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EC number: 278-947-6 | CAS number: 78560-45-9
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Remarks:
- 7-day dose range-finding study
- Type of information:
- experimental study
- Remarks:
- Supporting evidence of corrosivity
- Adequacy of study:
- key study
- Study period:
- 24th May 2017 to 8th June 2017
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The aim of this regulation driven 7-day dose-range finding study was to provide a basis for the selection of low dose levels to be used in repeated dose oral (gavage) toxicity study. The dose-range finding study and the full repeated dose study were planned to assess the possible health hazards, in particular local corrosive effects, which could arise from repeated exposure of trichloro(propyl)silane via oral administration to rats. Therefore, macroscopic and microscopic examinations of the animals were limited to the respiratory and gastrointestinal tracts.
- GLP compliance:
- no
- Remarks:
- a 7-day dose-range finding study was to provide a basis for the selection of low dose levels to be used in repeated dose oral (gavage) toxicity study.
- Limit test:
- no
Test material
- Reference substance name:
- Trichloro(propyl)silane
- EC Number:
- 205-489-6
- EC Name:
- Trichloro(propyl)silane
- Cas Number:
- 141-57-1
- Molecular formula:
- C3H7Cl3Si
- IUPAC Name:
- Trichloro(propyl)silane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: room temperature, stored under an Argon atmosphere to avoid hydrolysis
- Stability under test conditions: not specified
- Solubility and stability of the test substance in the solvent/vehicle: The test item was used as provided by the sponsor.
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: not applicable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: The test item was used as provided by the sponsor
- Preliminary purification step (if any): none
- Final dilution of a dissolved solid, stock liquid or gel: not applicable
- Final preparation of a solid: not applicable
Test animals
- Species:
- rat
- Strain:
- other: Wistar Crl:WI(Han)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 12 weeks old
- Weight at study initiation: males: 327 – 349 g; females: 213 – 241 g
- Fasting period before study: no
- Housing: The animals were kept in groups of 5 animals / sex / group / cage in IVC cages
- Diet (e.g. ad libitum): Altromin 1324 maintenance diet for rats and mice, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least 5 days
DETAILS OF FOOD AND WATER QUALITY: Certificates of food, water and bedding are filed for two years at BSL Munich and afterwards archived at Eurofins Munich
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3 °C
- Humidity (%): 55 +/- 10%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Control group: 0.101 ml/kg bw, low-dose group: 0.025 m/kg bw, mid-dose group: 0.050 ml/kg bw, high-dose group: 0.101 ml/kg bw. The application v
olume was calculated based on the density of 1.19 g/ml of the test item. The test item was applied undiluted due to the high instability of the test item in the presence of water.
For each animal the individual dosing volume was calculated on the basis of the body weight most recently measured. - Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 7-day treatment was planned, but the animals were treated for 2 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 30 mg/kg bw/day (nominal)
- Remarks:
- The lowest possible dose based on the minimum volume of neat test substance that can be dosed.
- Dose / conc.:
- 60 mg/kg bw/day (nominal)
- Dose / conc.:
- 120 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 3 males and 3 females per dose per group (except low dose); 5 males and 5 females for low dose group.
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale:
- Rationale for animal assignment (if not random): random
- Rationale for selecting satellite groups: satellite groups not used
- Post-exposure recovery period in satellite groups: none
- Section schedule rationale (if not random): random - Positive control:
- not used
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: General clinical observations were made at least once a day, approximately at the same time each day. Twice daily all animals were observed for morbidity and mortality.
- Cage side observations checked in table included: mortality, morbidity, general clinical observations
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: on study days 1 and 4 prior to dosing, and was planned for study day 7 prior to the scheduled necropsy
FOOD CONSUMPTION:
- Food consumption for each animal determined: Yes, on study days 1 prior to dosing and was also planned for the days of scheduled euthanasia
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Not applicable
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (See table 1) Detailed gross necropsy which included careful examination of the external surface of the body, all orifices and the cranial, thoracic and abdominal cavities and their contents. All macroscopic findings were recorded and organs showing gross abnormalities were preserved in neutral buffered formalin. Gross necropsy of all animals including decedent animals, without organ weights, were performed. At necropsy, special attention was paid to the gastrointestinal tract. The gastrointestinal tract was opened with scissors and cleaned with water to examine inner surfaces macroscopically for corrosive effects.
All animals intercurrently sacrificed were subjected to a gross necropsy.
HISTOPATHOLOGY: Yes (See table 1) - Statistics:
- Toxicology and pathology data were captured either on paper according to appropriate SOPs or using the validated computerised system Ascentos® System
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Moving the bedding, moderate to marked salivation and nasal discharge were noted directly after dosing in test animals. These signs represent typical signs of local reactions and were equally distributed among the dose groups in terms of incidence and severity. In addition stress-related effects such as piloerection, vocalization and chromodacryorrhea were recorded. Severe clinical findings such as moderate to marked reduced spontaneous activity, abnormal breathing, half eyelid-closure, slight wasp waist and hunched posture were also observed. All presented clinical signs were not recorded in control animals.
- Mortality:
- mortality observed, treatment-related
- Description (incidence):
- All 22 animals of the test item-treated groups were euthanised in a moribund condition for animal welfare reasons by study day 2. Two males had to be sacrificed on the first day of the study. All animals of the control groups survived until the scheduled sacrifice on day 8. Therefore, the mortality is considered to be related to the test item.
- Body weight and weight changes:
- not examined
- Description (incidence and severity):
- Body weight of animals of test item-treated groups could only be determined on study day 1 and no body weight gain could be determined during the treatment period as animals were sacrificed on study day 1 or 2.
On study day 1 mean values of body weight measurements in the dose groups were comparable to the control group in both males and females. - Food consumption and compound intake (if feeding study):
- not examined
- Description (incidence and severity):
- No effects of trichloro(propyl)silane on food consumption could be determined during the treatment period of the male and female dose groups when compared to the respective controls as animals were sacrificed on study day 1 or 2.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Erosions/ulcers concerning the complete stomach could be found in 6/10 animals of the low dose (LD) group, in 3/6 of the middle dose (MD) group and in all animals (6/6) of the high dose (HD) group. In addition, in 3 other animals foci and foamy contents could be observed (one each from low, mid and high dose groups). Moreover, a solid content was found in the esophagus of animals 13 (HD, male) and 25 (MD, female).
In 5/10 LD animals a discoloration of the esophagus was detected. 4/6 MD animals as well as 5/6 HD animals exhibited fluid/foam filled esophagi with two of the MD animals showing discoloration in addition.
The lungs of female 21 (LD group) were fluid filled and those of male 13 (HD group) had red discoloration.
Only two animals of the LD group (males 6 and 7) exhibited no macroscopic findings.
The abovementioned findings correlated with histopathological observations as outlined below. None of the presented macroscopic findings were recorded in control animals and were therefore considered to be related to the test item formulation. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Esophagus:
- inflammatory and/or degenerative lesions in all test item-treated animals.
- hyperacute lesions: mucosal degeneration (coagulation necrosis)
- acute inflammation in one low dose female.
- necrotizing inflammation in remaining animals in single case associated with ulceration and esophageal perforation
Trachea:
- acute inflammation or necrotizing inflammation in a few animals throughout all test item-treated groups.
Lungs:
- multifocal peribronchiolar inflammation was recorded in the lungs of one high dose animal affecting mainly the alveoli connecting the terminal end sacs associated with bronchiolar epithelium degeneration
- deposition of cellular detritus associated with degenerated epithelium in one mid dose animal
Stomach:
- inflammatory and degenerative lesions affected both the forestomach and the glandular stomach, consisting of inflammation and ulceration - Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Effect levels
- Key result
- Dose descriptor:
- LOAEL
- Effect level:
- ca. 30 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical signs
- gross pathology
- histopathology: neoplastic
- mortality
- Remarks on result:
- other: no NOAEL could be determined as animals were sacrificed prior to completion of the study.
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 30 mg/kg bw/day (actual dose received)
- System:
- respiratory system: upper respiratory tract
- Organ:
- oesophagus
- stomach
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- yes
Any other information on results incl. tables
Table 1: Mortality data
Males |
Males |
Males |
Males |
Females |
Females |
Females |
Females |
|
Group |
Animal No. |
Number of Application |
Time after last application (h:min) |
Group |
Animal No. |
Number of Application |
Time after last application (h:min) |
|
2 |
4 |
2 |
06:42 |
2 |
18 |
1 |
18:24 |
|
2 |
5 |
2 |
06:20 |
2 |
19 |
2 |
06:23 |
|
2 |
6 |
2 |
06:46 |
2 |
20 |
2 |
06:49 |
|
2 |
7 |
2 |
06:39 |
2 |
21 |
2 |
06:53 |
|
2 |
8 |
2 |
06:49 |
2 |
22 |
2 |
06:54 |
|
3 |
9 |
1 |
1: 58 |
3 |
23 |
1 |
18:07 |
|
3 |
10 |
2 |
02:38 |
3 |
24 |
2 |
02:55 |
|
3 |
11 |
2 |
01:41 |
3 |
25 |
1 |
18:19 |
|
4 |
12 |
2 |
02:40 |
4 |
26 |
2 |
02:54 |
|
4 |
13 |
1 |
02:13 |
4 |
27 |
2 |
02:53 |
|
4 |
14 |
2 |
01:44 |
4 |
28 |
2 |
02:34 |
Table2: Incidence and mean severity of lesions in esophagus
Dose (mg/kg) |
Control |
Control |
30 mg/kg |
30 mg/kg |
60 mg/kg |
60 mg/kg |
120 mg/kg |
120 mg/kg |
Total Animals/Sex Affected / Mean Severity |
(3) M |
(3) F |
(4) M* |
(5) F |
(3) M |
(3) F |
(3) M |
(3) F |
Food in lumen |
0 |
0 |
0 |
1 |
2 |
0 |
2 |
0 |
Degeneration, mucosal |
0 |
0 |
0 |
0 |
2/3.5 |
1/4.0 |
3/4.7 |
1/3.0 |
Inflammation, acute |
0 |
0 |
0 |
1/1.0 |
0 |
0 |
0 |
0 |
Inflammation, necrotizing |
0 |
0 |
4/2.8 |
4/3.3 |
1/3.0 |
2/2.5 |
0 |
2/4.0 |
Table3: Incidence and mean severity of lesions in trachea
Dose (mg/kg) |
Control |
Control |
30 mg/kg |
30 mg/kg |
60 mg/kg |
60 mg/kg |
120 mg/kg |
120 mg/kg |
Total Animals/Sex Affected / Mean Severity |
(3) M |
(3) F |
(5) M |
(5) F |
(3) M |
(3) F |
(3) M |
(3) F |
Inflammation, acute |
0 |
0 |
1/1.0 |
1/2.0 |
0 |
1/2.0 |
0 |
2/1.0 |
Inflammation, necrotizing |
0 |
0 |
0 |
1/3.0 |
1/3.0 |
1/1.0 |
1/2.0 |
0 |
Table4: Incidence and mean severity of lesions in lung
Dose (mg/kg) |
Control |
Control |
30 mg/kg |
30 mg/kg |
60 mg/kg |
60 mg/kg |
120 mg/kg |
120 mg/kg |
Total Animals/Sex Affected / Mean Severity |
(3) M |
(3) F |
(5) M |
(5) F |
(3) M |
(3) F |
(3) M |
(3) F |
Inflammation, peribronch. |
0 |
0 |
0 |
0 |
0 |
0 |
1/2.0 |
0 |
Degeneration, bronchiolar epithelium |
0 |
0 |
0 |
0 |
0 |
1/1.0 |
1/1.0 |
0 |
Detritus intrabronchial |
0 |
0 |
0 |
0 |
0 |
1/2.0 |
1/2.0 |
0 |
Table5: Incidence and mean severity of lesions in stomach
Dose (mg/kg) |
Control |
Control |
30 mg/kg |
30 mg/kg |
60 mg/kg |
60 mg/kg |
120 mg/kg |
120 mg/kg |
Total Animals/Sex Affected / Mean Severity |
(3) M |
(3) F |
(5) M |
(5) F |
(3) M |
(3) F |
(3) M |
(3) F |
Inflammation, forestomach |
0 |
0 |
0 |
0 |
0 |
1/2.0 |
0 |
0 |
Erosion, glandular stomach |
0 |
0 |
0 |
0 |
1/2.0 |
0 |
0 |
0 |
Ulceration, forestomach/ Glandular stomach |
0 |
0 |
1/3.0 |
0 |
1/3.0 |
0 |
2/3.5 |
0 |
Ulceration, glandular stomach |
0 |
0 |
2/1.5 |
2/2.0 |
0 |
1/3.0 |
1/3.0 |
3/2.0 |
Table6: Time of death after last application and related major pathology
Group Males |
Animal No. |
Time after last application (h:min) |
Number of Applications |
Main Findings |
2 |
4 |
06:42 |
2 |
Necrotizing inflammation in esophagus, Stomach ulceration |
2 |
5 |
06:20 |
2 |
Necrotizing inflammation in esophagus, Stomach ulceration |
2 |
6 |
06:46 |
2 |
Necrotizing inflammation in esophagus |
2 |
7 |
06:39 |
2 |
Necrotizing inflammation in esophagus |
2 |
8 |
06:49 |
2 |
Stomach ulceration |
3 |
9 |
1: 58 |
1 |
Mucosal degeneration in esophagus |
3 |
10 |
02:38 |
2 |
Necrotizing inflammation in esophagus, Stomach ulceration |
3 |
11 |
01:41 |
2 |
Mucosal degeneration in esophagus Necrotizing inflammation in trachea |
4 |
12 |
02:40 |
2 |
Mucosal degeneration in esophagusStomach ulceration |
4 |
13 |
02:13 |
1 |
Mucosal degeneration in esophagus,Stomach ulceration |
4 |
14 |
01:44 |
2 |
Mucosal degeneration in esophagusNecrotizing inflammation in trachea Stomach ulceration |
Table7: Time of death after last application and related major pathology
Group Females |
Animal No. |
Time after last application (h:min) |
Number of Applications |
Main Findings |
2 |
18 |
18:24 |
1 |
Necrotizing inflammation in esophagus, Stomach ulceration |
2 |
19 |
06:23 |
2 |
Necrotizing inflammation in esophagus Necrotizing inflammation in trachea |
2 |
20 |
06:49 |
2 |
Necrotizing inflammation in esophagus |
2 |
21 |
06:53 |
2 |
Necrotizing inflammation in esophagus |
2 |
22 |
06:54 |
2 |
Stomach ulceration |
3 |
23 |
18:07 |
1 |
Necrotizing inflammation in esophagus Necrotizing inflammation in trachea |
3 |
24 |
02:55 |
2 |
Necrotizing inflammation in esophagus Stomach inflammation |
3 |
25 |
18:19 |
1 |
Mucosal degeneration in esophagus Stomach ulceration |
4 |
26 |
02:54 |
2 |
Mucosal degeneration in esophagus,Stomach ulceration |
4 |
27 |
02:53 |
2 |
Necrotizing inflammation in esophagus, Stomach ulceration |
4 |
28 |
02:34 |
2 |
Necrotizing inflammation in esophagusStomach ulceration |
Applicant's summary and conclusion
- Conclusions:
- Trichloro(propyl)silane was tested in a regulatory driven 7-day dose range-finding study (non-GLP) in order to determine the feasibility of dosing chlorosilanes (at low doses to avoid corrosive effects) in repeated dose oral toxicity tests. In this study a NOAEL could not be determined due to the corrosive effects of the test substance on the gastrointestinal and respiratory tracts. All animals administered the tests substance were sacrificed on study day 2 due to ethic reasons. The findings at pathology and histophathology showed signs of corrosion which was considered to be related to the hydrolysis product hydrocloric acid.
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