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EC number: 946-756-3 | 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 gene mutation study in bacteria
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-10-13 to 2004-01-08
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997-07-21
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2000-05-19
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of (9Z,11E)-octadeca-9,11-dienoic acid and (10E,12Z)-octadeca-10,12-dienoic acid and octadec-9-enoic acid
- Molecular formula:
- C18H32O2, C18H32O2, C18H34O2
- IUPAC Name:
- Reaction mass of (9Z,11E)-octadeca-9,11-dienoic acid and (10E,12Z)-octadeca-10,12-dienoic acid and octadec-9-enoic acid
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No. of test material: GR31143161
- Expiration date of the batch: 24.04.2014
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature
OTHER SPECIFICS: colourless-yellowish liquid
Method
- Target gene:
- his
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:
- Phenobarbital and ß-Naphthoflavone induced male rat liver.
- Test concentrations with justification for top dose:
- Experiment I and II ( except for strains TA 1537 and TA 102 without 89 mix): 33, 1 00, 333, 1000, 2500, and 5000 µg/plate
Experiment II (strains TA 1537 and TA 102 without 89 mix): 0.3, 1, 3, 10, 33, 100, 250, and 500 µg/plate
ln the pre-experiment the concentration range of the test item was 3- 5000 µg/plate. The pre-experiment is reported as part of experiment I since no relevant toxic effects were observed and 5000 µg/plate were chosen as maximal concentration for experiment I. - Vehicle / solvent:
- - Solvent used: ethanol
- Justification for choice of solvent: The solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria.
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- without S9 mix, TA1535, TA100, 10 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 4-nitro-o-phenylene-diamine
- Remarks:
- without S9 mix, TA1537, 50 µg/plate; TA98, 10 µg/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Remarks:
- without S9 mix, TA102, 4 µL/plate
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- with S9 mix, TA1535, TA1537, TA98, TA100, 2.5 µg/plate; TA102, 10 µg/plate
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 60 min
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: 3
DETERMINATION OF CYTOTOXICITY
- Method: Reduction in the number of spontaneaus revertants or a clearing of the bacterial background lawn. - Rationale for test conditions:
- To establish a dose response effect six dose Ievels with adequately spaced concentrations were tested. The maximum dose Ievel was 5000 µg/plate.
- Evaluation criteria:
- A test item is considered as a mutagen if a biologically relevant increase in the number of revertants exceeding the threshold of twice (strains TA 98, TA 100, and TA 102) or thrice ( strains TA 1535 and TA 1537) the colony count of the corresponding solvent control is observed.
A dose dependent increase is considered biologically relevant if the threshold is exceeded at more than one concentration.
An increase exceeding the threshold at only one concentration is judged as biologically relevant if reproduced in an independent secend experiment.
A dose dependent increase in the number of revertant colonies below the threshold is regarded as an indication of a mutagenic potential if reproduced in an independent second experiment. However, whenever the colony counts remain within the historical range of negative and solvent contros such an increase is not considered biologically relevant. - Statistics:
- A statistical analysis of the data is not required.
Results and discussion
Test resultsopen allclose all
- Key result
- 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:
- valid
- Positive controls validity:
- valid
- Key result
- 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:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1535
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
Any other information on results incl. tables
Table 1: Cytotoxic effects
Strain |
Experiment I |
Experiment II |
||
|
- S9 mix |
+ S9 mix |
- S9 mix |
+ S9 mix |
TA1535 |
- |
- |
5000 |
- |
TA1537 |
2500 |
5000 |
100 |
2500, 5000 |
TA98 |
- |
- |
- |
- |
TA100 |
- |
- |
- |
- |
TA102 |
- |
- |
33 - 500 |
- |
Table 2: Summary of results, without S9 mix
Concentration [µg/plate] |
Revertants/plate [Mean] |
|||||||||
TA1535 |
TA1537 |
TA98 |
TA100 |
TA102 |
||||||
I |
II |
I |
II |
I |
II |
I |
II |
I |
II |
|
Neg. Control |
11 |
19 |
6 |
5 |
25 |
28 |
185 |
17 |
200 |
234 |
Solvent Control |
16 |
22 |
6 |
5 |
25 |
29 |
188 |
183 |
177 |
169 |
Pos. Control # |
602 |
1075 |
54 |
73 |
165 |
199 |
557 |
502 |
1339 |
917 |
0.3 |
- |
- |
- |
7 |
- |
- |
- |
- |
- |
150 |
1 |
- |
- |
- |
4 |
- |
- |
- |
- |
- |
166 |
3 |
- |
- |
- |
6 |
- |
- |
- |
- |
- |
172 |
10 |
- |
- |
- |
6 |
- |
- |
- |
- |
- |
175 |
33 |
13 |
18 |
6 |
6 |
23 |
20 |
222 |
158 |
152 |
52 |
100 |
11 |
18 |
5 |
8 |
20 |
21 |
225 |
174 |
161 |
32 |
250 |
- |
- |
- |
8 |
- |
- |
- |
- |
- |
18 |
333 |
9 |
14 |
4 |
- |
21 |
17 |
148 |
152 |
159 |
- |
500 |
- |
- |
- |
4 |
- |
- |
- |
- |
- |
0 |
1000 |
7 |
14 |
3 |
- |
19 |
14 |
206 |
124 |
152 |
- |
2500 |
11 |
16 |
3 |
- |
19 |
20 |
232 |
154 |
155 |
- |
5000 |
9 |
9 |
5 |
- |
20 |
21 |
208 |
178 |
153 |
- |
- Not performed
# Sodium azide (10.0 µg/plate) strains TA 1535 and TA 100; 4-nitro-o-phenylene-diamine strains TA 1537 (50 µg/plate) and TA 98 (10.0 µg/plate), Methylmethanesulfonate (4 1 µL/plate) strain TA 102
Table 3: Summary of results, with S9 mix
Concentration [µg/plate] |
Revertants/plate [Mean] |
|||||||||
TA1535 |
TA1537 |
TA98 |
TA100 |
TA102 |
||||||
I |
II |
I |
II |
I |
II |
I |
II |
I |
II |
|
Neg. Control |
11 |
11 |
10 |
14 |
21 |
18 |
179 |
188 |
184 |
216 |
Solvent Control |
19 |
27 |
9 |
13 |
28 |
31 |
202 |
190 |
176 |
134 |
Pos. Control ## |
312 |
274 |
265 |
224 |
498 |
472 |
801 |
709 |
1355 |
1246 |
33 |
20 |
29 |
10 |
8 |
30 |
29 |
257 |
156 |
156 |
122 |
100 |
18 |
19 |
10 |
12 |
33 |
25 |
211 |
196 |
172 |
108 |
333 |
16 |
17 |
9 |
11 |
32 |
25 |
210 |
167 |
153 |
116 |
1000 |
12 |
14 |
6 |
6 |
29 |
19 |
198 |
114 |
152 |
98 |
2500 |
13 |
19 |
6 |
4 |
31 |
26 |
179 |
137 |
162 |
102 |
5000 |
13 |
18 |
4 |
3 |
30 |
27 |
174 |
142 |
109 |
156 |
## 2-aminoanthracene (2.5 µg/plate) strains TA 1535, TA 1537, TA 98, and TA 100; 2-aminoanthracene (10.0 µg/plate) strain TA 102
Applicant's summary and conclusion
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.