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EC number: 938-513-5 | CAS number: 1187872-27-0
- 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:
- 2016-11-02 till 2016-11-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: guideline-conform study under GLP without deviations
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Fatty acids, C18 unsatd., reaction products with triethanolamine
- EC Number:
- 938-513-5
- Cas Number:
- 1187872-27-0
- IUPAC Name:
- Fatty acids, C18 unsatd., reaction products with triethanolamine
- Test material form:
- liquid: viscous
Constituent 1
Method
Species / strain
- Species / strain / cell type:
- other: TA 1535, TA 1537, TA 98, TA 100, and WP2 uvrA
- Additional strain / cell type characteristics:
- not applicable
- Metabolic activation:
- with and without
- Metabolic activation system:
- Phenobarbital/Beta-naphthoflavone induced rat liver S9
- Test concentrations with justification for top dose:
- Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II:
Strain TA 100: 1; 3; 10; 33; 100; 333; 1000; and 2500 µg/plate
The remaining strains: 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Based on the observed toxic effects and the precipitation of the test item at least seven concentrations were tested in experiment II. 5000 µg/plate were chosen as maximal concentration. - Vehicle / solvent:
- Solvent used: Ethanol
Justification for choice of solvent: best suitable solvent, because of its solubility properties
Controls
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine, 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (experiment I: plate incorporation assay; experiment II: pre-incubation assay
exposure duration: 72 hours
Number of Replications: 3 plates for each concentration incl. the controls
DETERMINATION OF CYTOTOXICITY: Evident as a reduction in the number of spontaneous revertants (below the induction factor of 0.5) or a clearing of the bacterial background lawn. - 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 WP2 uvrA) 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 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 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:
- other: TA 1535, TA 1537, TA 98, TA 100, and WP2 uvrA
- Metabolic activation:
- with and without
- Additional information on results:
- TEST SPECIFIC CONFOUNDING FACTORS
Effects of pH: none
Water solubility: not soluble
Precipitation: The test item precipitated in the overlay agar in the test tubes from 1000 up to 5000 µg/plate. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 2500 to 5000 µg/plate. The undissolved particles had no influence on the data recording.
Other confounding effects: none
COMPARISON WIT HISTORICAL CONTROL DATA: performed
ADDITIONAL INFORMATION ON CYTOTOXICITY:
Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at the following concentrations (µg/plate):
Experiment I: TA 100 without S9 mix: 100 - 5000 µg/plate
TA 100 with S9 mix: 2500 - 5000 µg/plate
Experiment II: TA 1537 without S9 mix: 1000 - 5000 µg/plate
TA 100 without S9 mix: 333 - 2500 µg/plate - Remarks on result:
- other: reverse mutation assay migrated from the field Test System
Any other information on results incl. tables
Summary of Experiment I
Date plated: 02.11.2016
Date counted: 09.11.2016
|
Test Group |
Dose Level (per plate) |
TA 1535 Revertant Colony Counts (Mean ±SD) |
TA 1537 Revertant Colony Counts (Mean ±SD) |
TA 98 Revertant Colony Counts (Mean ±SD) |
TA 100 Revertant Colony Counts (Mean ±SD) |
WP2 uvrA Revertant Colony Counts (Mean ±SD) |
|
|
|
|
|
|
|
|
Without |
Ethanol |
|
12 ± 0 |
10 ± 3 |
29 ± 6 |
135 ± 16 |
37 ± 7 |
Activation |
Untreated |
|
13 ± 6 |
11 ± 1 |
23 ± 3 |
147 ± 14 |
44 ± 11 |
|
Emulsogen |
3 µg |
13 ± 6 |
11 ± 4 |
28 ± 5 |
139 ± 15 |
33 ± 7 |
|
TO |
10 µg |
9 ± 2 |
10 ± 1 |
28 ± 5 |
144 ± 7 |
39 ± 11 |
|
|
33 µg |
11 ± 5 |
11 ± 1 |
36 ± 8 |
121 ± 17 |
38 ± 10 |
|
|
100 µg |
11 ± 3 |
9 ± 3 |
38 ± 2 |
59 ± 2 |
44 ± 7 |
|
|
333 µg |
9 ± 3 |
13 ± 3 |
31 ± 5 |
23 ± 2R |
37 ± 10 |
|
|
1000 µg |
9 ± 2 |
13 ± 3R |
38 ± 11R |
19 ± 2R M |
40 ± 4 |
|
|
2500 µg |
9 ± 2P M |
10 ± 1P M R |
20 ± 2P M R |
12 ± 2P M R |
26 ± 5P M |
|
|
5000 µg |
8 ± 2P M |
12 ± 4P M R |
21 ± 1P M R |
10 ± 2P M R |
27 ± 2P M |
|
NaN3 |
10 µg |
1549 ± 108 |
|
|
2669 ± 39 |
|
|
4-NOPD |
10 µg |
|
|
552 ± 45 |
|
|
|
4-NOPD |
50 µg |
|
96 ± 7 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
975 ± 104 |
|
|
|
|
|
|
|
|
With |
Ethanol |
|
19 ± 2 |
13 ± 3 |
45 ± 9 |
112 ± 8 |
42 ± 4 |
Activation |
Untreated |
|
13 ± 6 |
15 ± 3 |
40 ± 2 |
98 ± 19 |
40 ± 3 |
|
Emulsogen |
3 µg |
17 ± 5 |
13 ± 6 |
53 ± 13 |
80 ± 20 |
39 ± 7 |
|
TO |
10 µg |
13 ± 2 |
17 ± 6 |
52 ± 14 |
71 ± 24 |
46 ± 4 |
|
|
33 µg |
17 ± 3 |
13 ± 2 |
41 ± 9 |
75 ± 21 |
57 ± 5 |
|
|
100 µg |
15 ± 5 |
16 ± 3 |
40 ± 2 |
69 ± 16 |
49 ± 7 |
|
|
333 µg |
16 ± 5 |
16 ± 4 |
44 ± 4 |
105 ± 9 |
41 ± 8 |
|
|
1000 µg |
14 ± 4 |
15 ± 5 |
46 ± 3 |
103 ± 9 |
40 ± 5 |
|
|
2500 µg |
16 ± 2P |
17 ± 2P |
47 ± 10P |
43 ± 13P |
45 ± 9P |
|
|
5000 µg |
11 ± 4P M |
9 ± 2P M |
47 ± 13P |
39 ± 2P |
26 ± 5P M |
|
2-AA |
2.5 µg |
425 ± 26 |
120 ± 10 |
4485 ± 452 |
2912 ± 106 |
|
|
2-AA |
10.0 µg |
|
|
|
|
302 ± 93 |
|
|
|
|
|
|
|
|
Summary of Experiment II
Date plated: 18.11.2016
Date counted: 21.11.2016
|
Test Group |
Dose Level (per plate) |
TA 1535 Revertant Colony Counts (Mean ±SD) |
TA 1537 Revertant Colony Counts (Mean ±SD) |
TA 98 Revertant Colony Counts (Mean ±SD) |
TA 100 Revertant Colony Counts (Mean ±SD) |
WP2 uvrA Revertant Colony Counts (Mean ±SD) |
|
|
|
|
|
|
|
|
Without |
Ethanol |
|
13 ± 2 |
15 ± 4 |
29 ± 4 |
194 ± 1 |
40 ± 7 |
Activation |
Untreated |
|
12 ± 3 |
14 ± 2 |
26 ± 1 |
202 ± 7 |
36 ± 4 |
|
Emulsogen |
1 µg |
|
|
|
190 ± 20 |
|
|
TO |
3 µg |
|
|
|
206 ± 21 |
|
|
|
10 µg |
11 ± 4 |
15 ± 5 |
39 ± 6 |
191 ± 18 |
42 ± 7 |
|
|
33 µg |
12 ± 5 |
12 ± 3 |
34 ± 6 |
176 ± 16 |
45 ± 3 |
|
|
100 µg |
14 ± 3 |
10 ± 3 |
30 ± 2 |
149 ± 8 |
43 ± 5 |
|
|
333 µg |
16 ± 2 |
13 ± 2 |
34 ± 2 |
80 ± 3 |
48 ± 11 |
|
|
1000 µg |
11 ± 5 |
6 ± 2 |
24 ± 10 |
43 ± 12 |
46 ± 3 |
|
|
2500 µg |
11 ± 3P |
6 ± 1P M |
30 ± 7P |
46 ± 6P M |
50 ± 7P |
|
|
5000 µg |
11 ± 2P M |
4 ± 1P M |
20 ± 4P M |
|
34 ± 9P M |
|
NaN3 |
10 µg |
1591 ± 43 |
|
|
2508 ± 102 |
|
|
4-NOPD |
10 µg |
|
|
499 ± 18 |
|
|
|
4-NOPD |
50 µg |
|
111 ± 9 |
|
|
|
|
MMS |
2.0 µL |
|
|
|
|
830 ± 36 |
|
|
|
|
|
|
|
|
With |
Ethanol |
|
17 ± 3 |
15 ± 2 |
44 ± 6 |
203 ± 12 |
61 ± 8 |
Activation |
Untreated |
|
10 ± 0 |
13 ± 3 |
39 ± 9 |
210 ± 7 |
49 ± 3 |
|
Emulsogen |
1 µg |
|
|
|
208 ± 13 |
|
|
TO |
3 µg |
|
|
|
209 ± 16 |
|
|
|
10 µg |
16 ± 5 |
12 ± 4 |
39 ± 7 |
196 ± 12 |
57 ± 5 |
|
|
33 µg |
18 ± 3 |
13 ± 3 |
37 ± 9 |
181 ± 15 |
51 ± 4 |
|
|
100 µg |
16 ± 3 |
12 ± 2 |
37 ± 1 |
203 ± 18 |
55 ± 6 |
|
|
333 µg |
16 ± 1 |
14 ± 2 |
49 ± 11 |
192 ± 9 |
51 ± 12 |
|
|
1000 µg |
21 ± 4 |
14 ± 2 |
44 ± 5 |
201 ± 24 |
53 ± 9 |
|
|
2500 µg |
17 ± 2P |
17 ± 3P |
34 ± 5P |
174 ± 9P |
57 ± 8P |
|
|
5000 µg |
15 ± 1P M |
8 ± 2P M |
23 ± 3P M |
|
43 ± 3P M |
|
2-AA |
2.5 µg |
447 ± 39 |
155 ± 30 |
5595 ± 259 |
5303 ± 330 |
|
|
2-AA |
10.0 µg |
|
|
|
|
392 ± 102 |
|
|
|
|
|
|
|
|
Key to Plate Postfix Codes:
P: Precipitate
M: Manuel Count
R: Reduced Background growth
Key to positive controls:
NaN3: sodium azide
4 -NOPD: 4 -nitro-o-phenylene-diamine
MMS: methyl methane sulfonate
2-AA: 2 -aminoanthracene
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it can be stated that during the described mutagenicity test and under the experimental conditions reported, the test item did not induce gene mutations by base pair changes or frameshifts in the genome of the strains used.
Therefore, the test item is considered to be non-mutagenic in this Salmonella typhimurium and Escherichia coli reverse mutation assay. - Executive summary:
The test item was assessed for its potential to induce gene mutations according to the plate incorporation test (experiment I) and the pre-incubation test (experiment II) usingSalmonellatyphimuriumstrains TA 1535, TA 1537, TA 98, TA 100, and theEscherichia colistrain WP2 uvrA.
The assay was performed in two independent experiments both with and without rat liver microsomal activation. Each concentration and the controls were tested in triplicate. The test item was tested at the following concentrations:
Pre-Experiment/Experiment I: 3; 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
Experiment II:
Strain TA 100: 1; 3; 10; 33; 100; 333; 1000; and 2500 µg/plate
The remaining strains: 10; 33; 100; 333; 1000; 2500; and 5000 µg/plate
The test item precipitated in the overlay agar in the test tubes from 1000 up to 5000 µg/plate. Precipitation of the test item in the overlay agar on the incubated agar plates was observed from 2500 to 5000 µg/plate. The undissolved particles had no influence on the data recording.
The plates incubated with the test item showed reduced background growth at the following concentrations (µg/plate):
Strain
Experiment I
Experiment II
without S9 mix
with S9 mix
without S9 mix
with S9 mix
TA 1535
/
/
/
/
TA 1537
1000 – 5000
/
/
/
TA 98
1000 – 5000
/
/
/
TA 100
333 – 5000
/
/
/
WP2 uvrA
/
/
/
/
/ = normal background growth
Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5), were observed at the following concentrations (µg/plate):
Strain
Experiment I
Experiment II
without S9 mix
with S9 mix
without S9 mix
with S9 mix
TA 1535
/
/
/
/
TA 1537
/
/
1000 – 5000
/
TA 98
/
/
/
/
TA 100
100 – 5000
2500 – 5000
333 – 2500
/
WP2 uvrA
/
/
/
/
/ = no Toxic effects, evident as a reduction in the number of revertants (below the induction factor of 0.5)
No substantial increase in revertant colony numbers of any of the five tester strains was observed following treatment with the test item at any concentration 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. They showed a distinct increase in induced revertant colonies.
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