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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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2014-11-26 to 2014-12-04
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 Jul 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Lot/batch No.of test material: 003
- Expiration date of the lot/batch: 01 Jan 2020
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: Room temperature, exclusion of direct sunlight, test substance is hygroscopic
- Stability under test conditions: stable
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix (phenobarbital and β-naphthoflavone induced rat liver)
- Test concentrations with justification for top dose:
- 0; 33; 100; 333; 1 000; 2 700 and 5400 μg/plate
- Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in water, DMSO was used as vehicle, which had been demonstrated to be suitable in bacterial reverse mutation tests and for which historical control data are available
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 2-AA
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- with S9 mix (all tester strains tested)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- MNNG
- Positive control substance:
- other: N-methyl-N'-nitro-N-nitrosoguanidine
- Remarks:
- without S9 mix; 5 µg/plate (TA1535, TA100)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- NOPD
- Positive control substance:
- other: 4-nitro-o-phenylenediamine
- Remarks:
- without S9 mix; 10 μg/plate (TA 98)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- AAC
- Positive control substance:
- 9-aminoacridine
- Remarks:
- without S9 mix; 100 µg/plate (TA1537)
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Remarks:
- 4-NQO
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- without S9 mix; 5 µg/plate (E. coli WP2 uvrA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation) (SPT); preincubation (PIT)
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 - 72 hours in the dark at 37 °C
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: decrease in the number of his+ or trp+ revertants - Evaluation criteria:
- Acceptance criteria
Generally, the experiment was considered valid if the following criteria were met:
• The number of revertant colonies in the negative controls was within the range of the historical negative control data for each tester strain.
• The sterility controls revealed no indication of bacterial contamination.
• The positive control substances both with and without S9 mix induced a distinct increase in the number of revertant colonies within the range of the historical positive control data or above.
• Fresh bacterial culture containing approximately 10^9 cells per mL were used.
Assessment criteria
The test substance was considered positive in this assay if the following criteria were met:
• A dose-related and reproducible increase in the number of revertant colonies, i.e. at least doubling (bacteria strains with high spontaneous mutation rate, like TA98, TA100 and E.coli WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA1535 and TA1537) of the spontaneous mutation rate in at least one tester strain either without S9 mix or after adding a metabolizing system.
A test substance was generally considered non-mutagenic in this test if:
• The number of revertants for all tester strains were within the historical negative control data range under all experimental conditions in at least two experiments carried out independently of each other.
Results and discussion
Test results
- Key result
- Species / strain:
- bacteria, other: TA98, TA100, TA1535, TA1537, E. coli WP2 uvrA
- 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:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: No
- Effects of osmolality: No
- Evaporation from medium: No
- Water solubility: No
- Precipitation:
RANGE-FINDING/SCREENING STUDIES:
HISTORICAL CONTROL DATA (with ranges, means and standard deviation and confidence interval (e.g. 95%)
- Positive historical control data:
- Negative (solvent/vehicle) historical control data:
ADDITIONAL INFORMATION ON CYTOTOXICITY:
- Measurement of cytotoxicity used: [complete, e.g. CBPI or RI in the case of the cytokinesis-block method; RICC, RPD or PI when cytokinesis block is not used]
- Other observations when applicable: [complete, e.g. confluency, apoptosis, necrosis, metaphase counting, frequency of binucleated cells]
Any other information on results incl. tables
Table 1 Raw data
Experiment 1 (SPT) |
|||||
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates with different strains of Salmonella typhimurium and Escherichia coli |
||||
|
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2 uvrA |
|
|
||||
|
Results with S9 |
||||
DMSO |
12 |
9.7 |
31 |
37 |
66.7 |
33 |
11.7 |
9.3 |
27.7 |
32.3 |
66.7 |
100 |
9.3 |
8.7 |
33.7 |
38 |
63 |
333 |
12.7 |
8.7 |
30.3 |
37.7 |
64.7 |
1000 |
11.3 |
8 |
26.7 |
29 |
71.3 |
2700 |
11.7 |
3 |
30.7 |
43.7 |
60.3 |
5400 |
11 |
4 |
22 |
34.3 |
52.7 |
positive control |
202 |
140.3 |
1672.7 |
746.3 |
206 |
|
|
||||
|
Results without S9 |
||||
DMSO |
11.7 |
7.3 |
25 |
38.7 |
65 |
33 |
10.3 |
7.3 |
25 |
35.7 |
60.3 |
100 |
12.3 |
10 |
23 |
40.3 |
61.3 |
333 |
12 |
7.3 |
22.7 |
31.3 |
59.7 |
1000 |
12 |
11 |
27.3 |
34 |
47 |
2700 |
15 |
6.3 |
20.7 |
42.3 |
48 |
5400 |
10.7 |
1.7 |
20.3 |
24.3 |
38.7 |
positive control |
4552 |
697.7 |
444 |
4474 |
900.3 |
|
|
|
|
|
|
Experiment 2 (PIT) |
|||||
Dose (µg/plate) |
Mean number of revertant colonies/3 replicate plates with different strains of Salmonella typhimurium and Escherichia coli |
||||
|
TA1535 |
TA1537 |
TA98 |
TA100 |
WP2 uvrA |
|
|
||||
|
Results with S9 |
||||
DMSO |
9 |
10.3 |
28.3 |
28.3 |
86.7 |
33 |
9.3 |
7.3 |
32.3 |
29.7 |
88 |
100 |
9.3 |
7.3 |
30 |
27.3 |
86.3 |
333 |
9.7 |
6.7 |
25.7 |
29 |
94.3 |
1000 |
7.7 |
6.3 |
35 |
30.7 |
88.3 |
2700 |
9 |
5.7 |
19 |
27.3 |
97.7 |
5400 |
7.3 |
6 |
21 |
29.7 |
79 |
positive control |
179.3 |
116.7 |
1276.3 |
663 |
208.7 |
|
|
||||
|
Results without S9 |
||||
DMSO |
11.3 |
7.3 |
21 |
31.7 |
99.7 |
33 |
9.7 |
7.7 |
20.3 |
27 |
90.3 |
100 |
12 |
5.3 |
19.7 |
28.7 |
97 |
333 |
8 |
4.3 |
22.3 |
25.3 |
79.7 |
1000 |
9.3 |
8.3 |
16 |
23.3 |
92 |
2700 |
8.7 |
4.3 |
21 |
24.3 |
75.7 |
5400 |
7 |
4.7 |
19.3 |
29 |
89.7 |
positive control |
1568.3 |
591.3 |
354.3 |
2092.3 |
253 |
Applicant's summary and conclusion
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.
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.
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