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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
Endpoint summary
Administrative data
Description of key information
In the key study for repeated dose toxicity via oral gavage, administration of the test material to rat for 28 days resulted in no adverse effects, and a NOAEL of >1000 mg/kg bw/day was identified (Safepharm, 2004b).
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Link to relevant study records
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2003-04-30 to 2003-11-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 1995
- Deviations:
- no
- GLP compliance:
- yes
- Limit test:
- no
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Ltd, UK
- Age at study initiation: 5-6 weeks old
- Weight at study initiation: males 109 to 154g; females 110 to 152g
- Housing: in groups of 5 in polypropylene grid-floor cages
- Diet: pelleted diet (Rodent 5LF2 (Certified) Diet), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ± 2°C
- Humidity (%): 55 ± 15%
- Air changes (per hr): 15/ hour
- Photoperiod (hrs dark / hrs light): 12/ 12 - Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: The test material was prepared at the appropriate doses as a suspension in dried Arachis Oil BP. Formulations were stable for at least 14 days. Formulations were prepared weekly and stored at approximately +4°C in the dark under silica gel.
- Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- The concentration of test material in the formulations was determined by gas chromatography (GC) using an external standard technique. The test material formulations were extracted with acetonitrile to give a final, theoretical test material concentration of approximately 0.05 mg/ml. Standard solutions of test material was prepared in acetonitrile at a nominal concentration of 0.05 mg/mI. The test material formulations were mixed thoroughly and samples were taken from the top, middle and bottom ofthe container. Sampling was performed in triplicate. The test material formulations were sampled and analysed initially and then after storage at approximately +4°C in the dark for fourteen days. The test material formulations were sampled and analysed within two days of preparation.
- Duration of treatment / exposure:
- 28 days.
- Frequency of treatment:
- 7 days per week
- Dose / conc.:
- 15 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 150 mg/kg bw/day (actual dose received)
- Dose / conc.:
- 1 000 mg/kg bw/day (actual dose received)
- No. of animals per sex per dose:
- 5 male and 5 female rats per dose
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Based on dose range finding test
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: immediately before dosing and at 1 and 5 hours post-administration during the working week; immediately before dosing and at 1 hour after dosing during the weekends.
BODY WEIGHT: Yes
- Time schedule for examinations: individual body weights were recorded on days 0 (before the start of the treatment), 7, 14, 21 and 28. Also recorded at terminal kill.
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: Yes
FOOD CONSUMPTION:
- Food consumption was recorded for each cage group at weekly intervals throughout the study.
WATER CONSUMPTION:
- Water intake was observed daily, for each cage group, by visual inspection of the water bottles.
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: on day 28 (the end of the study)
- Anaesthetic used for blood collection: No data
- Animals fasted: No
- How many animals: all test and control animals
- Parameters checked in table [No.2] were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: on day 28 (the end of the study)
- Animals fasted: No
- How many animals: all test and control animals
- Parameters checked in table [No. 1] were examined.
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: prior to the start of the treatment, on days 7, 13, 20 and 27
- Dose groups that were examined: all test and control animals
- Battery of functions tested: Motor activity; forelimb/ hindlimb grip strength; sensory reactivity - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes. When the dosing period was completed, all animals were killed by intravenous overdose injection of sodium pentobarbitone. Macroscopic abnormalities were recorded (Table 3).
HISTOPATHOLOGY: Yes. Tissue samples were taken from all the animals and preserved in buffered 10 % formalin. The examined tissues were: adrenals, aorta, bone and bone marrow, brain (including cerebellum, cerebrum and pons), caecum, colon, duodenum, epididymides, eyes, gross lesions, heart, oesophagus, ovaries, pancreas, pituitary, prostate, rectum, salivary glands, sciatic nerve, seminal vesicles, skin, spinal cord, spleen, ileum, jejunum, kidneys, liver, lungs, lymph nodes, muscle, stomach, testes, thymus, thyroid/parathyroid, urinary bladder, uterus, trachea (Table 3). - Other examinations:
- ORGAN WEIGHTS:
The organs examined at the end of the study were dissected free from fat and weighed before fixation. The examined organs were: adrenals, brain, epididymides, heart, kidneys, liver, ovaries, spleen, testes, thymus (Table 3). - Statistics:
- Group mean values were calculates. Appropriate standard deviations were included. Haematological, blood chemical, organ weight, weekly body weight gain, quantitative functional performance and sensory reactivity data were assessed for dose response relationship linear regression analysis, followed by one way analysis of variance (ANOVA) incorporating Levene's test for homogeneity of variance. Where variances were shown to be homogenous, pairwise comparison were conducted using Dunnett's test. Where Levene's test showed unequal variances, the data were analysed using non-parametric methods: Kruskal-Wallis ANOVA and Mann-Whitney 'D' test.
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- Slight reduction in food consumption in female group, in comparison with the control group. No clear dose relationship, thus considered not to be toxicologically important. Food consumption in males was similar to the control group.
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Description (incidence and severity):
- No intergroup differences
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related changes were detected
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No treatment-related differences were detected in the blood
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- No treatment-related changes were detected
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No treatment-related orgain weights changes were detected
- Gross pathological findings:
- no effects observed
- Description (incidence and severity):
- No abnormalities were noted
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY: No mortality was noted during the 28-day study period.
BODY WEIGHT AND WEIGHT GAIN: No adverse effect on body weight gain was observed.
FOOD CONSUMPTION AND COMPOUND INTAKE (if feeding study): Slight reduction in food consumption in females, in comparison with the control group. No clear dose relationship, thus considered not to be toxicologically important. Food consumption in males was similar to the control group.
FOOD EFFICIENCY: No treatment-related changes in food efficiency were observed.
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): No treatment-related changes in water consumprion were observed.
HAEMATOLOGY: No treatment-related changes were detected in the haematological parameters measured.
CLINICAL CHEMISTRY: There were no treatment-related or statistically significant differences detected in the blood chemical parameters measured.
NEUROBEHAVIOUR: During the open-field assessment, hunched posture was noted in one female treated with 1000 mg/kg/day. The isolated finding was associated with the dosing procedure. No such observations were reported in any other test animal.
Males treated with 1000 mg/kg/day showed a statistically significant increase (p<0.05) in forelimb grip strength compared with controls. No such changes were detected in females treated with 1000 mg/kg/day or in animals from the remaining treatment groups. In the absence of any associated changes an increase in this parameter was considered unlikely to be toxicologically significant.
There were no treatment-related changes in sensory reactivity.
ORGAN WEIGHTS: Statistically significant findings were confined to males treated with 1000 mg/kg/day and involved a reduction (p<0.001) in relative thymus weight compared with controls. However, all individual values were within the historical ranges for rats of this strain and age and in the absence of any histopathological evidence of a treatment-related effect, this reduction was considered to be without toxicological importance. No toxicologically significant organ weight changes were detected.
GROSS PATHOLOGY: No treatment-related macroscopic abnormalities were noted.
HISTOPATHOLOGY: All morphological changes detected were those commonly observed in laboratory maintained rats of the age and strain employed, and there were no differences in incidence or severity between control and treatment groups that were considered to be of toxicological significance. - Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 000 mg/kg bw/day (actual dose received)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse effects observed
- Critical effects observed:
- no
- Conclusions:
- In the 28-day oral repeated dose toxicity study, conducted according to OECD TG 407, and in compliance with GLP, a NOAEL value of >= 1000 mg/kg/bw was reported for [3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- NOAEL
- 1 000 mg/kg bw/day
- Study duration:
- subacute
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: inhalation - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - systemic effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Repeated dose toxicity: dermal - local effects
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
A good quality, 28-day repeated dose oral toxicity study in rats is available for the registered substance. The study was conducted according to OECD TG 407 and in compliance with GLP (Safepharm, 2004b). Male and female rats (5 per sex per dose) were dosed by oral gavage with 0, 15, 150 and 1000 mg/kg bw for 4 weeks. There were no treatment-related mortalities, clinical signs or body weight changes and no effects on haematological, blood biochemical or urinalysis parameters. There were no abnormal findings at necropsy. The NOAEL was therefore the maximum dose of 1000 mg/kg bw/day,
A good quality supporting study is also available for the read-across substance [3-(2,3-epoxypropoxy)propyl]trimethoxysilane (CAS 2530-83-8). The study was conducted according to OECD TG 407 and in compliance with GLP (Dow Corning Corporation, 1981). Male and female animals were exposed to 40, 400 or 1000 mg/kg bw/day test material 5 days per week for 4 weeks by oral gavage. There were no test substance-related mortalities or body weight changes. There were no test substance-related effects on haematological, blood biochemical or urinalysis parameters. There were no abnormal findings at necropsy. The NOAEL was therefore the maximum dose of 1000 mg/kg bw/day. This is included as supporting information to justify read-across for reproductive and developmental endpoints (Section 5.9).
Justification for classification or non-classification
Based on the available data, no classification is required for [3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane for repeated dose toxicity in accordance with Regulation (EC) No. 1272/2008.
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