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EC number: 936-560-6 | CAS number: 212070-45-6
- 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:
- 2017-02-01 to 2017-02-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 30 May 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 21 July 1997
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- 9-Octadecenamide, N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl]-, (9Z)-
- Cas Number:
- 178436-06-1
- Molecular formula:
- C36H71NO4
- IUPAC Name:
- 9-Octadecenamide, N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl]-, (9Z)-
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Characteristics: (Off-) white powder
- Storage conditions: at room temperature (+10 °C to +25 °C)
Method
- Target gene:
- histidine operon
Species / strainopen allclose all
- Species / strain / cell type:
- S. typhimurium TA 98
- Additional strain / cell type characteristics:
- other: uvrB-, rfa-, pKM 101, resistance to Ampicillin
- Species / strain / cell type:
- S. typhimurium TA 100
- Additional strain / cell type characteristics:
- other: uvrB-, rfa-, pKM 101, resistance to Ampicillin
- Species / strain / cell type:
- S. typhimurium TA 102
- Additional strain / cell type characteristics:
- other: rfa-, pKM 101/pAQ1, resistance to Ampicillin
- Species / strain / cell type:
- S. typhimurium TA 1535
- Additional strain / cell type characteristics:
- other: uvrB-, rfa-, non-resistance to Ampicillin
- Species / strain / cell type:
- S. typhimurium TA 1537
- Additional strain / cell type characteristics:
- other: uvrB-, rfa-, non-resistance to Ampicillin
- Metabolic activation:
- with and without
- Metabolic activation system:
- S9 fraction, Aroclor 1254-induced, from male Sprague-Dawley rat liver (Trinova Biochem GmbH, Gießen, Germany
- Test concentrations with justification for top dose:
- 1, 3.16, 10, 31.6, 100 and 316 µg/plate. Two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) were carried out in test strain TA100. Ten concentrations ranging from 0.316 to 5000 µg/plate were tested. Concentrations of 1000 µg/plate and higher were not evaluable due to pronounced test item precipitation. Hence, 316 µg/plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test.
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: ethanol (Batch no. F2540; Honeywell Specialty Chemicals)
- Justification for choice of solvent/vehicle: The test item was not soluble in water or dimethylsulfoxide (DMSO).
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
- benzo(a)pyrene
- mitomycin C
- other: 2-amino-anthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation
- Cell density at seeding: 0.1 mL of approximately 1.00E+08 viable cells in the late exponential or early stationary phase
DURATION
- Preincubation period: 20 minutes at 37°C
- Exposure duration: 37°C for 48 -72 h
NUMBER OF REPLICATIONS:
- Plates: 3 per concentration and experiment
- Experiments: 2 independent experiments, each with and without metabolic activation
DETERMINATION OF CYTOTOXICITY
- Method: Cytotoxicity is evidenced by a reduction in the number of spontaneous revertants by at least 50%, a clearing or diminution of the background lawn or by the degree of survival of the treated cultures. Insolubility could have been assessed as precipitation in the final mixture under the actual test conditions and evident to the unaided eye. - Evaluation criteria:
- Acceptance Criteria:
The results of the negative and positive control cultures should be within the range of the historical data generated by the testing facility. The range of spontaneous reversion frequencies per plate is based on Kirkland (1990):
TA98: 20-60
TA100: 100-200
TA102: 240-320
TA1535: 10-35
TA1537: 3-20
The numbers may be slightly different on plates with S9 and may vary slightly from experiment to experiment. Cytotoxicity is defined as a reduction in the number of colonies by more than 50 % compared with the vehicle control and/or a scarce background lawn.
Historical background data of revertant colony numbers of the negative and positive controls without and with metabolic activation for the experiments of the years 2015 to 2017 (most recent background data, not audited by the QAU-department) are given in Table 1 in section “any other details on results incl. tables”. - Statistics:
- Interpretation of results:
A test item is considered to show a positive response if
- the number of revertants is significantly increased (p ≤ 0.05, U-test according to MANN and WHITNEY) compared to the solvent control to at least 2-fold of the solvent control for TA98, TA100, TA1535 and TA1537 and 1.5-fold of the solvent control for TA102 in both independent experiments.
or
- a concentration-related increase over the range tested in the number of the revertants per plate is observed. The Spearman's rank correlation coefficient may be applied.
- positive results have to be reproducible and the histidine independence of the revertants has to be confirmed by streaking random samples on histidine-free agar plates.
Biological relevance of the results should be considered first. A test item for which the results do not meet the above-mentioned criteria is considered as non-mutagenic in the AMES test.
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:
- cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not examined
- 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:
- not examined
- 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:
- not examined
- 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:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Effects of pH: not reported
- Effects of osmolarity: not reported
- Evaporation from medium: not reported
- Water solubility: the test item is insoluble in water
- Precipitation: see section “any other information on results incl. tables”.
RANGE-FINDING/SCREENING STUDIES: see section “any other information on results incl. tables”.
HISTORICAL CONTROL DATA see tables 1 and 2 in section “any other information on results incl. tables”.
Any other information on results incl. tables
Preliminary test
The test substance was examined in two preliminary cytotoxicity tests (plate incorporation test without and with metabolic activation) in test strain TA100. Ten concentrations ranging from 0.316 to 5000 µg/plate were tested. Test item precipitation was noted starting at the concentration of 316 µg/plate. Concentrations of 1000 µg/plate and higher were not evaluable due to pronounced test item precipitation (see tables 2 and 3). Hence, 316 µg/plate were chosen as top concentration for the main study in the plate incorporation test and in the preincubation test.
Main study
Six concentrations ranging from 1.0 to 316 µg of the test item per plate were employed in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation.
Cytotoxicity
Test item precipitation was noted in the plate incorporation test and in the preincubation test, each carried out without and with metabolic activation at the top concentration of 316 µg/plate in all test strains. Reduction of the number of revertants by more than 50% was noted in both experiments at the top concentration of 316 µg/plate in the following test strains:
Plate incorporation test:
- S9: TA1535 and TA1537;
+S9: TA1537;
Preincubation test:
- S9: TA98, TA102, TA1535 and TA1537;
+S9: TA1535 and TA1537.
Mutagenicity
No increase in revertant colony numbers as compared with control counts was observed up to a concentration of 316 µg/plate, that led to test item precipitation, in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation test and preincubation test).
The positive control items showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system. The results of the negative and positive control cultures are within the range of the historical data generated by the test facility (see table 1). A summary of the results is given in tables 4 to 7.
Table 1: history profile of negative and positive control values of the years 2015 to 2017 (n= 80 studies). Data obtained from plate incorporation and preincubation tests.
Negative reference item |
||||||||||
Strain |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
|||||
S9-mix |
-S9 |
+ S9 |
-S9 |
+ S9 |
-S9 |
+ S9 |
-S9 |
+ S9 |
-S9 |
+ S9 |
Mean |
30.3 |
32.1 |
145.1 |
145.2 |
277.3 |
279.0 |
19.7 |
19.9 |
6.7 |
6.7 |
SD |
5.6 |
5.9 |
18.4 |
19.2 |
16.5 |
17.2 |
4.4 |
4.6 |
1.7 |
1.8 |
Min |
20 |
20 |
107 |
101 |
245 |
203 |
10 |
10 |
2 |
3 |
Max |
49 |
49 |
195 |
198 |
323 |
324 |
34 |
36 |
10 |
10 |
Positive reference item |
||||||||||
Strain |
TA 98 |
TA 100 |
TA 102 |
TA 1535 |
TA 1537 |
|||||
S9-mix |
-S9 |
+ S9 |
-S9 |
+ S9 |
-S9 |
+ S9 |
-S9 |
+ S9 |
-S9 |
+ S9 |
|
2-nitro-fluorene |
Benzo[a]-pyrene |
Sodium azide |
2-amino-anthracene |
Mitomycin C |
Benzo[a]-pyrene |
Sodium azide |
2-amino-anthracene |
9-amino-acridine |
Benzo[a]-pyrene |
Mean |
151.2 |
150.4 |
952.9 |
948.8 |
1029.7 |
1024.3 |
135.6 |
135.4 |
76.7 |
77.6 |
SD |
27.9 |
28.8 |
99.7 |
103.7 |
102.3 |
97.1 |
28.8 |
28.4 |
26.5 |
26.4 |
Min |
91 |
96 |
677 |
703 |
756 |
781 |
51 |
49 |
28 |
31 |
Max |
293 |
291 |
1213 |
1195 |
1637 |
1366 |
266 |
270 |
185 |
184 |
Table 2: Preliminary cytotoxicity test without metabolic activation. Plate incorporation test with TA 100.
Test item (µg/plate) |
Background lawn |
Revertants plate 1 |
Revertants plate 2 |
0.316 |
normal |
121 |
127 |
1 |
normal |
144 |
142 |
3.16 |
normal |
116 |
149 |
10 |
normal |
144 |
134 |
31.6 |
normal |
142 |
149 |
100 |
normal |
146 |
146 |
316 |
test item precipitation |
110 |
100 |
1000 |
test item precipitation |
0 |
0 |
3160 |
test item precipitation |
0 |
0 |
5000 |
test item precipitation |
0 |
0 |
Solvent control 100 µL/plate |
normal |
147 |
149 |
Table 3: Preliminary cytotoxicity test with metabolic activation. Plate incorporation test with TA 100.
Test item (µg/plate) |
Background lawn |
Revertants plate 1 |
Revertants plate 2 |
0.316 |
normal |
130 |
120 |
1 |
normal |
163 |
127 |
3.16 |
normal |
120 |
153 |
10 |
normal |
131 |
131 |
31.6 |
normal |
158 |
161 |
100 |
normal |
144 |
143 |
316 |
test item precipitation |
114 |
97 |
1000 |
test item precipitation |
0 |
0 |
3160 |
test item precipitation |
0 |
0 |
5000 |
test item precipitation |
0 |
0 |
Solvent control 100 µL/plate |
normal |
153 |
157 |
Table 4: Plate incorporation test without metabolic activation
Test item (µg/plate) |
Number of reverted colonies (mean values, n=3) |
||||
|
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
1.0 |
22.7 |
112.3 |
281.7 |
24.3 |
6.3 |
3.16 |
24.0 |
119.3 |
292.0 |
15.0 |
6.0 |
10.0 |
28.3 |
118.0 |
287.7 |
18.7 |
6.0 |
31.6 |
26.0 |
120.3 |
284.0 |
17.3 |
5.3 |
100 |
25.7 |
128.0 |
251.0 |
16.3 |
6.7 |
316 |
22.7 test item precipitation |
109.0 test item precipitation |
260.7 test item precipitation |
11.0 test item precipitation |
2.0 test item precipitation |
Vehicle control 100 µL/plate |
32.7 |
128.0 |
271.3 |
26.7 |
6.7 |
Positive reference item |
2-nitro-fluorene |
Sodium azide |
Mitomycin C |
Sodium azide |
9-amino-acridine |
Concentration µg/plate |
10 |
10 |
10 |
10 |
100 |
|
193.7 |
993.0 |
1093.3 |
136.0 |
73.3 |
Table 5: Plate incorporation test with metabolic activation
Test item (µg/plate) |
Number of reverted colonies (mean values, n=3) |
||||
|
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
1.0 |
29.7 |
119.3 |
255.3 |
23.0 |
4.3 |
3.16 |
29.3 |
132.0 |
293.0 |
19.0 |
6.0 |
10.0 |
24.7 |
119.0 |
264.3 |
22.7 |
4.0 |
31.6 |
24.3 |
132.0 |
277.7 |
16.7 |
5.7 |
100 |
30.7 |
118.7 |
258.3 |
19.0 |
5.0 |
316 |
22.7 test item precipitation |
108.3 test item precipitation |
245.0 test item precipitation |
10.0 test item precipitation |
2.0 test item precipitation |
Vehicle control 100 µL/plate |
30.7 |
120.0 |
274.0 |
17.0 |
5.3 |
Positive reference item |
Benzo[a]pyrene |
2-amino-anthracene |
Benzo[a]pyrene |
2-amino-anthracene |
Benzo[a]pyrene |
Concentration µg/plate |
10 |
2 |
10 |
2 |
10 |
|
184.0 |
992.7 |
1088.3 |
137.7 |
77.3 |
Table 6: Preincubation test without metabolic activation
Test item (µg/plate) |
Number of reverted colonies (mean values, n=3) |
||||
1.0 |
31.7 |
117.3 |
281.7 |
16.7 |
8.0 |
3.16 |
29.3 |
113.0 |
276.0 |
17.0 |
8.3 |
10.0 |
28.7 |
118.7 |
258.7 |
18.0 |
6.3 |
31.6 |
28.3 |
129.0 |
267.0 |
16.0 |
6.7 |
100 |
29.7 |
120.3 |
288.7 |
20.7 |
5.7 |
316 |
12.0 test item precipitation |
79.7 test item precipitation |
126.7 test item precipitation |
9.0 test item precipitation |
2.3 test item precipitation |
Vehicle control 100 µL/plate |
30.7 |
125.0 |
286.7 |
18.3 |
6.0 |
Positive reference item |
2-nitro-fluorene |
Sodium azide |
Mitomycin C |
Sodium azide |
9-amino-acridine |
Concentration µg/plate |
10 |
10 |
10 |
10 |
100 |
|
165.7 |
998.3 |
1036.7 |
139.7 |
32.3 |
Table 7: Preincubation test with metabolic activation
Test item (µg/plate) |
Number of reverted colonies (mean values, n=3) |
||||
|
TA98 |
TA100 |
TA102 |
TA1535 |
TA1537 |
1.0 |
32.0 |
116.3 |
267.3 |
22.7 |
9.7 |
3.16 |
32.0 |
118.3 |
273.7 |
23.3 |
9.3 |
10.0 |
33.3 |
109.3 |
276.3 |
26.3 |
6.7 |
31.6 |
32.3 |
118.7 |
271.0 |
20.7 |
4.3 |
100 |
29.0 |
111.3 |
252.3 |
18.3 |
7.0 |
316 |
15.3 test item precipitation |
75.3 test item precipitation |
202.7 test item precipitation |
9.0 test item precipitation |
2.0 test item precipitation |
Vehicle control 100 µL/plate |
22.7 |
131.0 |
302.0 |
25.0 |
7.3 |
Positive reference item |
Benzo[a]pyrene |
2-amino-anthracene |
Benzo[a]pyrene |
2-amino-anthracene |
Benzo[a]pyrene |
Concentration µg/plate |
10 |
2 |
10 |
2 |
10 |
|
163.3 |
1029.7 |
997.3 |
137.7 |
65.0 |
Applicant's summary and conclusion
- Conclusions:
- Under the described conditions and tested up to a concentration of 316 µg/plate, that led to test item precipitation, the test substance caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation. Therefore, the test substance is considered non-mutagenic in the bacterial reverse mutation assay.
- Executive summary:
The potential of Ceramide IIIB to induce gene mutations was examined in 5 Salmonella typhimurium strains in two independent experiments without and with metabolic activation (plate incorporation test and preincubation test).
The test item was completely dissolved in ethanol for concentrations lower than 1000 µg/plate. The vehicle ethanol was employed as the negative control.
In two preliminary cytotoxicity tests, test item precipitation was noted starting at the concentration of 316 µg/plate. Concentrations of 1000 µg/plate and higher were not evaluable due to pronounced test item precipitation. Thus, six concentrations ranging from 1.0 to 316 µg/plate were employed in the main experiment.
Cytotoxicity as determined by the reduction of the number of revertants by more than 50% was noted at the top concentration of 316 µg/plate in some of the test strains with and without metabolic activation.
No increase in revertant colony numbers as compared with control up to a concentration of 316 µg/plate was observed in any of the 5 test strains in two independent experiments without and with metabolic activation, respectively (plate incorporation test and preincubation test).
The positive control items showed a significant increase in the number of revertant colonies of the respective test strain and confirmed the validity of the test conditions and the sensitivity of the test system.
In conclusion, the test substance was tested up to a concentration of 316 µg/plate, which led to precipitation but caused no mutagenic effect in the Salmonella typhimurium strains TA98, TA100, TA102, TA1535 and TA1537 neither in the plate incorporation test nor in the preincubation test each carried out without and with metabolic activation.
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