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EC number: 419-560-6 | CAS number: 4369-14-6
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 7th April 1994 - 10th November 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
- Remarks:
- The study was conducted according to an older (1981) version of OECD Test Guideline 407, therefore some of the examination parameters in the current guideline were not assessed
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 419-560-6
- EC Name:
- -
- Cas Number:
- 4369-14-6
- Molecular formula:
- C9H18O5Si
- IUPAC Name:
- 3-(trimethoxysilyl)propyl prop-2-enoate
1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Details on species / strain selection:
- Not specified, noting the rat is the preferred species for OECD Test Guideline 407
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Japan, Inc.
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 5 weeks old
- Weight at study initiation: Males 124.7-159.6 g, females 117.9-144 g
- Fasting period before study: Not specified
- Housing: Individually
- Diet: MF pelleted diet, ad libitum
- Water : City water supply (chlorinated), ad libitum
- Acclimation period: Yes, but duration not specified
DETAILS OF FOOD AND WATER QUALITY: Contaminants in both the diet and drinking water were regularly analyzed by the laboratory, with the results indicating no effect on this study.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23+/-2
- Humidity (%): 55+/-10
- Air changes (per hr): 10 to 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS:
For preparation of the substance, it was weighed accurately and dissolved in olive oil by stirring to make the highest formulation of 10 w/v % (0.1 g/mL). This formulation then was diluted with olive oil to make three lower formulations of 0.08, 0.4, 2.0 w/v %. Based on stability testing, the dosing formulations were prepared once a week for dosing.
VEHICLE :
- Justification for use and choice of vehicle: Not specified
- Concentration in vehicle: 0, 0.08, 0.4, 2.0, 10.0 w/v %
- Amount of vehicle (if gavage): 10 mL/kg
- Lot/batch no.: 146RSP or 147RTT - Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- The stability test of the substance was confirmed indicating that it was stable enough in the dosing formulations for 7 days, thus the formulations were prepared weekly.
- Duration of treatment / exposure:
- Treatment period: 28 days
Recovery period: 14 days - Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- Control group
- Dose / conc.:
- 8 mg/kg bw/day (nominal)
- Remarks:
- Low dose (LD)
- Dose / conc.:
- 40 mg/kg bw/day (nominal)
- Remarks:
- Mid dose (MD) #1
- Dose / conc.:
- 200 mg/kg bw/day (nominal)
- Remarks:
- Mid dose (MD) #2
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- High dose (HD)
- No. of animals per sex per dose:
- Test group: 6M, 6F
Recovery group: 6M, 6F - Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale:
A preliminary oral toxicity test was conducted by dosing with the substance via oral gavage daily for 14 days at three doses of 50, 250, and 500 mg/kg bw/day. Abnormal changes were noted in hematological examinations, blood chemical examinations and necropsy in the 1000 mg/kg bw/day group. Based on these preliminary findings, the main test was conducted by oral gavage at 0 (vehicle control), 8, 40, 200, and 1000 mg/kg bw/day and the recovery test at 0 (vehicle control), 200, and 1000 mg/kg bw/day.
- Rationale for animal assignment: Random
- Fasting period before blood sampling for clinical biochemistry: Yes, overnight
- Rationale for selecting satellite groups: To investigate the reversibility of the effects
- Post-exposure recovery period in satellite groups: 14 days
- Section schedule rationale: Random - Positive control:
- Not used
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: The general condition of all animals was observed at least once per day.
DETAILED CLINICAL OBSERVATIONS: No
BODY WEIGHT: Yes
- Time schedule for examinations: At study days -2, 1, 3, 5, 8, 10, 12, 15, 17, 19, 22, 24, 26 and 28 and recovery days 1, 3, 5, 8, 10, 12 and 14.
FOOD CONSUMPTION: Yes
- Time schedule for examinations: Once before dosing was started and twice weekly during the dosing and recovery periods.
FOOD EFFICIENCY: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: At the end of dosing period and at the end of the recovery period
- Anaesthetic used for blood collection: Ether
- Animals fasted: Yes, overnight
- How many animals: All animals
- Parameters checked in Table 1 below were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: At the end of dosing period and at the end of the recovery period
- Animals fasted: Yes
- How many animals: All animals
- Parameters checked in Table 1 below were examined.
URINALYSIS: Yes
- Time schedule for collection of urine: On day 28 of the study period and on day 14 of the recovery period
- Metabolism cages used for collection of urine: Yes
- Animals fasted: Yes
- Parameters checked in Table 1 below were examined.
NEUROBEHAVIOURAL EXAMINATION: No
IMMUNOLOGY: No - Sacrifice and pathology:
- SACRIFICE:
Method not specified
GROSS PATHOLOGY: Yes
See Table 2 below
HISTOPATHOLOGY: Yes
See Table 2 below - Statistics:
- The data for body weight, food consumption, haematological examination, blood chemical examination, urine volume and organ weights were analysed using Bartlett's test for homogeneity of variance at a significance level of 5%. The data of homogeneous variance were then analysed for significant difference by one way analysis of variance. If there was a significant difference, then the data were analysed for significant difference in comparison with that of the control group by Dunnett's test, in case of an equal number of data. Otherwise, in case of an unequal number, by Scheffé's test. The data of not homogenous variance was analysed by Kruskal-Wallis test. If there was a significant difference, then the data were analysed for significant difference in comparison with the control group by nonparametric Dunnet's test, in case of an equal number of data. Otherwise, in case of an unequal number, by nonparametric Scheffé's test.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- The test substance-related clinical signs observed at 200 and/or 1000 mg/kg bw/day are considered by the reviewer to be non-adverse or not toxicologically relevant (i.e., not indicative of signicant toxic effects).
Salivation in nearly all animals from both sexes from 200 mg/kg bw/day group and higher groups), decreased spontaneous locomotion, decreased respiratory rate and ptosis in males of 1000 mg/kg bw/day group and marks of reddish tears in both sexes of 1000 mg/kg bw/day group were observed and considered to be test substance-related. The salivation seen in the lower doses and vehicle control group was not identified as test substance-related because it occurred sporadically in 2 to 4 animals per group. - Mortality:
- no mortality observed
- Description (incidence):
- No test or recovery animal deaths occurred during the study period.
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No test substance-related changes to body weight or body weight gain were observed in the treated or recovery animals.
- Food consumption and compound intake (if feeding study):
- no effects observed
- Description (incidence and severity):
- No effects on food consumption of toxicological significance were observed in the treated or recovery animals.
High food consumption was noted in treated males from 1000 mg/kg bw/day group from day 22 to 28. This effect was not considered to be of toxicological significance since it did not affect the body weight gain for these animals. No effect on food consumption was seen in the treated females or the recovery animals. - Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No test substance-related haematological changes were noted in the treated or recovery animals.
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- No effects on clinical biochemistry of toxicological significance were observed in treated or recovery animals.
Increased chloride in treated males from 8 mg/kg bw/day group and increased alanine aminotransferase in treated males and females at 1000 mg/kg bw/day group was noted. These effects were not considered to be of toxicological significance as there were no effects seen at necropsy and histopathology to indicate changes in organ function. No test substance-related effects were seen in recovery group males. Increased potassium levels were noted in recovery females from 200 mg/kg bw/day. - Endocrine findings:
- not examined
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No test substance-related urinalysis changes were seen in the treated or recovery animals.
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No test substance-related organ weight changes were noted in the treated or recovery animals.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Test substance-related gross pathology was identified locally in the stomach of treated males and females at 1000 mg/kg bw/day, with these effects attributable to the corrosive properties of the substance. No pathology indicative of systemic toxicity was seen in test or recovery animals.
At the end of the dosing period In males at 1000 mg/kg bw/day, a blackish region of mucosa in the glandular stomach (2/6) was observed, with scab formation observed in a single male each at 8 and 40 mg/kg bw/day (1/6), but no gross findings reported for 200 mg/kg bw/day.
An elevated region of mucosa in the female forestomach (1/6) was observed at 1000 mg/kg bw/day.
At the end of the recovery period, no test substance-related effets were observed in recovery males, with scab formation (1/6 recovery females) at 1000 mg/kg bw/day. - Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Test substance-related histopathology was identified locally in the stomach of treated males (at 1000 mg/kg bw/day) and females (from 200 mg/kg bw/day), with these effects attributable to the corrosive properties of the substance. No pathology indicative of systemic toxicity was seen in test or recovery animals.
At the end of the dosing period, hyperplasia of the mucous epithelium at the limiting ridge in the forestomach (4/6) and necrosis of the mucous epithelium in the glandular stomach ((2/6) were observed in males at 1000 mg/kg bw/day. Hyperplasia of mucous epithelium at the limiting ridge in the forestomach of females at 200 mg/kg bw/day (2/6) and 1000 mg/kg bw/day (4/6) was observed. These findings were considered to be test substance-related.
No test substance-related histopathology was seen in recovery males. Hyperplasia of mucous epithelium at the limiting ridge of the forestomach of recovery females at 200 mg/kg bw/day (3/6) and 1000 mg/kg bw/day (1/6) was observed. - Histopathological findings: neoplastic:
- not examined
- Other effects:
- not examined
Effect levels
open allclose all
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- local effects
- Effect level:
- 40 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- gross pathology
- histopathology: non-neoplastic
- Key result
- Dose descriptor:
- NOAEL
- Remarks:
- systemic effects
- Effect level:
- >= 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No adverse or toxicologically relevant systemic effects seen.
- Remarks on result:
- other: As concluded by the reviewer. A systemic NOAEL was not identified by the study authors.
Target system / organ toxicity
- Key result
- Critical effects observed:
- yes
- Lowest effective dose / conc.:
- 200 mg/kg bw/day (nominal)
- System:
- gastrointestinal tract
- Organ:
- stomach
- Treatment related:
- yes
- Dose response relationship:
- yes
- Relevant for humans:
- not specified
Applicant's summary and conclusion
- Conclusions:
- For the 28-day oral repeated dose toxicity study with 3-(trimethoxysilyl)propyl acrylate, conducted according to OECD Test Guideline 407 and in compliance with GLP, the systemic NOAEL is considered to be equal to or higher than 1000 mg/kg bw/day, based on the lack of effects indicating adverse toxicity or toxicological relevance. The local NOAEL is considered to be 40 mg/kg bw/day, based on the local pathology in the stomach (in females from 200 mg/kg bw/day, males at 1000 mg/kg bw/day). The local stomach effects are attributed to the corrosive properties of the test substance.
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