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EC number: 448-250-3 | 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:
- 17 Jul - 28 Jul 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)
- Version / remarks:
- adopted July 21, 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- published June 8, 2000
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): AF-654
- Physical state: white powder
- Lot/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 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 Aroclor 1254 (experiment I: S9 mix contained 5% (v/v) S9-fraction; experiment II: S9 mix contained 10% (v/v) S9-fraction)
- Test concentrations with justification for top dose:
- pre-experiment (with and without S9 mix): 3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate for TA 100 and E. coli WP2 uvr A
experiment I (with and without S9 mix): 3, 10, 33, 100 and 333 µg/plate for TA 98, TA 1535 and TA 1537
experiment II (with and without S9 mix): 3, 10, 33, 100 and 333 µg/plate for all strains - 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
- sodium azide
- methylmethanesulfonate
- other: daunomycin; 2-aminoanthracene
- Remarks:
- -S9: sodium azide (SA, 5µg/plate, TA1535); 9-aminoacridine (9AC, 60µg/plate, TA1537); daunomycin (DM, 4µg/plate, TA98), methylmethanesulfonate (MMS, 650µg/plate, TA100); 4-nitroquinoline-N-oxide (4-NQO, 10µg/plate, E. coli); +S9: 2-aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hours
NUMBER OF REPLICATIONS: triplicates each in 2 independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: reduction of bacterial background lawn, increase in size of microcolonies, reduction of revertant colonies
OTHER:
The dose range finding test was reported as part of the first experiment of the mutation assay. - Evaluation criteria:
- Acceptability criteria:
1) The negative control data (number of spontaneous revertants per plate) should be within the laboratory background historical range for each tester strain.
2) 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 two times the concurrent vehicle control group mean.
3) The selected dose range should induce 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.
Evaluation criteria:
A test substance is considered negative (not mutagenic) in the test if:
a) The total number of revertants in any tester strain at any concentration is not greater than two times the solvent value, with or without metabolic activation.
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) 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.
b) The positive 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, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation was observed at concentrations of 100 µg/plate and above in the top agar and on the plates at 333 µg/plate at the start and the end of the incubation period.
RANGE-FINDING/SCREENING STUDIES:
Selection of an adequate range of doses was based on a dose rane finding test with strain TA 100 and E. coli WP2uvrA in the presence and absence of S9 mix using eight concentrations (3, 10, 33, 100, 333, 1000, 3330 and 5000 µg/plate). The highest concentration chosen for the main assay was the level at which the test substance showed limited solubility (333 µg/plate). This dose range finding test was reported as a part of the first experiment of the mutation assay.
COMPARISON WITH HISTORICAL CONTROL DATA:
All values are within the range of historical control data, except the response for TA98 in the absence of S9 mix (first experiment, negative control). Since this value was just outside the limit of the range the validity of the test was considered to be not affected. - 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).
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 |
E. coli WP2 |
TA98 |
TA1537 |
||
– |
DMSO |
138 ± 6 |
8 ± 2 |
9 ± 2 |
11 ± 2 |
4 ± 1 |
– |
3 |
139 ± 1 |
7 ± 2 |
11 ± 2 |
10 ± 2 |
6 ± 3 |
– |
10 |
137 ± 15 |
8 ± 2 |
8 ± 1 |
11 ± 3 |
4 ± 2 |
– |
33 |
156 ± 6 |
7 ± 2 |
8 ± 2 |
11 ± 1 |
5 ± 3 |
– |
100 |
145 ± 20 |
9 ± 1 |
12 ± 1 |
14 ± 1 |
3 ± 1 |
– |
333SP |
149 ± 5 |
10 ± 3 |
12 ± 3 |
12 ± 3 |
3 ± 2 |
– |
1000MP |
129 ± 4 |
- |
9 ± 2 |
- |
- |
– |
3330MP |
136 ± 21 |
- |
11 ± 3 |
- |
- |
– |
5000MP |
128 ± 9 |
- |
13 ± 2 |
- |
- |
Positive controls, –S9 |
Name |
MMS |
SA |
4-NQO |
DM |
9AC |
Concentrations (μg/plate) |
650 |
5 |
10 |
4 |
60 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
962 ± 22 |
244 ± 16 |
812 ± 73 |
516 ± 71 |
280 ± 46 |
|
+ |
DMSO |
140 ± 21 |
10 ± 1 |
10 ± 1 |
17 ± 1 |
4 ± 4 |
+ |
3 |
142 ± 4 |
6 ± 2 |
10 ± 2 |
14 ± 4 |
6 ± 2 |
+ |
10 |
140 ± 16 |
7 ± 4 |
10 ± 2 |
13 ± 2 |
6 ± 2 |
+ |
33 |
140 ± 8 |
6 ± 1 |
12 ± 2 |
17 ± 2 |
4 ± 2 |
+ |
100 |
155 ± 6 |
7 ± 2 |
12 ± 2 |
20 ± 5 |
4 ± 2 |
+ |
333SP |
149 ± 9 |
6 ± 1 |
9 ± 2 |
15 ± 7 |
5 ± 2 |
+ |
1000MP |
134 ± 20 |
- |
8 ± 2 |
- |
- |
+ |
3330MP |
143 ± 11 |
- |
10 ± 3 |
- |
- |
+ |
5000MP |
151 ± 10 |
- |
11 ± 2 |
- |
- |
Positive controls, +S91 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
1 |
1 |
5 |
1 |
2.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
717 ± 50 |
100 ± 4 |
73 ± 11 |
520 ± 7 |
75 ± 16 |
Table 2. Test results of experiment 2 (plate incorporation).
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 |
E. coli WP2 |
TA98 |
TA1537 |
||
– |
DMSO |
138 ± 13 |
10 ± 4 |
13 ± 3 |
15 ± 6 |
5 ± 2 |
– |
3 |
142 ± 9 |
11 ± 3 |
17 ± 4 |
13 ± 1 |
4 ± 2 |
– |
10 |
137 ± 6 |
9 ± 1 |
12 ± 3 |
17 ± 4 |
6 ± 3 |
– |
33 |
132 ± 12 |
11 ± 6 |
14 ± 2 |
12 ± 1 |
5 ± 3 |
– |
100 |
151 ± 9 |
9 ± 6 |
16 ± 4 |
13 ± 3 |
5 ± 2 |
– |
333SP |
139 ± 15 |
9 ± 2 |
13 ± 4 |
15 ± 3 |
5 ± 1 |
Positive controls, –S9 |
Name |
MMS |
SA |
4-NQO |
DM |
9AC |
Concentrations (μg/plate) |
650 |
5 |
5 |
4 |
60 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
1025 ± 27 |
351 ± 20 |
712 ± 6 |
499 ± 79 |
220 ± 34 |
|
+ |
DMSO |
141 ± 15 |
10 ± 3 |
19 ± 4 |
23 ± 2 |
6 ± 2 |
+ |
3 |
137 ± 18 |
6 ± 1 |
16 ± 2 |
21 ± 3 |
7 ± 3 |
+ |
10 |
127 ± 7 |
9 ± 5 |
14 ± 2 |
18 ± 6 |
6 ± 3 |
+ |
33 |
139 ± 13 |
6 ± 4 |
13 ± 2 |
20 ± 3 |
5 ± 1 |
+ |
100 |
130 ± 8 |
8 ± 3 |
12 ± 1 |
19 ± 4 |
4 ± 2 |
+ |
333SP |
121 ± 6 |
8 ± 2 |
16 ± 4 |
21 ± 1 |
6 ± 2 |
Positive controls, +S92 |
Name |
2AA |
2AA |
2AA |
2AA |
2AA |
Concentrations (μg/plate) |
1 |
1 |
5 |
1 |
2.5 |
|
Mean No. of colonies/plate (average of 3 ± SD) |
766 ± 45 |
128 ± 11 |
122 ± 4 |
436 ± 46 |
201 ± 19 |
1: The S9 mix contained 5% (v/v) S9 fraction
2: The S9 mix contained 10% (v/v) S9 fraction
SP: slight precipitate
MP: moderate precipitate
2AA: 2-aminoanthracene
MMS: methylmethanesulfonate
SA: sodium azide
4-NQO: 4-nitroquinoline-N-oxide
DM: daunomycin
9AC: 9-aminoacridine
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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