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EC number: - | 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
Endpoint summary
Administrative data
Description of key information
Repeated dose toxicity: Oral
A 2-week range-finding rat oral study found some evidence of toxicity at 600 mg/kg bw/day but no clear effects at 200 mg/kg bw/day. Dose levels of 70, 200 and 600 mg/kg bw/day were selected for the 90-day oral toxicity study.
Repeated dose toxicity: inhalation
a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Repeated dose toxicity: dermal
The acute dermal toxicity value for the test substance (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver.
Key value for chemical safety assessment
- Toxic effect type:
- dose-dependent
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: oral, other
- Type of information:
- experimental study
- Remarks:
- Read across data
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- secondary literature
- Justification for type of information:
- Data is from secondary source
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- September 1998
- GLP compliance:
- not specified
- Limit test:
- no
- Species:
- rat
- Strain:
- other: Crl:CD(SD)BR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Epona Associates, LLC
- Females (if applicable) nulliparous and non-pregnant: [yes/no] : no data available
- Age at study initiation: 7 week
- Weight at study initiation: males ; 213 - 279 , females : 150 - 207
- Fasting period before study: no data available
- Housing: no data available
- Diet (e.g. ad libitum): no data available
- Water (e.g. ad libitum): no data available
- Acclimation period: no data available
DETAILS OF FOOD AND WATER QUALITY:
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data available
- Humidity (%): no data available
- Air changes (per hr): no data avaialble
- Photoperiod (hrs dark / hrs light): no data available
IN-LIFE DATES: From: To: - Route of administration:
- oral: gavage
- Vehicle:
- peanut oil
- Details on oral exposure:
- The test article in the vehicle, peanut oil, was administered orally by gavage to three groups of rats (five/sex) for 14 consecutive days at dosage levels of 70, 200 and 600 mg/kg bw/day. A concurrent control group received the vehicle on a comparable regimen. All animals were dosed at a volume of 10 mL/kg bw.
- Details on analytical verification of doses or concentrations:
- 70, 200 and 600 mg/kg/day
- Duration of treatment / exposure:
- 90 days
- Frequency of treatment:
- Daily
- Dose / conc.:
- 70 mg/kg bw/day (nominal)
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Dose / conc.:
- 600 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5/sex/dose
- Control animals:
- yes, concurrent vehicle
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes / No / Not specified : yes
- Time schedule: twice daily
- Cage side observations checked in table [No.?] were included.
DETAILED CLINICAL OBSERVATIONS: Yes / No / Not specified : Yes
- Time schedule: Weekly
BODY WEIGHT: Yes / No / Not specified : Yes
- Time schedule for examinations: Weekly
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): no data available
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes / No / Not specified : no data avaiable
- Compound intake calculated as time-weighted averages from the consumption and body weight gain data: Yes / No / Not specified : no data avaiable
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: Yes / No / Not specified : no data avaiable
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / Not specified : no data available
- Time schedule for examinations:
OPHTHALMOSCOPIC EXAMINATION: Yes / No / Not specified : NO
- Time schedule for examinations:
- Dose groups that were examined:
HAEMATOLOGY: Yes / No / Not specified : NO
- Time schedule for collection of blood:
- Anaesthetic used for blood collection: Yes (identity) / No / Not specified
- Animals fasted: Yes / No / Not specified
- How many animals:
- Parameters checked in table [No.?] were examined.
CLINICAL CHEMISTRY: Yes / No / Not specified
- Time schedule for collection of blood:
- Animals fasted: Yes / No / Not specified
- How many animals:
- Parameters checked in table [No.?] were examined.
PLASMA/SERUM HORMONES/LIPIDS: Yes / No / Not specified
- Time of blood sample collection:
- Animals fasted: Yes / No / Not specified
- How many animals:
URINALYSIS: Yes / No / Not specified
- Time schedule for collection of urine:
- Metabolism cages used for collection of urine: Yes / No / Not specified
- Animals fasted: Yes / No / Not specified
- Parameters checked in table [No.?] were examined.
NEUROBEHAVIOURAL EXAMINATION: Yes / No / Not specified
- Time schedule for examinations:
- Dose groups that were examined:
- Battery of functions tested: sensory activity / grip strength / motor activity / other:
IMMUNOLOGY: Yes / No / Not specified
- Time schedule for examinations:
- How many animals:
- Dose groups that were examined:
- Parameters checked in table [No.?] were examined.
OTHER: - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- All analyses were conducted using two-tailed tests for minimum significance levels of 1% and 5% comparing the test article-treated groups to the control group by sex. All means were presented with standard deviations (S.D.) and the number of sampling units (N) used to calculate the means. Statistical analyses were not conducted if the number of animals was two or less. All statistical tests were performed by a Digital® MicroVAX® 3400 computer with appropriate programming. Body weight, body weight change, food consumption, clinical pathology, and absolute and relative organ weight data were subjected to a one-way analysis of variance (ANOVA), followed by Dunnett's test.
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- The only definite test article-related clinical observations were signs of abnormal respiration (rales and/or labored respiration) in the 600 mg/kg bw/day group. These findings were noted in two males and two females during the last three days of dosing and/or prior to necropsy. Another female in the 600 mg/kg bw/day group had rales on one occasion during this period.
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- At 600 mg/kg bw/day, males had a reduction in the body weight, however, it was not a statistically significant difference.
- Food consumption and compound intake (if feeding study):
- effects observed, non-treatment-related
- Description (incidence and severity):
- At 600 mg/kg bw/day, males had a reduction in the food consumption, however, it was not a statistically significant difference.
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Endocrine findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Immunological findings:
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Other effects:
- not specified
- Dose descriptor:
- LOAEL
- Effect level:
- 600 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- gross pathology
- Dose descriptor:
- NOAEL
- Effect level:
- 200 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- gross pathology
- Critical effects observed:
- no
- Conclusions:
- A 2-week range-finding rat oral study found some evidence of toxicity at 600 mg/kg bw/day but no clear effects at 200 mg/kg bw/day. Dose levels of 70, 200 and 600 mg/kg bw/day were selected for the 90-day oral toxicity study.
- Executive summary:
A repeated dose 90 days toxicity study of 3-aminopropyltriethoxysilane (CAS no: 919-30-2 ) was performed in rats with strain Crl:CD(SD)BR. The test substance was administered orally in peanut oil at dosage levels for 70, 200 and 600 mg/kg/day for 90 day. In the key 90-day oral repeated dose toxicity study, the high dose of 600 mg/kg bw/day was not well tolerated by a number of animals which were terminated prior to the scheduled necropsy. The main findings at this dose were clinical signs (rales and poor clinical condition), changes in some liver enzyme values, and/or an increase in mean relative liver weights (males only) and microscopic changes of hepatocellular vacuolation in the liver (males only). Based on these findings the NOAEL was defined as the intermediate dose of 200 mg/kg bw/day. The study was conducted according to OECD Test Guideline 408 and in compliance with GLP. In a supporting 14-day oral range-finding study conducted at the same doses that preceded the 90-day study, similar clinical signs and hepatic changes were recorded.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 200 mg/kg bw/day
- Study duration:
- subchronic
- Species:
- rat
- Quality of whole database:
- Data is from secondary source
Repeated dose toxicity: inhalation - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: inhalation, other
- Data waiving:
- exposure considerations
- Justification for data waiving:
- a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Reference
Endpoint conclusion
- Quality of whole database:
- Waiver
Repeated dose toxicity: dermal - systemic effects
Link to relevant study records
- Endpoint:
- repeated dose toxicity: dermal, other
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Reference
Endpoint conclusion
- Quality of whole database:
- Waiver
Additional information
Repeated dose toxicity: Oral
Study 1: A repeated dose 90 days toxicity study of 3-aminopropyltriethoxysilane (CAS no: 919-30-2 ) was performed in rats with strain Crl:CD(SD)BR. The test substance was administered orally in peanut oil at dosage levels for 70, 200 and 600 mg/kg/day for 90 day. In the key 90-day oral repeated dose toxicity study, the high dose of 600 mg/kg bw/day was not well tolerated by a number of animals which were terminated prior to the scheduled necropsy. The main findings at this dose were clinical signs (rales and poor clinical condition), changes in some liver enzyme values, and/or an increase in mean relative liver weights (males only) and microscopic changes of hepatocellular vacuolation in the liver (males only). Based on these findings the NOAEL was defined as the intermediate dose of 200 mg/kg bw/day. The study was conducted according to OECD Test Guideline 408 and in compliance with GLP. In a supporting 14-day oral range-finding study conducted at the same doses that preceded the 90-day study, similar clinical signs and hepatic changes were recorded.
Study 2: The test substance was tested for the repeated dose toxicity via oral route in rats. 10 rats per sex per dose of Sprague-Dawley strain were treated with the test substance. Rats were treated at the dose concentraion 0, 25, 125, and 500 mg/kg bw/day. No treatment related adverse effects were observed at the highest dose of 500 mg/kg bw/day. Hence, the No Observed Adverse Effect Level (NOAEL) can be considered to be greater than 500 mg/kg bw/day.
Repeated dose toxicity: inhalation
a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment
Repeated dose toxicity: dermal
The acute dermal toxicity value for the test substance (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver.
Justification for classification or non-classification
Based on the data available for the target chemical, the test chemical does not show repeated dose toxicity by oral route of exposure. Hence the test chemical is not likely to be toxic upon repeated exposure by oral route, dermal and inhalation route of exposure.
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