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EC number: 200-917-8 | CAS number: 75-94-5
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 1993
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to an appropriate OECD test guideline and in compliance with GLP, using a closely related test substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OTS 798.4350 (Inhalation Developmental Toxicity Screen)
- 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
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD(R)
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The analytically determined concentrations of A-171 vapor were 24.6, 96.7 and 312.0 ppm for target concentrations of 25, 100 and 300 ppm, respectively.
- Details on mating procedure:
- Mating not performed; timed-pregnant CD® rats were exposed during gestation
- Duration of treatment / exposure:
- gestation days 6-15
- Frequency of treatment:
- 6 hours/day
- Duration of test:
- Up to gestation day 21
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
25, 100 and 300 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
24.6, 96.7 and 312.0 ppm
Basis:
analytical conc.
- Remarks:
- Doses / Concentrations:
ca. 0.15, 0.60, and 1.8 mg/L
Basis:
other: conversion of analytical concentration to mg/L
- No. of animals per sex per dose:
- 25 timed-pregnant CD® rats/dose level
- Control animals:
- yes
- Details on study design:
- Four groups, each consisting of 25 timed-pregnant CD® rats, were exposed to A-171 (vinyltrimethoxysilane; CAS No. 2768-02-7) vapor or filtered air for 6 hours/day on gestational days (gd) 6 through 15. Target concentrations of A-171 were 0 (control), 25, 100, and 300 ppm. The dams were sacrificed on gestation day 21.
Examinations
- Maternal examinations:
- Clinical observations were made daily. In addition, each group of dams was observed from outside their respective exposure chambers for overt clinical signs during the actual exposures. Body weights were measured on gd 0, 6, 9, 12, 15, 18 and 21. Maternal food consumption was measured at
3-day intervals throughout gestation. At scheduled sacrifice on gd 21, the dams were evaluated for body weight, liver and kidney weights, and gravid uterine weight, . Maternal liver, kidneys, and the upper and lower respiratory tract were retained in 10% neutral buffered formalin. - Ovaries and uterine content:
- The number of corpora lutea, and number and status of implantation sites (including early and late resorptions, dead fetuses, and live fetuses) were evaluated.
- Fetal examinations:
- All live and dead fetuses were dissected from the uterus, weighed and examined externally for malformations, variations, and gender determinations.
Approximately one-half of the live fetuses in each litter were examined for visceral and craniofacial malformations and variations. The remaining one-half of the fetuses were stained with alizarin red S and were examined for skeletal malformations and variations.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
The pregnancy rate was equivalent for all groups and ranged from 96 to 100%. No treatment-related mortality occurred during the study. One dam from the 300 ppm group was removed from the study on gd 14 due to trauma unrelated to exposure. Another 300 ppm female delivered early on gd 21, and therefore, was removed from the study and all data summaries with the exception of pregnancy calculations. Two females, one each from the 25 and 300 ppm groups, had only non-viable implants and one female each from the 25 and 100 ppm groups were not pregnant. There were no
treatment-related effects on gestational body weight, food consumption or clinical signs. However, on gd 6 to 9 body weight gain was decreased by 28 and 34% in the 100 and 300 ppm groups, respectively. Macroscopic assessment of the dams and organ weights measured at necropsy did not reveal any treatment-related effects. Assessment of the various reproductive endpoints did not reveal any differences among the groups.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 25 ppm
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 100 ppm
- Basis for effect level:
- other: other:
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Details on embryotoxic / teratogenic effects:
Fetal examinations indicated no evidence of treatment-related embryolethality or teratogenicity. Developmental delay in the 300 ppm group was indicated by an increase in the incidence of delayed skeletal ossification of the anterior arch of the atlas, thoracic centra, interparietal, matatarsals, and phalanges. A statistical increase in the number of litters at 100 ppm with unossified anterior arch of the atlas was not considered to be biologically significant because no other endpoints were similarly affected and the incidence (79.2%) was close to that observed in historical controls (29.2-73.9%). Mean fetal body weight/litter were not different among control and treated groups.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Exposure of pregnant CD® rats during organogenesis to A-171
by inhalation resulted in slight maternal toxicity at 100
and 300 ppm as evidenced by concentration-dependent
reductions in gestational body weight gain (gd 6-9). There
was evidence of slightly delayed development in fetuses from
the 300 ppm group as indicated by delayed ossification in several skeletal districts. No exposure-related embryotoxicity or teratogenicity was observed in this study.
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