Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 701-264-6 | 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 based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- GLP-Guideline study. 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:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- adopted in 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.10 (Mutagenicity - In Vitro Mammalian Chromosome Aberration Test)
- Version / remarks:
- adopted in 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Department of Health of the Government of the United Kingdom, UK
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- Fatty acids, C8-18 and C18-unsatd., esters with neopentyl glycol
- EC Number:
- 286-072-6
- EC Name:
- Fatty acids, C8-18 and C18-unsatd., esters with neopentyl glycol
- Cas Number:
- 85186-86-3
- IUPAC Name:
- 85186-86-3
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Physical state: yellow liquid
- Analytical purity: 100%
- Lot/batch No.: OE10817
- Storage condition of test material: room temperature in the dark
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):
- - Type and identity of media:
Eagle’s minimal essential medium with HEPES buffer (MEM) supplemented “in-house” with L-glutamine, supplemented with
- penicillin/streptomycin
- amphotericin B
- 10% foetal bovine serum (FBS)
- Metabolic activation:
- with and without
- Metabolic activation system:
- cofactor supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of rats with a mixture of phenobarbitone and beta-naphthoflavone
- Test concentrations with justification for top dose:
- 4 (20)-hour without S9: 40, 80, 160, 320, 480, 640, 960, 1280 µg/mL
4 (20)-hour withS9 (2%): 40, 80, 160, 320, 480, 640, 960, 1280 µg/mL - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: acetone
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- acetone
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: mitomycin C, 0.4 and 0.2 µg/mL (exp 1 and exp 2, respectively); cyclophosphamide, 5 µg/mL in both experiments
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration: 4 and 24 h
- Fixation time (start of exposure up to fixation or harvest of cells): 24 h
SPINDLE INHIBITOR (cytogenetic assays): colchicine 0.1 µg/mL
STAIN (for cytogenetic assays):
NUMBER OF REPLICATIONS: 2
NUMBER OF CELLS EVALUATED: 100
DETERMINATION OF CYTOTOXICITY
- Method: mitotic index
OTHER EXAMINATIONS:
- Determination of polyploidy: yes - Evaluation criteria:
- A test substance was considered positive in the chromosome aberration test if: a) It induced a dose-related marked increase in the % of cells with chromosome aberrations b) It induced a marked increase in the % of cells with chromosome aberrations in absence of a clear-dose response relationship. For the modest increases in aberration frequency a dose response relationship was generally required together with appropriate statistical tests.
- Statistics:
- Fisher´s Exact test
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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: There was no significant change in pH when the test item was dosed into media.
- Effects of osmolality: The osmolality did not increase by more than 50 mOsm.
Precipitation: Experiment 1: A greasy/oily precipitate of the test item was observed at the end of exposure, at and above 160 µg/mL, in the 4(20)-hour exposure group in the absence of S9, and at and above 80 µg/mL, in the 4(20)-hour exposure group in the presence of S9.
Experiment 2: A greasy/oily precipitate of the test item was observed at the end of exposure, at and above 80 µg/mL, in the 4(20)-hour exposure group in the presence of S9. In the 24 hour exposure group in the absence of S9 a cloudy precipitate was observed at the end of exposure at and above 80 µg/mL oily precipitate was not noted at and above 160 µg/mL.
RANGE-FINDING/SCREENING STUDIES:
The selection of the maximum dose level for Experiment 1 and Experiment 2 was based on the toxicity seen around the onset of precipitating dose levels and was 1280 µg/mL for the 4(20)-hour exposure groups and for the continuous exposure group. It was considered that above this dose level the exposure of the cells to the test item was reduced due to the item forming a greasy/oily precipitate and this was indicated by absence of S9 and continuous exposure group.
COMPARISON WITH HISTORICAL CONTROL DATA:
Many experiments with human lymphocytes have established a range if aberration frequencies acceptable for control cultures. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1. Test results of experiment I.
Test item |
Concentration |
Mitotic Index |
Aberrant cells in % |
|
|
in µg/mL |
in % |
with gaps |
without gaps |
Treatment period 4 h, without S9 mix |
||||
Acetone |
0 |
100 |
0.0 |
0.0 |
MMC |
0.4 |
39 |
5.0 |
51.0 |
Test substance |
80 |
106 |
0.0 |
0.5 |
320 |
91 |
0.0 |
0.5 |
|
640 |
122 |
0.0 |
0.5 |
|
1280 |
123 |
0.0 |
0.0 |
|
Treatment period 4 h, with S9 mix |
||||
Acetone |
0 |
100 |
0.5 |
1.0 |
CP |
5 |
32 |
12.7 |
20.7 |
Test substance |
40 |
102 |
2.0 |
1.0 |
320 |
83 |
0.0 |
0.5 |
|
640 |
66 |
0.0 |
0.5 |
|
|
1280 |
98 |
0.5 |
0.0 |
MMC: Mitomycin C; CP: Cyclophosphamide (positive controls)
Table 2. Test results of experiment II.
Test item |
Concentration |
Mitotic Index |
Aberrant cells in % |
|
|
in µg/mL |
in % |
with gaps |
without gaps |
Treatment period 24 h, without S9 mix |
||||
Acetone |
0 |
100 |
0 |
0.5 |
MMC |
0.2 |
24 |
7.0 |
31.0 |
Test substance |
40 |
106 |
1.0 |
0.0 |
160 |
83 |
1.5 |
0.0 |
|
640 |
76 |
0.5 |
0.0 |
|
1280 |
78 |
1.0 |
0.0 |
|
Treatment period 4 h, with S9 mix |
||||
Acetone |
0 |
100 |
0.0 |
1.0 |
CP |
5 |
24 |
2.7 |
20.7 |
Test substance |
40 |
110 |
0.5 |
1.0 |
320 |
64 |
0.0 |
0.5 |
|
640 |
62 |
0.0 |
0.5 |
|
|
1280 |
67 |
0.0 |
0.0 |
MMC: Mitomycin C; CP: Cyclophosphamide (positive controls)
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.