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EC number: 401-300-8 | CAS number: 86168-95-8
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
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:
- 1985-03-05 to 1985-04-05
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study close to Guideline with acceptable restrictions (pre-incubation method not performed)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 985
- Report date:
- 1985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- QAU statement included
- Type of assay:
- bacterial reverse mutation assay
Test material
- Details on test material:
- - Physical state: solid
- Analytical purity: commercial grade
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction of liver from rats induced with Aroclor 1254
- Test concentrations with justification for top dose:
- 0.08 - 5000 µg / 0.1 mL range in the toxicity test
20 - 5000 µg / 0.1 mL range in the mutagenicity test - Vehicle / solvent:
- Acetone
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: TA 98: daunorubicin-HCl; TA 100: 4-nitroquinoline-N-oxide; TA 102: mitomycin-C; TA 1535: sodium acide; TA 1537: 9(5)-aminoacridine hydrochloride monohydrate
- Remarks:
- without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- with activation
Migrated to IUCLID6: TA 98, TA 100, TA 1537: 2-aminoanthracene;TA 102: 2-aminoanthracene; TA 1535: cyclophosphamide
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: incubated for about 48 hours at 37 ± 1.5 °C in darkness
NUMBER OF REPLICATIONS: without and with the addition of microsomal activation mixture three Petri dishes were prepared per strain and per group (i.e. per concentration or per control group). In order to confirm the results the experiments were repeated.
DETERMINATION OF CYTOTOXICITY
- Method: reduction in the colony count
OTHER:
The test substance was suspended in acetone. Acetone alone was used for the negative controls (the substances and vehicles used for the positive controls are indicated below). Each Petri dish contained:
1) approx. 20 mL of minimum agar (Agar, Difco Laboratories, Detroit, Michigan, U.S.A., plus salts (Vogel-Bonner Medium E) and glucose),
2) 0.1 mL of a solution of the test substance or the vehicle and 0.1 mL of a bacterial culture (in nutrient broth, Difco Laboratories, Detroit, Michigan, U.S.A., 0.8 % plus 0.5 % NaCl) in 2.0 mL of soft agar. The soft agar was composed of: 100 mL of 0.6 % agar solution with 0.6 % NaCl and 10 mL of a solution of 1-histidine, 0.5 mM (Fluka, Buchs, Switzerland) and +biotin 0.5 mM (Fluka, Buchs, Switzerland).
In the experiments in which the substance was metabolically activated, 0.5 mL of an activation mixture was added also. 1 mL activation mixture contained: 0.3 mL S9 fraction of liver from rats (Tif:RAIf(SPF)) induced with Aroclor 1254 (Analabs., Inc., North Haven, Connecticut, U.S.A.) and 0.7 mL of a solution of co-factors.
Positive control experiments were carried out simultaneously with the following substances:
1) for strain TA 98: daunorubicin-HCl (DAUNOBLASTIN®, Farmitalia, Montedison Farmaceutica GmbH, Freiburg i. Br., Germany), 5 and 10 µg/0.1 mL phosphate buffer
2) for strain TA 100: 4-nitroquinoline-N-oxide (Fluka, Buchs, Switzerland), 0.125 and 0.25 µg/0.1 mL phosphate buffer
3) for strain TA 102 : mitomycin-C (SYNTEX PHARM AG, Allschwil/Basle, Switzerland), 0.5 and 1.0 µg/0.1 mL bidistilled water
4) for strain TA 1535: sodium acide (Fluka, Buchs, Switzerland), 2.5 and 5.0 µg/0.1 mL bidistilled water
5) for strain TA 1537: 9(5)- aminoacridine hydrochloride monohydrate (Fluka, Buchs, Switzerland), 50 and 100 µg/0.1 mL DMSO.
The activation mixture was tested with strains TA 98, TA 100, TA 1537: 2-aminoanthracene (EGA-Chemie, Steinheim, Germany), 5 µg/0.1 mL DMSO; 2) with strain TA 102: 2-aminoanthracene, 20 µg/0.1 mL DMSO; 3) with strain TA 1535: cyclophosphamide (ENDOXAN-ASTA® , Asta-Werke, Bielefeld, Germany), 250 µg/0.1 mL phosphate buffer. - Evaluation criteria:
- The test substance is generally considered to be nonmutagenic if the colony count in relation to the negative control is not doubled at any concentration.
- Statistics:
- When the colonies had been counted, the arithmetic mean was calculated.
Results and discussion
Test results
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- Growth-inhibiting effect occurred in the experiments without microsomal activation at the highest concentration
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: At concentrations of 1250 µg/0.1 mL and above precipitation of the test substance was perceptible in soft agar.
RANGE-FINDING/SCREENING STUDIES:
A preliminary toxicity test was carried out with the concentrations ranging from 0.08 to 5000 µg / 0.1 mL. Thereupon, the concentration of 5000 µg / 0.1 mL was used as the highest in the mutagenicity test and the tests were performed with the following concentrations of the trial substance without and with microsomal activation: 20, 78, 313, 1250 and 5000 µg / 0.1 mL.
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Owing to a growth-inhibiting effect of the substance a reduction in the colony count was observed in the experiments without microsomal activation at the highest concentration. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Experiment I
TA 98 | TA 100 | TA 102 | TA 1535 | TA 1537 | ||||||
Dose (µg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
solvent control | 28 | 50 | 140 | 152 | 172 | 317 | 13 | 20 | 5 | 16 |
20 | 26 | 51 | 170 | 145 | 201 | 285 | 15 | 22 | 7 | 17 |
78 | 26 | 60 | 147 | 130 | 230 | 305 | 13 | 17 | 8 | 13 |
313 | 28 | 48 | 134 | 127 | 207 | 276 | 8 | 22 | 5 | 15 |
1250 | 23 | 43 | 161 | 133 | 211 | 230 | 17 | 20 | 8 | 19 |
5000 | 8 | 39 | 111 | 114 | 95 | 264 | 14 | 12 | 6 | 12 |
solvent control | 24 | 43 | 152 | 122 | 215 | 259 | 10 | 16 | 7 | 18 |
positive control A | 370 | 291 | 1001 | 492 | 792 | 2352 | 852 | 391 | 19 | 54 |
positive control B | 714 | 1456 | 1631 | 1165 | 372 |
Experiment II
TA 98 | TA 100 | TA 102 | TA 1535 | TA 1537 | ||||||
Dose (µg/plate) | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 | -S9 | +S9 |
solvent control | 23 | 34 | 126 | 123 | 256 | 296 | 17 | 14 | 12 | 19 |
20 | 26 | 43 | 133 | 114 | 293 | 325 | 12 | 15 | 10 | 19 |
78 | 23 | 39 | 120 | 118 | 332 | 330 | 13 | 12 | 13 | 19 |
313 | 26 | 48 | 120 | 124 | 318 | 307 | 16 | 20 | 6 | 16 |
1250 | 24 | 37 | 100 | 106 | 286 | 290 | 14 | 17 | 9 | 20 |
5000 | 24 | 42 | 95 | 112 | 193 | 283 | 16 | 17 | 5 | 20 |
solvent control | 21 | 39 | 112 | 117 | 258 | 335 | 18 | 16 | 8 | 14 |
positive control A | 659 | 922 | 725 | 674 | 851 | 1227 | 836 | 396 | 39 | 129 |
positive control B | 874 | 1194 | 1073 | 1104 | 635 |
Positive Controls
Without S9 mix:
TA 98: daunorubicin-HCl, A: 5 and B: 10 µg/0.1 mL phosphate buffer
TA 100: 4-nitroquinoline-N-oxide, A: 0.125 and B: 0.25 µg/0.1 mL phosphate buffer
TA 102: mitomycin-C, A: 0.5 and B: 1.0 µg/0.1 mL bidistilled water
TA 1535: sodium azide, A: 2.5 and B: 5.0 µg/0.1 mL bidistilled water
TA 1537: 9(5)- aminoacridine hydrochloride monohydrate, A: 50 and B: 100 µg/0.1 mL DMSO
With S9-Mix:
TA 98, TA 100, TA 1537: 2-aminoanthracene, 5 µg/0.1 mL DMSO
TA 102: 2-aminoanthracene, 20 µg/0.1 mL DMSO
TA 1535: cyclophosphamide, 250 µg/0.1 mL phosphate buffer
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Based on the presented results and under the conditions employed, the test article did not induce point mutations in presence or absence of a metabolic activation system and is therefore regarded as not mutagenic in the Ames test. - Executive summary:
In order to investigate the test article's potential to cause point mutation in bacteria, an AMES test similar in design to the OECD guideline No. 471 was carried out with the tester strains Salmonella typhimurium TA 98, TA 100, TA 102, TA 1535 and TA 1537. The test article was applied by the plate incorporation method at concentrations of 20, 78, 313, 1250 and 5000 µg/0.1 ml either with or without a metabolic activation system (rat liver S9 mix). The experiment was performed in triplicates and repeated once for confirmation. Positive controls were performed in parallel to check the tester strains sensitivity. In none of the experiments did treatment with the test substance lead to an increase in the incidence of histidine-prototrophic mutants in comparison with the controls. A growth-inhibiting effect occurred in the experiments without microsomal activation at the highest concentration. At the concentrations of 1250 µg/0.1 ml and above the substance precipitated in soft agar. In conclusion, no evidence of the induction of point mutations by the test substance or by its metabolites formed as a result of microsomal activation was detectable in the strains of S. typhimurium used in these experiments. Therefore, the substance is considered as not mutagenic in this assay.
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.
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