPI |
% Control CBPI |
Micronuclei (MN) Per 1000 Bi-nucleate cells |
%Cells with MN |
Mean % Cells with MN |
||||
Mono |
Bi |
Multi |
1 MN |
2 MN |
>2 MN |
|||||||
0 |
4Hr-S9 |
A |
230 |
195 |
75 |
1.69 |
100 |
4 |
0 |
0 |
0.40 |
0.45 |
B |
184 |
229 |
87 |
1.81 |
5 |
0 |
0 |
0.50 |
||||
255 P |
A |
207 |
194 |
99 |
1.78 |
109 |
5 |
0 |
0 |
0.50 |
0.45 |
|
B |
166 |
239 |
95 |
1.86 |
4 |
0 |
0 |
0.40 |
||||
510 P |
A |
206 |
197 |
97 |
1.78 |
107 |
6 |
0 |
0 |
0.60 |
0.65 |
|
B |
175 |
242 |
83 |
1.82 |
7 |
0 |
0 |
0.70 |
||||
1020 P |
A |
187 |
214 |
99 |
1.82 |
111 |
5 |
0 |
0 |
0.50 |
0.35 |
|
B |
178 |
217 |
105 |
1.85 |
2 |
0 |
0 |
0.20 |
||||
MMC 0.2 |
A |
232 |
231 |
37 |
1.61 |
77 |
70 |
8 |
1 |
7.90 |
8.60*** |
|
B |
257 |
216 |
27 |
1.54 |
86 |
6 |
1 |
9.30 |
MMC = Mitomycin C
P= Undissolved solid material of the test item observed at end of exposure period
*** = P<0.001
Table 3
- CBPI and Micronucleus Data –
Experiment 1 with Metabolic Activation (S9) (2%)
Dose level (μg/ml) |
Exposure Time +/-S9 |
Replicate |
Nucleate cells /500 cells |
CBPI |
% Control CBPI |
Micronuclei (MN) Per 1000 Bi-nucleate cells |
%Cells with MN |
Mean % Cells with MN |
||||
Mono |
Bi |
Multi |
1 MN |
2 MN |
>2 MN |
|||||||
0 |
4Hr+S9 |
A |
232 |
193 |
75 |
1.69 |
100 |
6 |
0 |
0 |
0.60 |
0.45 |
B |
167 |
240 |
93 |
1.85 |
3 |
0 |
0 |
0.30 |
||||
255P |
A |
205 |
190 |
105 |
1.8 |
102 |
6 |
0 |
0 |
0.60 |
0.55 |
|
B |
207 |
202 |
91 |
1.77 |
5 |
0 |
0 |
0.50 |
||||
510 P |
A |
191 |
228 |
81 |
1.78 |
99 |
5 |
1 |
0 |
0.60 |
0.50 |
|
B |
202 |
220 |
78 |
1.75 |
4 |
0 |
0 |
0.40 |
||||
1020 P |
A |
217 |
206 |
77 |
1.72 |
97 |
6 |
0 |
0 |
0.60 |
0.50 |
|
B |
198 |
215 |
87 |
1.77 |
4 |
0 |
0 |
0.40 |
||||
CP 5 |
A |
389 |
107 |
4 |
1.23 |
34 |
56 |
4 |
0 |
6.00 |
5.85*** |
|
B |
358 |
136 |
6 |
1.3 |
54 |
3 |
0 |
5.70 |
CP = Cyclophosphamide
P= Undissolved solid material of the test item observed at end of exposure period
***= P<0.001
Table 4 - CBPI and Micronucleus Data – Experiment 2 without Metabolic Activation (S9)
Dose Level (μg/ml) |
Exposure Time +/-S9 |
Replicate |
Nucleate cells / 500 cells |
CBPI |
% Control CBPI |
Micronuclei (MN) Per 1000 Bi-nucleate cells |
%Cells with MN |
Mean % Cells with MN |
||||
Mono |
Bi |
Multi |
1 MN |
2 MN |
>2 MN |
|||||||
0 |
20Hr-S9 |
A |
94 |
228 |
178 |
2.17 |
100 |
5 |
0 |
0 |
0.50 |
0.50 |
B |
75 |
222 |
203 |
2.26 |
4 |
1 |
0 |
0.50 |
||||
255 P |
A |
98 |
244 |
158 |
2.12 |
96 |
6 |
1 |
0 |
0.70 |
0.65 |
|
B |
86 |
221 |
193 |
2.21 |
5 |
1 |
0 |
0.60 |
||||
510 P |
A |
114 |
230 |
156 |
2.08 |
93 |
5 |
1 |
0 |
0.60 |
0.35 |
|
B |
96 |
223 |
181 |
2.17 |
1 |
0 |
0 |
0.10 |
||||
1020 P |
A |
84 |
230 |
186 |
2.20 |
97 |
6 |
0 |
0 |
0.60 |
0.30 |
|
B |
104 |
220 |
176 |
2.14 |
0 |
0 |
0 |
0.00 |
||||
DC 0.075 |
A |
220 |
215 |
65 |
1.69 |
57 |
28 |
6 |
3 |
3.70 |
4.45*** |
|
B |
219 |
216 |
65 |
1.69 |
44 |
3 |
5 |
5.20 |
DC = Demecolcine
Table 5
- CBPI and Micronucleus Data –
Experiment 2 with Metabolic Activation (S9) (1%)
Dose level (μg/ml) |
Exposure Time +/-S9 |
Replicate |
Nucleate cells / 500 cells |
CBPI |
% Control CBPI |
Micronuclei (MN) Per 1000 Bi-nucleate cells |
%Cells with MN |
Mean % Cells with MN |
||||
Mono |
Bi |
Multi |
1 MN |
2 MN |
>2 MN |
|||||||
0 |
4Hr+S9 |
A |
166 |
188 |
146 |
1.96 |
100 |
3 |
0 |
0 |
0.30 |
0.50 |
B |
164 |
210 |
126 |
1.92 |
6 |
1 |
0 |
0.70 |
||||
255 P |
A |
166 |
223 |
111 |
1.89 |
86 |
6 |
1 |
0 |
0.70 |
0.55 |
|
B |
231 |
173 |
96 |
1.73 |
4 |
0 |
0 |
0.40 |
||||
510 P |
A |
140 |
238 |
122 |
1.96 |
88 |
7 |
0 |
0 |
0.70 |
0.95 |
|
B |
235 |
186 |
79 |
1.69 |
11 |
1 |
0 |
1.20 |
||||
1020 P |
A |
144 |
220 |
136 |
1.98 |
102 |
4 |
0 |
0 |
0.40 |
0.50 |
|
B |
169 |
193 |
138 |
1.94 |
5 |
0 |
1 |
0.60 |
||||
CP 5 |
A |
252 |
218 |
30 |
1.56 |
56 |
59 |
4 |
1 |
6.40 |
5.85*** |
|
B |
267 |
215 |
18 |
1.50 |
43 |
8 |
2 |
5.30 |
P= Undissolved solid material of the test item observed at end of exposure period
*** = P<0.001
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
The registered substance is a man-made polycrystalline wool, comprising fibres with an alumina/silica composition. These fibres are essentially insoluble in water, releasing <0.01 wt% of aluminium oxide (Al2O3) and silicon dioxide (SiO2) in a 24h water extraction study. Neither aluminium oxide nor silicon dioxide is classified as a hazardous substance under EU CLP criteria, and neither has been reported to be mutagenic. Hence there is no expectation of mutagenic activity of these fibres. Naturally occurring mineral fibres such as asbestos which (unlike the registered substance) are classified as carcinogenic have been shown to cause chromosome damage in vitro (and some have also shown evidence of DNA interaction in specific types of assay, probably associated with localised active oxygen release), but give mainly negative results in gene mutation assays (bacterial and mammalian).
The clearly negative results obtained when the registered substance was tested for micronucleus induction (chromosome damage) in cultured human lymphocytes therefore provide a firm basis for distinguishing these polycrystalline wool fibres from genotoxic mineral fibres such as asbestos. Taking account of these findings, the physical form of the fibres and their chemical composition, a conclusion of non-genotoxicity can be reached without further testing.
Justification for selection of genetic toxicity endpoint
The genotoxicity endpoints of gene mutation (in bacterial systems) and chromosome damage (in human cells) have been investigated. Chromosomal damage arising from impairment of mitosis has been recognised as a major indicator of genotoxicity for fibres showing mutagenic activity (NIOSH, 2008: Revised Draft NIOSH Current Intelligence Bulletin on Asbestos Fibers and Other Elongated Mineral Particles, State of the Science and Roadmap for Research. US Department of Health and Human Services Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, June 2008. Also Jaurand, MC, 1997: Mechanisms of Fiber-induced Genotoxicity. Environmental Health Perspectives Vol. 105 Supplement 5, 1073-1084). The endpoint investigated in the selected principal study record for genotoxicity (micronucleus test of polycrystalline wool in cultured lymphocytes) is a sensitive indicator of such chromosome damage, monitored in cultured human cells.
Justification for classification or non-classification
In vitro tests for (bacterial) gene mutation and (human cell) chromosome damage have shown no activity of the registered substance. Its chemical composition and essential water insolubility give rise to no expectation of genotoxicity. The absence of activity seen in the human lymphocyte micronucleus test clearly distinguishes the registered substance from other mineral fibres known to cause chromosome damage in mammalian cell assays in vitro. Hence it is concluded that no classification in respect of mutagenic activity is warranted.
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