Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 213-986-4 | CAS number: 1071-22-3
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- not known
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in accordance with an appropriate OECD test guideline and in compliance with GLP, using a related test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
- Report date:
- 2005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: OECD TG 422
- Qualifier:
- according to guideline
- Guideline:
- other: USEPA OPPTS 870.3650
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 3-(triethoxysilyl)propiononitrile
- EC Number:
- 213-050-5
- EC Name:
- 3-(triethoxysilyl)propiononitrile
- Cas Number:
- 919-31-3
- IUPAC Name:
- 3-(triethoxysilyl)propanenitrile
- Details on test material:
- 3-(triethoxysilyl)propanenitrile (CAS # 919-31-3); purity
was >97.8 %
Lot 4A-4363-BS
Colorless to clear liquid
expiration 18-APR-2005
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HanBrl:WIST (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Rats were obtained from RCC Ltd Laboratory Animal Services, Fullinsdorf, Switzerland.
Animals were a minimum of 8 weeks of age at delivery. Males were 227-271 grams and females were 165-216 grams. Animals were acclimated for 7 days prior to pairing, under test conditions with an evaluation of the health status. Animals rooms were air conditioned with 10-15 air changes per hour; the environment was monitored continously with recordings of temperature and relative humidity, 12 hours artificial fluorescent light/12 hours dark with background music played at a centrally defined low volume for at least 8 hours during the light period. Animals were housed in Makrolon (R) cages with wire mesh tops and standard granulated softwood bedding. Pelleted standard rat/mouse maintenance diet was available ad libitum. Tap water from Fullinsdorf in bottles was available ad libitum.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test item was administered once daily, by gavage. All animals received a dose volume of 2 ml/kg body weight with a daily adjustment of the individual volume to the actual body weight. Control animals were dosed with the vehicle alone.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Samples for determination of actual test item concentrations, stability (7 day) and homogeneity in the prepared mixtures were taken on the first day of preparation. Samples for determination of actual test item concentrations and homogeneity were also taken on one occasion during the gestation period. Analysis were performed using a Gas Chromatographic method.
- Duration of treatment / exposure:
- Males and toxicity group females: at least 28 days; Reproductive group females: throughout the pre-pairing (14 day), pairing and gestation periods until day 3 of lactation
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100, 500, and 1000 mg/kg bw/day
Basis:
- No. of animals per sex per dose:
- 10 males/20 females/group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- The test substance was administered once daily orally (by gavage) to 10 males and 20 female (10 toxicity group and 10 reproductive group females) rats at doses of 100, 500 and 1000 mg/kg bw/day. A concurrent vehicle control group (dried corn oil) was also included. Males and toxicity
group females were sacrificed after they had been treated for at least 28 days; reproductive group females were dosed throughout the
prepairing (14 day), pairing and gestation periods until day 3 of lactation up to a maximum of 44 days; reproductive group females and
pups were sacrificed on day 4 of lactation.
Examinations
- Observations and examinations performed and frequency:
- All animals were observed at least twice daily to assess external condition, behavior and mortality/morbidity. Detailed clinical observations
were conducted outside the home cage once prior to the first test item administration and weekly thereafter. The FOB evaluation was
performed on all adult males and all toxicity group females prior to the start of dosing and during the last week of dosing. Body weights and
food consumption were recorded weekly. From all males and all toxicity group females, blood samples were obtained on the day of scheduled
necropsy for hematology and clinical chemistry parameters evaluations. - Sacrifice and pathology:
- Organs examined at necropsy (macroscopic and microscopic): Animals were subjected to a complete gross necropsy that included
examination of the cranial, thoracic, and abdominal cavities and their contents. Tissues and organs were collected for histological
examination. The following organs were collected for males and females and weighed: adrenals, brain, heart, kidneys, liver, lungs,
spleen, thymus, uterus, ovaries, testes, prostate, seminal vesicles, and epididymides. - Statistics:
- Statistical Methods: Mean and standard deviation of data were calculated. Univariate one-way analysis of variance was used to assess the
significance of intergroup differences. Dunnett t-test, based on a pooled variance estimate, was used for intergroup comparisons. The
Steel test (rank test) was applied when the data could not be assumed to follow a normal distribution. Fisher's Exact test for 2x2 tables
was applied if the variables could be dichotomized without loss of information. Quantitative data were used by a one-way analysis of
variance (ANOVA) when the variance were considered homogeneous according to Bartlett. Alternatively, if the variances were considered
to be heterogeneous, a non-parametric Kruskal-Wallis was used. Treated group were then compared to the control groups using Dunnett
test. Statistically significant probabilities are reported at either the p<0.05 or p<0.01 levels.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Haematological findings:
- effects observed, treatment-related
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Details on results:
- Oral administration of 3-(triethoxysilyl)propanenitrile to male and toxicity group female rats at concentrations of 1000 mg/kg/day for 28
consecutive days was generally well tolerated. No effects were observed in the body weight and food consumption. None of the parameters
under investigation during the FOB gave any indication of treatment-related effects. Increased organ weights (kidneys, spleen, heart and liver
in males; kidneys and spleen in toxicity group females), slight reduction in red cell count (not statistically significant), hemoglobin
concentration and hematocrit in males and toxicity group females and histopathological changes in kidneys (chronic tubular lesions of minimal
to moderate severity with hyperplasia of the renal pelvis epithelium and renal pyelonephritis) were noted in males and toxicity group females
dosed at 1000 mg/kg bw/day.
Administration of 500 mg/kg bw/day resulted in increased organ weights (kidneys, heart and liver in males only) and histopathological changes in
kidneys including chronic tubular lesions, hyperplasia of the renal pelvis epithelium and renal pyelonephritis (males and toxicity group females)
and spleen including extramedullary hematopoiesis (males only).
Administration of 100 mg/kg bw/day resulted in increased liver weight in males. In the absence of a histopathologic correlate the increased liver
weight was considered most probably of adaptive nature and therefore of no adverse character.
Based on these data, the No Observed Adverse Effect Level (NOAEL) for toxicity of 3-(triethoxysilyl)propanenitrile was considered to be 100
mg/kg bw/day.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (nominal)
- Sex:
- male/female
- Dose descriptor:
- LOAEL
- Effect level:
- 500 mg/kg bw/day (nominal)
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
ABSOLUTE MEAN LIVER WEIGHT in grams (St. Dev.):
Males:
0 mg/kg: 9.40 (0.52)
100 mg/kg: 10.25 (0.93)
500 mg/kg: 10.33* (0.73)
1000 mg/kg: 10.26 (1.03)
Toxicity group females:
0 mg/kg: 6.31 (0.48)
100 mg/kg: 6.05 (0.51)
500 mg/kg: 6.26 (0.46)
1000 mg/kg: 6.76 (0.50)
RELATIVE MEAN LIVER/BODY WEIGHT in grams (St. Dev.):
Males:
0 mg/kg: 2.66 (0.12)
100 mg/kg: 2.86 (0.19)
500 mg/kg: 2.98** (0.13)
1000 mg/kg: 2.95** (0.23)
Toxicity group females:
0 mg/kg: 2.91 (0.27)
100 mg/kg: 2.80 (0.23)
500 mg/kg: 2.89 (0.20)
1000 mg/kg: 3.13 (0.14)
RELATIVE MEAN LIVER/BRAIN WEIGHT in grams (St. Dev.):
Males:
0 mg/kg: 464.83 (31.38)
100 mg/kg: 510.76* (43.28)
500 mg/kg: 519.72* (32.61)
1000 mg/kg: 507.52 (52.15)
Toxicity group females:
0 mg/kg: 334.47 (18.01)
100 mg/kg: 329.74 (35.48)
500 mg/kg: 339.49 (20.97)
1000 mg/kg: 358.50 (22.19)
Where:
*/**: Dunnett-test based on pooled variance sig. at 5% or 1% level, respectively.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, the NOAEL for
3-(triethoxysilyl)propanenitrile in the rat via the oral
route was determined to be 100
mg/kg bw/day.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.