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EC number: 213-914-1 | CAS number: 1066-40-6
- 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 vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 983
- Report date:
- 1983
- Reference Type:
- publication
- Title:
- Genotoxicity studies on selected organosilicon compounds: in vitro assays.
- Author:
- Isquith, A. et al.
- Year:
- 1 988
- Bibliographic source:
- Fd Chem Toxicol 26: 255-261
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 426
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 478 (Genetic Toxicology: Rodent Dominant Lethal Test)
- Principles of method if other than guideline:
- Extended Dominant Lethal Assay as recommended by the U.S. Food and Drug Administration (Green, et al 1977)
- GLP compliance:
- not specified
- Type of assay:
- rodent dominant lethal assay
Test material
- Reference substance name:
- Hydroxytrimethylsilane
- EC Number:
- 213-914-1
- EC Name:
- Hydroxytrimethylsilane
- Cas Number:
- 1066-40-6
- Molecular formula:
- C3H10OSi
- IUPAC Name:
- hydroxytrimethylsilane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Research, Haslett, Michigan
- Age at study initiation: 10 - 12 weeks
- Weight at study initiation: mean 355 - 375 g
- Assigned to test groups randomly: [yes, under following basis: randomly selected using a computer program]
- Housing: wire-bottomed stainless steel cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24 °C
- Humidity (%): 45 - 55 % relative humidity
- Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: none
- Justification for choice of solvent/vehicle: N/A
- Concentration of test material in vehicle: test material was given neat
- Amount of vehicle (if gavage or dermal): none
- Type and concentration of dispersant aid (if powder): N/A
- Lot/batch no. (if required): N/A
- Purity: N/A - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
DIET PREPARATION
- Rate of preparation of diet (frequency): daily, 5 days per week for 8 weeks
- The test substance was administered undiluted by oral gavage.
- Storage temperature of food: no data - Duration of treatment / exposure:
- The exposure period lasted 8 weeks
- Frequency of treatment:
- Daily, for 5 days per week
- Post exposure period:
- 2 weeks
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 20, 100, 200 mg/kg
Basis:
analytical conc.
- No. of animals per sex per dose:
- 15 males per dose group. 4 females per male (2 matings per week over 2 weeks)
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- triethylenemelamine
- Justification for choice of positive control(s): no data
- Route of administration: Oral gavage
- Doses / concentrations: 0.05 mg/kg/day
Examinations
- Tissues and cell types examined:
- Ovaries and uteri examined at necropsy. The number of corpora lutea and living and dead implantations were counted and recorded for each pregnant female.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: A two week subchronic dosing assay was conducted on sexually mature male Sprague-Dawley rats to determine a maximum tolerated dose level (MTD). The test material was administered undiluted by oral gavage. A level was selected which gave some evidence of biological effect (transient sedation) without producing sufficient toxicity to interfere with the test system. Based on this determination, male rats were randomly assigned to one of five experimental dosing groups (15 males/group).
DETAILS OF SLIDE PREPARATION: microscopic examination (no other information)
METHOD OF ANALYSIS: Number of corpora lutea, preimplantation loss, total number of implants, live and dead implants (restorations) counted for each mated female.
- Evaluation criteria:
- Examine for evidence that the test substance reaches mammalian germinal tissue and induces chromosomal aberrations. The analysis considers both effects per litter and total number of effects / total number of pups.
- Statistics:
- Data analysed for statistical significance (p <0.05 for all cases) by a computer program specifically designed for analysis of dominant lethal studies.
The program first tests the data for goodness to fit. Parametrically distributed data is analysed for statistical significance by Fishers Exact Probability Test while non-parametric data is automatically shifted to an analysis by the Wilcoxon Test as modified by Haseman and Hoel (1974).
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Additional information on results:
- One male from the high dose group died acutely due to lung damage caused by a dosing accident. One animal from the intermediate dose group failed to gain weight and was eating and drinking poorly. The animal was sacrificed and evidence of erosion of the gastric mucosa noted. The death was not attributed to TMS.
Any other information on results incl. tables
Table 2: Number of males / pregnant females / non-pregnant females
Dose Group (mg / kg) |
0 |
20 |
100 |
200 |
Positive Control |
Total Number of Males |
15 |
15 |
14 |
14 |
15 |
Number of fertile Males |
13 |
14 |
12 |
12 |
13 |
Number of Pregnant females |
42 |
40 |
46 |
36 |
52 |
Number of non-pregnant females |
18 |
20 |
10 |
20 |
8 |
Table 3: Effect on Fertility index
Dose (mg/kg) |
Fertile/Total Males |
Fertility Index* |
||
Mating # 1 |
Mating # 2 |
Mating # 1 |
Mating # 2 |
|
0 |
8/15 |
13/15 |
53.3 |
86.7 |
20 |
6/15 |
14/15 |
40 |
93.3 |
100 |
11/14 |
12/14 |
78.6 |
85.7 |
200 |
6/14 |
12/14 |
42.9 |
85.7 |
Positive control |
13/15 |
13/15 |
86.7 |
86.7 |
*Number of fertile males / Total number of males x 100
Table 4: Effect on pre-implantation loss
Week of Mating |
Dose Level (mg/kg) |
Preimplantation Loss Rate (a) |
% Loss (b) |
Average % Response ± S.D (c) |
1 |
0 |
5/8 |
62.5 |
10.85 ± 13.93 |
20 |
1/6 |
16.7 |
1.23 ± 3.14 |
|
100 |
7/11 |
63.6 |
7.02 ± 8.84 |
|
200 |
4/6 |
66.7 |
6.67 ±5.95 |
|
Positive Control |
5/8 |
62.5 |
7.97 ± 17.81 |
|
2 |
0 |
7/13 |
53.8 |
9.05 ± 14.42 |
20 |
9/14 |
64.3 |
7.11 ± 8.82 |
|
100 |
7/13 |
53.8 |
2.75 ± 4.8 |
|
200 |
7/12 |
58.3 |
12.69 ± 24.55 |
|
Positive Control |
8/13 |
61.5 |
10.68 ± 13.8 |
|
3 |
0 |
10/13 |
76.9 |
9.44 ± 10.02 |
20 |
9/14 |
64.3 |
5.33 ± 5.6 |
|
100 |
7/12 |
58.3 |
4.11 ± 4.29 |
|
200 |
8/12 |
66.7 |
7.83 ± 10.39 |
|
Positive Control |
9/13 |
69.2 |
10.42 ± 10.83 |
(a) Total number of males producing preimplantation / Total number of fertile males
(b) Preimplantation loss rate x 100
(c) Total preimplantation loss / Total number Corpora Lutea x 100 = Mean (x) percent loss
Table 5 : Effect on Resorption rate
Week of Mating |
Dose Level (mg/kg) |
Resorption Rate (a) |
Resorption% (b) |
Average % Response ± S.D (c) |
1 |
0 |
1/8 |
12.5 |
1.14 ± 3.22 |
20 |
3/6 |
50 |
3.35 ± 3.68 |
|
100 |
3/11 |
27.3 |
3.05 ± 7.02 |
|
200 |
1/6 |
16.7** |
0.63 ± 1.55 |
|
Positive Control |
10/13 |
76.9 |
18.95** ± 13.34 |
|
2 |
0 |
5/13 |
38.5 |
2.19 ± 3.12 |
20 |
4/14 |
28.6 |
2.61 ± 5.6 |
|
100 |
5/12 |
41.7 |
2.3 ± 2.99 |
|
200 |
3/12 |
25 |
1.69 ± 3.48 |
|
Positive Control |
9/13 |
69 |
13.8** ± 21.17 |
|
3 |
0 |
6/13 |
46.2 |
1.99 ± 2.29 |
20 |
6/14 |
42.9 |
2.32 ± 3.24 |
|
100 |
6/12 |
50 |
2.59 ± 4.17 |
|
200 |
4/12 |
33.3 |
1.65 ± 3.26 |
|
Positive Control |
12/13 |
92.3* |
16.08** ± 11.54 |
(a) Total number of males producing preimplantation / Total number of fertile males
(b)Resorption rate x 100
(c) Total average percent resorption rate (Total resorptions/ Total implants per fertile male / Total number fertile males
* Significant at p <0.05
** Significant at p <0.01
No dose-related deaths, clinical symptoms or behavioural changes were observed.
Male rats receiving mid to high dose showed signs of sedation immediately after dosing.
There was no significant difference between the mean body weight gain for any of the dosing groups compared to negative control group.
There was no statistically significant difference in fertility index / pre-implantation loss or resorption rate in any of the groups dosed with TMS compared to the negative control group.
A clear dominant lethal syndrome was evident in the positive control group.
Applicant's summary and conclusion
- Conclusions:
- Trimethylsilane has been tested in a rodent dominant lethal assay according to OECD 426 (1981) and equivalent to OECD 478. The test substance was administered by oral gavage to male rats at three dose levels, five days per week over eight weeks, gave no evidence of inducing chromosomal damage in germinal tissue; there was no substance related effect on fertility index, per-implantation loss or resorption rate. A clear dominant lethal syndrome was evident in the positive control group. Although the test material was administered at a high enough level to induce transient sedation without toxicity, no reduction in male fertility or increase in dominant lethality was obtained. It is concluded that the test substance is negative for genetic toxicity to germ cells under the conditions of the test.
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