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EC number: 807-674-2 | CAS number: 109884-54-0
- 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:
- 26 May - 13 Aug 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant Guideline study. No historical positive control data, but positive control chemicals produced a statistically significant increase in the incidence of cells with chromosome aberrations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- (1997)
- Deviations:
- yes
- Remarks:
- (no historical positive control data), according to current OECD Guideline 473 adopted 2014, at least 300 well-spread metaphases should be scored per concentration
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 109884-54-0
- Cas Number:
- 109884-54-0
- IUPAC Name:
- 109884-54-0
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: clear colourless liquid
- Analytical purity: 100%
- Batch No.: OE31003999
- Expiration date of the batch: 03 October 2017
- Stability under test conditions: in vehicle ethanol: stable
- Storage condition of test material: at room temperature in the dark
- Hygroscopic: yes, store in well-sealed container
- Volatile: no
Constituent 1
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- lymphocytes: cultured peripheral human lymphocytes
- Details on mammalian cell type (if applicable):
- 0.4 ml whole blood of a healthy male donor treated with heparin was added to 5 mL or 4.8 ml culture medium and 0.1 mL (9 mg/mL) Phytohaemagglutinin and was cultured for 48 h and thereafter exposed to selected doses of the test substance.
- Type and identity of media: RPMI 1640 medium supplemented with 20% (v/v) heat-inactivated (56°C; 30 min) foetal calf serum, L-glutamine (2 mM), penicillin/streptomycin (50 U/mL and 50 µg/mL respectively) and 30 U/ml heparin
- Average Generation Time (AGT) of the cells and the age of the donor at the time the AGT:
Dose range finding study / First cytogenetic assay: age 22, AGT = 12.8 h
Second cytogenetic assay: age 31, AGT = 13.5 h (24 h treatment); age 35, AGT = 13.2 h (48 h treatment)
- Environmental conditions: humidity: 80 - 100% (actual range 52 - 90%); 5.0 ± 0.5% CO2 in air, temperature: 37.0 ± 1.0°C (actual range 34.5 - 37.4°C) - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat S9 homogenate, prepared from male Sprague Dawley rats that have been dosed orally with a suspension of phenobarbital (80 mg/kg body weight) and ß-naphthoflavone (100 mg/kg)
- Test concentrations with justification for top dose:
- Dose range finding test:
- 1.7, 5.4, 17, 52, 164, 512, 1600 µg/mL (without S9-mix, 24 h and 48 h exposure time)
Experiment 1:
- 5.4, 17, 52 µg/mL (with and without S9-mix, 3 h exposure time)
Experiment 2:
- 17, 164, 1600 µg/mL (without S9-mix, 24 h and 48 h exposure time) - Vehicle / solvent:
- - Vehicle used: ethanol (final concentration in culture medium: 0.5 - 1.0% (v/v))
The test substance was difficult to dissolve in aqueous solutions. It was soluble in ethanol at concentrations of 102.4 mg/mL and below but formed a suspension at the concentration of 160 mg/mL.
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- (ethanol)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: -S9-mix: Mitomycin C (0.5 and 0.75 µg/mL for 3 h, 0.2 and 0.3 µg/mL for 24 h, 0.1 and 0.15 µg/mL for 48 h exposure period); +S9-mix: Cyclophosphamide (10 µg/mL for 3 h exposure period (24 h fixation time)); Solvent: Hanks’ Balanced Salt Solution (HBSS)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration:
Dose range finding test: 24 and 48 h
First cytogenetic assay: 3 h
Second cytogenetic assay: 24 h and 48 h
- Fixation time (start of exposure up to fixation or harvest of cells):
Dose range finding test: 24 and 48 h
First cytogenetic assay: 24 h
Second cytogenetic assay: 24 h and 48 h
SPINDLE INHIBITOR: colchicine (0.5 µg/mL medium)
STAIN: 5% (v/v) Giemsa solution in Sörensenbuffer pH 6.8
NUMBER OF REPLICATIONS: Duplicates in two independent experiments
NUMBER OF CELLS EVALUATED:
100 metaphase chromosome spreads per culture were examined for chromosome aberrations. (200 metaphase chromosome spreads were examined for one solvent control since a high incidence of cells with aberrations was observed)
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index of 1000 cells
OTHER EXAMINATIONS:
- Determination of polyploidy: yes
- Determination of endoreplication: yes - Evaluation criteria:
- A test substance was considered positive (clastogenic) in the chromosome aberration test if:
a) It induced a dose-related statistically significant (Chi-square test, one-sided, p < 0.05) increase in the number of cells with chromosome aberrations.
b) A statistically significant and biologically relevant increase in the frequencies of the number of cells with chromosome aberrations was observed in the absence of a clear dose-response relationship.
A test substance was considered negative (not clastogenic) in the chromosome aberration test if none of the tested concentrations induced a statistically significant (Chi-square test, one-sided, p < 0.05) increase in the number of cells with chromosome aberrations. - Statistics:
- Chi-square test, one-sided, p < 0.05
Results and discussion
Test results
- Species / strain:
- lymphocytes: cultured peripheral human lymphocytes
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- (test substance was tested beyond the limit of solubility)
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: The test substance precipitated in the culture medium at a concentration of 52 µg/mL and above.
RANGE-FINDING/SCREENING STUDIES:
At the 24 h and 48 h continuous exposure time single blood cultures were treated with 1.7, 5.4, 17, 52, 164, 512 and 1600 µg test substance/mL culture medium without S9-mix. The test substance was tested beyond the limit of solubility.
The test substance was not cytotoxic and difficult to dissolve in aqueous solutions, the highest concentration analysed was determined by the solubility in the culture medium.
COMPARISON WITH HISTORICAL CONTROL DATA:
The mean number of cells with chromosome aberrations found in the solvent control cultures was within or just above the laboratory historical control data range. Since clear negative results were observed in all test substance concentrations this deviation does not have any influence on study integrity.
The number of polyploid cells and cells with endoreduplicated chromosomes in the solvent control cultures was within the laboratory historical control data range. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1: Results of first cytogenetic assay
Test item | Concentration | Mitotic index | Number of aberrant cells | |
in µg/mL | in % | with gaps | without gaps | |
Exposure period 3 h, fixation time 24 h, without S9-mix | ||||
Ethanol | 0.5% (v/v) | 100 | 1 | 1 |
Test substance | 5.4 µg/mL | 98 | 1 | 0 |
17 µg/mL | 92 | 1 | 1 | |
52 µg/mL1 | 95 | 5 | 4 | |
Mitomycin C | 0.5 µg/mL | 66 | 58* | 58* |
Exposure time 3 h, fixation time 24 h, with S9 -mix | ||||
Ethanol | 0.5% (v/v) | 100 | 1 | 1 |
Test substance | 5.4 µg/mL | 99 | 2 | 1 |
17 µg/mL | 98 | 0 | 0 | |
52 µg/mL1 | 96 | 2 | 1 | |
Cyclophosphamide | 10 µg/mL | 50 | 58* | 58* |
1 the test substance precipitated in the culture medium
* Significantly different from control group (Chi-square test)
Table 2: Results of second cytogenetic assay
Test item | Concentration | Mitotic index | Number of aberrant cells | |
in µg/mL | in % | with gaps | without gaps | |
Exposure period 24 h, fixation time 24 h, without S9 -mix | ||||
Ethanol | 0.5% (v/v) | 100 | 0 | 0 |
Test substance | 17 µg/mL | 89 | 4 | 4 |
164 µg/mL1 | 63 | 0 | 0 | |
1600 µg/mL1 | 55 | 0 | 0 | |
Mitomycin C | 0.2 µg/mL | 53 | 52* | 52* |
Exposure period 48 h, fixation time 48 h, without S9 -mix | ||||
Ethanol | 0.5% (v/v) | 100 | 102 | 92 |
Test substance | 17 µg/mL | 92 | 5 | 5 |
164 µg/mL1 | 91 | 3 | 3 | |
1600 µg/mL1 | 99 | 4 | 4 | |
Mitomycin C | 0.1 µg/mL | 88 | 61* | 60* |
1 The test substance precipitated in culture medium
2 Both slides of the B culture were examined for chromosome aberrations
* Significantly different from control group (Chi-square test)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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