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EC number: 246-115-1 | CAS number: 24271-12-3
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
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- 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
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- Endpoint summary
- Stability
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- 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:
- 12 Oct - 11 Dec 2017
- 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 guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- Adopted in 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- adopted in 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.5100 - Bacterial Reverse Mutation Test (August 1998)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Bayrisches Landesamt für Gesundheit und Lebensmittelsicherheit, Schwabach, Germany
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Octadecyl docosanoate
- EC Number:
- 246-115-1
- EC Name:
- Octadecyl docosanoate
- Cas Number:
- 24271-12-3
- Molecular formula:
- C40H80O2
- IUPAC Name:
- octadecyl docosanoate
Constituent 1
Method
- Target gene:
- his operon
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:
- cofactor-supplemented post-mitochondrial fraction (S9 mix), prepared from the livers of male rats, treated with phenobarbital and β-naphthoflavone
- Test concentrations with justification for top dose:
- Prior to the main experiments, a range-finding study was performed using the TA 98 and TA 100 strains with following test concentrations: 3.16, 10.0, 31.6, 100, 316, 1000, 2500, 5000 μg/plate with and without metabolic activation.
Experiment 1: 10.0, 31.6, 100, 316, 1000, 2500, 5000 μg/plate with and without metabolic activation
Experiment 2: 1.58, 5.00, 15.8, 50, 158, 500, 1580, 5000 μg/plate with and without metabolic activation - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: tetrahydrofuran
- Justification for choice of solvent/vehicle: The solvent was compatible with the survival of the bacteria and the S9 activity. (A correction factor of 1.09 was applied to consider the purity of the test item)
Controls
- Untreated negative controls:
- yes
- Remarks:
- destilled water
- Negative solvent / vehicle controls:
- yes
- Remarks:
- tetrahydrofuran
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- methylmethanesulfonate
- other: 4-nitro-o-phenylene-diamine (NPD); 2-aminoanthracene (2AA)
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
DURATION
- Exposure duration: 48 h
NUMBER OF REPLICATIONS: triplicates each in two independent experiments
DETERMINATION OF CYTOTOXICITY
- Method: inspection of the bacterial background lawn (toxicity is determined by a clearing or diminution of the background lawn) - Evaluation criteria:
- Acceptance criteria
The study was considered valid if for each strain:
- the bacteria demonstrate their typical responses to ampicillin (TA 98, TA 100, TA 102)
- the negative/solvent control plates with and without S9 mix are within the historical control data ranges (Control limit ranges (Poisson-based) of mean values)
- corresponding background growth on negative control, solvent control and test plates is observed
- the positive controls show a distinct enhancement of revertant rates over the control plate
- at least five different concentrations of each tester strain are analysable.
Evaluation criteria
The Mutation Factor is calculated by dividing the mean value of the revertant counts by the mean values of the solvent control (the exact and not the rounded values are used for calculation).
A test item is considered as mutagenic if:
- a clear and dose-related increase in the number of revertants occurs and/or
- a biologically relevant positive response for at least one of the dose groups occurs in at least one tester strain with or without metabolic activation.
A biologically relevant increase is described as follows:
- if in tester strains TA 98, TA 100 and TA 102 the number of reversions is at least twice as high
- if in tester strains TA 1535 and TA 1537 the number of reversions is at least three times higher than the reversion rate of the solvent control.
According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
A test item producing neither a dose related increase in the number of revertants nor a reproducible biologically relevant positive response at any of the dose groups is considered to be non-mutagenic in this system. - Statistics:
- According to OECD guidelines, the biological relevance of the results is the criterion for the interpretation of results, a statistical evaluation of the results is not regarded as necessary.
Results and discussion
Test resultsopen allclose all
- Key result
- Species / strain:
- S. typhimurium TA 1537
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A reduced background lawn was observed in exp.1 starting at a concentration of 2500 µg/plate and in exp. 2 at 5000 µg/plate, with and without S9-Mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Key result
- Species / strain:
- S. typhimurium TA 98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- A reduced background lawn was observed in exp.1 starting at a concentration of 2500 µg/plate and in exp. 2 at 5000 µg/plate, with and without S9-Mix.
- 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:
- cytotoxicity
- Remarks:
- A reduced background lawn was observed in exp.1 starting at a concentration of 2500 µg/plate and in exp. 2 at 5000 µg/plate, with and without S9-Mix.
- 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
- Remarks:
- A reduced background lawn was observed in exp.1 starting at a concentration of 2500 µg/plate and in exp. 2 at 5000 µg/plate, with and without S9-Mix.
- 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
- Remarks:
- A reduced background lawn was observed in exp.1 starting at a concentration of 2500 µg/plate and in exp. 2 at 5000 µg/plate, with and without S9-Mix.
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- RANGE-FINDING/SCREENING STUDIES: Reduced background lawn was observed in both tested strains (TA 98 and TA 100) starting at a test substance concentration of 2500 µg/plate with and without metabolic activation. There was no relevant increase in the number of revertants in cells treated with the test substance. The positive controls induced a clear increase in the number of revertants (at least 4.2-fold).
HISTORICAL CONTROL DATA
please refer to Table 3 in "Any other information on results incl. tables"
Any other information on results incl. tables
Table 1:Summary of test results (Experiment 1; Plate Incorporation Method)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate |
||||
Frameshift type |
Base-pair substitution type |
|||||
TA1537 |
TA98 |
TA100 |
TA1535 |
TA102 |
||
- |
Negative control (distilled water) |
21 ± 3.8 |
26 ± 2.3 |
106 ± 6.4 |
23 ± 1.5 |
217 ± 24.8 |
Solvent control (tetrahydrofuran) |
19 ± 3.5 |
18 ± 2.9 |
77 ± 2.6 |
26 ± 1.0 |
191 ± 7.6 |
|
10.0 |
18 ± 1.5 |
27 ± 5.7 |
73 ± 6.1 |
23 ± 1.0 |
203 ± 25.2 |
|
31.6 |
16 ± 0.6 |
26 ± 6.5 |
65 ± 13.4 |
24 ± 2.1 |
207 ± 41.4 |
|
100 |
20 ± 2.1 |
25 ± 5.8 |
71 ± 9.1 |
27 ± 1.0 |
246 ± 25.2 |
|
316 |
17 ± 0.6 |
25 ± 5.5 |
95 ± 23.0 |
26 ± 5.3 |
225 ± 23.5 |
|
1000 |
19 ± 2.5 |
24 ± 1.0 |
74 ± 11.8 |
26 ± 1.0 |
227 ± 35.2 |
|
2500 |
1 ± 1.2 B, P |
9 ± 1.2 B, P |
26 ± 5.1 B, P |
10 ± 1.5 B, P |
218 ± 9.6 P |
|
5000 |
0 ± 0.0 B, P |
1 ± 1.0 B, P |
7 ± 4.6 B, P |
1 ± 0.6 B, P |
12 ± 1.5 B, P |
|
Positive controls (unit/plate) |
NPD |
NPD |
SA |
SA |
MMS |
|
Mean No. of colonies/plate (average of 3 plates) |
173 ± 16.6 |
297 ± 65.3 |
591 ± 41.8 |
380 ± 39.5 |
817 ± 17.6 |
|
+ |
Negative control (distilled water) |
15 ± 2.5 |
25 ± 3.5 |
84 ± 4.7 |
29 ± 63.1 |
209 ± 10.0 |
Solvent control (tetrahydrofuran) |
15 ± 0.6 |
21 ± 1.2 |
77 ± 10.4 |
31 ± 2.5 |
207 ± 6.0 |
|
10.0 |
13 ± 1.0 |
26 ± 3.2 |
76 ± 4.9 |
24 ± 4.0 |
238 ± 9.5 |
|
31.6 |
14 ± 2.5 |
23 ± 3.5 |
78 ± 7.8 |
29 ± 3.8 |
238 ± 9.2 |
|
100 |
16 ± 2.6 |
25 ± 2.3 |
80 ± 10.1 |
27 ± 4.5 |
259 ± 30.3 |
|
316 |
12 ± 1.0 |
23 ± 4.5 |
83 ± 10.0 |
27 ± 1.2 |
210 ± 38.7 |
|
1000 |
14 ± 1.5 |
27 ± 1.0 |
89 ± 9.0 |
28 ± 7.0 |
255 ± 15.8 |
|
2500 |
0 ± 0.0 B, P |
12 ± 1.0 B, P |
24 ± 2.6 B, P |
7 ± 0.6 B, P |
260 ± 11.0 P |
|
5000 |
0 ± 0.0 B, P |
2 ± 1.0 B, P |
11 ± 1.0 B, P |
0 ± 0.6 B, P |
15 ± 0.0 B, P |
|
Positive controls (µg/plate) |
2AA |
2AA |
2AA |
2AA |
2AA |
|
Mean No. of colonies/plate (average of 3 plates) |
106 ± 6.2 |
128 ± 38.7 |
320 ± 16.5 |
217 ± 35.2 |
715 ± 21.1 |
2AA = 2-aminoanthracene
B = reduced background lawn
MMS = methylmethanesulfonate
NPD = 4-nitro-1,2-phenylene-diamine
P = precipitation
SA = sodium azide
SD = standard deviation
Table 2: Summary of test results (Experiment 2; Plate Incorporation Method)
With or without S9-Mix |
Test substance concentration (μg/plate) |
Mean number of revertant colonies per plate |
||||
Frameshift type |
Base-pair substitution type |
|||||
TA1537 |
TA98 |
TA100 |
TA1535 |
TA102 |
||
- |
Negative control (distilled water) |
25 ± 5.9 |
32 ± 3.1 |
98 ± 18.0 |
20 ± 1.5 |
363 ± 9.7 |
Solvent control (tetrahydrofuran) |
32 ± 1.5 |
31 ± 8.5 |
114 ± 2.3 |
18 ± 2.3 |
244 ± 35.5 |
|
1.58 |
25 ± 1.0 |
24 ± 2.6 |
82 ± 19.3 |
21 ± 2.6 |
325 ± 62.2 |
|
5.0 |
24 ± 2.1 |
25 ± 5.9 |
68 ± 2.6 |
19 ± 2.1 |
329 ± 25.6 |
|
15.8 |
27 ± 1.0 |
36 ± 4.4 |
86 ± 18.0 |
23 ± 1.5 |
236 ± 21.5 |
|
50 |
28 ± 5.0 |
26 ± 4.7 |
88 ± 15.6 |
21 ± 2.1 |
257 ± 20.1 |
|
158 |
24 ± 8.4 |
29 ± 4.7 |
74 ± 9.0 |
20 ± 2.5 |
290 ± 89.1 |
|
500 |
23 ± 1.0 |
28 ± 3.2 |
79 ± 19.2 |
21 ± 2.0 |
321 ± 66.3 |
|
1580 |
20 ± 3.8 P |
23 ± 3.1 P |
77 ± 19.3 P |
19 ± 1.2 P |
308 ± 18.2 P |
|
5000 |
4 ± 1.0 B, P |
13 ± 3.1 B, P |
10 ± 2.0 B, P |
5 ± 0.6 B, P |
23 ± 4.4 B, P |
|
Positive controls (unit/plate) |
NPD |
NPD |
SA |
SA |
MMS |
|
Mean No. of colonies/plate (average of 3 plates) |
112 ± 7.0 |
320 ± 35.8 |
1376 ± 82.9 |
1167 ± 64.7 |
1404 ± 48.8 |
|
+ |
Negative control (distilled water) |
18 ± 0.6 |
30 ± 3.1 |
72 ± 3.5 |
14 ± 1.5 |
384 ± 17.4 |
Solvent control (tetrahydrofuran) |
20 ± 3.8 |
28 ± 4.6 |
95 ± 9.3 |
15 ± 1.0 |
364 ± 58.6 |
|
1.58 |
21 ± 1.7 |
29 ± 4.5 |
89 ± 32.7 |
14 ± 1.5 |
337 ± 10.6 |
|
5.0 |
19 ± 1.5 |
28 ± 7.4 |
94 ± 23.8 |
14 ± 1.2 |
393 ± 45.6 |
|
15.8 |
22 ± 1.5 |
24 ± 1.5 |
85 ± 12.5 |
15 ± 2.5 |
330 ± 16.5 |
|
50 |
23 ± 1.5 |
26 ± 6.2 |
79 ± 8.1 |
14 ± 1.5 |
394 ± 37.1 |
|
158 |
22 ± 2.6 |
21 ± 4.0 |
94 ± 27.0 |
15 ± 2.5 |
289 ± 27.9 |
|
500 |
26 ± 2.0 |
20 ± 0.0 |
65 ± 8.4 |
18 ± 1.5 |
355 ± 8.1 |
|
1580 |
17 ± 2.1 P |
22 ± 4.0 P |
71 ± 5.5 P |
6 ± 1.7 P |
358 ± 33.3 P |
|
5000 |
2 ± 1.0 B, P |
4 ± 1.0 B, P |
10 ± 2.0 B, P |
3 ± 2.1 B, P |
32 ± 6.1 B, P |
|
Positive controls (µg/plate) |
2AA |
2AA |
2AA |
2AA |
2AA |
|
Mean No. of colonies/plate (average of 3 plates) |
201 ± 15.4 |
1731 ± 186.7 |
2406 ± 15.0 |
229 ± 25.0 |
1014 ± 83.5 |
2AA = 2-aminoanthracene
B = reduced background lawn
MMS = methylmethanesulfonate
NPD = 4-nitro-1,2-phenylene-diamine
P = precipitation
SA = sodium azide
SD = standard deviation
Table 3: Historical control data (2014 -2016)
|
S9-Mix |
|
Revertants/plate |
||||
TA1537 |
TA98 |
TA100 |
TA1535 |
TA102 |
|||
Negative control |
- |
Mean ± SD |
8.2 ± 2.9 |
24.2 ± 6.7 |
90.7 ± 15.6 |
13.8 ± 6.7 |
270.4 ± 55.0 |
Min - Max |
3 - 35 |
11 - 58 |
49 - 155 |
4 - 41 |
141 - 472 |
||
LCL99 - UCL99 |
0.0 - 16.9 |
4.1 - 44.3 |
43.9 - 137.5 |
0.0 - 33.9 |
105.5 - 435.2 |
||
+ |
Mean ± SD |
8.3 ± 3.1 |
29 ± 6.8 |
96.4 ± 14.1 |
10.5 ± 4.5 |
339.7 ± 71.3 |
|
Min - Max |
3 - 36 |
15 - 59 |
62 - 160 |
3 - 38 |
157 - 586 |
||
LCL99 - UCL99 |
0.0 - 17.6 |
8.7 - 49.4 |
54.1 - 138.8 |
0.0 - 23.9 |
125.9 - 553.6 |
||
Positive control * |
- |
Mean ± SD |
94.5 ± 22.7 |
430.7 ± 155.5 |
612.1 ± 220.0 |
792.0 ± 299.5 |
1729.2 ± 518.8 |
Min - Max |
35 - 273 |
141 - 1830 |
132 - 1423 |
38 - 1854 |
272 - 3321 |
||
LCL99 - UCL99 |
26.5 - 162.5 |
0.0 - 897.2 |
0.0 - 1272.0 |
0.0 - 1690.5 |
172.9 - 3285.5 |
||
+ |
Mean ± SD |
234.1 ± 101.4 |
1880.5 ± 708.5 |
1727.7 ± 522.0 |
133.9 ± 134.9 |
801.2 ± 223.7 |
|
Min - Max |
26 - 682 |
70 - 3606 |
169 - 3132 |
22 - 1954 |
137 - 3588 |
||
LCL99 - UCL99 |
0.0 - 538.3 |
0.0 - 4006.1 |
161.8 - 3293.6 |
0.0 - 538.7 |
130.3 - 1472.2 |
* = - S9 Mix: 4-nitro-1,2-phenylene-diamine for TA 98 and TA 1537, sodium azide for TA 100 and TA 1537, methylmethanesulfonate for TA 102; + S9 Mix: 2-aminoanthracene for all 5 strains
LCL99 = Lower Control Limit (99% Poisson-based)
Max = maximum of revertants/plate
Min = minimum of revertants/plate
UCL99 = Upper Control Limit (99% Poisson-based)
SD = standard deviation
Applicant's summary and conclusion
- Conclusions:
- Based on the results of the conducted study the test substance did not exhibit mutagenic properties in bacterial cells with and without metabolic activation.
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