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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: - | 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:
- 03 Apr - 21 Apr 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
- Remarks:
- (duplicate instead of triplicate plating was performed)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 21 July 1997
- Deviations:
- yes
- Remarks:
- duplicate instead of triplicate plating was performed
- Qualifier:
- according to guideline
- Guideline:
- other: SystemsGuidelines for Japanese Industrial Safety and Health Act and Chemical Substance Control Law
- Version / remarks:
- Criteria for Mutagenicity Test in Bacterial Systems (Ministry of Labour, Japan, Notification No.77 dated September 1, 1988 and Notification No.67 dated J une 2, 1997)
Japanese Ministry of Health, Labor and Welfare, Japanese Ministry of Economy, Trade and Industry and Japanese Ministry of the Environment, Heisei 23.3.31 Yakushokuhatsu Notification No. 0331-7, Heisei 23.3.29 Seikyoku Notification No. 5, Kanpokihatsu Notification No. 110331009
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
- Solubility and stability of the test substance in the solvent/vehicle: ≥ 50 mg/mL in water, stable for 20 hours at room temperature and prepared just before use
FORM AS APPLIED IN THE TEST: liquid
Method
- Target gene:
- his operon, tryp operon
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 male rats, treated with phenobarbital and 5,6-benzoflavone
- Test concentrations with justification for top dose:
- First experiment (dose-finding study, all strains): 4.88 - 5000 µg/plate with and without metabolic activation (tested up to the limit concentration)
Second experiment (main assay, all strains): 156 - 5000 µg/plate with and without metabolic activation (tested up to the limit concentration) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: The solvent was chosen based on its solubiulity properties and its nontoxicity for the bacteria.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- sterilized purified water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- sodium azide
- other: 2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide; 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: The dose-finding assay and main assay were carried out in duplicate plating for each dose level.
DETERMINATION OF CYTOTOXICITY
- Method: Inspection of the bacterial plate - Evaluation criteria:
- Acceptance criteria
When at least one plate count in the solvent and positive control group is within the acceptance control range (mean ± 3SD, calculated from the historical control data, see table 3), the assay is judged to be acceptable.
Evaluation criteria
When the test substance shows a dose-dependent increase in the number of revertant colonies to at least twice as many as that of the solvent control, the response is judged to be positive 4 5). The study director judges the result with scientific consideration of biological relevance. When the positive response is reproducible, the test substance is judged to have mutagenic potential. - Statistics:
- No statistics were performed.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- number of revertants is close to or within historical control date range
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- number of revertants is close to or within historical control date range
- Key result
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- number of revertants is close to or within historical control date range
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- number of revertants is close to or within historical control date range
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- number of revertants is close to or within historical control date range
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- number of revertants is close to or within historical control date range
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- decrease in number of revertants in exp. 2, starting at 1250 µg/mL, with S9 mix (around 32-45%)
- Vehicle controls validity:
- valid
- Remarks:
- number of revertants is close to or within historical control date range
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- number of revertants is close to or within historical control date range
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Remarks:
- number of revertants is close to or within historical control date range
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks:
- number of revertants is close to or within historical control date range
Any other information on results incl. tables
Table 1: Summary of test results (experiment 1; dose-finding assay)
With or without S9-Mix | Test substance concentration (μg/plate) | Mean number of revertant colonies per plate (average of 2 plates) | ||||
Frameshift type | Base-pair substitution type | |||||
TA98 | TA1537 | TA100 | TA1535 | WP2 uvrA | ||
– | Solvent control (water) | 20 | 7 | 104 | 9 | 22 |
– | 4.88 | 21 | 7 | 110 | 8 | 19 |
– | 19.5 | 23 | 4 | 105 | 7 | 23 |
– | 78.1 | 20 | 9 | 106 | 8 | 19 |
– | 313 | 15 | 6 | 102 | 5 | 14 |
– | 1250 | 18 | 9 | 108 | 11 | 21 |
– | 5000 | 15 | 5 | 111 | 13 | 19 |
– | Positive controls (concentrations (µg/plate)) | AF-2 (0.1) |
9AA (80) |
AF-2 (0.01) |
SA (0.5) |
AF-2 (0.01) |
Mean No. of colonies/plate (average of 2 plates) | 432 | 341 | 646 | 306 | 107 | |
+ | Solvent control (water) | 29 | 15 | 104 | 6 | 24 |
+ | 4.88 | 34 | 14 | 110 | 10 | 21 |
+ | 19.5 | 34 | 14 | 126 | 8 | 18 |
+ | 78.1 | 32 | 13 | 115 | 7 | 26 |
+ | 313 | 43 | 13 | 111 | 9 | 21 |
+ | 1250 | 36 | 13 | 112 | 7 | 24 |
+ | 5000 | 46 | 10 | 126 | 7 | 18 |
+ | Positive controls (concentrations (µg/plate)) | 2AA (0.5) |
2AA (2) |
2AA (1) |
2AA (2) |
2AA (10) |
Mean No. of colonies/plate (average of 2 plates) | 259 | 147 | 708 | 206 | 264 |
SA = sodium azide
AF-2=2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide
9AA= 9-Aminoacridine
2AA = 2-Aminoanthracene
SD = standard deviation
Table 2: Summary of test results (experiment 2; main assay)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate (average of 2 plates) |
|||||
Frameshift type |
Base-pair substitution type |
||||||
TA98 |
TA1537 |
TA100 |
TA1535 |
WP2 uvrA |
|||
– |
Solvent control (water) |
20 |
11 |
106 |
10 |
21 |
|
– |
156 |
29 |
14 |
114 |
11 |
27 |
|
– |
313 |
27 |
11 |
106 |
12 |
16 |
|
– |
625 |
27 |
10 |
112 |
13 |
22 |
|
– |
1250 |
23 |
6 |
113 |
12 |
17 |
|
– |
2500 |
30 |
11 |
110 |
7 |
23 |
|
– |
5000 |
27 |
15 |
105 |
9 |
22 |
|
– |
Positive controls (concentrations (µg/plate)) |
AF-2 |
9AA |
AF-2 |
SA |
AF-2 |
|
Mean No. of colonies/plate (average of 2 plates) |
370 |
388 |
633 |
347 |
84 |
||
+ |
Solvent control (water) |
43 |
22 |
115 |
12 |
24 |
|
+ |
156 |
43 |
19 |
109 |
9 |
23 |
|
+ |
313 |
42 |
19 |
119 |
9 |
18 |
|
+ |
625 |
43 |
22 |
119 |
14 |
23 |
|
+ |
1250 |
41 |
15 |
115 |
9 |
24 |
|
+ |
2500 |
43 |
16 |
119 |
8 |
23 |
|
+ |
5000 |
44 |
12 |
126 |
14 |
31 |
|
+ |
Positive controls (concentrations (µg/plate)) |
2AA |
2AA |
2AA |
2AA |
2AA |
|
Mean No. of colonies/plate (average of 2 plates) |
249 |
137 |
727 |
206 |
297 |
SA = sodium azide
AF-2 =2-(2-Furyl)-3-(5-nitro-2-furyl) acrylamide
9AA= 9-Aminoacridine
2AA = 2-Aminoanthracene
SD = standard deviation
Table 3: Historical control data (Jan - Dec 2013)
|
|
Revertant colonies |
|||
Test strain |
S9 Mix |
Solvent control |
Positive control(1) |
||
|
|
Mean ± SD |
Number of data |
Mean ± SD |
Number of data |
TA100 |
- |
90.7 ± 8.93 |
203 |
574.5 ± 68.48 |
199 |
TA1535 |
- |
10.5 ± 2.56 |
162 |
287.4 ± 40.55 |
162 |
WP2 uvrA |
- |
18.1 ± 3.91 |
159 |
96.4 ± 13.59 |
159 |
TA98 |
- |
20.7 ± 3.95 |
158 |
353.0 ± 34.85 |
158 |
TA1537 |
- |
9.0 ± 2.69 |
162 |
445.2 ± 75.08 |
162 |
TA100 |
+ |
92.2 ± 10.32 |
193 |
566.1 ± 55.17 |
193 |
TA1535 |
+ |
10.3 ± 2.54 |
157 |
165.5 ± 16.44 |
157 |
WP2 uvrA |
+ |
21.6 ± 4.69 |
161 |
270.3 ± 49.98 |
161 |
TA98 |
+ |
30.7 ± 5.29 |
196 |
192.6 ± 23.40 |
192 |
TA1537 |
+ |
15.7 + 3.93 |
157 |
99.9 ± 18.23 |
157 |
Mean ± 3SD were set as the acceptable control range.
(1) Positive control substances
Test strain |
S9 Mix |
Chemical |
Dose [µg/plate] |
TA100 |
- |
2-(2-fury 1)-3-(5-nitro-2-fury 1) acrylamide |
0.01 |
TA1535 |
- |
sodium azide |
0.5 |
WP2 uvrA |
- |
2-(2-fury 1)-3-(5-nitro-2-fury 1) acrylamide |
0.01 |
TA98 |
- |
2-(2-fury 1)-3-(5-nitro-2-fury 1) acrylamide |
0.1 |
TA1537 |
- |
9-aminoacridine |
80 |
TA100 |
+ |
2-aminoanthracene |
1 |
TA1535 |
+ |
2 |
|
WP2 uvrA |
+ |
10 |
|
TA98 |
+ |
0.5 |
|
TA1537 |
+ |
2 |
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.
ECHA har meget materiale online på dit sprog, men en del af det er kun på engelsk. Læs mere om ECHA’s flersprogspolitik.
Velkommen til ECHA's websted. Webstedet understøtter ikke fuldt ud Internet Explorer 7 (og tidligere udgaver). Du skal opgradere din Internet Explorer til en nyere udgave.
Dette websted anvender cookies for at sikre dig den bedste brugeroplevelse.
Få mere at vide om, hvordan vi anvender cookies.