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EC number: 295-734-3 | CAS number: 92128-40-0
- 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:
- end on January 22, 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was performed according to OECD guideline and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
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:
- Oils, fish, oxidized
- EC Number:
- 269-122-1
- EC Name:
- Oils, fish, oxidized
- Cas Number:
- 68187-75-7
- IUPAC Name:
- 68187-75-7
- Details on test material:
- - Name of test material (as cited in study report): Triglycerides, C12-24, saturated and unsaturated, oxidized
- Substance type: UVCB
- Physical state: liquid
- Stability under test conditions: data not available
- Storage condition of test material: at room temperature
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100, TA 102
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/beta-Naphthoflavone induced rat liver S9 is used as the metabolic activation system.
- Test concentrations with justification for top dose:
- - Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
- Experiment II: 33; 100; 333; 1000; 2500; and 5000 µg/plate - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: DMSO
- Justification for choice of solvent/vehicle: the solvent was chosen because of its solubility properties and its relative nontoxicity to the bacteria.
Controls
- Untreated negative controls:
- yes
- Remarks:
- untreated
- Negative solvent / vehicle controls:
- yes
- Remarks:
- DMSO
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: WITH S9-MIX: sodium azide (TA 1535, TA 100, 10 µg/pl), 4-nitro-o-phenylene-diamine (10 µg/pl in TA 98, 50 µg/pl in TA 1537), methyl methane sulfonate (TA 102, 3.0 µL/pl) - WITHOUT S9-MIX: 2-aminoanthracene (2.5 µg/pl (10.0 µg/pl in TA 102))
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: plate incorporation test (experiment I) and pre-incubation test (experiment II)
DURATION
- Preincubation period: 60 minutes in the pre-incubation test
- Exposure duration: at least 48 hours (at 37 °C in the dark)
NUMBER OF REPLICATES: three at each concentration
OTHER: the colonies were counted using the Petri Viewer Mk2 (Perceptive Instruments Ltd, Suffolk CB9 7BN, UK) with the software program Ames Study Manager. - 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 second experiment.
A dose dependent increase in the number of revertant colonies below the threshold isregarded 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 controls such an increase is not considered biologically relevant. - Statistics:
- According to the OECD guideline 471, a statistical analysis of the data is not mandatory.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA 1535, TA 1537, TA 98, TA 100, TA 102
- 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
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: the test item precipitated in the overlay agar in the test tubes from 1000 µg/plate up to 5000 µg/plate. Precipitation of the test item on the incubated agar plates was observed from 2500 µg/plate up to 5000 µg/plate. The undissolved particles of the test item had no influence on the data recording.
- Effects of pH, effects of osmolality, evaporation from medium,water solubility, other confounding effects: data not available
RANGE-FINDING/SCREENING STUDIES: in the pre-experiment the concentration range of the test item was 3 – 5000 µg/plate. The pre-experiment is reported as experiment I. Since no toxic effects were observed 5000 µg/plate were chosen as maximal concentration. - Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
Table 1 : Summary of Results Pre-Experiment and Experiment I
Metabolic acitivation |
Test Group |
Dose level (per plate) |
Revertant colony counts (Mean) |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
|||
Without activation |
DMSO |
|
16 |
12 |
26 |
108 |
349 |
Untreated |
|
11 |
10 |
31 |
110 |
370 |
|
Oxidized fish oil |
3 µg |
14 |
12 |
27 |
114 |
339 |
|
10 µg |
15 |
11 |
25 |
113 |
337 |
||
33 µg |
14 |
13 |
24 |
117 |
366 |
||
100 µg |
15 |
11 |
28 |
115 |
350 |
||
333 µg |
14 |
8 |
23 |
129 |
327 |
||
1000 µg |
12 |
6 |
31 |
125 |
336 |
||
2500 µg |
15 P |
7 P |
29 P |
137 P |
335 P |
||
5000 µg |
14 P |
9 P |
23 P |
167 P |
325 P |
||
NaN3 |
10 µg |
1566 |
|
|
1851 |
|
|
4-NOPD |
10 µg |
|
|
276 |
|
|
|
4-NOPD |
50 µg |
|
103 |
|
|
|
|
MMS |
3.0 µL |
|
|
|
|
1916 |
|
With activation |
DMSO |
|
17 |
12 |
33 |
133 |
446 |
Untreated |
|
14 |
13 |
40 |
148 |
567 |
|
Oxidized fish oil |
3 µg |
19 |
11 |
33 |
147 |
521 |
|
10 µg |
17 |
15 |
31 |
149 |
471 |
||
33 µg |
16 |
15 |
30 |
131 |
473 |
||
100 µg |
16 |
14 |
31 |
140 |
458 |
||
333 µg |
14 |
12 |
37 |
141 |
458 |
||
1000 µg |
14 |
11 |
31 |
142 |
440 |
||
2500 µg |
22 P |
8 P |
27 P |
144 P |
476 P |
||
5000 µg |
18 P |
8 P |
35 P |
143 P |
472 P |
||
2 –AA |
2.5 µg |
295 |
353 |
1702 |
2683 |
|
|
2 –AA |
10 µg |
|
|
|
|
1702 |
P = precipitates
Table 2 : Summary of Results Experiment II
Metabolic acitivation |
Test Group |
Dose level (per plate) |
Revertant colony counts (Mean) |
||||
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
|||
Without activation |
DMSO |
|
13 |
9 |
29 |
121 |
405 |
Untreated |
|
12 |
11 |
27 |
133 |
395 |
|
Oxidized fish oil |
33 µg |
12 |
11 |
28 |
131 |
382 |
|
100 µg |
12 |
8 |
27 |
115 |
428 |
||
333 µg |
13 |
8 |
25 |
118 |
430 |
||
1000 µg |
10 |
8 |
29 |
128 |
379 |
||
2500 µg |
17 P |
8 P |
27 P |
147 P |
413 P |
||
5000 µg |
14 P |
7 P |
32 P |
168 P |
371 P |
||
NaN3 |
10 µg |
1897 |
|
|
2022 |
|
|
4-NOPD |
10 µg |
|
|
318 |
|
|
|
4-NOPD |
50 µg |
|
109 |
|
|
|
|
MMS |
3.0 µL |
|
|
|
|
1661 |
|
With activation |
DMSO |
|
15 |
8 |
34 |
135 |
534 |
Untreated |
|
16 |
11 |
33 |
153 |
591 |
|
Oxidized fish oil |
33 µg |
21 |
11 |
36 |
142 |
502 |
|
100 µg |
16 |
12 |
36 |
152 |
537 |
||
333 µg |
18 |
7 |
32 |
148 |
553 |
||
1000 µg |
13 |
13 |
34 |
151 |
538 |
||
2500 µg |
17 |
7 |
42 |
161 |
547 |
||
5000 µg |
28 |
12 |
47 |
155 |
513 |
||
2 –AA |
2.5 µg |
345 |
221 |
1849 |
2167 |
|
|
2 –AA |
10 µg |
|
|
|
|
3200 |
P = precipitates
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
Triglycerides, C12-24, even, saturated and unsaturated, oxidized is non-mutagenic by Ames bacterial reverse mutation assay under the condition of the test employed. - Executive summary:
In a reverse gene mutation assay in bacteria (Sokolowski A, 2010), strains TA 1535, TA 1537, TA 98, TA 100, TA 102 of S. typhimurium were exposed to Triglycerides, C12-24, even, saturated and unsaturated, oxidized in DMSO at concentrations of 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate (Pre-Experiment/Experiment I, plate incorporation) and 33; 100; 333; 1000; 2500; and 5000 µg/plate (Experiment II, pre-incubation method) in the presence and absence of mammalian metabolic activation.
Triglycerides, C12-24, even, saturated and unsaturated, oxidized oil was tested up to limit concentration (5000 µg/plate).
The plates incubated with the test item showed normal background growth up to 5000 µg/plate with and without S9 mix in all strains used.
No toxic effects, evident as a reduction in the number of revertants (below the indication factor of 0.5), occurred in the test groups with and without metabolic activation.
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with Oxidized fish oil at any dose level, neither in the presence nor absence of metabolic activation (S9 mix). There was also no tendency of higher mutation rates with increasing concentrations in the range below the generally acknowledged border of biological relevance.
Appropriate reference mutagens were used as positive controls and showed a distinct increase
of induced revertant colonies.
This study is classified as acceptable. This study satisfies the requirement for Test Guideline OECD 471 for in vitro mutagenicity (bacterial reverse gene mutation) data.
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