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EC number: 204-710-3 | CAS number: 124-70-9
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on generations indicated in Effect levels (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- Not provided
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study but some basic information regarding the study is not available.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Combined Repeated Dose and Reproductive / Developmental Toxicity Screening Test (Precursor Protocol of GL 422)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Trimethoxyvinylsilane
- EC Number:
- 220-449-8
- EC Name:
- Trimethoxyvinylsilane
- Cas Number:
- 2768-02-7
- IUPAC Name:
- trimethoxy(vinyl)silane
- Details on test material:
- Purity 100%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: T23-48:Crl:CD(SD)IGS
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on exposure:
- Exposure period: Pre-mating period (14 days), during mating and post-mating up to 43 days for males; pre-mating (14 days) and mating period, during pregnancy and lactation, until day 4 post-partum for females
- Details on mating procedure:
- Not available
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- Premating exposure period (males): 14 days prior to mating
Premating exposure period (females): 14 days prior to mating
Duration of test: Males: 43 days; Females: day 4 of lactation - Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
62.5, 250 and 1000 mg/kg bw/day in corn oil (vehicle)
Basis:
nominal conc.
- No. of animals per sex per dose:
- male (6/dose group) and female (12/dose group)
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Male (6/dose group) and female (12/dose group) Crl:CD(SD)IGS rats were dosed by oral gavage once a day at 0 (corn oil), 62.5, 250, and 1000 mg/kg bw/day, throughout the pre-mating period (14 days), during the mating and post-mating periods until final sacrifice for the males (at 43 days) and throughout pre-mating (14 days) and mating period, during pregnancy and lactation, until day 4 post-partum inclusive for the females (Hashima, year not available).
Post-exposure period: Yes, for a sub group of males and females for 14 days
Additional details regarding this study are provided in section 7.5.1.
Examinations
- Parental animals: Observations and examinations:
- Regarding reproductive toxicity, the number of estrous cases, number of conceiving days, number of pregnant females, gestation length, delivery conditions, nursing conditions, number of corpora lutea, number of implantation sites, and the implantation rate were evaluated.
Additional details regarding this study are provided in section 7.5.1. - Litter observations:
- Regarding the pups, the number of births, number of stillbirths, number of pups born, and general signs were examined.
- Reproductive indices:
- The copulation index, fertility index, and gestation index were assessed.
- Offspring viability indices:
- Regarding the pups, delivery index, birth index, and live birth index were assessed.
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- effects observed, treatment-related
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- no effects observed
Details on results (P0)
Additional details provided in section 7.5.1
Effect levels (P0)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male
- Basis for effect level:
- other: No effects on reproductive performance.
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (nominal)
- Sex:
- female
- Basis for effect level:
- other: Low number of estrous cases.
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- no effects observed
- Mortality / viability:
- no mortality observed
Details on results (F1)
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: No effects were noted.
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The NOAELs for reproductive performance of parental animals were estimated to be 1000 mg/kg bw/day for males and 250 mg/kg bw/day for females. The NOAEL for offspring was 1000 mg/kg bw/day.
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