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EC number: 219-842-7 | CAS number: 2550-02-9
- 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 TG 401), rat: LD50 > 5110 mg/kg bw.
No measured acute inhalation data are available for the registered
substance, triethoxypropylsilane, however reliable data are available
for the structural analogue substance trimethoxypropylsilane (CAS
1067-25-0)
Inhalation (OECD TG 403), rat: 4 h: LC50 > 22200 mg/m³.
No measured data are available for the dermal route (data waiving
according to Column 2 of REACH Annex VIII, Section 8.5.3).
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:
- 01-10-1991 to 08-10-1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- yes
- Remarks:
- dose volume exceeded
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Bor: WISW (SPFCpb)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Versuchstierzucht GmbH & Co. KG., D-4799 Borchen.
- Age at study initiation: 8 weeks (males) and 9 weeks (females)
- Weight at study initiation: 147-165 g (males) and 132-142 g (females)
- Fasting period before study: Approx. 16 hours before treatment
- Housing: Macrolon cages, type II. One animal per cage. Animal bedding chips, supplied by Jelu-Werk, J. Ehrler, Industriemehule, D-7092 Rosenberg/Württ.
- Diet: Standard diet ad libitum, ssniff R, Special diet for rats.
- Water: Water was provided ad libitum in drinking water quality from Stadtwerke Bielefeld, using an automatic drinking water system with drinking nipples.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.5 – 22.5
- Humidity (%): 40-70
- Photoperiod (hrs dark / hrs light):12/12
IN-LIFE DATES: From: 01-10-1991 To: 15-10-1991 - Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 237 mg/mL
- Justification for choice of vehicle: substance is insoluble in water.
- Lot/batch no. (if required): 8249
MAXIMUM DOSE VOLUME APPLIED: 21.5 mL/kg (guideline: <= 1 mL/100 g bw)
DOSAGE PREPARATION (if unusual): prepared as emulsion before dosing - Doses:
- 5110 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were continuously observed for first 4 to 6 hours after administration and then once daily. The nature of the toxicity as well as the onset, the intensity, and the duration of the signs were recorded. Mortality was checked twice daily (a.m. and p.m.), on weekends only once. The body weights were recorded at the beginning and also 7 and 14 days after administration
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, body orifices, body cavities (thoracic and abdominal), and their content. - Statistics:
- None given.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 5 110 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: Signs of toxicity were restrained gait, slight to moderate clonic convulsions, slight to moderate mydriasis, and diarrhea in male and female rats. In additions , male animals showed slight hypokinesia, chromoacryorrhea, and piloerection. In one female ani
- Gross pathology:
- Necropsy and histopathological examinations revealed no substance-related findings
- 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 conducted in rats according to the now deleted OECD 401 and in compliance with GLP, the LD50 for triethoxypropylsilane was greater than 5110 mg/kg bw.
Reference
Table 2. Body weights (g) – Individual Values.
Dose (mg/kg bw) |
Animal No. |
Day 0 |
Day 7 |
Day 14 |
Male animals |
|
|
|
|
5110 |
1 |
165 |
224 |
243 |
2 |
154 |
215 |
237 |
|
3 |
147 |
202 |
227 |
|
4 |
149 |
201 |
224 |
|
5 |
152 |
203 |
226 |
|
Female animals |
|
|
|
|
5110 |
6 |
142 |
160 |
162 |
7 |
136 |
173 |
171 |
|
8 |
136 |
160 |
159 |
|
9 |
135 |
174 |
173 |
|
10 |
132 |
148 |
149 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- > 5 110 mg/kg bw
- Quality of whole database:
- The available information comprises an adequate and reliable study, 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- Deviations unlikely significantly to affect the outcome of the study: excursions from recommended relative humidity and temperature; limited reporting of clinical observations.
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: Wistar derived Crl:WI(WU)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Sulzfeld, GERMANY
- Age at study initiation: 7 weeks
- Weight at study initiation: mean - 218 g (males), 166 g (females)
- Fasting period before study: none stated
- Housing: (after exposure) 5 males or 5 females per suspended stainless steel cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 15 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): during exposure: mean 22.6; after exposure: 22 +/-3 (excursion 18.5 for 1 h)
- Humidity (%): during exposure: mean 79 +/-15 (excursion >70% for 2 h); after exposure: 30-70 (excursions 29, 74, 95 for 1 h on each occasion)
- Air changes (per hr): during exposure: 38; after exposure: 10
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1990-02-07 To: 1990-02-21 - Route of administration:
- inhalation
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: horizontal glass chamber; animals separated by perforated stainless steel plates
- Exposure chamber volume: 16 L (total volume)
- Method of holding animals in test chamber: see above
- Source and rate of air: 0.6 m³/h; flow velocity 34 m/h; ventilation frequency 38/h
- System of generating particulates/aerosols: heated air bubbled through heated test material at 35° C, passed through heated Pall filter (30 °C) to remove aerosol as far as possible
- Method of particle size determination: to determine aerosol content: 11-stage cascade impactor
- Treatment of exhaust air: no details
- Temperature, humidity, pressure in air chamber: (mean of hourly measurements) 22.6 deg C; 79 +/-15%; pressure unstated
TEST ATMOSPHERE
- Brief description of analytical method used: hourly GC analysis
- Samples taken from breathing zone: yes
TEST ATMOSPHERE: 22.2+/-6.9 g/m³ (4 measurements); nominal 59.8 g/m³; particle size tabulated, about 1% of the total test atmosphere consisted of aerosol. - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- Single exposure concentration:
22.9 +/-6.9 g/m³ (measured)
59.8 g/m³ (nominal) - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observations daily; body weights prior to exposure and on observation days 7 and 14.
- Necropsy of survivors performed: yes - Statistics:
- None relating to LC50.
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 22 200 mg/m³ air (analytical)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- One of each sex died during exposure. One male died on observation day 4.
- Clinical signs:
- other: irregular breathing, narcosis shortly after exposure (see under "any other information o nresults" for more details
- Body weight:
- Body weights were reduced in two females on days 14, or 7 and 14.
- Gross pathology:
- The lungs of the three animals that died during treatment or observation were discoloured red, spotted or swollen. No abnormalities were found in the remaining animals autopsied on day 14.
- 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 study according to OECD 403 and in accordance with GLP (reliability score 1) the LC50 for the structural analogue substance trimethoxypropylsilane (CAS: 1067-25-0) was in excess of 22200 mg/m³ in the rat.
Reference
Table 1: Concentrations, exposure conditions and mortality per animals treated
Nominal Conc. (g/m3) |
Analytical Conc. (g/m3) |
Mortality (dead/total) |
||
Males |
Females |
Combined |
||
59.8 |
22.2 +/- 6.9 |
2/5 |
1/5 |
3/10 |
Clinical signs: Shortly after exposure, restlessness and irregular breathing was observed followed by narcosis and deep and irregular breathing. Wet noses and dirty fur were common observations on the first day of the observation period, but there were no abnormalities thereafter. Just before death the male demonstrated lethargy, showed flabby muscles, incoordination, piloerection and a visually increased breathing frequency. These findings are reported as narative - full tabulated details are not presented.
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LC50
- Value:
- > 22 200 mg/m³ air
- Quality of whole database:
- The available information comprises an adequate and reliable study from a reference substance with similar structure and intrinsic properties. Read-across is justified based on similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006.
Acute toxicity: via dermal route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
Studies were chosen as key when the available study was of relevance and of sufficient quality for classification, labelling and for risk assessment
The key acute oral toxicity study which was conducted in compliance with GLP and according to the now deleted OECD TG 401, reports an LD50value of > 5110 mg/kg bw/d after single oral administration of the registered substance. Both sexes showed restrained or stilted gait (10/10), clonic convulsions (10/10), mydriasis (2/5m, 5/5f) and diahorrea (2/5m, 1/5f). Males exhibited slight hypokinesia (2/5m), chromodacryorrhea (1/5m) and piloerection (2/5m). Symptoms were observed between 35 minutes and three days after administration (ASTA Medica, 1992a).
No measured acute inhalation data are available for the registered substance, triethoxypropylsilane, however data are available for the structural analogue substance trimethoxypropylsilane (CAS: 1067-25-0). In accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5 “Grouping of substances and read across” and following the Read across assessment framework (RAAF, ECHA 2017) read across from an analogue substance has been applied to support the human health hazard assessment of tritethoxypropylsilane. Details on read across justifications can be found in the attached justification in the respective target entry and in the overall justification for grouping of substances attached in IUCLID Section 13.
The key acute inhalation toxicity study which was conducted in compliance with GLP and according to OECD TG 403 is available for the structural analogue substance trimethoxypropylsilane and which reports an LC50 value of > 22200mg/m³ in rats. Shortly after exposure, restlessness and irregular breathing was observed followed by narcosis and deep and irregular breathing. Wet noses and dirty fur were common observations on the first day of the observation period, but there were no abnormalities thereafter. Just before death the male demonstrated lethargy, showed flabby muscles, incoordination, piloerection and a visually increased breathing frequency (TNO, 1990). The LC50 for the target chemical is also considered to be 22200 mg/m³.
No measured data are available for the dermal route.
Justification for classification or non-classification
The available data on acute oral and inhalation toxicity (lethality) of the registered substance and the structural analogue substance, trimethoxypropylsilane (CAS 1067 -25 -0), respectively, do not meet the criteria for classification according to Regulation (EC) 1272/2008 , and are therefore conclusive but sufficient for classification of the registered substance.
Classification as STOT-SE Cat 3, with the hazard statement 'H336: May cause drowsiness and dizziness' according to Regulation (EC) 1272/2008 is not warranted for the test substance. Although signs of narcosis were observed in the acute inhalation study, this was rather linked to the systemic effects provoked by the test substance after exposure at a concentration exceeding the limit dose stated in the corresponding OECD guideline. In addition the reported concentration could have been higher due to the whole-body inhalation and possible additional oral uptake of the test substance. Mortality and clinical signs as laboured breathing and lethargy were observed. At necropsy dark red discoloured lungs were reported, thus leading to the conclusion that the narcotic effects were rather a consequence of anoxia provoked by systemic effects.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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