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EC number: 242-053-4 | CAS number: 18169-57-8
- 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:
- From 25 Nov 1991 to 13 Dec 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted in accordance with an appropriate OECD test guideline and in compliance with GLP, using a closely related substance.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 17980-47-1
- EC Number:
- 605-871-6
- Cas Number:
- 17980-47-1
- IUPAC Name:
- 17980-47-1
- Reference substance name:
- Triethoxyisobutylsilane
- EC Number:
- 402-810-3
- EC Name:
- Triethoxyisobutylsilane
- IUPAC Name:
- Triethoxyisobutylsilane
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Ltd, Manston Kent, UK
- Age at study initiation: 44-70 days
- Weight at study initiation: post coitum (day 0): approx 244-247 g
- Housing: after mating, 1/polypropylene cage with autoclaved sawdust bedding
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: at least 13 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-75
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1991-11-18 To: 1991-12-18
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Test substance was dissolved in dried arachis oil by shaking to achieve a homogenous mixture. Control vehicle was prepared weekly.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- GC
- Details on mating procedure:
- - Impregnation procedure: cohoused
- If cohoused:
- M/F ratio per cage: 1:2
- Length of cohabitation: 9 days
- Proof of pregnancy: vaginal plug / sperm in vaginal smear referred to as day 0 of pregnancy - Duration of treatment / exposure:
- gestation days 6-15
- Frequency of treatment:
- daily
- Duration of test:
- Mating to sacrifice on GD20
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 250, 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 24 pregnant females
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: range finding study
- Rationale for animal assignment: random with adjustment for body weight
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: once or twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once or twice daily
BODY WEIGHT: Yes
- Time schedule for examinations: days 0, 3, 6-16 inclusive, 18 and 20
FOOD CONSUMPTION: Yes
- Food consumption for each animal determined : Yes
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: uterine contents - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes / No / No data
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes / No / No data
Also - position and type of implantations - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: Yes (incl. eyes and ossification) - Statistics:
- Body weight and food consumption: one way analysis of variance followed by pair wise analysis of group values by students t test.
Mean foetal weight, post-implantation loss and group mean incidence of specific foetal anomalies: Kruskall-Wallis non-parametric analysis of variance followed by pair wise Mann-Whitney U test. - Indices:
- Values given as percentages (e.g. preimplantation and postimplantation loss)
- Historical control data:
- None given.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:yes
Details on maternal toxic effects:
1000 mg/kg bw/day: slight reduction in body weight gain on day 9 (significant p<0.05); weights remained below controls for the rest of the study but the difference was not statistically significant.
1000 mg/kg bw/day: reduction in food intake on days 6-9 (significant p<0.01); intake remained below controls but the difference was not statistically significant.
50 mg/kg bw/day: significant (p<0.05) reduction in food consumption; considered of no toxicological significance as this effect was not seen at 250 mg/kg bw/day.
Slight maternal toxicity at the top-dose.
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- LOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: developmental toxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 250 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:yes
Details on embryotoxic / teratogenic effects:
1000 mg/kg bw/day:slight increase in post implantation loss (not statistically significant: 8.4% compared to 2-4.5% in other treated groups and the control group). Corresponding reduction in preimplantation loss.
1000 mg/kg bw/day: slight reduction in mean foetal weight (not statistically significant: 3.86 g compared to 3.94-3.98 in every other treated and untreated group). Three foetuses were described as small (compared to controls); one in each of the other treated groups was similarly described.
No clear evidence of treatment-related foetal abnormalities
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- A well reported prenatal developmental toxicity study conducted according to the current guideline (OECD 414) and GLP found that gavage administration of 1000 mg/kg bw/day to rats on gestation days 6-15 caused slight maternal toxicity but gave no evidence developmental effects. No maternal toxicity was seen at the lower dose of 250 mg/kg bw/day. The observed reduction in food consumption can be explained by reduced acceptance of food, and the subsequent reduction in body weight was reversible. The applicant therefore considers that these are not true adverse effects and NOAEL for maternal toxicity was greater than or equal to 1000 mg/kg/day.
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