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EC number: 800-426-4 | CAS number: 1373883-45-4
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 19 Nov 1992 - 27 Feb 1993
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP-Guideline study, tested with the source substance Fatty acids, C18-unsatd., dimers (CAS No. 61788-89-4). According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: UK Department of Health Report on Health and Social Subjects No. 35. Guidelines for the testing of chemicals for mutagenicity (1989)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Fatty acids, C18-unsatd., dimers
- EC Number:
- 500-148-0
- EC Name:
- Fatty acids, C18-unsatd., dimers
- Cas Number:
- 61788-89-4
- IUPAC Name:
- 61788-89-4
- Details on test material:
- - Name of test material (as cited in study report): Dimer acid
- Physical state: viscous golden liquid
- Substance type: UVCB
- Analytical purity: dimer content 73%, trimer content 21%
- Expiration date of the lot/batch: April 1993
- Storage condition of test material: room temperature
Constituent 1
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- lymphocytes: human blood (males)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: RPMI 1640 + 20% foetal calf serum + 175 µg/mL phytohaemagglutinin
- Properly maintained: yes
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats treated with Aroclor 1254.
- Test concentrations with justification for top dose:
- Experiment 1:
0.6, 1.2, 2.3, 4.7, 9.4, 18.8, 37.5, 75, 150, 300 µg/mL (18 h harvest, with and without metabolic activation)
Experiment 2:
37.5, 75, 150, 300 µg/mL (18 h harvest, without metabolic activation)
75, 150, 300 µg/mL (18 h harvest, with metabolic activation)
9.4, 18.8, 37.5, 75, 150, 300 µg/mL (32 h harvest, without metabolic activation)
18.8, 37.5, 75, 150, 300 µg/mL (32 h harvest, with metabolic activation) - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: based on assessment of test substance solubility prior to commencing of testing.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO (10 µL/mL)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- ethylmethanesulphonate
- Remarks:
- 500 and 750 µg/mL without metabolic activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO (10 µL/mL)
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cyclophosphamide
- Remarks:
- 10 and 15 µg/mL with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 18 and 32 h (without metabolic activation) ; 3 h (with metabolic activation)
- Expression time (cells in growth medium): 15 and 29 h (after treatmet with metabolic activation)
- Fixation time (start of exposure up to fixation or harvest of cells): 18 and 32 h
SPINDLE INHIBITOR: colchicine (0.25 µg/mL)
STAIN: Giemsa (1:9 dilution in buffered distilled water)
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 100 per culture
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index - Evaluation criteria:
- A test result was considered positive, if a clear treatment-related and statistically significant increase (Fisher’s test) in the number of cells containing chromosome aberrations, not falling within the historical control of the testing facility (0-5.25%) and some evidence of a dose-relationship was observed.
- Statistics:
- The number of aberrant cells in each treatment group was compared with the solvent control value by means of the Fisher's test.
Results and discussion
Test results
- Species / strain:
- lymphocytes: human blood (males)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 300 µg/mL (18 h harvest ) and from 150 µg/mL (32 h harvest), without metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Water solubility: prior to commencing testing, the solubility of the test substance was assessed. The test substance dissolved at 500 mg/mL in DMSO. However on dosing at 1% v/v into aqueous tissue culture medium, a precipitate was found. The final concentration used for subsequent testing was 300 µg/mL, at which a slight precipitate was observed.
- Precipitation: in the main tests, slight to heavy precipitate was observed at 150 and 300 µg/mL with and without metabolic activation for both the 18 and 32 h harvest.
COMPARISON WITH HISTORICAL CONTROL DATA:
The solvent control values were within the historical control of the testing facility (0-5.25%).
ADDITIONAL INFORMATION ON CYTOTOXICITY:
In Experiment 1, at 300 µg/mL, the mitotic index was reduced to 65% of the solvent control value in the absence of S9 mix and no decrease was observed in its presence.
In Experiment 2, in the presence of S9 mix (18 and 32 h harvest) and in the absence of S9 mix (18 h harvest), no significant reductions in mitotic index were observed at the maximum achievable concentration of 300 µg/mL. In the absence of S9 mix at 32 h harvest, the highest analysable concentration of 150 µg/mL caused a decrease in mitotic index to 63% of the solvent control value. The highest concentration of 300 µg/mL was too toxic for analysis. - 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 chromosome aberration test in human lymphocytes (duplicate cultures), Experiment 1.
Test item |
Concentration (µg/mL) |
Relative mitotic index (%) |
Mean No. of aberrant cells per 100 cells examined |
|
Without gaps |
With gaps |
|||
Exposure: without S9 mix, 18 h harvest |
||||
DMSO |
10 µL/mL |
100 |
0.25 |
0.25 |
Test substance |
0.6 |
90 |
ND |
ND |
1.2 |
98 |
ND |
ND |
|
2.3 |
101 |
ND |
ND |
|
4.7 |
95 |
ND |
ND |
|
9.4 |
93 |
ND |
ND |
|
18.8 |
100 |
ND |
ND |
|
37.5 |
107 |
ND |
ND |
|
75 |
104 |
1.5 |
1.5 |
|
150 |
80 |
1.5 |
1.5 |
|
300 (Pa) |
65 |
1.0 |
1.5 |
|
Ethylmethanesulphonate |
500 |
ND |
28.0* |
28.0* |
Exposure: with S9 mix, 18 h harvest (3 h + 15 h recovery) |
||||
DMSO |
10 µL/mL |
100 |
0.5 |
0.5 |
Test substance |
0.6 |
102 |
ND |
ND |
1.2 |
107 |
ND |
ND |
|
2.3 |
111 |
ND |
ND |
|
4.7 |
112 |
ND |
ND |
|
9.4 |
112 |
ND |
ND |
|
18.8 |
127 |
ND |
ND |
|
37.5 |
110 |
ND |
ND |
|
75 |
114 |
0.0 |
0.0 |
|
150 |
91 |
0.5 |
0.5 |
|
300 (Pb) |
111 |
0.0 |
0.0 |
|
Cyclophosphamide |
10 |
ND |
34.0* |
34.0* |
ND: not determined
Pa: Precipitate on dosing, still apparent when the culture was harvested.
Pb: Precipitate on dosing, still apparent at the end of treatment (3 h) and when the culture was harvested.
* P < 0.001
Table 2. Results of chromosome aberration test in human lymphocytes (duplicate cultures), Experiment 2.
Test item |
Concentration (µg/mL) |
Relative mitotic index (%) |
Mean No. of aberrant cells per 100 cells examined |
|
Without gaps |
With gaps |
|||
Exposure: without S9 mix, 18 h harvest |
||||
DMSO |
10 µL/mL |
100 |
0.25 |
0.25 |
Test substance |
37.5 |
100 |
ND |
ND |
75 |
85 |
0.5 |
0.5 |
|
150 (Pc) |
100 |
0.0 |
0.0 |
|
300 (Pd) |
70 |
0.0 |
0.0 |
|
Ethylmethanesulphonate |
500 |
ND |
14.5* |
15.0* |
Exposure: with S9 mix, 18 h harvest (3 h + 15 h recovery) |
||||
DMSO |
10 µL/mL |
100 |
1.25 |
1.5 |
Test substance |
75 |
94 |
0.5 |
1.0 |
150 (Pc) |
100 |
1.0 |
1.0 |
|
300 (Pe) |
113 |
0.0 |
0.0 |
|
Cyclophosphamide |
10 |
ND |
27.0* |
28.0* |
Exposure: without S9 mix, 32 h harvest |
||||
DMSO |
10 µL/mL |
100 |
1.25 |
2.0 |
Test substance |
9.4 |
103 |
ND |
ND |
18.8 |
72 |
ND |
ND |
|
37.5 |
53 |
ND |
ND |
|
75 |
63 |
ND |
ND |
|
150 (Pc) |
63 |
0.5 |
0.5 |
|
300 (Pd) |
3 |
ND |
ND |
|
Exposure: with S9 mix, 32 h harvest (3 h + 29 h recovery) |
||||
DMSO |
10 µL/mL |
100 |
1.0 |
1.25 |
Test substance |
18.8 |
98 |
ND |
ND |
37.5 |
103 |
ND |
ND |
|
75 |
103 |
ND |
ND |
|
150 (Pf) |
118 |
ND |
ND |
|
300 (Pg) |
89 |
1.0 |
1.0 |
ND: not determined
Pc: Slight precipitate on dosing, not apparent when the cultures were harvested.
Pd: Heavier precipitate on dosing, still apparent when the cultures were harvested.
Pe: Heavier precipitate on dosing, not apparent when the cultures were harvested.
Pf: Slight precipitate on dosing, not apparent at the end of treatment (3 h).
Pg: Heavier precipitate on dosing, still apparent at the end of treatment (3 h).
* P < 0.001
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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