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EC number: 457-900-5 | 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:
- 23 May - 15 Jun 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP- Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): PM-5927
- Physical state: off-white powder
- Lot/batch No.: 07-02
- Expiration date of the lot/batch: 05 Feb 2008
- Storage condition of test material: at room temperature protected from light
Method
- Target gene:
- his operon (S. typhimurium strains), trp operon (E. coli strains)
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Cofactor supplemented post-mitochondrial fraction (S9-mix), prepared from the livers of rats treated with phenobarbital (80 mg/kg bw) and beta-naphthoflavone (100 mg/kg bw)
- Test concentrations with justification for top dose:
- Dose range finding test: 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate for TA 100 and E. coli WP2 uvr A (with and without metabolic activation)
Experiment 1: 33, 100, 333, 1000 and 3300 µg/plate for TA 98, TA 1535 and TA 1537 (with and without metabolic activation)
Experiment 2: 10, 33, 100, 333, 1000 and 2000 μg/plate for all strains (with and without metabolic activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- methylmethanesulfonate
- other: 2-aminoanthracene
- Remarks:
- See 'Any other information on materials and methods incl. tables' for details
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: reduction of background bacterial lawn - Evaluation criteria:
- The assays were considered acceptable if they met the following criteria:
a) the negative control data (number of spontaneous revertants per plate) should be within the laboratory historical range for each tester strain.
b) the positive control chemicals should produce responses in all tester strains, which are within the laboratory historical range documented for each positive control substance. Furthermore, the mean plate count should be at least 3 times the concurrent vehicle control group.
c) the selected dose range should include a clearly toxic concentration or should exhibit limited solubility as demonstrated by the preliminary toxicity range-finding test or should extend to 5 mg/plate.
A test substance is considered negative (not mutagenic) in the test if:
a) the total number of revertants in tester strain TA 100 is not greater than 2 times the concurrent control, and the total number of revertants in tester strains TA 1535, TA 1537, TA 98 or WP2 uvr A is not greater than 3 times the concurrent control.
b) the negative response should be reproducible in at least one independently repeated experiment.
A test substance is considered positive (mutagenic) in the test if:
a) the total number of revertants in tester strain TA 100 is greater than 2 times the concurrent control, and the total number of revertants in tester strains TA 1535, TA 1537, TA 98 or WP2 uvr A is greater than 3 times the concurrent control.
b) in case a positive response will be repeated, the positive response should be reproducible in at least one independently repeated experiment.
The preceding criteria were not absolute and other modifying factors might enter into the final evaluation decision. - Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation was observed in the dose-range finding test at the start or at the end of the incubation period in both test strains (TA 100, E. coli WP2 uvrA)
RANGE-FINDING/SCREENING STUDIES:
A range-finding study was performed with TA 100 and E. coli WP2 uvr A, using 8 concentrations ranging from 33-5000 μg/plate (with and without metabolic activation). The highest concentration of the test substance used in the subsequent mutation assay was the level at which the test substance showed limited cytotoxicity (2000 µg/plate). The results were presented as part of experiment 1.
COMPARISON WITH HISTORICAL CONTROL DATA: yes; the results fall within the historical data range. See Table 3 under 'Any other information on results incl. tables'
ADDITIONAL INFORMATION ON CYTOTOXICITY: In the range-finding study, a reduction in bacterial background lawn and/or number of revertant colonies was observed from concentrations of 1000 µg/plate in TA 100 and from concentrations of 3330 µg/plate in WP2 uvrA, with and without metabolic activation. - 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 method)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
WP2 uvR |
TA98 |
TA1537 |
||
– |
DMSO |
118 ± 13 |
12 ± 4 |
10 ± 3 |
24 ± 4 |
13 ± 4 |
– |
3 |
108 ± 13 |
- |
13 ± 3 |
- |
- |
– |
10 |
112 ± 4 |
7 ± 2 |
12 ± 1 |
21 ± 5 |
10 ± 3 |
– |
33 |
99 ± 9 |
8 ± 2 |
13 ± 6 |
18 ± 4 |
12 ± 1 |
– |
100 |
124 ± 4 |
7 ± 2 |
10 ± 4 |
16 ± 2 |
11 ± 3 |
– |
333 |
98 ± 5 |
8 ± 1 |
11 ± 3 |
19 ± 3 |
7 ± 3 |
– |
1000 |
92 ± 19* |
4 ± 1* |
10 ± 2 |
13 ± 3 |
8 ± 1 |
– |
2000 |
- |
MC |
- |
1 ± 1* |
MC* |
– |
3330 |
0 ± 0* |
- |
MC* |
- |
- |
– |
5000 |
0 ± 0* |
- |
0 ± 0* |
- |
- |
Positive controls, –S9 |
Name |
MMS |
SA |
4-NQO |
NF |
9AC |
Concentrations (μg/plate) |
650 |
5 |
10 |
10 |
60 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1062 ± 40 |
966 ± 23 |
696 ± 40 |
1047 ± 7 |
271 ± 49 |
|
+ |
DMSO |
90 ± 7 |
10 ± 1 |
26 ± 4 |
31 ± 2 |
13 ± 4 |
+ |
3 |
98 ± 8 |
- |
25 ± 6 |
- |
- |
+ |
10 |
104 ± 13 |
6 ± 2 |
24 ± 2 |
23 ± 5 |
12 ± 5 |
+ |
33 |
96 ± 11 |
6 ± 3 |
29 ± 9 |
21 ± 5 |
9 ± 3 |
+ |
100 |
97 ± 7 |
8 ± 2 |
29 ± 5 |
26 ± 3 |
10 ± 2 |
+ |
333 |
90 ± 4 |
5 ± 2 |
22 ± 2 |
22 ± 5 |
10 ± 3 |
+ |
1000 |
66 ± 13* |
6 ± 2* |
22 ± 3 |
17 ± 3 |
6 ± 3 |
+ |
2000 |
- |
0 ± 0* |
- |
2 ± 2* |
0 ± 0* |
+ |
3330 |
MC* |
- |
10 ± 3* |
- |
- |
+ |
5000 |
0 ± 0* |
- |
5 ± 2* |
- |
- |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
1 |
1 |
10 |
1 |
2.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
996 ± 40 |
221 ± 23 |
311 ± 8 |
830 ± 48 |
459 ± 16 |
MMS: methylmethanesulfonate
SA : sodium azide
4-NQO: 4-nitroquinoline N-oxide
NF: 2-nitrofluorene
9AC: 9-aminoacridine
2-AA: 2 -amino-anthracene
*: slight/moderate/extreme reduction in bacterial background lawn
MC: microcolonies
-: not tested
Table 2. Test results of experiment 2 (plate incorporation method)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 3 plates ± Standard deviation) |
||||
Base-pair substitution type |
Frameshift type |
|||||
TA 100 |
TA1535 |
WP2 uvR |
TA98 |
TA1537 |
||
– |
DMSO |
79 ± 9 |
6 ± 3 |
14 ± 3 |
13 ± 1 |
6 ± 1 |
– |
10 |
76 ± 6 |
5 ± 2 |
15 ± 2 |
24 ± 8 |
9 ± 4 |
– |
33 |
78 ± 8 |
5 ± 0 |
20 ± 4 |
22 ± 5 |
7 ± 2 |
– |
100 |
75 ± 3 |
6 ± 2 |
19 ± 3 |
24 ± 2 |
7 ± 4 |
– |
333 |
92 ± 11 |
8 ± 4 |
21 ± 2 |
14 ± 4 |
4 ± 1 |
– |
1000 |
38 ± 70* |
6 ± 1* |
14 ± 4 |
18 ± 4 |
3 ± 2 |
– |
2000 |
MC* |
MC* |
11 ± 1* |
9 ± 1* |
MC* |
Positive controls, –S9 |
Name |
MMS |
SA |
4-NQO |
NF |
9AC |
Concentrations (μg/plate) |
650 |
5 |
10 |
10 |
60 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1013 ± 88 |
871 ± 17 |
1170 ± 10 |
978 ± 45 |
373 ± 90 |
|
+ |
DMSO |
69 ± 3 |
5 ± 2 |
15 ± 1 |
17 ± 3 |
7 ± 1 |
+ |
10 |
65 ± 2 |
4 ± 1 |
15 ± 1 |
14 ± 1 |
6 ± 1 |
+ |
33 |
50 ± 8 |
5 ± 1 |
16 ± 1 |
15 ± 4 |
5 ± 2 |
+ |
100 |
47 ± 5 |
4 ± 2 |
19 ± 5 |
13 ± 2 |
8 ± 3 |
+ |
333 |
57 ± 4 |
4 ± 2 |
14 ± 2 |
15 ± 4 |
6 ± 2 |
+ |
1000 |
44 ± 12* |
2 ± 1* |
17 ± 5 |
15 ± 4 |
4 ± 3* |
+ |
2000 |
MC* |
4 ± 2* |
12 ± 3* |
3 ± 3* |
MC* |
Positive controls, +S9 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
2.5 |
1 |
10 |
1 |
5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
786 ± 30 |
150 ± 4 |
294 ± 10 |
381 ± 17 |
216 ± 51 |
MMS: methylmethanesulfonate
SA : sodium azide
4-NQO: 4-nitroquinoline N-oxide
NF: 2-nitrofluorene
9AC: 9-aminoacridine
2-AA: 2 -amino-anthracene
*: slight/moderate/extreme reduction in bacterial background lawn
MC: microcolonies
-: not tested
Table 3. Historical controls
Strain |
Control |
without S9-mix |
with S9-mix |
|
|
Mean ± 3 x SD |
Mean ± 3 x SD |
TA100 |
Solvent |
126 ± 79 |
116 ± 83 |
TA100 |
Positive |
1038 ± 596 |
1094 ± 996 |
TA1535 |
Solvent |
13 ± 14 |
12 ± 14 |
TA1535 |
Positive |
1145 ± 819 |
183 ± 233 |
WP2 uvR |
Solvent |
14 ± 17 |
15 ± 8 |
WP2 uvR |
Positive |
643 ± 565 |
254 ± 343 |
TA98 |
Solvent |
20 ± 19 |
25 ± 21 |
TA98 |
Positive |
1053 ± 748 |
648 ± 166 |
TA1537 |
Solvent |
6 ± 8 |
6 ± 9 |
TA1537 |
Positive |
315 ± 415 |
334 ± 433 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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