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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 939-562-5 | 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
Link to relevant study records
- 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:
- 2009-10-02 to 2009-12-14
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-documented guideline study according to GLP. Read-across from analogue substance (Alcohols, C18-22, distn. residues). For details please refer to the read-across report.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- in vitro mammalian chromosome aberration test
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Ham's F-10 containing HEPES buffer and supplemented with minocycline (basic medium, medium for treatment in the presence of S9 mix and for washing cultures before or after treatment), basic medium with 10% (v/v) foetal bovine serum (medium for cell growth and treatment in the absence of S9 mix)
- Periodically checked for Mycoplasma contamination: yes - Additional strain / cell type characteristics:
- other: Modal chromosome number: 21
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 mix prepared from S9 fraction obtained from male rats dosed with Arochlor 1254
- Test concentrations with justification for top dose:
- First test:
1. Experiment: 0.78, 1.56, 3.13, 6.25, 12.5, 25, 50, 100 and 200 µg/ml
2. Experiment: 25, 50, 100 and 200 µg/ml - Vehicle / solvent:
- - Vehicle/solvent used: DMSO
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: with S9 mix: cyclophosphamid (CP); without S9 mix: methyl methanesulphonate (MMS)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in medium
DURATION
- Exposure duration:
1. Experiment: -S9/+S9: 6 hours
2. Experiment: -S9: 22 hours; +S9: 6 hours
- Fixation time (start of exposure up to fixation or harvest of cells):
1. Experiment: -S9/+S9: 24 hours
2. Experiment: -S9: 24 and 48 hours; +S9: 24 hours
SPINDLE INHIBITOR (cytogenetic assays): Colcemid (0.1 µg/ml)
STAIN (for cytogenetic assays): 5% Giemsa
NUMBER OF REPLICATIONS: two cultures per dose level, controls and vehicle control
NUMBER OF CELLS EVALUATED: 200 metaphases per dose level (100 per replicate)
DETERMINATION OF CYTOTOXICITY
- Method: Slides were examined for evidence of metaphase cells and signs of cellular necrosis. From the cell counts, the number if cells recovered per culture, was calculated. This was then compared with the number of cells (mean of 2 cultures) recovered from the vehicle control cultures.
OTHER EXAMINATIONS:
- Determination of polyploidy: Yes
- Other: During the first test, the osmotic pressure of selected concentrations of the test substance was measured; observations of precipitation were made at the end of the treatment period. - Evaluation criteria:
- The results for test item and positive control treated cultures are evaluated by comparison with the concurrent vehicle control cultures and with historical negative control data. A negative response was recorded if responses from the test item treated cultures are within the 95% confidence limits for the historical negative control data.
The response at a single dose was classified as significant if the percent of aberrant cells is consistently greater than the 99% confidence limits for the historical negative control data or greater than double the frequency of an elevated vehicle or untreated control culture if appropriate.
A test was positive if the response in at least one acceptable dose level was significant by the criterion described above.
A test item was positive if Test 1 was positive, as described above or if one of the tests was positive and the other test gave indications of activity. These indications may be suspicious levels of aberrant cells (between 95% and 99% confidence limits).
Experiments that met in part the criteria for a positive response, or marginally met all the criteria, were classed as inconclusive. - Statistics:
- No statistical analysis was performed.
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- 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: the colour of the medium was not changed by the test substance indicating no change of the pH
- Effects of osmolality: no effect on osmotic pressure at selected concentrations tested
- Precipitation: precipitation was noted at dose levels of 100 and 200 µg/ml in both the presence and absence of S9 mix in experiment 1 and in cultures treated with 200 µg/ml in both the presence and absence of S9 in experiment 2
RANGE-FINDING/SCREENING STUDIES: No toxicity was noted in any of the cultures treated with test substance up to 200 µg/mL
COMPARISON WITH HISTORICAL CONTROL DATA: The vehicle control cultures had levels of structural and numerical aberration within the 95% confidence limits of the historical negative control data. - Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
It was concluded that Alcohols, C18-22 Distn. Residues were not clastogenic when tested with Chinese hamster ovary cells in vitro, when tested up to a concentration of 200 µg/mL.
This result is used in a read-across approach in the REACH registration of Alcohols, C12 -18, distn. residues. - Executive summary:
All cultures treated with Alcohols, C18-22, distn. residues had levels of structural aberrations within the 95% confidence limits for a negative response. An extra assessment of polyploidy was carried out on the cultures treated in the absence of S9 mix and harvested at 48 h. All the cultures treated with Alcohols, C18-22, distn. residues had levels of polyploidy within the 95% confidence limits for a negative response.
This result is used in a read-across approach in the REACH registration of Alcohols, C12 -18, distn. residues.
Reference
Table 1a. Aberration Data: Experiment 1 | ||||||||||
Exposure duriation / Harvest Time | S9 mix | Concentration (µg/ml) | Aberration frequency | Aberrant Cell Frequency (%) | ||||||
(Lesions/ Cell) | Including Gaps | Excluding Gaps | ||||||||
6 h / 24 h | - | 0 (DMSO) | 0.00 | 0 | 0 | |||||
0 (DMSO) | 0.00 | 0 | 0 | |||||||
50 | 0.00 | 0 | 0 | |||||||
50 | 0.00 | 0 | 0 | |||||||
100 | 0.00 | 0 | 0 | |||||||
100 | 0.00 | 0 | 0 | |||||||
200 | 0.00 | 0 | 0 | |||||||
200 | 0.00 | 0 | 0 | |||||||
30 µg/ml MMS | 0.04 | 3 | 3 | |||||||
40 µg/ml MMS | 0.29 | 16 | 14 | |||||||
6 h / 24 h | + | 0 (DMSO) | 0.00 | 0 | 0 | |||||
0 (DMSO) | 0.00 | 0 | 0 | |||||||
50 | 0.00 | 0 | 0 | |||||||
50 | 0.02 | 2 | 1 | |||||||
100 | 0.00 | 0 | 0 | |||||||
100 | 0.00 | 0 | 0 | |||||||
200 | 0.00 | 0 | 0 | |||||||
200 | 0.01 | 1 | 0 | |||||||
40 µg/ml CP | 0.18 | 14 | 13 | |||||||
50 µg/ml CP | 0.13 | 11 | 8 | |||||||
Table 1b. Aberration Data: Experiment 2 | ||||||||||
Exposure duriation / Harvest Time | S9 mix | Concentration (µg/ml) | Aberration frequency | Aberrant Cell Frequency (%) | ||||||
(Lesions/ Cell) | Including Gaps | Excluding Gaps | ||||||||
22 h / 24 h | - | 0 (DMSO) | 0.00 | 0 | 0 | |||||
0 (DMSO) | 0.01 | 1 | 0 | |||||||
50 | 0.01 | 1 | 0 | |||||||
50 | 0.00 | 0 | 0 | |||||||
100 | 0.00 | 0 | 0 | |||||||
100 | 0.00 | 0 | 0 | |||||||
200 | 0.00 | 0 | 0 | |||||||
200 | 0.01 | 1 | 1 | |||||||
30 µg/ml MMS | 0.06 | 5 | 3 | |||||||
40 µg/ml MMS | 0.29 | 11 | 10 | |||||||
22 h / 48 h | - | 0 (DMSO) | 0.00 | 1 | 0 | |||||
0 (DMSO) | 0.00 | 0 | 0 | |||||||
50 | 0.00 | 0 | 0 | |||||||
50 | 0.00 | 0 | 0 | |||||||
100 | 0.00 | 0 | 0 | |||||||
100 | 0.00 | 0 | 0 | |||||||
200 | 0.00 | 0 | 0 | |||||||
200 | 0.00 | 0 | 0 | |||||||
30 µg/ml MMS | 0.06 | 3 | 2 | |||||||
40 µg/ml MMS | 0.25 | 13 | 12 | |||||||
6 h / 24 h | + | 0 (DMSO) | 0.01 | 1 | 0 | |||||
0 (DMSO) | 0.00 | 0 | 0 | |||||||
50 | 0.00 | 0 | 0 | |||||||
50 | 0.01 | 1 | 0 | |||||||
100 | 0.00 | 0 | 0 | |||||||
100 | 0.00 | 0 | 0 | |||||||
200 | 0.00 | 0 | 0 | |||||||
200 | 0.00 | 0 | 0 | |||||||
40 µg/ml CP | 0.02 | 1 | 1 | |||||||
50 µg/ml CP | 0.10 | 8 | 8 | |||||||
Table 2: Polyploid data | ||||||||||
Concentration (µg/ml) | No. Of Diploid cells | No. of Polyploid cells | Frequency of Polyploid cells | |||||||
Normal | Endoploid | |||||||||
0 (DMSO) | 300 | 0 | 0 | 0.00 | ||||||
0 (DMSO) | 300 | 1 | 0 | 0.33 | ||||||
50 | 300 | 0 | 0 | 0.00 | ||||||
50 | 300 | 1 | 0 | 0.33 | ||||||
100 | 300 | 0 | 0 | 0.00 | ||||||
100 | 300 | 1 | 0 | 0.33 | ||||||
200 | 300 | 2 | 0 | 0.66 | ||||||
200 | 300 | 0 | 0 | 0.00 | ||||||
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Additional information
In Vitro:
A suite of in vitro mutagenicity studies were conducted on alcohols, C18-22, distillation residues (CAS No. 1160164-88-4), including the Ames test, in vitro mouse lymphoma assay and the CHO chromosome aberration assay. All these in vitro studies were negative for mutagenicity.
A GLP compliant OECD 471 bacterial reverse mutation assay was conducted with alcohols, C18-22, distillation residues (CAS No. 1160164-88-4). Revertant colonies were assessed following treatment with 6 / 20 / 60 / 200 / 600 / 2000 µg/plate of the test item in the absence and presence of S9 metabolic activation. It was concluded that the test item was not mutagenic in strains of Salmonella typhimurium and Escherichia coli, when tested in the absence and presence of metabolic activation up to and beyond its limit of solubility in the test system.
The mammalian cell gene mutation potential of alcohols, C18-22, distillation residues (CAS No. 1160164-88-4) was assessed in mouse lymphoma L5178Y cells. The test item was tested in the presence and absence of metabolic activation at doses of 25, 50, 100 and 200 µg/ml (not cytotoxic but up to precipitating concentrations). Alcohols, C18-22 distillation residues are not mutagenic in mouse lymphoma L5178Y cells, in either the absence or the presence of S9 mix, when tested in dimethylsulphoxide up to and beyond its limit of solubility in the test system.
A GLP compliant OECD 473 Chromosomal Aberrations Assay with Chinese Hamster Ovary Cell Cultures in vitro was conducted with alcohols, C18-22, distillation residues (CAS No. 1160164-88-4). It was concluded that alcohols, C18-22 distillation residues were not clastogenic when tested with Chinese hamster ovary cells in vitro, when tested up to a concentration of 200 µg/mL.
On the basis of the consistently negative study results from the in vitro genotoxicity data available (above), alcohols, C18-22 distillation residues are non-genotoxic. This result is used in a read-across approach in the REACH registration of Alcohols, C12 -18, distn. residues.Justification for selection of genetic toxicity endpoint
GLP guideline study.
No substances specific data are available for Alcohols, C12-18, distn. residues. Therefore, available data for the analogue substance Alcohols. C18-22, distn. residues are used. Details on the read-across justification are summarized in the attached read-across report.
Justification for classification or non-classification
These findings do not warrant the classification of alcohols, C18-22, distillation residues as genotoxic under the new Regulation (EC) 1272/2008 on classification, labeling and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.
This finding is used in a read-across approach in the REACH registration of Alcohols, C12 -18, distn. residues.
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.