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EC number: 943-282-9 | CAS number: -
- 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:
- 2016-05-26 to 2016-06-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Version / remarks:
- 1997
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.13/14 (Mutagenicity - Reverse Mutation Test Using Bacteria)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Reaction mass of octadecan-1-ol and trimethyl(octadecyloxy)silane
- Molecular formula:
- CH3(CH2)17OSi(CH3)3
- IUPAC Name:
- Reaction mass of octadecan-1-ol and trimethyl(octadecyloxy)silane
- Test material form:
- other: Off-white waxy solid
1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 0008287484
- Expiration date of the lot/batch: 2017-03-03
- Purity test date: 2015-11-18
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: stored sealed away from air exposure
- Stability under test conditions:
- Solubility and stability of the test substance in the solvent/vehicle: the test item was soluble and stable in anhydrous tetrahydrofuran (THF)
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium:
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no correction was made for the purity/composition of the test item
- Final dilution of a dissolved solid, stock liquid or gel: the test item was disolved in anhydrous tetrahydrofuran (THF)
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2
- Additional strain / cell type characteristics:
- other: Each strain contained the following mutations: rfa: defective lipopolysaccharide cellcoat; gal: mutation in the galactose metabolism; chl: mutation in nitrate reductase; bio: defective biotin synthesis; uvrB: loss of the excision repait system
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat liver S9
- Test concentrations with justification for top dose:
- Dose-range finding study: 1.7, 5.4, 17, 52, 164, 512, 1600, 5000 µg/plate (TA100 and WP2uvrA)
Experiement 1: 52, 164, 512, 1600, 5000 µg/plate (TA1535, TA1537, TA98)
Experiment 2: 275, 492, 878, 1568, 2800, 5000 µg/plate (all test strains)
Experiement 3: 86, 154, 275, 492, 878 µg/plate (all test strains)
Limited solubility was exhibited at 5000 µg/plate. - Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: anhydrous tetrahydrofuran (THF)
- Justification for choice of solvent/vehicle: the test item was soluble and stable in the vehicle.
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- THF
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- THF
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: ICR-191
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- THF
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- THF
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- methylmethanesulfonate
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- THF
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 4-nitroquinoline-N-oxide
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- THF
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation)
- Cell density at seeding (if applicable): 10⁹ cells/ml
ACTIVATION SYSTEM: 10 mL of S9 mix contained: 30 mg NADP, 15.2 mg glucose-6-phosphate in 5.5 ml Milli-Q water or 5.0 ml Milli-Q water, 2 Ml 0.5 M sodium phosphate buffer pH 7.4, 1 ml 0.08 M MgCl, 1 ml 0.33 M KCl. To 9.5 ml of S9-mix components 0.5 ml S9-fraction was added (5% (v/v) S9-fraction) to complete the S9-mix in the first experiment and to 9.0 ml of S9-mix components 1.0 ml S9-fraction was added (10% (v/v) S9-fraction) to complete the S9-mix in the second experiment.
DURATION
- Exposure duration: 48 h +/- 4 h
- Mutation assay details:
Dose-range finding study: eight different doses of the test item were tested with and without metabolic activation in TA100 and WP2uvrA
Experiment 1: five different doses of the test item were tested with and without metabolic activation in TA1535, TA1537 and TA98
Experiment 2: five different doses of the test item were tested with and without metabolic activation in all test strains
Experiment 3: five different doses of the test item were tested with and without metabolic activation in all test strains
SELECTION AGENT (mutation assays): Selective agar plates were used: biotin and histidine-containing agar plates for Salmonella typhimurium; tryptophan-containing plates for Escherichia coli
NUMBER OF REPLICATIONS: triplicate plates
DETERMINATION OF CYTOTOXICITY
- Method: nuber of revertants, reduction of bacterial background lawn - Rationale for test conditions:
- Three different experiements were performed with different dose selection until no precipitate of the test item was observed.
- Evaluation criteria:
- The test item is considered negative when:
- the total number of revertants in the tester strain TA100 or WP2uvrA is not greater than two times the concurrent control, and the total number of revertants in tester strains TA1535, TA1537 and TA98 is not greater then three the concurrent vehicle control;
- the negative control should be reproducible in at least one follow-up experiment; - Statistics:
- Not used
Results and discussion
Test resultsopen allclose all
- Species / strain:
- bacteria, other: TA1535, TA1537 and TA98
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 512 µg/plate TA98, with metabolic activation
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- bacteria, other: TA1535, TA1537, TA98, TA100 and WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- cytotoxicity
- Remarks:
- at 512 in TA98 with and without S9 mix
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Species / strain:
- bacteria, other: TA1535, TA1537, TA100, TA98 and WP2uvrA
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity, but tested up to precipitating concentrations
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- TEST-SPECIFIC CONFOUNDING FACTORS
- Precipitation:
Experiment 1: precipitation was observed at the start and the end of the incubation period at concentration of 512 µg/plate
Experiment 2: precipitation was observed at the start of the incubation period at the concentration of 492 µg/plate and higher, and at all dose levels at the end of the incubation period except in strains TA98 (+/- S9 mix), TA100 (+/- S9 mix) and TA1537 (+ S9 mix) at 275 µg/plate.
Experiment 3: precipitation was observed at the start of the incubation period at 275 µg/plate and higher, and at 878 µg/plate at the end of the incubation period.
RANGE-FINDING/SCREENING STUDIES:
Precipitation of the test item was observed at the start of the incubation period at 164 µg/plate and higher and at the end of the incubation period at 1600 and 5000 µg/plate.
HISTORICAL CONTROL DATA
- Positive historical control data: positive control results were within the ranges of historical control data
- Negative (solvent/vehicle) historical control data: negative control results were within the ranges of historical control data - Remarks on result:
- other:
- Remarks:
- Experiment 1
Any other information on results incl. tables
Table 1: Mean number of revertant colonies in dose-range finding test
Concentration µL/plate |
TA 100 |
WP2uvrA |
||
+MA |
-MA |
+MA |
-MA |
|
Positive control |
1285 |
1098 |
501 |
1337 |
Negative control |
112 |
128 |
42 |
36 |
1.7 |
110 |
111 |
41 |
35 |
5.4 |
125 |
124 |
42 |
34 |
17 |
121 |
105 |
45 |
39 |
52 |
122 |
113 |
45 |
40 |
164 |
140 |
118 |
48 |
42 |
512 |
126np |
124np |
58np |
40np |
1600 |
126sp |
135sp |
44sp |
30sp |
5000 |
111mp |
121mp |
47mp |
36mp |
Table 2: Mean number of revertant colonies in experiment 1
Concentration µL/plate |
TA 98 |
TA 1535 |
TA 1537 |
|||
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
|
Positive control |
1254 |
1217 |
193 |
974 |
379 |
638 |
Negative control |
19 |
12 |
6 |
7 |
7 |
6 |
52 |
15 |
14 |
8 |
4 |
8 |
9 |
164 |
19np |
22np |
7np |
9 np |
5np |
9np |
512 |
7sp |
11sp |
10sp |
11sp |
7sp |
5sp |
1600 |
hp |
hp |
hp |
hp |
hp |
hp |
5000 |
hp |
hp |
hp |
hp |
hp |
hp |
Table 3: Mean number of revertant colonies in experiment 2
Concentration µg/plate |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2uvrA |
|||||
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
|
Positive control |
148 |
698 |
300 |
808 |
459 |
1595 |
803 |
960 |
315 |
1135 |
Solvent control |
14 |
14 |
9 |
5 |
20 |
21 |
96 |
123 |
60 |
42 |
275 |
8sp |
10sp |
5np |
4sp |
13np |
12np |
95np |
125np |
43sp |
25sp |
492 |
13sp |
12sp |
8sp |
9sp |
16np |
16sp |
92sp |
115sp |
39mp |
19mp |
878 |
11sp |
9mp |
8sp |
6np |
14mp |
13mp |
89sp |
127sp |
27mp |
24mp |
1568 |
8mp |
13mp |
4mp |
3np |
8mp |
8mp |
75mp |
99mp |
28mp |
20mp |
2800 |
9mp |
hp |
6mp |
hp |
hp |
hp |
88mp |
hp |
31mp |
hp |
5000 |
10mp |
hp |
3mp |
hp |
hp |
hp |
81mp |
hp |
24mp |
hp |
Table 3: Mean number of revertant colonies in experiment 3
Concentration µg/plate |
TA 1535 |
TA 1537 |
TA 98 |
TA 100 |
WP2uvrA |
|||||
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
+MA |
-MA |
|
Positive control |
158 |
846 |
244 |
1132 |
603 |
1290 |
956 |
951 |
288 |
1285 |
Solvent control |
6 |
11 |
7 |
5 |
27 |
13 |
105 |
135 |
38 |
32 |
86 |
11 |
10 |
7 |
8 |
25 |
16 |
101 |
112 |
42 |
30 |
154 |
8 |
10 |
9 |
6 |
25 |
23 |
112 |
113 |
56 |
44 |
275 |
11 |
14 |
4 |
9 |
25 |
20 |
107 |
111 |
51 |
41 |
492 |
19np |
16np |
8np |
10np |
23np |
22np |
110np |
131np |
52np |
42np |
878 |
17sp |
21sp |
8sp |
12sp |
26sp |
19sp |
109sp |
124sp |
52sp |
42sp |
hp |
Heavy Precipitate,the number of revertant colonies could not be determined. |
np |
No precipitate |
sp |
Slight Precipitate |
Applicant's summary and conclusion
- Conclusions:
- Trimethyl(octadecyloxy)silane in stearyl alcohol was tested in a valid bacterial reverse mutation assay, conducted according to OECD TG 471 and in compliance with GLP using Salmonella typhimurium strains (TA1535, TA1537, TA98 and TA100) and Escherichia coli (WP2uvrA). No increase in the number of revertant was observed in any test strains , with or without metabolic activation, when tested up to precipitating concentrations. Appropriate positive and solvent controls were included and gave the expected results. It is concluded that the test substance is negative for mutagenicity to bacteria under the conditions of the test.
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