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EC number: 457-320-2 | 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 cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 9 February to 12 April 1999
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP, on related material
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Details on test material:
- - Name of test material (as cited in study report): NB 6786-35
- Substance type: technical product
- Physical state: black viscous liquid
- Analytical purity: 94 ± 2% (based on a calculational method)
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: tris(dicocodithiocarbamato) tris(μ-sulfido) (μ3-thio)-triangulotrimolybdenum (IV) dicocothiocarbamate
- Lot/batch No.: NB 6786-35
- Storage condition of test material: room temperature in dark
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- lymphocytes: human
- Details on mammalian cell type (if applicable):
- not applicable
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- post-mitochondrial fraction derived from the liver of Aroclor 1254-induced rats (S-9)
- Test concentrations with justification for top dose:
- Study 1 (without S9): 0, 39.06, 78.13, 156.25, 312.5, 625, 1250, 2500 and 5000 μg/ml
(with S9): 0, 50, 100, 150, 200, 250, 300, 400, 600 and 800 μg/ml
Study 2 (without S9): 0, 125, 250, 750, 1000, 2000, 3000 and 4000 μg/ml
(with S9): 0, 50, 100, 150, 200, 250, 300, 400, 600 and 800 μg/ml - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: culture medium
- Justification for choice of solvent/vehicle: insoluble in water and acetone, but soluble in culture medium to about 10 mg/ml
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- culture medium
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- Remarks:
- without S9
Migrated to IUCLID6: 0.1 μg/ml
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- with S9
Migrated to IUCLID6: 6 μg/ml
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: (study 1): 3 hr both with and without S9;
(study 2): 3 hr with S9, 21 hr without S9
- Fixation time (start of exposure up to fixation or harvest of cells): 21 hr
SPINDLE INHIBITOR (cytogenetic assays): Colcemid
STAIN (for cytogenetic assays): 10% Giemsa
NUMBER OF REPLICATIONS: duplicate cultures
NUMBER OF CELLS EVALUATED: 100 per culture (200 per dose level)
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: no data - Evaluation criteria:
- The assay was considered positive if statistically significant increases (P < 0.01) in the frequency of aberrations were observed at one or more concentrations and the increases were reproducible between the replicate cultures
- Statistics:
- Fisher exact test
Results and discussion
Test results
- Species / strain:
- lymphocytes: human
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
RANGE-FINDING/SCREENING STUDIES: study 1 was a range-finding study
COMPARISON WITH HISTORICAL CONTROL DATA: historical data on spontaneous levels and positive controls for January 1997 to December 1998 given in report
ADDITIONAL INFORMATION ON CYTOTOXICITY: see Table 1
Based on the mitotic indices the dose levels selected for metaphase analysis were:
Study 1: 1250, 2500 and 5000 μg/ml (without S9)
78.13, 156.25 and 312.5 μg/ml (with S9)
Study 2: 2000, 3000 and 4000 μg/ml (without S9)
400, 600 and 800 μg/ml (with S9)
There was no increase in polyploidy in treated cultures compared to the vehicle control.
Responses obtained from the negative and positive controls demonstrated that the system was capable of detecting chemicals that caused chromosomal damage.
Any other information on results incl. tables
Table 1. Summary of results
Exposure period (hr) |
S9 mix |
Concentration of test substance (μg/ml) |
Cells with CAs excluding gaps (%) |
Cells with CAs including gaps (%) |
Mitotic index (%) |
Study 1 |
|
|
|
|
|
3 |
- |
0 |
0 |
1.0 |
100 |
|
|
1250 |
0.5 |
1.5 |
94 |
|
|
2500 |
0 |
3.0 |
78 |
|
|
5000 |
0.5 |
1.0 |
37 |
|
|
0.1 mitomycin C |
13.5*** |
20.0*** |
- |
3 |
+ |
0 |
0 |
1.0 |
100 |
|
|
78.13 |
0.5 |
2.0 |
93 |
|
|
156.25 |
1.0 |
2.0 |
114 |
|
|
312.5 |
0 |
0.5 |
29 |
|
|
6 cyclophosphamide |
10.5*** |
19.5*** |
- |
Study 2 |
|
|
|
|
|
21 |
- |
0 |
0.5 |
0.5 |
100 |
|
|
2000 |
0.5 |
1.0 |
92 |
|
|
3000 |
0.5 |
1.5 |
85 |
|
|
4000 |
1.0 |
2.0 |
58 |
|
|
0.1 mitomycin C |
13.5*** |
21.0*** |
- |
3 |
+ |
0 |
0.5 |
0.5 |
100 |
|
|
400 |
0.5 |
1.0 |
96 |
|
|
600 |
0.5 |
1.5 |
81 |
|
|
800 |
1.0 |
2.0 |
59 |
|
|
6 cyclophosphamide |
10.5*** |
17.0*** |
- |
*** P <0.001
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
In a GLP study conducted according to OECD guideline 473, EC# 434-650-5 - a substance structurally and chemically similar to EC# 457-3320-2 - showed no ability to induce chromosome aberrations or polyploidy in primary cultures of human lymphocytes, when tested at up to 800 or 5000 μg/ml with or without S9, respectively. - Executive summary:
In a GLP study conducted according to OECD guideline 473, the ability of EC# 434-650-5 (tris(dicocodithiocarbamato) tris(μ-sulfido) (μ3-thio)-triangulotrimolybdenum (IV) dicocothiocarbamate), a substance structurally and chemically similar to EC# 457-320-2, to cause chromosome aberrations was assessed in cultures of human lymphocytes.
Lymphocytes, obtained from healthy male volunteers, were grown in culture medium for 48 hr before the addition of the test substance, in the presence and absence of a rat liver metabolic activation fraction (S9). Two independent studies were carried out. In the first, up to 5000 or 800 μg/ml were incubated without or with S9, respectively, for 3 hr, before removal of the test substance and a further 18 hr incubation. In the second study up to 4000 or 800 μg/ml were incubated without or with S9, respectively, but in this case the cultures without S9 were exposed to the test substance for the entire 21 hr incubation period. Cell division was stopped in metaphase 2 hr before the end of the incubation period, after which the cells were fixed, stained with Giemsa and slides prepared. The proportion of mitoses (mitotic index) per 1000 cells were recorded and used to select the dose levels for scoring of chromosome aberrations. One hundred metaphases were scored for each duplicate culture.
No statistically significant increases in the number of chromosome aberrations or induction of polyploidy were observed with the test substance compared to the vehicle controls. Cytotoxicity was apparent as shown by the decrease in the mitotic indices of the treated cells at the higher dose levels, both with and without S9. The positive controls gave the expected response demonstrating the sensitivity of the test system.
In conclusion, EC# 434-650-5 showed no ability to induce chromosome aberrations or polyploidy in primary cultures of human lymphocytes, when tested at up to 800 or 5000 μg/ml with or without S9, respectively.
In view of the structural and chemical similarities, it is considered that the results of this study can be used for read-across to EC# 457-320-2.
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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