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EC number: 291-707-5 | CAS number: 90459-62-4
- 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
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 06 March 2018 - 13 April 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- adopted 21st July 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Octadecanoic acid, reaction products with diethylenetriamine, di-Me sulfate-quaternized
- EC Number:
- 291-707-5
- EC Name:
- Octadecanoic acid, reaction products with diethylenetriamine, di-Me sulfate-quaternized
- Cas Number:
- 90459-62-4
- Molecular formula:
- C24H55N3O6S
- IUPAC Name:
- bis(2-aminoethyl)amine octadecanoic acid dimethyl sulfate
- Test material form:
- solid
- Remarks:
- paste
Constituent 1
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:
- sodium phenobarbitone and β-naphthoflavone induced rat liver S9 fraction
- Test concentrations with justification for top dose:
- 0.005, 0.016, 0.05, 0.16 and 0.5 mg/plate based on the results of solubility, precipitation and initial cytotoxicity test
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: distilled water
Controls
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- 2-nitrofluorene
- sodium azide
- mitomycin C
- other: 2-Aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
DURATION
- Preincubation period: 30 min
- Exposure duration: 66 hours and 45 mins (plate incorporation), 65 hrs and 30 mins (preincubation assay)
NUMBER OF REPLICATIONS: 3
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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 100
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Species / strain:
- S. typhimurium TA 102
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Vehicle controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation: no precipitation
RANGE-FINDING/SCREENING STUDIES:
Based on the results of precipitation test, the concentrations of 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4 and 5 mg/plate were selected for the initial cytotoxicity test.
The test item resulted in cytotoxicity and it was observed by a thinning of the bacterial background lawn. The tester strain exposed with test item in the presence and absence of metabolic activation system resulted in cytotoxicity and those concentrations are graded as 0 (Absent lawn) for 0.8, 0.9, 1, 2, 3, 4 and 5 mg/plate, 1+ (extremely reduced lawn) for 0.7 mg/plate, 2+ (moderately reduced lawn) for 0.6 mg/plate and 3 + (Slightly reduced lawn) for 0.5 mg/plate when compared to vehicle control.
The test item was found to be cytotoxic up to the maximum concentration of 0.5 mg/plate tested when compared to the vehicle control.
On the basis of cytotoxicity results 0.5 mg/plate was considered as the highest test concentration for the main mutagenicity assay.
Any other information on results incl. tables
Solubility Test
The test item formed milky white suspension in distilled water at a concentration of 50 mg/mL.
Precipitation Test
The test item resulted in no precipitation at and up to 5 mg/plate.
Initial Cytotoxicity Test
Based on the results of precipitation test, the concentrations of 0.5, 0.6, 0.7, 0.8, 0.9, 1, 2, 3, 4 and 5 mg/plate were selected for the initial cytotoxicity test.
The test item resulted in cytotoxicity and it was observed by a thinning of the bacterial background lawn. The tester strain exposed with test item in the presence and absence of metabolic activation system resulted in cytotoxicity and those concentrations are graded as 0 (Absent lawn) for 0.8, 0.9, 1, 2, 3, 4 and 5 mg/plate, 1+ (extremely reduced lawn) for 0.7 mg/plate, 2+ (moderately reduced lawn) for 0.6 mg/plate and 3 + (Slightly reduced lawn) for 0.5 mg/plate when compared to vehicle control.
The test item was found to be cytotoxic up to the maximum concentration of 0.5 mg/plate tested when compared to the vehicle control.
On the basis of cytotoxicity results 0.5 mg/plate was considered as the highest test concentration for the main mutagenicity assay.
TABLE 1. SUMMARY OF INITIAL CYTOTOXICITY TEST-SALMONELLA TYPHIMURIUM TA100TESTER STRAIN
Test Item Concentration (mg/plate) |
No. of Revertants/plate |
|||||||||||
With S9 |
Without S9 |
|||||||||||
R1 |
R2 |
R3 |
Average |
±SD |
Bacterial Lawn Intensity |
R1 |
R2 |
R3 |
Average |
±SD |
Bacterial Lawn Intensity |
|
Vehicle Control |
94 |
90 |
98 |
94 |
4.0 |
4+ |
99 |
95 |
92 |
95 |
3.5 |
4+ |
0.5 |
53 |
58 |
61 |
57 |
4.0 |
3+ |
50 |
55 |
52 |
52 |
2.5 |
3+ |
0.6 |
32 |
39 |
30 |
34 |
4.7 |
2+ |
33 |
36 |
29 |
33 |
3.5 |
2+ |
0.7 |
15 |
18 |
16 |
16 |
1.5 |
1+ |
17 |
19 |
15 |
17 |
2.0 |
1+ |
0.8 |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
0 |
0.9 |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
0 |
1 |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
0 |
2 |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
0 |
3 |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
0 |
4 |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
0 |
5 |
0 |
0 |
0 |
0 |
0.0 |
0 |
0 |
0 |
0 |
0 |
0.0 |
0 |
Values of Revertants are in Mean±SD
Lawn intensity:
4+= Thick lawn: Distinguished by a healthy (Normal) background lawn comparable to vehicle control plates.
3+=Slightly thin lawn: Distinguished by a noticeable thinning (Slightly reduced) of the background lawn compared to vehicle control plates.
2+=Thin lawn: Distinguished by a marked thinning (Moderately reduced) of the background lawn compared to solvent/vehicle control plates.
1+=Very thin lawn: Distinguished by an extreme thinning(Extremely reduced)of the background lawn compared to solvent/vehicle control plates.
0=No lawn: Distinguished by a complete lack of any background lawn compared to solvent/vehicle control plates.
.
TABLE 2. SUMMARY OF COLONY COUNTS OF REVERTANTS OF TRIAL-I
Plate Incorporation Method
Treatment |
Test Concentration (mg/plate) |
No. of Revertants (Mean of 3 Plates) |
|||||||||||
With S9 |
|
Without S9 |
|||||||||||
Salmonella typhimurium |
Salmonella typhimurium |
||||||||||||
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
||||
Vehicle Control |
100 µL of Distilled water |
Mean |
29.0 |
110.0 |
264.3 |
23.7 |
10.0 |
27.3 |
114.3 |
264.0 |
22.3 |
10.0 |
|
±SD |
3.6 |
5.6 |
12.9 |
2.5 |
3.6 |
3.2 |
22.0 |
7.9 |
3.1 |
2.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
Leomin KP |
0.005 |
Mean |
29.0 |
101.7 |
265.0 |
23.3 |
11.0 |
27.0 |
113.3 |
262.3 |
22.0 |
8.7 |
|
±SD |
4.0 |
4.7 |
11.4 |
2.5 |
1.0 |
3.0 |
21.1 |
5.5 |
2.0 |
3.8 |
|||
Fold Increase |
1.0 |
0.9 |
1.0 |
1.0 |
1.1 |
1.0 |
1.0 |
1.0 |
1.0 |
0.9 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.016 |
Mean |
28.0 |
111.0 |
256.3 |
22.0 |
9.0 |
25.7 |
105.7 |
253.7 |
22.0 |
9.3 |
||
±SD |
2.0 |
10.6 |
8.1 |
3.0 |
2.6 |
3.5 |
8.1 |
6.4 |
3.6 |
0.6 |
|||
Fold Increase |
1.0 |
1.0 |
1.0 |
0.9 |
0.9 |
0.9 |
0.9 |
1.0 |
1.0 |
0.9 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.05 |
Mean |
28.0 |
108.0 |
264.0 |
21.7 |
9.3 |
26.7 |
101.0 |
264.0 |
21.3 |
8.3 |
||
±SD |
4.0 |
6.0 |
11.5 |
3.2 |
2.1 |
2.5 |
10.6 |
5.0 |
2.5 |
3.2 |
|||
Fold Increase |
1.0 |
1.0 |
1.0 |
0.9 |
0.9 |
1.0 |
0.9 |
1.0 |
1.0 |
0.8 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.16 |
Mean |
26.7 |
98.7 |
256.3 |
21.3 |
8.0 |
26.3 |
95.0 |
254.7 |
20.0 |
7.7 |
||
±SD |
4.9 |
8.0 |
11.2 |
2.5 |
1.0 |
3.2 |
7.2 |
4.7 |
3.0 |
1.5 |
|||
Fold Increase |
0.9 |
0.9 |
1.0 |
0.9 |
0.8 |
1.0 |
0.8 |
1.0 |
0.9 |
0.8 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
|||
0.5 |
Mean |
17.0 |
57.7 |
208.7 |
16.7 |
5.3 |
15.7 |
57.3 |
207.7 |
13.7 |
4.0 |
||
±SD |
2.6 |
4.0 |
7.5 |
0.6 |
3.2 |
1.5 |
5.0 |
6.7 |
1.5 |
1.0 |
|||
Fold Increase |
0.6 |
0.5 |
0.8 |
0.7 |
0.5 |
0.6 |
0.5 |
0.8 |
0.6 |
0.4 |
|||
Lawn Intensity |
3+ |
3+ |
3+ |
3+ |
3+ |
3+ |
3+ |
3+ |
3+ |
3+ |
|||
Positive Control |
100 µL of respective Positive Control |
Mean |
348.7 |
405.7 |
606.0 |
125.7 |
105.0 |
343.3 |
401.0 |
609.0 |
119.0 |
100.3 |
|
±SD |
15.7 |
15.3 |
7.0 |
8.5 |
4.6 |
18.4 |
10.5 |
8.2 |
14.9 |
4.2 |
|||
Fold Increase |
12.0 |
3.7 |
2.3 |
5.3 |
10.5 |
12.6 |
3.5 |
2.3 |
5.3 |
10.0 |
|||
Lawn Intensity |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
4+ |
Values of Revertants are in Mean±SD
Positive controls:
For with S9:
For Salmonella typhimurium TA98, TA100, TA102, TA1535 and TA1537 = 4 µg/plate of 2-Aminoanthracene
For without S9:
For TA98: 2 µg/plate of 2-Nitrofluorene
For TA100 and TA1535: 1 µg/plate of Sodium azide.
For TA102: 0.5 µg/plate of Mitomycin C
For TA1537: 50 µg/plate of 9-Aminoacridine
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the study, it is concluded that the test item is non-mutagenic in the Bacterial Reverse Mutation Test up to the highest tested concentration of 0.5 mg/plate under the test conditions.
- Executive summary:
In a reverse gene mutation assay in bacteria according to OECD Guideline 471, strains TA 1535, TA 1537, TA 98, TA 100 and TA 102 ofS. typhimurium were exposed toOctadecanoic acid, reaction products with diethylenetriamine, di-Me sulfate-quaternizedat concentrations of 0.005, 0.016, 0.05, 0.16 and 0.5 mg/plate based on the results of solubility, precipitation and initial cytotoxicity test in the presence and absence of mammalian metabolic activation (sodium phenobarbitone and β-naphthoflavone induced rat liver S9 fraction). Distilled water was used as vehicle. The test was performed as plate incorporation and pre-incubation assay.
Octadecanoic acid, reaction products with diethylenetriamine, di-Me sulfate-quaternized was tested uo to cytotoxic concentrations. The positive controls induced the appropriate responses.
There was noevidenceof induced mutant colonies over background.
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