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EC number: 267-023-8 | CAS number: 67762-55-4
- 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 gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 30 April 1996 to 13 August 1996
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study conducted to GLP in accordance with generally accepted scientific principles, possibly with incomplete reporting or methodological deficiencies, which do not affect the quality of the relevant results.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 996
- Report date:
- 1996
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Alkenes, C15-18 α-, sulfurized
- EC Number:
- 267-023-8
- EC Name:
- Alkenes, C15-18 α-, sulfurized
- Cas Number:
- 67762-55-4
- Molecular formula:
- Not applicable, complex UVCB
- IUPAC Name:
- Alkenes, C15-18 α-, sulfurized
- Test material form:
- other: liquid (unspecified)
- Details on test material:
- - Appearance: dark liquid
- Storage conditions: room temperature in a clear glass container
Constituent 1
Method
- Target gene:
- Histidine requirement in the Salmonella typhimurium strains.
Tryptophan requirement in the Escherichia coli strain.
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and TA 102
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Stock cultures were prepared in Oxoid nutrient broth #2.
- Properly maintained: yes, stored frozen. All tester strains were checked for the presence of the appropriate genetic markers on approximately a monthly basis. - Additional strain / cell type characteristics:
- other: All strains contain an rfa mutation and all except TA102 contain a uvrB deletion mutation. In addition, strains TA98, TA100 and TA102 contain the plasmid pKM101.
- Species / strain / cell type:
- E. coli WP2 uvr A
- Details on mammalian cell type (if applicable):
- - Type and identity of media: Stock cultures were prepared in Oxoid nutrient broth #2.
- Properly maintained: yes, stored frozen. All tester strains were checked for the presence of the appropriate genetic markers on approximately a monthly basis. - Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Rat liver homogenate (6 % S9 in standard co-factors)
- Test concentrations with justification for top dose:
- Preliminary Toxicity Test:
0, 50, 167, 500, 1670 and 5000 µg/plate
Mutation Test:
Experiments 1 and 2: 0, 50, 167, 500, 1670, 5000 and 10 000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: isocetyl alcohol
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- isocetyl alcohol
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- N-ethyl-N-nitro-N-nitrosoguanidine
- mitomycin C
- other: 2-aminofluorene, 2-anthramine
- Details on test system and experimental conditions:
- - EXPERIMENT 1
METHOD OF APPLICATION: in agar (direct plate incorporation)
2 mL of molten top agar (supplemented with 0.5 mM histidine or tryptophan/0.5 mM biotin) was combined with 0.1 mL tester strain and 0.1 mL of the appropriate concentration of the test material or solvent in sterile glass tubes. Cultures treated in the presence of metabolic activation also contained 0.5 mL of the S9 mixture. The tubes were vortexed and the mixture was poured onto minimal glucose plates, evenly distributed and allowed to solidify. Within an hour all plates were inverted and incubated in the dark.
DURATION
- Exposure duration: 48 hours at 37 °C.
NUMBER OF REPLICATIONS: The tests were performed in triplicate.
- EXPERIMENT 2
METHOD OF APPLICATION: pre-incubation
In the absence of metabolic activation, 0.5 mL 0.2 M Na₂HPO₄ (pH 7.4), 0.1 mL tester strain and 0.1 mL of the appropriate concentration of the test material or solvent first were combined and incubated, with shaking, at approximately 30 °C for approximately 30 minutes.
In the presence of metabolic activation, 0.5 mL S9 mixture, 0.1 mL tester strain and 0.1 mL of the appropriate concentration of the test material or solvent first were combined and incubated, with shaking, at approximately 30 °C for approximately 30 minutes.
Following the 30-minute pre-incubation period, 2 mL of molten, supplemented top agar was added to each tube. The tubes were vortexed and the mixture was poured onto minimal glucose plates, evenly distributed and allowed to solidify. Within an hour all plates were inverted and incubated in the dark.
DURATION
- Exposure duration: 48 hours at 37 °C.
NUMBER OF REPLICATIONS: The tests were performed in triplicate.
DETERMINATION OF CYTOTOXICITY
- Method: Inhibited growth was characterised by the absence of a confluent bacterial lawn and/or the presence of pindot colonies. - Evaluation criteria:
- A positive result is defined as a statistically significant, dose-dependent increase in the number of histidine- or tryptophan-independent revertants with at least one dose level inducing a revertant frequency that is two-fold the solvent control value. Statistical analyses are performed using the program developed by Snee and Irr (1981), with significance established at the 95 % confidence limit. If the test material does not induce a statistically significant, dose-dependent increase in revertant frequency, but does induce a revertant frequency at one dose level that is two-fold the spontaneous control value, the result is considered equivocal. A negative result is defined as the absence of a statistically significant or dose-dependent increase in the number of histidine or tryptophan-independent revertants.
- Statistics:
- Statistical analyses are performed only when a 50 % increase in revertant frequency, relative to the concurrent negative controls, is observed. As this was not the case for the test material, no analysis took place.
Results and discussion
Test resultsopen allclose all
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium 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 applicable
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- E. coli WP2 uvr A
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES
Results indicated that the test material was not toxic to any strain at any dose evaluated under either treatment condition. In addition, the test material was found to be incompletely soluble (droplets were observed) at all doses.
BACTERIAL CONTAMINANT EVALUATION
To ensure sterility, standard contamination evaluations were performed with each assay. The solvent, S9 mix and highest dose of the test material were evaluated at the same volumes used in the assay. Both top agars also were plated alone on minimal glucose plates. All plating was done in triplicate. Plates were incubated for 48 hours at 37°C and then scored for bacterial growth.
MUTAGENICITY EXPERIMENTS
Six doses of the test material were evaluated in the event of insolubility at the highest dose levels. Normal growth was observed in all tester strains at all doses evaluated with and without S9, and the test material was found to be incompletely soluble at all doses (droplets were seen), under both treatment conditions.
Revertant frequencies for all doses in all tester strains with and without S9 under both treatment conditions approximated or were less than those observed in the concurrent negative control cultures.
All positive and negative control values were within acceptable ranges. - 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
+/- S9 Mix |
Concentration (µg/plate) |
Mean number of colonies/plate |
|||||
Base-pair Substitution Type |
Frameshift Type |
||||||
TA100 |
TA1535 |
TA102 |
WP2uvrA |
TA98 |
TA1537 |
||
- - - - - - - |
Solvent 50 167 500 1670 5000 10 000 |
96 67 96 113 108 100 104 |
7 7 7 9 6 6 10 |
292 294 292 275 277 269 290 |
5 7 3 5 4 5 7 |
26 30 30 27 27 25 23 |
10 9 12 11 9 11 12 |
+ + + + + + + |
Solvent 50 167 500 1670 5000 10 000 |
98 119 112 100 101 95 101 |
10 6 5 5 8 5 9 |
290 300 309 289 311 297 307 |
7 6 6 4 5 5 8 |
35 35 25 30 38 36 31 |
10 10 12 11 8 10 13 |
|
|
Positive Controls |
|||||
- |
Name |
SA |
SA |
MMC |
ENNG |
2NF |
9AA |
Concentration (µg/plate) |
10 |
10 |
2.5 |
2 |
5 |
150 |
|
Mean no. colonies/plate |
1014 |
1109 |
1599 |
158 |
422 |
947 |
|
+ |
Name |
2AM |
2AM |
2AF |
2AM |
2AM |
2AM |
Concentration (µg/plate) |
2.5 |
2.5 |
30 |
80 |
2.5 |
2.50 |
|
Mean no. colonies/plate |
1905 |
124 |
852 |
506 |
2345 |
489 |
SA = Sodium azide
2AM = 2-anthramine
9AA = 9-aminoacridine
2NF = 2-nitrofluorene
MMC = Mitomycin C
2AF = 2-aminofluorene
ENNG = N-ethyl-N’-nitro-N-nitrosoguanidine
Table 2: Experiment 2
+/- S9 Mix |
Concentration (µg/plate) |
Mean number of colonies/plate |
|||||
Base-pair Substitution Type |
Frameshift Type |
||||||
TA100 |
TA1535 |
TA102 |
WP2uvrA |
TA98 |
TA1537 |
||
- - - - - - - |
Solvent 50 167 500 1670 5000 10 000 |
91 83 99 86 94 8 92 |
10 12 10 9 7 9 8 |
270 291 252 268 288 272 263 |
7 6 4 6 6 6 5 |
29 26 30 28 28 30 29 |
9 9 8 7 10 11 9 |
+ + + + + + + |
Solvent 50 167 500 1670 5000 10 000 |
97 101 108 95 94 104 97 |
8 8 8 4 5 7 5 |
312 332 302 298 315 318 286 |
8 5 6 5 7 6 9 |
31 35 35 32 34 35 34 |
11 14 11 8 9 11 7 |
|
|
Positive Controls |
|||||
- |
Name |
SA |
SA |
MMC |
ENNG |
2NF |
9AA |
Concentration (µg/plate) |
10 |
10 |
2.5 |
2 |
5 |
150 |
|
Mean no. colonies/plate |
958 |
1023 |
1343 |
527 |
523 |
1746 |
|
+ |
Name |
2AM |
2AM |
2AF |
2AM |
2AM |
2AM |
Concentration (µg/plate) |
2.5 |
2.5 |
30 |
80 |
2.5 |
2.5 |
|
Mean no. colonies/plate |
1533 |
113 |
744 |
508 |
1821 |
496 |
SA = Sodium azide
2AM = 2-anthramine
9AA = 9-aminoacridine
2NF = 2-nitrofluorene
MMC = Mitomycin C
2AF = 2-aminofluorene
ENNG = N-ethyl-N’-nitro-N-nitrosoguanidine
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of this study, the test material was considered to be non-mutagenic. - Executive summary:
The potential of the test material to cause mutagenic effects in bacteria was assessed in accordance with the standardised guideline OECD 471 under GLP conditions.
Salmonella typhimurium strains TA1535, TA1537, TA98, TA100 and TA102 and Escherichia coli strain WP2uvrA were treated with the test material, using the plate incorporation and pre-incubation methods, at six dose levels, both with and without metabolic activation. The dose levels assessed were 50, 167, 500, 1670, 5000 and 10 000 µg/plate.
The test material caused no visible reduction in the growth of the bacterial background lawn at any dose level. No toxicologically significant increases in the frequency of revertant colonies were recorded for any of the bacterial strains, with any dose of the test material, either with or without metabolic activation or exposure method.
The vehicle and positive controls were within the normal range.
The test material was considered to be non-mutagenic under the conditions of this test.
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