Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 929-915-1 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
- Bacterial mutagenicity: Not mutagenic in the Ames test with and without metabolic activation.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- histidine and tryptophan
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9-mix
- Test concentrations with justification for top dose:
- 33, 100, 333, 1000, 2500, 5000µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: Due to insolubility 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. - Untreated negative controls:
- other: sterility control
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- 9-aminoacridine
- other: 2-aminoanthracene, 4-nitroquinoline-N-oxide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Preincubation period: 20 minutes
- Exposure duration: 48-72h at 37°C in the dark
NUMBER OF REPLICATIONS: 3 - Evaluation 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.
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 TA 98, TA 100 and E.coli WP2 uvrA) or tripling (bacteria strains with low spontaneous mutation rate, like TA 1535 and TA 1537) 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 range of the historical negative control data under all experimental conditions in at least two experiments carried out independently of each other. - Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slight cytotoxicity observed at 5000µg/plate with S9 mix in the SPT and PIT
- 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:
- cytotoxicity
- Remarks:
- slight cytotoxicity observed at 5000µg/plate in the PIT with metabolic activation
- 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:
- 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
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- slight cytotoxicity observed at 5000µg/plate in the PIT with and without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- Test substance precipitation was found from about 1000 μg/plate onward in the standard plate test and from about 2500 μg/plate in the preincubation test with and without S9 mix.
- Conclusions:
- Under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
- Executive summary:
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA 98) and Escherichia coli WP2 uvrA, in a reverse mutation assay up to the limit concentration of 5000 μg/plate. The standard plate test (SPT) and preincubation test (PIT) were performed both with and without metabolic activation (liver S9 mix from induced rats). Precipitation of the test substance was found from about 1000 μg/plate onward in the standard plate test and from about 2500 μg/plate in the preincubation test with and without S9 mix. A weak bacteriotoxic effect was occasionally observed depending on the strain and test conditions at 5000 μg/plate. A relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test without S9 mix or after the addition of a metabolizing system.
Under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
Reference
Standard Plate Test
E.coli WP2 uvrA
Dose [µg/plate] | Without S9 [Revertants/plate] |
With S9 [Revertants/plate] | ||
Mean | Standard Deviation | Mean | Standard Deviation | |
DMSO | 23.3 | 6.1 | 20.7 | 5.9 |
33 | 24.7 | 5.9 | 24.3 | 7.5 |
100 | 19.0 | 5.3 | 26.3 | 5.5 |
333 | 25.0 | 10.0 | 27.7 | 2.1 |
1000 | 25.0 | 10.5 | 21.3 | 11.8 |
2500 | 19.3 |
3.2 |
21.3 |
3.1 |
5000 |
16.3 |
4.0 |
17.7 |
3.8 |
5.0 (4 -NQO) |
1450.7 |
53.2 |
- |
- |
60 (2 -AA) |
- |
- |
109.7 |
12.9 |
TA 1535
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
10.0 |
2.6 |
9.0 |
2.0 |
33 |
8.0 |
2.0 |
7.3 |
2.1 |
100 |
8.3 |
0.6 |
8.7 | 1.5 |
333 | 12.0 | 3.6 | 7.7 | 1.5 |
1000 | 8.0 | 2.6 |
7.7 |
2.3 |
2500 |
9.0 |
1.0 |
7.7 |
1.5 |
5000 |
8.3 |
2.1 |
4.7 |
0.6 |
5.0 (MNNG) |
3479.0 |
378.9 |
- |
- |
2.5 (2 -AA) |
- |
- |
232.0 |
9.8 |
TA 100
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
91.3 |
19.0 |
82.3 |
0.6 |
33 |
108.3 |
24.4 |
91.7 |
7.1 |
100 |
88.0 |
11.1 |
95.7 |
3.8 |
333 |
88.7 |
17.2 |
112.0 |
11.8 |
1000 |
114.0 |
20.7 |
101.3 |
11.4 |
2500 |
82.7 |
8.0 |
83.0 |
5.0 |
5000 |
82.0 |
10.1 |
60.3 |
6.7 |
5.0 (MNNG) |
4008.7 |
386.0 |
- |
- |
2.5 (2 -AA) |
- |
- |
2567.7 |
19.9 |
TA 1537
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
8.0 |
2.62 |
7.0 |
2.0 |
33 | 7.3 | 3.2 | 11.0 | 1.0 |
100 | 5.7 | 3.1 | 9.3 | 2.5 |
333 | 7.0 | 2.0 | 7.0 | 1.0 |
1000 | 6.7 | 3.1 | 9.7 | 4.0 |
2500 |
9.7 |
3.5 |
7.7 |
3.1 |
5000 |
6.3 |
3.1 |
9.0 |
2.6 |
100 (AAC) | 1219.3 | 211.6 | - | - |
2.5 (2 -AA) | - | - | 218.7 | 8.4 |
TA 98
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
16.0 |
2.6 |
25.0 |
2.6 |
33 |
15.0 |
4.4 |
19.7 |
2.9 |
100 |
18.7 |
2.9 |
29.3 |
8.3 |
333 |
20.3 |
2.1 |
22.7 |
4.0 |
1000 |
21.7 |
6.4 |
27.7 |
7.5 |
2500 |
16.7 |
1.5 |
25.7 |
2.1 |
5000 |
16.7 |
1.5 |
22.0 |
2.0 |
10 (NOPD) |
539.3 |
32.7 |
- |
- |
2.5 (2 -AA) |
- |
- |
2113.3 |
90.0 |
Preincubation Test
TA 1535
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
9.7 |
2.1 |
9.0 |
0.0 |
33 |
6.3 |
3.5 |
6.7 |
0.6 |
100 |
8.3 |
1.5 |
10.0 |
1.7 |
333 |
11.7 |
2.3 |
8.3 |
1.2 |
1000 |
9.7 |
3.2 |
7.0 |
2.6 |
2500 |
10.7 |
2.1 |
7.3 |
2.5 |
5000 |
6.7 |
1.5 |
4.7 |
0.6 |
5.0 (MNNG) |
5509.3 |
382.9 |
- |
- |
2.5 (2 -AA) |
- |
- |
332.0 |
16.5 |
TA 100
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
104.0 |
13.9 |
110.0 |
5.6 |
33 |
109 -3 |
5.5 |
105.7 |
10.8 |
100 |
106.3 |
13.4 |
105.7 |
13.9 |
333 |
101.0 |
15.9 |
104.3 |
7.4 |
1000 |
106.7 |
7.2 |
103.0 |
9.2 |
2500 | 102.0 | 15.6 | 105.7 |
21.8 |
5000 |
102.3 |
2.5 |
96.7 |
8.1 |
5.0 (MNNG) |
4232.7 |
364.5 |
- |
- |
2.5 (2 -AA) |
- |
- |
2966.0 |
49.9 |
TA 1537
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
8.0 |
1.0 |
9.0 |
1.0 |
33 |
8.3 |
1.5 |
8.0 |
4.0 |
100 |
10.0 |
3 .6 |
9.7 |
0.6 |
333 |
7.0 |
4.0 |
7.3 |
2.3 |
1000 |
8.3 |
3.5 |
9.0 |
2.0 |
2500 |
7.0 |
2.0 |
9.3 |
3.2 |
5000 |
9.3 |
4.5 |
5.3 |
4.0 |
100 (AAC) |
943.3 |
172.1 |
- |
- |
2.5 (2 -AA) |
- |
- |
257.7 |
18.5 |
TA 98
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
27.0 |
10.4 |
28.3 |
4.0 |
33 |
18.3 |
5.8 |
28.0 |
14.7 |
100 |
27.0 |
5.2 |
25.7 |
2.1 |
333 |
27.0 |
9.2 |
28.7 |
2.3 |
1000 |
21.3 |
5.1 |
27.0 |
6.2 |
2500 |
26.7 |
1.2 |
31.7 |
8.5 |
5000 |
25.0 |
4.0 |
29.3 |
6.0 |
10 (NOPD) |
608.3 |
52.7 |
- |
- |
2.5 (2 -AA) |
- |
- |
2473.0 |
14.1 |
E.coli WP2 uvrA
Dose [µg/plate] |
Without S9 [Revertants/plate] |
With S9 [Revertants/plate] |
||
|
Mean |
Standard Deviation |
Mean |
Standard Deviation |
DMSO |
22.3 |
4.5 |
22.0 |
2.0 |
33 |
20.0 |
0.0 |
20.3 |
11.0 |
100 |
23.7 |
5.5 |
21.7 |
11.6 |
333 |
21.0 |
9 .0 |
24.0 |
6.6 |
1000 |
16.0 |
6.0 |
29.0 |
1.7 |
2500 |
16.0 |
4.6 |
23.0 |
5.6 |
5000 |
25.0 |
4.0 |
14.0 |
5.2 |
5.0 (4 -NQO) |
746.3 |
69.6 |
- |
- |
60 (2 -AA) |
- |
- |
94.3 |
11.2 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Bacterial Mutagenicity:
The test substance was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium (TA 1535, TA 100, TA 1537, TA 98) and Escherichia coli WP2 uvrA, in a reverse mutation assay up to the limit concentration of 5000 μg/plate. The standard plate test (SPT) and preincubation test (PIT) were performed both with and without metabolic activation (liver S9 mix from induced rats). Precipitation of the test substance was found from about 1000 μg/plate onward in the standard plate test and from about 2500 μg/plate in the preincubation test with and without S9 mix. A weak bacteriotoxic effect was occasionally observed depending on the strain and test conditions at 5000 μg/plate. A relevant increase in the number of his+ or trp+ revertants was not observed in the standard plate test or in the preincubation test without S9 mix or after the addition of a metabolizing system.
Under the experimental conditions of this study, the test substance is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.
Justification for classification or non-classification
As there is no indication for genotoxic potential, classification for genotoxicity is not warranted according to the EC Directive (No.93/21/EEC) and CLP (No. 1272/2008 of 16 December 2008).
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.