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EC number: 213-050-5 | CAS number: 919-31-3
- 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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2004-09-06 to 2004-10-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
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: USEPA OPPTS 870.3650
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 422
- Version / remarks:
- 1996
- Deviations:
- no
- 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
- Molecular formula:
- C9H19NO3Si
- IUPAC Name:
- 3-(triethoxysilyl)propanenitrile
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HanBrl:WIST (SPF)
- 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 continuously 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 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 (dried corn oil)
- 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.
- Details on mating procedure:
- After a pre-pairing period of 14 days, males and females in the Reproductive groups were paired overnight, in the ratio of 1 male to 1 female. The female was placed with the same male until mating occurred or two weeks had elapsed. The day on which spermatozoa was observed was designated day 0 post coitum. After mating was ascertained, the animals were separated and housed individually. The females were allowed to litter and rear their progeny to day 4 of lactation.
- Duration of treatment / exposure:
- Pre-mating (14 days), mating, gestation, and postpartum days 1-3 for a maximum total of 44 days depending on duration of mating phase.
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (actual dose received)
- Remarks:
- Group 1
- Dose / conc.:
- 100 mg/kg bw/day (actual dose received)
- Remarks:
- Group 2
- Dose / conc.:
- 500 mg/kg bw/day (actual dose received)
- Remarks:
- Group 3
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- Remarks:
- Group 4
- No. of animals per sex per dose:
- 10/sex/dose
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Sex: male/female
Duration of test: up a maximum total of 44 days
Animals of both sexes received test article for 14 days prior to pairing and during pairing period. Daily dosing of the females was continued throughout pregnancy and up to day 3 of lactation. Males were dosed for a minimum of 28 days.
Examinations
- Maternal examinations:
- The dams and pups were observed daily for survival and behavioural abnormalities in nursing. No tissues were collected from the dams or pups for microscopic examination.
- Ovaries and uterine content:
- Organs examined at necropsy (macroscopic and microscopic): The number of implantation sites and corpora lutea were determined at necropsy.
- Fetal examinations:
- Pup litter size, any gross abnormalities and weight, sex ratios, pup viability, litter weight gain, and macroscopic observations. The dams and pups were observed daily for survival and behavioural abnormalities in nursing. Macroscopic examination was performed at necropsy for the pups. No tissues were collected from the dams or pups for microscopic examination.
- Statistics:
- Statistical methods: Mean and standard deviations of data of various parameters 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. For pup data, the litter is the appropriate unit for statistical comparison. Statistically significant probabilities are reported at either the p<0.05 or p<0.01 levels.
- Indices:
- Gonadal function, mating behaviour, conception, development of the conceptus and parturition
Results and discussion
Results: maternal animals
General toxicity (maternal animals)
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- Commencing around day 14 of gestation and for the duration of the remaining treatment period, all females of the high dose group showed signs of discomfort after administration of the test article (pushing head through bedding material).
During this period, stretched forelimbs were noted on single or few days in six females.
For four females, saltatory spasms were noted for up to few days. These clinical signs were considered to be test item-related. - Dermal irritation (if dermal study):
- not examined
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effects were observed in mean absolute or mean weight gains in any of the treated groups.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Mean food consumption was similar in all groups and not affected from treatment.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- 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:
- no effects observed
- Description (incidence and severity):
- No macroscopic findings were noted during macroscopic examination.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
Maternal developmental toxicity
- Number of abortions:
- no effects observed
- Pre- and post-implantation loss:
- no effects observed
- Description (incidence and severity):
- The mean number of implantations per litter and post-implantation loss were unaffected by treatment. The mean numbers of implantations per dam were 13.7, 13.5, 14.2 and 13.6 in order of ascending dose level. The mean incidence of post-implantation loss as a percentage of total implantations was 10.2, 10.4, 4.9 and 12.3% in order of ascending dose level.
- Total litter losses by resorption:
- no effects observed
- Early or late resorptions:
- not specified
- Dead fetuses:
- no effects observed
- Description (incidence and severity):
- Neonatal mortality was generally low and not affected by treatment with the test item. The total numbers of pup loss during the first four days of life were 1, 2, 3 and 3 in order of ascending dose level, corresponding to 0.8, 1.7, 2.2 and 2.8% of living pups.
- Changes in pregnancy duration:
- no effects observed
- Description (incidence and severity):
- The duration of gestation was unaffected by treatment. Mean duration of gestation was 21.6, 21.6, 21.7 and 21.7 days, in order of ascending dose level.
- Changes in number of pregnant:
- no effects observed
- Description (incidence and severity):
- Number of pregnant per dose level: 10, 10, 10 and 9 (one female was not pregnant) for 0, 100, 500 and 1000 mg/kg bw/day
- Other effects:
- not specified
Effect levels (maternal animals)
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: no adverse findings related to development in maternal animals
- Dose descriptor:
- NOAEL
- Effect level:
- ca. 100 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- histopathology: non-neoplastic
- organ weights and organ / body weight ratios
Results (fetuses)
- Fetal body weight changes:
- no effects observed
- Reduction in number of live offspring:
- no effects observed
- Description (incidence and severity):
- Neonatal mortality was generally low and not affected by treatment with the test item. The total numbers of pup loss during the first four days of life were 1, 2, 3 and 3 in order of ascending dose level, corresponding to 0.8, 1.7, 2.2 and 2.8% of living pups.
- Changes in sex ratio:
- no effects observed
- Changes in litter size and weights:
- no effects observed
- Changes in postnatal survival:
- no effects observed
Effect levels (fetuses)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: based on no adverse developmental effects in pups
Fetal abnormalities
- Abnormalities:
- no effects observed
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
Reproduction data: Summary of performance
Table 1: F0 animals breeding for F1 Litters
Group (mg/kg/day) | 1 (0) | 2 (100) | 3 (500) | 4 (1000) |
Number of females paired | 10 | 10 | 10 | 10 |
Number of females mated | 10 | 10 | 10 | 10 |
Number of pregnant females | 10 | 10 | 10 | 9 (A) |
Number of females delivering pups | 10 | 10 | 10 | 9 |
Number of females with live pups on day 4 post-partum | 10 | 10 | 10 | 9 |
(A) = Female No 79 was not pregnant
Applicant's summary and conclusion
- Conclusions:
- In a combined repeated dose oral toxicity study with the reproduction/developmental toxicity screening test with the registered substance 3-(triethoxysilyl)propiononitrile, conducted according to OECD Test Guidelines 422 and in compliance with GLP, the NOAEL for developmental toxicity was concluded to be greater than or equal to 1000 mg/kg bw/day based on no treatment-related effects observed in any of the developmental parameters evaluated.
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