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EC number: 220-780-8 | CAS number: 2897-60-1
- 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:
- 28.10.1981 to 18.02.1982
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 982
- Report date:
- 1982
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Deviations:
- yes
- Remarks:
- Limited details on test substance, dosing during organogenesis only.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- [3-(2,3-epoxypropoxy)propyl]trimethoxysilane
- EC Number:
- 219-784-2
- EC Name:
- [3-(2,3-epoxypropoxy)propyl]trimethoxysilane
- Cas Number:
- 2530-83-8
- Molecular formula:
- C9H20O5Si
- IUPAC Name:
- Trimethoxy-[3-(oxiran-2-ylmethoxy)propyl]silane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- not specified
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:2
- Length of cohabitation: No data
- Further matings after two unsuccessful attempts: No data
- Verification of same strain and source of both sexes: No data
- Proof of pregnancy: vaginal plug or sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- Test substance exposure occurred during the primary period of organogenesis, i.e., gestation days 6-15.
- Frequency of treatment:
- Once per day on gestation days 6-15
- Duration of test:
- 15 days (dams killed on gestation day 20)
- No. of animals per sex per dose:
- 20 females
- Control animals:
- other: yes, with water only.
- Details on study design:
- Sex: female
Duration of test: 3 weeks
Examinations
- Statistics:
- Fetal body weights and body measurements, maternal body weights, weights of the maternal livers and uteri and food consumption data were analyzed statistically by a one-way analysis of variance and Dunnett's test (Steel and Torrie, 1960). The Wilcoxon test as modified by Haseman and Hoel (1974) was used to evaluate incidences of fetal resorptions and alterations. Other incidence data were analyzed statistically by the Fischer exact test (Seigel, 1956). The level of significance chosen for all cases was p < 0.05.
- Historical control data:
- The incidence of malformations and variations in the historical controls is not available. These data were not collected by the laboratory that conducted this study.
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day
- Based on:
- test mat.
- Basis for effect level:
- other: No adverse effects observed.
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
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: No adverse effects observed.
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- no
Any other information on results incl. tables
There were no test substance-related mortalities. One rat
(subsequently replaced) in the 50 mg/kg/day group died as
the result of dosing trauma. There were no test
substance-related effects on clinical condition, behaviour,
body weight, body weight gain or food consumption. No
effects on liver or gravid uterine weight were observed. No
effects on the number of implantation sites or corpora lutea
per dam were observed. The incidence of pregnancy was not
affected by treatment with the test substance; all rats were
confirmed to be pregnant at the gestation day 20
(laparo hysterectomies). No adverse effects on the number of
live fetuses per litter, mean litter size, sex ratio, fetal
body weight or crown-rump length were observed. The
incidence of fetal resorptions was not altered by test
substance administration. No external, visceral or skeletal
alterations were observed among test substance-treated rats
at an incidence that was statistically different from the
control group. When considered collectively, the incidence
of total major malformations observed in the external, soft
tissue or skeletal examinations was not significantly
different among the treated groups as compared to the
control group. No major malformations were observed among
litters of rats that received either 500 or 1000 mg/kg/day
of the test substance. The sporadic variations and
malformations seen occurred at an incidence comparable to a
historical control incidence for Sprague-Dawley rats
reported in the literature.
Applicant's summary and conclusion
- Conclusions:
- In a good quality developmental toxicity study (reliability score 1), similar to OECD 414 and GLP, 3-glycidoxypropyltrimethoxysilane exhibited no adverse effects on the maternal animals or the offspring. The NOAEL for maternal and developmental toxicity was at least 1000 mg/kg bw/day.
- Executive summary:
In a good quality developmental toxicity study (reliability score 1), similar to OECD 414 and GLP, 3-glycidoxypropyltrimethoxysilane exhibited no adverse effects on the maternal animals or the offspring. The NOAEL for maternal and developmental toxicity was at least 1000 mg/kg bw/day.
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