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EC number: 267-008-6 | CAS number: 67762-27-0 This substance is identified by SDA Substance Name: C16-C18 alkyl alcohol and SDA Reporting Number: 19-060-00.
- 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 gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Alcohols, C16-18 is a member and is from Long Chain Alcohols (C6-22 primary aliphatic alcohols) category.
The Long Chain Alcohols (C6-22 primary aliphatic alcohols) category is considered suitable as a source of data for Alcohols, C16-18.
Considered valid for read-across for purposes of classification.
No further vertebrate testing can be justified.
Long Chain Alcohols (C6-22 primary aliphatic alcohols) category covers a family of 30 primary aliphatic alcohols within a carbon chain length range of C6-C22. Commercial products generally include several aliphatic alcohol components, with a range of carbon chain lengths present. The family consists of alcohols with varying compositions and structures. Composition depends on the route to manufacture and the related feedstocks. Most of the alcohols have linear carbon chains but certain manufacturing processes create branched structures. Data are also available for eleven other similar substances, which support the category. Non-sponsored alcohols may not be HPV or may not be produced by members of the consortium, but have structures similar to sponsored linear alcohols.
Key points are that the members share:
• The same structural features
• Similar metabolic pathways
• Common mode of ecotoxicological action
• Common levels and mode of human health related effects.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Data source
Referenceopen allclose all
- Reference Type:
- review article or handbook
- Title:
- Unnamed
- Year:
- 2 022
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Octadecan-1-ol
- EC Number:
- 204-017-6
- EC Name:
- Octadecan-1-ol
- Cas Number:
- 112-92-5
- Molecular formula:
- C18H38O
- IUPAC Name:
- octadecan-1-ol
- Test material form:
- solid: compact
- Details on test material:
- - Name of test material (as cited in study report): KALCOHL 8098 ; 1-octadecanol
- Substance type: white granular solid
- Physical state: solid
- Lot/batch No.: 3349
- Expiration date of the lot/batch: no data
- Storage condition of test material: room temperature in the dark
- Other: Date received: 22 January 1996
Constituent 1
Method
- Target gene:
- histidine
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 prepared from the livers of male Sprague-Dawley induced with Aroclor 1254
- Test concentrations with justification for top dose:
- 50, 150, 500, 1500 and 5000 µg/plate
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol
- Justification for choice of solvent/vehicle: not stated
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1103 3 and 5 µg/plate respectively
- Remarks:
- TA100 and TA1535 without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 25 0.2 µg/plate
- Remarks:
- TA98 without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 28 80 µg/plate
- Remarks:
- TA1537 without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1342 4-nitro-o-phenylenediamine, 5 µg/plate
- Remarks:
- TA102 without S9
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 1342 2-aminoanthracene, 0.5, 1 or 2 µg/plate
- Remarks:
- All strains with metabolic activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 hrs
NUMBER OF REPLICATIONS: Duplicate tests each performed in triplicate
DETERMINATION OF CYTOTOXICITY
- Method: other: Thinning of background lawn - Evaluation criteria:
- A dose related and statistically significant increase in reverse mutation rate in one or more bacterial strains at sub-toxic dose levels. For a negative result the numbers of induced revertants should be less than two fold compared to controls.
- Statistics:
- All data statistically analysed using the methods recommended by the UKEMS and normally Dunnett¿s method of linear regression used to evaluate the result.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Remarks:
- 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: no data
- Effects of osmolality: no data
- Evaporation from medium: no data
- Water solubility: no data
- Precipitation: seen at >=500 µg/plate but this did not interfere with scoring of the plate, plates were counted manually at 5000 µg/plate
- Other confounding effects: no data
RANGE-FINDING/SCREENING STUDIES: The test material was non-toxic to strain TA100. Precipitation occurred at >=500 µg/plate.
COMPARISON WITH HISTORICAL CONTROL DATA: no data
ADDITIONAL INFORMATION ON CYTOTOXICITY: There was no evidence of cytotoxicity up to 5000 µg/plate with or without S9. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1 Experiment 1 Plate incorporation Revertants per plate (mean of three plates)
Concentration µg/plate | TA 100 | TA 1535 | TA 102 | TA 98 | TA 1537 | |||||
- MA | + MA | - MA | + MA | - MA | + MA | - MA | + MA | - MA | + MA | |
0* | 122 | 124 | 29 | 35 | 20 | 26 | 23 | 34 | 7 | 12 |
50 | 115 | 121 | 28 | 35 | 16 | 27 | 24 | 31 | 7 | 12 |
150 | 126 | 114 | 33 | 36 | 24 | 28 | 25 | 35 | 8 | 10 |
500 | 130 | 116 | 30 | 36 | 17 | 27 | 21 | 39 | 8 | 11 |
1500 | 131 | 103 | 30 | 37 | 17 | 27 | 20 | 36 | 5 | 9 |
5000 | 123 | 107 | 32 | 32 | 14 | 21 | 17 | 34 | 5 | 9 |
Positive control | 419 | 672 | 137 | 171 | 544 | 235 | 148 | 236 | 277 | 209 |
* Solvent control with ethanol
Table 2 Experiment 2 Plate incorporation Revertants per plate (mean of three plates)
Concentration µg/plate | TA 100 | TA 1535 | TA 102 | TA 98 | TA 1537 | |||||
- MA | + MA | - MA | + MA | - MA | + MA | - MA | + MA | - MA | + MA | |
0* | 118 | 110 | 31 | 24 | 13 | 11 | 25 | 23 | 8 | 8 |
50 | 121 | 113 | 33 | 27 | 10 | 10 | 27 | 23 | 8 | 8 |
150 | 121 | 107 | 31 | 27 | 10 | 7 | 24 | 23 | 9 | 6 |
500 | 118 | 105 | 32 | 25 | 10 | 11 | 25 | 20 | 7 | 8 |
1500 | 103 | 101 | 30 | 29 | 8 | 14 | 24 | 25 | 7 | 6 |
5000 | 90 | 97 | 24 | 17 | 9 | 13 | 14 | 23 | 6 | 8 |
Positive control | 530 | 600 | 171 | 195 | 589 | 196 | 152 | 305 | 496 | 206 |
* Solvent control with ethanol
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results :
negative with metabolic activation
negative without metabolic activation
In a reliable study conducted according to OECD guideline 471, the C18 alcohol Kalcohl 8098 did not increase the reverse mutation rate in any of the histidine dependent bacterial strains of Salmonella typhimurium tested in the presence or absence of metabolic activation at concentrations up to 5000 µg/plate. The top concentration was not cytotoxic. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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