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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
Endpoint summary
Administrative data
Key value for chemical safety assessment
Effects on fertility
Description of key information
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 Guideline 422 and in compliance with GLP, a NOAEL for maternal and reproductive toxicity was concluded to be = 1000 mg/kg bw/day based on no treatment-related effects observed in any of the reproductive parameters evaluated (RCC Ltd, 2005).
Link to relevant study records
- Endpoint:
- one-generation reproductive 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
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test)
- Version / remarks:
- 1996
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: USEPA OPPTS 870.3650
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- 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 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. - 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)
- Details on mating procedure:
- Females were paired with males (1:1) from the same treatment group until evidence of mating was obtained (vaginal plug or sperm-positive vaginal smear). Length of cohabitation did not exceed 14 days.
- 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:
- Exposure period: Premating (14 days), mating, gestation, and postpartum days 1-3 for a maximum total of 44 days depending on duration of mating phase.
Premating exposure period (males): 14 days
Premating exposure period (females): 14 days
Duration of test: up to a maximum of 44 days - Frequency of treatment:
- daily
- Details on study schedule:
- 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.
- 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/group
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- 3-(Triethoxysilyl)propiononitrile was administered once daily orally (by gavage) to 10 males and 20 females (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.
Details on mating: 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. - Parental animals: Observations and examinations:
- Parameters assessed during study (maternal and fetal): Maternal body weight, food consumption, and clinical observations.
Clinical observations performed and frequency: General clinical observations were made twice daily to assess external condition, behaviour and mortality/morbidity. Detailed clinical observations were conducted weekly and were performed after the exposure period. Examinations included assessment of external condition, behaviour, autonomic activity, gait and posture. Additionally, the females were observed for signs of difficult or prolonged parturition. The dams were observed daily for survival and behavioural abnormalities in nesting. - Litter observations:
- Live birth, stillbirth, any gross abnormalities and weight, litter weight gain, and macroscopic observations were noted.
- Postmortem examinations (parental animals):
- Organs examined at necropsy (macroscopic and microscopic): The number of implantation sites and corpora lutea were determined at necropsy.
- Postmortem examinations (offspring):
- Live birth, stillbirth, any gross abnormalities and weight, litter weight gain, and macroscopic observations were noted.
- 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. Statistically significant probabilities are reported at either the p<0.05 or p<0.01 levels.
- Reproductive indices:
- Gonadal function, mating behavior, conception, development of the conceptus and parturition
- 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.
- 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. There was a tendency towards slightly higher food consumption in Group 4 but that was considered to be incidental and of no toxicological relevance.
- 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):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
- Reproductive function: oestrous cycle:
- no effects observed
- Description (incidence and severity):
- The mean number of corpora lutea per dam (determined at necropsy) was similar in all groups (24.1, 23.5, 23.5 and 24.7 in order of ascending dose level) and gave no indication of a test item-related effect.
- Reproductive function: sperm measures:
- not specified
- Reproductive performance:
- no effects observed
- Description (incidence and severity):
- All females were mated within seven days. The median and mean precoital times were unaffected by treatment with the test item. The fertility rate was generally high and calculated fertility indices were similar in all groups. The gestation index was 100% in all groups.
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse findings for reproductive parameters
- Dose descriptor:
- NOAEL
- Effect level:
- 100 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- organ weights and organ / body weight ratios
- histopathology: non-neoplastic
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- No abnormal findings were noted at first litter check or during the first 4 days post-partum. Sex ratios were unaffected by treatment at first litter check and during the first four days post-partum.
- Mortality / viability:
- no mortality observed
- Description (incidence and severity):
- The number of live pups at first litter check was unaffected by treatment with the test item. The mean number of live pups per litter check was 12.3, 12.1, 13.5 and 11.9 in order of ascending dose level. Neonatal mortality was generally low and not affected by treatment with the test item.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- Mean pup weights at day 0 and day 1 post-partum were unaffected by treatment with the test item
- Food consumption and compound intake (if feeding study):
- not examined
- 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
- Sexual maturation:
- not examined
- Anogenital distance (AGD):
- not examined
- Nipple retention in male pups:
- 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 necropsy of F1 pups.
- Histopathological findings:
- not examined
- Other effects:
- not specified
- Behaviour (functional findings):
- not examined
- Developmental immunotoxicity:
- not examined
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no reproductive toxicity for F1 animals
- Reproductive effects observed:
- no
- 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, a NOAEL for reproductive 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 reproductive parameters evaluated in males and females animals.
Reference
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
Effect on fertility: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
The key study for reproductive toxicity is the only study available for this endpoint.
In this combined repeated dose oral toxicity study with the reproduction/developmental toxicity screening test, conducted according to OECD Test Guideline 422 and in compliance with GLP, 3-(triethoxysilyl)propiononitrile was administered orally by gavage to rats at dosages of 0, 100, 500 and 1000 mg/kg bw/day. Males and females of the toxicity group were treated for 28 days, females of the reproductive groups were treated for two weeks prior to pairing, during gestation and until day 3 of the lactation period.
There were no treatment-related effects on precoital time, fertility indices, mean duration of gestation, number of implantations, post-implantation loss, pup survival or litter size from birth through scheduled sacrifice on day 4 post-partum at any dosage. Based on the results of this screening study, the NOAEL for reproductive toxicity of 3-(triethoxysilyl)propiononitrile in the rat via oral dosing was determined to be greater than or equal to 1000 mg/kg bw/day (RCC Ltd, 2005)
Effects on developmental toxicity
Description of key information
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 Guideline 422 and in compliance with GLP, a NOAEL for maternal and developmental toxicity was concluded to be =1000 mg/kg bw/day based on no treatment-related effects observed in any of the developmental parameters evaluated (RCC Ltd, 2005)
Link to relevant study records
- 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
- 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
- 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. - 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
- 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. - 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
- 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
- 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
- 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
- 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
- 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
- Abnormalities:
- no effects observed
- Developmental effects observed:
- no
- 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.
Reference
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
Effect on developmental toxicity: via oral route
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Additional information
The key study for developmental toxicity is the only study available for this endpoint.
In this combined repeated dose oral toxicity study with the reproduction/developmental toxicity screening test, conducted according to OECD Test Guideline 422 and in compliance with GLP, 3-(triethoxysilyl)propiononitrile was administered orally by gavage to rats at dosages of 0, 100, 500 and 1000 mg/kg bw/day. Males and females of the toxicity group were treated for 28 days, females of the reproductive groups were treated for two weeks prior to pairing, during gestation and until day 3 of the lactation period.
No abnormal findings were noted for pups at first litter check or during the first 4 days post-partum. Sex ratios at first litter check and on day 4 post-partum were unaffected by treatment with the test item. Mean pup weights on day 0 and day 1 post-partum were unaffected by treatment with the test item. Mean pup weight development during the first 4 days post-partum lactation was unaffected by treatment with the test item. No macroscopic findings were noted during necropsy of F1 pups.
Based on the results of this screening study, the NOAEL for developmental toxicity of 3-(triethoxysilyl)propiononitrile in the rat via oral dosing was determined to be greater than or equal to 1000 mg/kg bw/day (RCC Ltd, 2005)
Justification for classification or non-classification
Based on the available data 3-(triethoxysilyl)propiononitrile is not classified for reproductive or developmental toxicity according to Regulation (EC) No 1272/2008
Additional information
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.