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EC number: 268-930-1 | CAS number: 68155-00-0 This substance is identified by SDA Substance Name: C14-C18 and C16-C18 unsaturated alkyl alcohol and SDA Reporting Number: 04-060-00.
- 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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Genetic toxicity in vitro
Description of key information
In vitro assessment of the mutagenic potential of the test substance, histidine-dependent auxotrophic mutants of Salmonella typhimurium, strains TA1535, TA1537, TA98 and TA100, and a tryptophan-dependent mutant of Escherichia coli, strain WP2 uvrA (pKM101), were exposed to the test substance diluted in dimethyl sulphoxide (DMSO). DMSO was also used as a vehicle control.
Link to relevant study records
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 10 March 2015 - 12 March 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to OECD and EC guidelines and in compliance with GLP
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- JAPAN: Guidelines for Screening Mutagenicity Testing Of Chemicals
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
- Target gene:
- Salmonella typhimurium: histidine
Escherichia coli: tryptophan - Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Species / strain / cell type:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Test concentrations with justification for top dose:
- Test 1: 5, 15, 50, 150, 1500, 5000 µg/plate
Test 2: 5, 15, 50, 150, 1500, 5000 µg/plate - Vehicle / solvent:
- - Vehicle used: DMSO
- Justification for choice: The solubility of UNJECOL 85AN was assessed at 50 mg/mL in water and in DMSO. It was found to be insoluble in water but
dissolved in DMSO. - Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- In the absence of S9 mix for strains TA100 and TA1535
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- In the absence of S9 mix for strain TA1537
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- In the absence of S9 mix for strain TA98
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Remarks:
- In the absence of S9 mix for strain WP2 uvrA (pKM101)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-Aminoanthracene
- Remarks:
- In the presence of S9 mix for strains TA100, TA1535 and WP2 uvrA (pKM101)
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- In the presence of S9 mix for strains TA98 and TA1537
- Details on test system and experimental conditions:
- Method of application: Bacterial culture and agar containing histidine, biotin and tryptophan, mixed and overlaid onto prepared Petri dishes containing agar.
Duration
Test 1: Incubated at approximately 37ºC for 72 hours
Test 2: 30 minute pre-incubation at 37ºC
Test 2 - repeat: As unclear results were seen in the second test with strain TA100 in the absence and presence of S9 mix and with strain TA1535 in the presence of S9 mix, the test was repeated using the same method as in the second test.
Number of replications: 3
Assay validity: After this period, the appearance of the background bacterial lawn was examined and revertant colonies counted using an automated colony counter. Some plates were scored manually because of the presence of precipitate.
Any toxic effects of the test substance may be detected by a substantial reduction in mean revertant colony counts, by a sparse or absent background bacterial lawn, or both. - Evaluation criteria:
- If exposure to a test substance produces a reproducible increase in mean revertant colony numbers of at least twice (three times in the case of strains TA1535 and TA1537) that of the concurrent vehicle controls, with some evidence of a positive concentration-response relationship, it is considered to exhibit mutagenic activity in this test system. If exposure to a test substance does not produce a reproducible increase in mean revertant colony numbers, it is considered to show no evidence of mutagenic activity in this test system. No statistical analysis is performed.
If the results obtained fail to satisfy the criteria for a clear “positive” or “negative” response, even after additional testing, the test data may be subjected to analysis to determine the statistical significance of any increases in revertant colony numbers. The statistical procedures used are those described by (Mahon et al 1989) and are usually Dunnett’s test followed, if appropriate, by trend analysis. Biological importance will be considered along with statistical significance. In general, treatment-associated increases in mean revertant colony numbers below two or three times those of the vehicle controls (as described above) are not considered biologically important. It should be noted that it is acceptable to conclude an equivocal response if no clear results can be obtained.
Occasionally, these criteria may not be appropriate to the test data and, in such cases, the Study Director would use his/her scientific judgement. - Statistics:
- None stated.
- Species / strain:
- S. typhimurium TA 1535, TA 1537, TA 98 and TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A pKM 101
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not valid
- Positive controls validity:
- valid
- Additional information on results:
- First test
No evidence of toxicity was obtained following exposure to UNJECOL 85AN. Precipitate was observed on all plates containing UNJECOL 85AN at 500, 1500 and 5000 μg/plate in the absence of S9 mix and at 1500 and 5000 μg/plate in the presence of S9 mix. A maximum exposure concentration of 5000 μg/plate was, therefore, selected for use in the second test. No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to UNJECOL 85AN at any concentration up to and including 5000 μg/plate in either the presence or absence of S9 mix.
Second test
Toxicity and inconsistent colony counts were observed in strain TA100 in the absence and presence of S9 mix and in strain TA1535 in the presence of S9 mix, therefore, an additional test was performed. No evidence of toxicity was obtained with any other strains following exposure to UNJECOL 85AN. Precipitate was observed on all plates containing UNJECOL 85AN at 500, 1500 and 5000 μg/plate in the absence of S9 mix and at 1500 and
5000 μg/plate in the presence of S9 mix.
No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to UNJECOL 85AN at any concentration up to and including 5000 μg/plate in either the presence or absence of S9 mix.
Second test - repeat
No evidence of toxicity was obtained following exposure to UNJECOL 85AN. Precipitate was observed on all plates containing UNJECOL 85AN at 500, 1500 and 5000 μg/plate in the absence of S9 mix and at 1500 and 5000 μg/plate in the presence of S9 mix.
No substantial increases in revertant colony numbers over control counts were obtained with any of the tester strains following exposure to UNJECOL 85AN at any concentration up to and including 5000 μg/plate in either the presence or absence of S9 mix. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
- Conclusions:
- Interpretation of results (migrated information):
negative
It was concluded that UNJECOL 85AN showed no evidence of mutagenic activity in this bacterial system under the test conditions employed.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (negative)
Genetic toxicity in vivo
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Bacterial reverse mutation (Ames) assay
In a study conducted according to OECD test guideline 471 (Japan Biological Chemistry Co. Ltd.), four mutant strains of Salmonella Typhimurium (TA1535, TA1537, TA98, and TA100) and one strain of Escherichia coli (WP2 uvrA) were treated with DMI at a series of concentrations (5 µg/plate 5000 µg/plate) with and without metabolic activation (S9 mix). No increase in the number of revertant colonies was seen relative to the concurrent vehicle controls in any of the strains tested at any concentration, either with or without metabolic activation and it was concluded that DMI showed no evidence of mutagenic activity in the bacterial system used, under the conditions employed
Ames: Negative with and without metabolic activation (S9 mix)
Justification for classification or non-classification
The test substance showed no evidence of mutagenic activity in this bacterial system under the test conditions employed with and without metabolic activation (S9 mix). Therefore the test substance is classified as No Category.
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