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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
Toxicity to reproduction
Administrative data
- Endpoint:
- one-generation reproductive toxicity
- Remarks:
- based on test type (migrated information)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from 14 Nov 1991 to 26 Mar 1992
- 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 test 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 415 [One-Generation Reproduction Toxicity Study (before 9 October 2017)]
- 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
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Ltd, Manston Kent, UK
- Age at study initiation: (P) 3-4 wk
- Weight at study initiation: (P) Males: treatment wk 1, approx 194-195 g; Females: treatment wk 1, approx 154-156 g;
- Housing: 1 mated female/polypropylene cage with soft wood bedding
- Use of restrainers for preventing ingestion (if dermal): yes/no
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: 16 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 40-70
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: From: 1991-11-14 To: 1992-03-26
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on exposure:
- PREPARATION OF DOSING SOLUTIONS:
Test substance filtered to remove sediment then dissolved in dried arachis oil by shaking to achieve a homogenous mixuture. From wk 12 two batches were prepared and analysed separately for each dose, then pooled prior to administration. Control vehicle was prepared weekly.
- Details on mating procedure:
- - M/F ratio per cage: 1:1
- Length of cohabitation: up to 3 wk
- Proof of pregnancy: vaginal smear - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- GC
- Duration of treatment / exposure:
- 74 days prior to mating (m,f); 3 wk mating (m,f): up to PND 21 (m,f)
- Frequency of treatment:
- daily
- Details on study schedule:
- P males and females 3-4 wk old at start of study; presumably 16-17 wk at mating.
Fi not mated.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 50, 250, 1000 mg/kg bw/day
Basis:
actual ingested
- No. of animals per sex per dose:
- 32
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: 14-day range finding study
- Rationale for animal assignment: random based on stratified body weights
Examinations
- Parental animals: Observations and examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule: daily (before and 1 h after dosing)
BODY WEIGHT: Yes / No / No data
- Time schedule for examinations: days 1, 4, 7, 14, 21
FOOD CONSUMPTION
- Food consumption: days 1, 4, 7, 14, 21
WATER CONSUMPTION No
- Oestrous cyclicity (parental animals):
- Not examined
- Sperm parameters (parental animals):
- Not examined
- Litter observations:
- STANDARDISATION OF LITTERS
- Performed on day 4 postpartum: yes
- If yes, maximum of 8 pups/litter (4/sex/litter as nearly as possible); excess pups were killed and discarded.
PARAMETERS EXAMINED
The following parameters were examined in F1 offspring:
number and sex of pups, stillbirths, live births, postnatal mortality, presence of gross anomalies, weight gain, physical abnormalities, reflexological observations.
GROSS EXAMINATION OF DEAD PUPS:
yes, for external and internal abnormalities - Postmortem examinations (parental animals):
- SACRIFICE
- Male animals: All surviving animals
- Maternal animals: All surviving animals PND21
GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations
HISTOPATHOLOGY
The tissues indicated in OECD 415 from all parental animals were prepared for microscopic examination - Postmortem examinations (offspring):
- GROSS NECROPSY
- Gross necropsy consisted of external and internal examinations
HISTOPATHOLOGY / ORGAN WEIGTHS
None - Statistics:
- Adult body weight and food consumption, litter size and weight, group mean pre-coital length, individual offspring bodyweight: F-max test with one way analysis of variance. For significant differences, pair wise comparison of control with treated groups using Students t test.
Gestation length, offspring sex rations, landmarks of offspring physical development, reflexological responses: Kruskall Wallis non-parametric rank sum test. There were no significant differences between control and treated groups so no pair wise evaluations were performed.
Mating, pregnancy, parturition indices: Fischer Exact Probability Test.
Offspring Viability Indices: Chi-squared analysis. - Reproductive indices:
- food conversion index; precoital interval; mating index; pregnancy index; gestation length; parturition index, live birth index
- Offspring viability indices:
- live birth index; viability index (days 1, 4, 7 14, 21); sex ratio; offspring physical development
Results and discussion
Results: P0 (first parental generation)
General toxicity (P0)
- Clinical signs:
- effects observed, treatment-related
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Other effects:
- no effects observed
Reproductive function / performance (P0)
- Reproductive function: oestrous cycle:
- no effects observed
- Reproductive function: sperm measures:
- not examined
- Reproductive performance:
- effects observed, treatment-related
Details on results (P0)
Salivation was seen in 3 males at 250 mg/kg bw/day.
At 1000 mg/kg bw/day a reduction in the total number of pregnancies was seen but without statistically significant differences in the mating and pregnancy indices. Therefore, this was considered not to be a treatment-related effect on fertility.
Effect levels (P0)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
Results: F1 generation
General toxicity (F1)
- Clinical signs:
- not examined
- Mortality / viability:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- Sexual maturation:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Histopathological findings:
- not examined
Details on results (F1)
At 1000 mg/kg bw/day there was a slight but statistically significant difference in group mean litter weights and individual offspring body weight on day 7 post partum, that continued through day 14 and 21. But the increase in weight gain, relative to the group starting weight for each period of measurement, was comparable for each group. At 1000 mg/kg bw/day the reduction in offspring body weight from day 7 post partum was not considered in the report to be evidence of an effect on offspring development. Measures of offspring development gave no indication of a treatment-related effect. There were no significant findings at 250 and 50 mg/kg bw/day.
Effect levels (F1)
- Dose descriptor:
- NOAEL
- Generation:
- F1
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- A well reported one generation toxicity study conducted according to the current guideline (OECD 415) and GLP found that gavage administration of up to 1000 mg/kg bw/day to parental rats for 10 wk prior to mating and throughout gestation and lactation gave no clear evidence of adverse reproductive effects in the parents or offspring.
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