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EC number: 679-769-5 | CAS number: 2675-94-7
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Ames: Negative
Chromosome aberration in mammallian cells: Negative
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 1993-07-06 to 1993-07-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 472 (Genetic Toxicology: Escherichia coli, Reverse Mutation Assay)
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
- Specific details on test material used for the study:
- Batach No.: not specifed
Purity: not specifed - Target gene:
- Histidine locus in several strains of Salmonella typhimurium and tryptophan locus of Escherichia coli (E. coli) strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- other: S. typhimurium TA 1538
- Species / strain / cell type:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver metabolic activation system (S-9 mix)
- Test concentrations with justification for top dose:
- -Dose-range Finding Test: TA 98, TA 100, TA 1538, TA 1535, TA1537 and the WP2uvrA, both with and without S9-mix: 5, 50, 500, 5000 μg/ plate.
Mutatuion Test 1: TA 98, TA 100, TA 1538, TA 1535, TA1537 and the WP2uvrA, both with and without S9-mix: 312.5, 625, 1250, 2500 and 5000 μg/ plate.
Mutatution Test 2: TA 98, TA 100, TA 1538, TA 1535, TA1537 and the WP2uvrA, both with and without S9-mix: 312.5, 625, 1250, 2500 and 5000 μg/ plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: Prior to commencing testing the solubiity of the material was assessed at 50 mg/mL in water in which it was found to be completely miscible. Water was therefore used as the solvent for this study. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- N-ethyl-N-nitro-N-nitrosoguanidine
- Remarks:
- without S-9 mix
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- with S-9 mix
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: preincubation
- Cell density at seeding: 2E+9 cells per mL
DURATION
- Exposure duration: all plates were incubated 3 days - Evaluation criteria:
- The mean number of revertant colonies for all treatment groups is compared with those obtained for solvent control groups. The mutagenic activity of a test material is assessed by applying the following criteria:
a) If treatment with a test material produces an increase in revertant colony numbers of at least twice the concurrent solvent controls, with some evidence of positive dose-relationship, in two separate experiments, with any bacterial strain either in presence or absence of S-9 mix it’s considered to show evidence of mutagenic activity in this test system. No statistical analysis is performed.
b) If treatment with a test material does not produce reproducible increases at least 1.5 times the concurrent controls, at any does level with any bacterial strain, it’s considered to show no evidence of mutagenic activity in this test system. No statistical analysis is performed.
c) If the result obtained fail to satisfy the criteria for a clear “positive” or “negative” response given in paragraphs (a) and (b), the following approach is taken in order to resolve the issue of the material’s mutagenic activity in this test system.
(1) Repeat test may be performed using modifications of the experimental method. These modifications include (but are not restricted to), the use of narrower dose range that already tested; the use of different levels of liver homogenate S-9 fraction in the S-9 mix. Should an increase in revertant colony numbers be observed which satisfies paragraph (a) the material is considered to show evidence of mutagenic activity in this test system. No statistical analysis is performed.
(2) If no clear “positive” response can be obtained the test data may be subjected to analysis to determine the statistical significance of any observed increases in revertant colony numbers. The statistical procedures used will be those described by Mahon et al. (1989). - Key result
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA1535, TA1537, TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- No substantial increases in revertant colony numbers of any the tester strains were observed following treatment with the test item at any dose level, in the presence or absence of S-9 mix in either mutation test.
Tester strain TA 98 was contaminated in the second mutation test but this contamination did not affect the counting of the plates. - Conclusions:
- When tested in water, the test item shows no evidence of mutagenic activity in this bacterial system.
- Executive summary:
In this in vitro assessment of the mutagenic potential of test item, histidine dependent auxotrophic mutants of Salmonella typhimurium (strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100) and a tryptophan dependent mutant of Escherichia coli (WP2 uvrA) were exposed to the test material, diluted in water which was used as a negative control.
Two independent mutation tests were performed, in the presence and absence of liver preparations from Aroclor 1254-induce rats.
In the preliminary dose range finding study with dose levels of up to 5000μg/plate no toxicity was observed. A top dose level of 5000μg/plate was chosen for subsequent mutation study. other dose levels used in mutation assays were: 2500, 1250, 625, 312.5μg/plate.
No evidence of mutagenic activity was seen at any dose level of test item in either mutation test.
The concurrent positive control compounds demonstrated the sensitivity of the assay and the metabolizing activity of the liver preparations.
It's concluded that, when tested in water, the test item shows no evidence of mutagenic activity in this bacterial system.
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 2013-08-26 to 2013-10-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 1997
- GLP compliance:
- yes
- Type of assay:
- other: in vitro chromosome aberration
- Specific details on test material used for the study:
- Bacth No.: not specified
Purity: 99.95% - Species / strain / cell type:
- other: Chinese hamster lung cell line
- Details on mammalian cell type (if applicable):
- CELLS USED
- Source of cells: Chinese hamster lung cells. The cell is obtained from American Type Culture Collection (2010-04, USA).
- Suitability of cells: it has been widely used and there are abundant basic information for chromosome aberration test.
-Store: in liquid nitrogen was thawed and cultured for 2~3 generation times.
Culture media and condition
- Media: minimum Essential Medium (Gibco) 500 mL supplemented with Fetal Bovine Serum (Gibco) 50 mL was used.
Condition: cultures were incubated at (37 ± 1) °C in a humidified atmosphere of (5 ± 1)% CO2. The CHL cells were subsequently subcultured every 3~4 days. - Metabolic activation:
- with and without
- Metabolic activation system:
- Sprague-Dawley male rat liver induced by Aroclor-1254 (S9)
- Test concentrations with justification for top dose:
- Main test with and without S9: 1300, 650 and 325 μg/mL
Confirmation test with and without S9: 1300, 650 and 325 μg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: water
- Justification for choice of solvent/vehicle: the tets item was soluble in sterile distilled water, so sterile distilled water was chosen as a vehicle and used in diluting the test substance. - Negative solvent / vehicle controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- mitomycin C
- other: Cyclophosphamide monohydrate (CPA)
- Details on test system and experimental conditions:
- - Cell density at seeding: 4000 cells/mL
DURATION
- Preincubation period: 3 days
- Exposure duration: 6 (24) hours without S9, 6 (6) hours with S9 - Evaluation criteria:
- Chromosome aberration was determined by following criteria.
Negative (-): less than 5%
Equivocal (+): from 5% to less than 10%
Positive (+): 10% or more - Key result
- Species / strain:
- mammalian cell line, other: CHL cell
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity nor precipitates, but tested up to recommended limit concentrations
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- -Decision of concentration
In the concentration range-finding test, cytotoxicity was less than 50% at all test concentration in absence of (S9) and presence (S9) of metabolic activation system. The highest concentration was selected at 1300 μg/mL for main test and confirmation test. Precipitation of test was not observed.
-Without metabolic activation I (S9- 6h) –Main test
In the absence (S9-) of metabolic activation I, the frequency of structural aberrant cells were 0.5%, 0.0%, 1.0% and 0.5% at the concentrations of 0, 325, 650 and 1300 μg/mL, respectively. All the results were less than 5% which was evaluated negative from criteria.
-With metabolic activation I (S9+ 6h) –Main test
In the presence (S9+) of metabolic activation I, the frequency of structural aberrant cells were 0.5%, 0.5%, 1.0% and 1.0% at the concentrations of 0, 325, 650 and 1300 μg/mL, respectively. All the results were less than 5% which was evaluated negative from criteria.
-Without metabolic activation II (S9- 24h) –Confirmation test
In the absence (S9-) of metabolic activation II, the frequency of structural aberrant cells were 0.5%, 0.5%, 0.0% and 0.0% at the concentrations of 0, 325, 650 and 1300 μg/mL, respectively. All the results were less than 5% which was evaluated negative from criteria.
-With metabolic activation II (S9+ 6h) –Confirmation test
In the presence (S9+) of metabolic activation II, the frequency of structural aberrant cells were 1.0%, 0.0%, 0.5% and 1.0% at the concentrations of 0, 325, 650 and 1300 μg/mL, respectively. All the results were less than 5% which was evaluated negative from criteria. - Conclusions:
- The test item was determined not induce chromosome aberration in CHL cell under the presence experimental condition.
- Executive summary:
The test substance was evaluated for its potential to induce chromosome aberration performing the chromosome aberration test with cultured Chinese hamster lung cell line (CHL) in the absence (S9-) and presence (S9+) of metabolic activation system under OECD Guideline 473. The test substance was prepared by dissolving in sterile distilled water.
In the main and confirmation test, the highest concentration was determined at 1300 μg/mL (about 10 mM) in either the absence (S9-) and presence (S9+) of metabolic activation system, because no growth inhibition more than 50% was observed in the concentration rang-finding test.
Five groups were included in both main and confirmation test, 3 dose level (325, 650 and 1300 μg/mL), negative and positive groups.
As a result of main and confirmation test, the frequency of structural aberrant cells was less than 5% at all test concentrations, and there was no increase of chromosome aberrations according to the concentration dependent manner compared with negative control.
Therefore, the test substance was determined not induce chromosome aberration in CHL cell under the presence experimental condition.
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
Justification for classification or non-classification
Negative result both in Ames study and In vitro chromosome aberration study.
Therefore in accordance with Regulation (EC) No. 1272/2008 Table 3.5.1, this substance should not be classified as mutagen.
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