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EC number: 448-060-0 | CAS number: 727678-39-9
- 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:
- 17 July - 04 August 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- 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): UY-330
- Physical state: solid
- Appearance: white powder
- Batch No.: CE-201
- Expiration date of the lot/batch: 01 Jan 2005
- Storage condition of test material: at room temperature in the dark
Method
- Target gene:
- his operon (S. typhimurium); trp operon (E. coli)
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 Aroclor 1254.
- Test concentrations with justification for top dose:
- First experiment: 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate with and without metabolic activation (TA 100 and WP2 uvr A; used as range-finding study); 3, 10, 33, 100 and 333 µg/plate with and without metabolic activation (TA 1535, TA 1537 and TA 98)
Second experiment: 3, 10, 33, 100 and 333 µg/plate with and without metabolic activation (all strains) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulfoxide (DMSO), 0.1 mL/plate
- Justification for choice of solvent/vehicle: Due to the limited solubility of the test substance in water, DMSO was selected as the vehicle.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9: sodium azide (5 µg/plate; TA1535), 9-aminoacridine (60 µg/plate; TA1537), daunomycin (4 µg/plate; TA98), methylmethanesulfonate (650 µg/plate; TA100), 4-nitroquinoline N-oxide (10 µg/plate; WP2uvrA); +S9: 2-aminoanthracene (1-5 µg/plate; all strains)
- 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 two different experiments
DETERMINATION OF CYTOTOXICITY
- Method: inspection of the bacterial background lawn - Evaluation criteria:
- A test substance is considered mutagenic in the test if it induces a number of revertant colonies, dose related, greater than two-times the number of revertants induced by the solvent control in any of the tester strains, either with or without metabolic activation. However, any mean plate count of less than 20 is considered to be not significant. Furthermore, the positive response should be reproducible in at least one independently repeated experiment.
A test substance is considered negative not mutagenic in the test if the total number of revertants in any tester strain at any concentration is not greater than two times the solvent control value, with or without metabolic activation. Additionally, the negative response should be reproducible in at least one independently repeated experiment. - Statistics:
- Mean values and standard deviation were calculated.
Results and discussion
Test resultsopen allclose all
- 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:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- 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
- Precipitation: The test substance precipitated in the top agar at concentrations of 100 and 333 µg/plate. On the plates, precipitation was observed at 333 µg/plate.
- Metabolic activation: In the first experiment, 5% (v/v) S9 fraction was added to the S9 mix and in the second experiment 10% (v/v) S9 fraction in the S9 mix was used. Therefore, the concentrations of the positive control in the second experiment were twice as high as in the first experiment.
The higher concentration of S9 fraction in the second experiment did not influence the results.
RANGE-FINDING/SCREENING STUDIES: To find an appropriate concentration range for the main study, the test substance was tested in concentrations of 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate in the tester strains TA 100 and WP2 uvr A with and without metabolic activation. The range finding study was conducted as a part of experiment 1.
The test substance precipitated in the top agar at concentrations of 100 µg/plate and higher. On the plates, precipitation was observed at concentrations of 333 µg/plate and higher.
No reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed.
COMPARISON WITH HISTORICAL CONTROL DATA: The negative and positive control values were within the historical control data ranges.
ADDITIONAL INFORMATION ON CYTOTOXICITY: No reduction of the bacterial background lawn and no biologically relevant decrease in the number of revertants were observed. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Mutagenic response of UY-330 in the S. typhimurium reverse mutation assay and in the E. coli reverse mutation assay – Experiment 1
UY-330: Bacterial Reverse Mutation Assay, mean revertants colonies/plate |
|||||
EXPERIMENT 1 |
|||||
|
Without S9-Mix
|
||||
Test item (µg/plate) |
TA1535 |
TA 1537 |
TA 98 |
TA 100 |
E.coli |
DMSO |
9 ± 4 |
7 ± 1 |
20 ± 3 |
138 ± 6 |
9 ± 2 |
3 |
12 ± 3 |
6 ± 2 |
18 ± 2 |
153 ± 12 |
8 ± 3 |
10 |
7 ± 2 |
7 ± 2 |
19 ± 3 |
140 ± 12 |
7 ± 2 |
33 |
12 ± 1 |
9 ± 1 |
16 ± 2 |
150 ± 12 |
9 ± 2 |
100 |
12 ± 3 |
12 ± 2 |
21 ± 2 |
148 ± 8 |
10 ± 1 |
333 |
14 ± 1 P |
7 ± 3 P |
16 ± 5 P |
134 ± 9 P |
9 ± 3 P |
1000 |
--- |
--- |
--- |
132 ± 10 P |
9 ± 3 P |
3330 |
--- |
--- |
--- |
120 ± 9 P |
9 ± 3 P |
5000 |
--- |
--- |
--- |
124 ± 6 P |
9 ± 2 P |
sodium azide |
354 ± 42 |
--- |
--- |
--- |
--- |
9-aminoacridine |
--- |
241 ± 65 |
--- |
--- |
--- |
daunomycin |
--- |
--- |
541 ± 62 |
--- |
--- |
MMS |
--- |
--- |
--- |
962 ± 22 |
--- |
4-NQO |
--- |
--- |
--- |
--- |
812 ± 73 |
|
With S9-Mix (5% v/v S9 fraction*)
|
||||
Test item (µg/plate) |
TA1535 |
TA 1537 |
TA 98 |
TA 100 |
E.coli |
DMSO |
14 ± 3 |
10 ± 3 |
25 ± 7 |
140 ± 21 |
10 ± 1 |
3 |
11 ± 3 |
5 ± 2 |
17 ± 2 |
134 ± 23 |
13 ± 3 |
10 |
13 ± 3 |
8 ± 3 |
23 ± 3 |
148 ± 15 |
10 ± 1 |
33 |
12 ± 2 |
7 ± 3 |
26 ± 4 |
139 ± 9 |
10 ± 1 |
100 |
11 ± 2 |
7 ± 1 |
25 ± 6 |
146 ± 15 |
14 ± 3 |
333 |
11 ± 2 P |
10 ± 2 P |
22 ± 1 P |
138 ± 12 P |
11 ± 3 P |
1000 |
--- |
--- |
--- |
131 ± 13 P |
10 ± 1 P |
3330 |
--- |
--- |
--- |
130 ± 12 P |
8 ± 3 P |
5000 |
--- |
--- |
--- |
131 ± 22 P |
8 ± 1 P |
2-AA |
167 ± 16 |
229 ± 28 |
741 ± 26 |
717 ± 50 |
73 ± 11 |
DMSO: dimethyl sulfoxide MMS: methylmethane sulfonate 4-NQO: 4-nitroquinoline N-oxide 2-AA: 2-aminoanthracene P: precipitation |
*Before use, all S9 batches were characterized with 5 µg/plate benzo[a]pyrene, which requires metabolic activation, in the tester strain TA 98.
Table 2: Mutagenic response of UY-330 in the S. typhimurium reverse mutation assay and in the E. coli reverse mutation assay – Experiment 2
UY-330: Bacterial Reverse Mutation Assay, mean revertants colonies/plate |
|||||
EXPERIMENT 2 |
|||||
|
Without S9-Mix
|
||||
Test item (µg/plate) |
TA1535 |
TA 1537 |
TA 98 |
TA 100 |
E.coli |
DMSO |
9 ± 2 |
8 ± 2 |
12 ± 3 |
132 ± 8 |
7 ± 2 |
3 |
11 ± 3 |
7 ± 2 |
16 ± 1 |
137 ± 15 |
8 ± 2 |
10 |
11 ± 5 |
7 ± 1 |
18 ± 3 |
141 ± 10 |
11 ± 5 |
33 |
13 ± 6 |
6 ± 1 |
13 ± 4 |
156 ± 3 |
13 ± 1 |
100 |
10 ± 3 |
6 ± 2 |
12 ± 3 |
130 ± 8 |
8 ± 1 |
333 |
13 ± 4 P |
10 ± 6 P |
15 ± 3 P |
136 ± 8 P |
9 ± 1 P |
sodium azide |
355 ± 75 |
--- |
--- |
--- |
--- |
9-aminoacridine |
--- |
297 ± 6 |
--- |
--- |
--- |
daunomycin |
--- |
--- |
326 ± 57 |
--- |
--- |
MMS |
--- |
--- |
--- |
965 ± 32 |
--- |
4-NQO |
--- |
--- |
--- |
--- |
1323 ± 72 |
|
With S9-Mix (10% v/v S9 fraction*)
|
||||
Test item (µg/plate) |
TA1535 |
TA 1537 |
TA 98 |
TA 100 |
E.coli |
DMSO |
11 ± 4 |
10 ± 4 |
19 ± 6 |
135 ± 9 |
8 ± 3 |
3 |
10 ± 7 |
7 ± 2 |
17 ± 6 |
137 ± 14 |
10 ± 2 |
10 |
7 ± 4 |
9 ± 1 |
16 ± 7 |
136 ± 14 |
9 ± 2 |
33 |
9 ± 5 |
10 ± 2 |
17 ± 8 |
147 ± 3 |
9 ± 2 |
100 |
7 ± 5 |
8 ± 2 |
17 ± 6 |
150 ± 11 |
9 ± 3 |
333 |
10 ± 6 P |
7 ± 3 P |
18 ± 8 P |
136 ± 9 P |
9 ± 1 P |
2-AA |
136 ± 6 |
218 ± 31 |
196 ± 35 |
829 ± 14 |
120 ± 13 |
DMSO: dimethyl sulfoxide MMS: methylmethane sulfonate 4-NQO: 4-nitroquinoline N-oxide 2-AA: 2-aminoanthracene P: precipitation |
*Before use, all S9 batches were characterized with 5 µg/plate benzo[a]pyrene, which requires metabolic activation, in the tester strain TA 98.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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