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EC number: 217-370-6 | CAS number: 1825-62-3
- 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
Endpoint summary
Administrative data
Description of key information
Oral (OECD 423), rat: LD50 > 2000 mg/kg bw
Inhalation (OECD 436), rat: LC50 > 20.57 mg/L
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 3 Nov - 21 Dec 1995
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Freie und Hansestadt Hamburg, Behörde für Arbeit, Gesundheit uns Soziales, Germany
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH, Sulzfeld, Germany
- Age at study initiation: 45 days (males), 56 days (females)
- Weight at study initiation: 191 - 200 g (males), 189 - 192 g (females)
- Fasting period before study: 16 h prior to application
- Housing: 2-3 animals per cage (Makrolon type III)
- Diet: ssniff R/M-H V 1530 (ssniff Spezialitäten GmbH, Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3
- Humidity (%): 55± 15
- Photoperiod (hrs dark / hrs light): 12/12 - Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: 2.67 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: no data - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- First step: 3 males
Second step: 3 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations were performed before and immediately, at 5, 15, 30 and 60 min, as well as at 3, 6 and 24 hours after administration. All surviving animals were observed for a period of 14 days (once daily). Body weight was determined before administartion and weekly thereafter.
- Necropsy of survivors performed: yes
- Other examinations performed: Changes of skin and fur, eyes and mucous membranes, respiratory and circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern were observed at least once daily untl all symptoms subsided (afterwards each working day). - Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality was observed after treatment with 2000 mg/kg bw.
- Clinical signs:
- other: No clinical signs of systemic toxicity were noted.
- Gross pathology:
- No organ abnormalities were observed at necropsy.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
- Conclusions:
- In an acute oral toxicity study with ethoxy(trimethyl)silane (according to OECD 423, GLP compliant) a LD50 >2000 mg/kg bw was derived. Treatment of 3 male and 3 female Crj:CD(SD) rats with the limit dose of 2000 mg/kg bw provoked no mortality or clinical signs of toxicity. No effect on body weight gain was observed and no findings were reported at necropsy.
Reference
Table 1: Body weight and relative body weight gain of the animals in the acute oral toxicity study.
Dose group [mg/kg bw] |
|
Bodyweight [g] |
|
|
Bodyweight gain [%] |
|
|
|
start |
after 7 d |
after 14 d |
day 1-7 |
day 1-14 |
2000 |
male |
196.7 |
262.3 |
323.3 |
33.4 |
64.4 |
2000 |
female |
190.3 |
216.0 |
234.3 |
13.5 |
23.1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 2 000 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017-04-18 to 2018-02-06
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)
- Version / remarks:
- 07 September 2009
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Version / remarks:
- August 1998
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- OGYÉI National Institute of Pharmacy and Nutrition, Budapest, Hungary, Budapest, Hungary
- Test type:
- acute toxic class method
- Limit test:
- no
- Species:
- rat
- Strain:
- other: CRL:WI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Research Models and Services, Germany GmbH, Sulzfeld, Germany
- Females nulliparous and non-pregnant: yes
- Age at study initiation: Group 1: 8 weeks old; Group 2: 9 weeks old
- Weight at study initiation: Group 1: 299-334 g (males) and 220-231 g (females); Group 2: 347-389 g (males) and 223-238 g (females)
- Housing: 3 animals by sex per cage
- Diet: ssniff SM R/M “Autoclavable Complete Feed for Rats and Mice – Breeding and Maintenance” provided ad libitum
- Water: tap water provided ad libitum
- Acclimation period: 6 days (Group 1), 12 days (Group 2)
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.7 – 26.4
- Humidity (%): 24 – 77
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 / 12 - Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: TSE Rodent Exposure System (TSE Systems GmbH, Bad Homburg, Germany)
- Method of holding animals in test chamber: Each rat was individually held in a tapered, polycarbonate restraining tube fitted onto a single tier of the exposure chamber. Only the nose of each animal was exposed to the test atmosphere.
- Source and rate of air: Fresh aerosol from the generation system was constantly supplied to the inner plenum (distribution chamber) of the exposure system from where, under positive pressure, it was distributed to the individual exposure ports. The flow of air through each port was at least 0.5 L/min.
TEST ATMOSPHERE
- Brief description of analytical method used: Vapour concentration was measured gravimetrically by adsorbent charcoal tube 17 times during each 4-hour exposure in both parts of the study.
- Samples taken from breathing zone: yes
CLASS METHOD (if applicable)
- Rationale for the selection of the starting concentration: The starting dose level, 10 mg/L was chosen by the Sponsor as the toxicity of the test item was unknown at 20 mg/L. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- ca. 4 h
- Concentrations:
- 10.27 mg/L and 20.57 mg/L
- No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14-day observation period
- Frequency of observations and weighing: Clinical observations were performed on all animals during exposure at hourly intervals, following removal from restraint, approximately 1 hour after exposure, and daily for 14 days thereafter. Body weight was measured on Days 0 (before the exposure), 1, 3, 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: All animals were subject to a gross necropsy which included a detailed examination of the abdominal and thoracic cavities. Special attention was given to the respiratory tract for macroscopic signs of irritancy or local toxicity. - Statistics:
- Not reported
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 20.57 mg/L air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortality occurred in Group 1 when exposed to a test atmosphere concentration of 10.27 mg/L for 4 hours and 1 out of the 6 animals died in Group 2 when exposed to a test atmosphere concentration of 20.57 mg/L for 4 hours.
- Clinical signs:
- other: Group 1: In the male animals, laboured respiration (slight to moderate), noisy respiration (slight), prostration/prone position, decreased activity (extreme) and incoordination (slight) were recorded on Day 0. These animals were symptom-free from Day 1. I
- Body weight:
- Slight body weight losses, noted in all animals of both Group 1 and Group 2 on Day 0-1, were considered to be related to the restraint and exposure procedures. No marked body weight loss was observed during the experiment in the surviving animals between Day 1-14. Body weights were within the range commonly recorded for this strain and age.
- Gross pathology:
- No test item-related macroscopic observations were noted at a dose level of 10.27 mg/L. There was no evidence of any changes in the rats dosed at 20.57 mg/L. No specific cause of death was determined for the animal, which was found dead on Day 2. Collapsed lungs were observed at necropsy and considered to be the agonal or post mortem change.
- Interpretation of results:
- other: CLP/EU GHS criteria are not met, no classification required according to Regulations (EC) No 1272/2008.
- Conclusions:
- In an acute inhalation toxicity study conducted according to OECD 436 and in compliance with GLP, the acute inhalation median lethal concentration (LC50) of ethoxy(trimethyl)silane in male and female Crl:WI rats was considered to be above 20.57 mg/L.
Reference
Endpoint conclusion
- Endpoint conclusion:
- adverse effect observed
- Dose descriptor:
- LC50
- Value:
- > 20.57 mg/L air
- Physical form:
- inhalation: vapour
- Quality of whole database:
- The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Oral
An acute oral toxicity study is available with ethoxy(trimethyl)silane (CAS 1825-62-3), which was conducted according to OECD 423 and in compliance with GLP (LPT, 2002). In a first step 3 male Crl:CD rats were treated with the limit dose of 2000 mg/kg bw. No mortality occurred and no clinical signs of systemic toxicity were noted. In accordance with the testing strategy supplied in OECD guideline 423 3 female animals were treated with 2000 mg/kg bw in the second step. Again no mortality and no clinical signs were observed. No findings after necropsy and no effects on body weight were observed in male and female animals. In conclusion a LD50 of >2000 mg/kg bw was derived.
Inhalation
An acute inhalation toxicity study is available with ethoxy(trimethyl)silane (CAS 1825-62-3), which was conducted according to OECD 436 and in compliance with GLP (Citoxlab, 2018). The test item was administered as vapour and the study was performed in two phases. The first exposure was performed at the target concentration of 10 mg/L on 3 animals of each sex (Group 1). Based on the results at this concentration, the second exposure was performed at the target concentration of 20 mg/L on 3 animals of each sex (Group 2). In both study phases, the animals were exposed to the test atmosphere for 4 hours using a nose-only exposure system.
No mortality occurred in Group 1 when exposed to a test atmosphere concentration of 10.27 mg/L for 4 hours and 1 out of the 6 animals died in Group 2 when exposed to a test atmosphere concentration of 20.57 mg/L for 4 hours. Clinical signs included prostration, with animals at the higher concentration being comatose but animals were symptom-free on Day 1 (Group 1) or Day 2 (Group 2). No marked body weight loss was observed during the experiment in the surviving animals between Day 1-14 and no test item-related macroscopic observations were noted at either dose level.
Based on these results, the acute inhalation median lethal concentration (LC50) of ethoxy(trimethyl)silane in male and female Crl:WI rats was therefore considered to be above 20.57 mg/L.
Justification for classification or non-classification
The available data on acute oral and inhalation toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008, and are therefore conclusive but not sufficient for classification.
No data on acute dermal toxicity are available.
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