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EC number: 939-600-0 | CAS number: 1471316-27-4
- 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:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant OECD Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 3013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5375 - In vitro Mammalian Chromosome Aberration Test
- Deviations:
- no
- GLP compliance:
- yes
- Remarks:
- Hessischens Ministerium für Umwelt, Energie, Landwirtschaft und Verbraucherschutz, Wiesbaden, Germany
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 70955-07-6
- EC Number:
- 615-218-7
- Cas Number:
- 70955-07-6
- IUPAC Name:
- 70955-07-6
- Details on test material:
- - Name of test material (as cited in study report): Alcohols, tallow, propoxylated (>1<2.5 mol PO)
- Physical state: lowly viscous fluid, yellowish, clear
- Analytical purity: 96.6%
- Lot/batch No.: CP11090009
- Expiration date of the lot/batch: April 18, 2013
- Storage condition of test material: Room temperature, avoid temperatures > 40°C
Constituent 1
Method
- Target gene:
- not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster lung fibroblasts (V79)
- Details on mammalian cell type (if applicable):
- Species/strain: lymphocytes: cultured peripheral human lymphocytes
Details on mammalian cell lines:
- Type and identity of media:
MEM medium (minimal essential medium) containing Hank’s salts,
glutamine and Hepes (25 mM) with glutamine supplemented with
- 10%(v/v) fetal bovine serum (FBS)
- 1% (v/v) penicillin/streptomycin (100 U/mL/100 Q g/mL)
During exposure to the test substance (4-hour treatment), MEM medium was used
without FBS supplementation.
- Properly maintained: yes/no
- Periodically checked for Mycoplasma contamination: yes
- Periodically checked for karyotype stability: yes
- Periodically "cleansed" against high spontaneous background: no
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with phenobarbital/beta-naphtoflavone
- Test concentrations with justification for top dose:
- 4 h treatment (IA), without S9 mix: 20.3, 40.6, 81.3, 162.5, 325.0 (Phase separation = PS), 650.0 PS, 1300.0 PS, 2600.0 PS, 5200 PS
18 h treatment (IIA) without S9 mix: 0.8, 1.6, 3.1, 6.3, 12.5, 25.0, 50.0, 100.0 PS, 200.0 PS
28 h treatment (IIA) without S9 mix: 0.8, 1.6, 3.1, 6.3, 12.5, 25.0, 50.0, 100.0 PS, 200.0 PS
4 h treatment (IA), with S9 mix: 20.3, 40.6, 81.3, 162.5, 325.0, 650.0, 1300.0 PS, 2600.0 PS, 5.2 PS
4 h treatment (IB) with S9 mix: 75.0, 150.0, 300.0 PS, 600.0 PS, 1000.0 PS, 1400.0 PS, 1800.0, 2000.0 PS, 2600.0 PS
4 h treatment (IC) with S9 mix75.0, 150.0, 300.0 PS, 600.0 PS, 1000.0 PS, 1400.0 PS, 1800.0, 2000.0 PS, 2600.0 PS
4 h treatment (IIB) with S9 mix: 30.0, 60.0, 80.0, 100.0, 120.0, 140.0, 160.0, 180.0, 200.0 - Vehicle / solvent:
- - Vehicle used: ethanol
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- Ethanol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- 1000 µg/mL (Exp IA) and 600 µg/mL (Exp. IIA), + S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- 2.0 µg/mL (Exp. IB), 1.4 µg/mL (Exp. IC), and 2.4 µg/mL (Exp. IIA and IIB), -S9
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4, 18 and 28 h
- Fixation time (start of exposure up to fixation or harvest of cells): 4h treatment: 18 and 28 h. 18 h treatment. 28 h treatment: 28 h
SPINDLE INHIBITOR (cytogenetic assays): Colcemid 0.2 µg/mL in medium
STAIN (for cytogenetic assays): Giemsa
NUMBER OF REPLICATIONS: two replications each in 5 independent experiments
NUMBER OF CELLS EVALUATED: 100 per culture, except for the positive controls in Experiment IIA and IIB after 28 h preparation interval with metabolic activation, where only 50 metaphases were evaluated
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- A test substance was considered positive (clastogenic) in the chromosome aberration test if:
a) It induced a dose-related or statistically significant (Fisher´s exact test, p < 0.05) increase in the number of cells with chromosome aberrations.
b) The number of induced structural chromosome aberrations is not in the range of laboratory control historical data. However, both biological and statistical significance should be considered together.
A test substance was considered negative (not clastogenic) in the chromosome aberration test if no significant increase in the number of cells with chromosome is observed and if the number of induced structural chromosome aberration in all evaluated dose groups is in the range of the laboratory historical control data. - Statistics:
- Fisher´s exact test, p < 0.05
Results and discussion
Test results
- Species / strain:
- Chinese hamster lung fibroblasts (V79)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- At the highest evaluated concentration in experiment IA (-S9 mix) and in experiment IC (+S9 mix) the mitotic index was 49.7, 45.3 % of control, respectively
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1 Summary of the chromosome aberration study without metabolic activation
Exp |
Preparation interval |
Test item concentration (µg/mL) |
Polyploid cells in % |
Endomitotic cells in % |
Cell numbers in % of control |
Mitotic indices in % of control |
Aberrant cells in % |
||
Incl. gaps* |
excl. gaps* |
With exchanges |
|||||||
Exposure period 4h without S9 mix |
|||||||||
IA
|
18 h
|
Solvent control 1 |
2.9 |
0.0 |
100.0 |
100.0 |
3.0 |
2.5 |
0.0 |
Positive control 2 |
n.d. |
n.d. |
n.d. |
80.0 |
17.0 |
17.0s |
11.0 |
||
20.3 |
3.8 |
0.0 |
100.2 |
96.4 |
1.5 |
0.5 |
0.5 |
||
40.6 |
2.5 |
0.0 |
79.6 |
95.2 |
1.0 |
1.0 |
0.0 |
||
81.3 |
2.2 |
0.0 |
73.4 |
49.7 |
1.5 |
1.5 |
0.0 |
||
Exposure period 18h without S9 mix |
|||||||||
II A
|
18 h
|
Solvent control 1 |
2.1 |
0.0 |
100.0 |
100.0 |
4.0 |
3.5 |
0.5 |
Positive control 3 |
n.d. |
n.d. |
n.d. |
66.1 |
29.0 |
28.5s |
14.0 |
||
1.6 |
2.2 |
0.0 |
87.4 |
86.0 |
0.5 |
0.5 |
0.0 |
||
3.1 |
2.3 |
0.0 |
90.6 |
88.3 |
2.0 |
1.0 |
0.0 |
||
6.3 |
2.4 |
0.0 |
103.0 |
95.1 |
1.0 |
0.5 |
0.0 |
||
Exposure period 28h without S9 mix |
|||||||||
II A
|
28 h
|
Solvent control 1 |
3.0 |
0.0 |
100.0 |
100.0 |
0.0 |
0.0 |
0.0 |
Positive control 3 |
n.d. |
n.d. |
n.d. |
66.6 |
34.5 |
34.5s |
25.5 |
||
1.6 |
2.6 |
0.0 |
110.1 |
86.5 |
3.5 |
2.0 |
0.0 |
||
3.1 |
2.5 |
0.0 |
91.6 |
82.6 |
1.5 |
0.5 |
0.0 |
||
6.3 |
1.3 |
0.0 |
91.8 |
68.0 |
0.0 |
0.0 |
0.0 |
* Including cells carrying exchanges
n.d. Not determined
S Aberration frequency statistically higher than corresponding control values
1 Ethanol 0.5% (v/v)
2 EMS 1000.0 µg/mL
3 EMS 600.0 µg/mL
Table 2 Summary of the chromosome aberration study with metabolic activation
Exp |
Preparation interval |
Test item concentration (µg/mL) |
Polyploid cells in % |
Endomitotic cells in % |
Cell numbers in % of control |
Mitotic indices in % of control |
Aberrant cells in % |
||||
Incl. gaps* |
excl. gaps* |
With exchanges |
|||||||||
Exposure period 4 hours with S9 mix |
|||||||||||
IB
|
18 h
|
Solvent control 1 |
1.9 |
0.0 |
100.0 |
100.0 |
3.5 |
2.0 |
0.0 |
||
Positive control 2 |
n.d. |
n.d. |
n.d |
60.7 |
26.0 |
26.0s |
10.5 |
||||
75.0 |
1.1 |
0.0 |
116.5 |
106.5 |
3.0 |
3.0 |
1.5 |
||||
150.0 |
0.9 |
0.0 |
87.0 |
82.1 |
2.0 |
2.0 |
0.5 |
||||
300.0 |
1.2 |
0.0 |
96.9 |
66.3 |
3.0 |
3.0 |
1.0 |
||||
IC
|
18 h
|
Solvent control 1 |
2.3 |
0.0 |
100.0 |
100.0 |
2.0 |
2.0 |
1.5 |
||
Positive control 3 |
n.d. |
n.d. |
n.d. |
59.6 |
23.5 |
23.5s |
14.5 |
||||
150.0 |
2.9 |
0.0 |
85.8 |
109.1 |
2.0 |
1.5 |
0.0 |
||||
300.0 |
2.9 |
0.0 |
77.4 |
80.5 |
1.5 |
1.5 |
1.0 |
||||
350.0 |
1.4 |
0.0 |
77.0 |
45.3 |
2.0 |
2.0 |
1.0 |
||||
IIA
|
28 h
|
Solvent control 1 |
1.3 |
0.0 |
100.0 |
100.0 |
2.5 |
2.0 |
0.5 |
||
Positive control 4# |
n.d. |
n.d. |
n.d. |
109.1 |
54.0 |
54.0S |
24.0 |
||||
25.0 |
2.5 |
0.0 |
76.1 |
99.7 |
1.5 |
1.5 |
0.5 |
||||
50.0 |
1.9 |
0.0 |
106.2 |
106.1 |
3.5 |
3.0 |
0.0 |
||||
100.0 |
1.7 |
0.0 |
90.6 |
68.5 |
2.5 |
1.5 |
0.0 |
||||
IIB
|
28 h
|
Solvent control 1 |
2.3 |
0.0 |
100.0 |
100.0 |
2.5 |
2.5 |
0.0 |
||
Positive control 4# |
n.d |
n.d. |
n.d. |
107.7 |
54.0 |
53.0s |
22.0 |
||||
120.0 |
1.5 |
0.0 |
106.1 |
97.8 |
3.0 |
2.5 |
1.0 |
||||
160.0 |
2.9 |
0.0 |
75.9 |
101.9 |
2.0 |
1.5 |
0.5 |
||||
200.0 |
3.0 |
0.0 |
74.0 |
56.9 |
0.5 |
0.5 |
0.0 |
||||
* Including cells carrying exchanges
n.d. Not determined
S Aberration frequency statistically higher than corresponding control values
PS Phase separation occurred at the end of treatment
# 50 metaphases per culture were evaluated
1 Ethanol 0.5% (v/v)
2 CPA 2.0 µg/mL
3 CPA 1.4 µg/mL
4 CPA 2.4 µg/mL
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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