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EC number: 245-904-8 | CAS number: 23843-64-3
- 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- 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
Test material
- Reference substance name:
- -
- EC Number:
- 449-160-7
- EC Name:
- -
- Cas Number:
- 116912-64-2
- IUPAC Name:
- ureidopropyltrialkoxysilane, mixed methoxy and ethoxy esters
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- Crl:(WI) BR (outbred, SPF quality)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Germany
- Age at study initiation: approx. 8 weeks
- Weight at study initiation: 282 ± 5 g (males); 209 ± 3 g (females)
- Fasting period before study: no data
- Housing: 5 animals per sex and per cage in stainless steel cages; single housing overnight in Makrolon plastic cages during activity monitoring
- Diet: standard pelleted laboratory animal diet (from Carfil Quality BVBA, Oud-Turnhout, Belgium), ad libitum
- Water: tap-water, ad libitum
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 (Fluctuations were observed, but were not considered to be relevant)
- Humidity (%): 50 (Fluctuations were observed, but were not considered to be relevant)
- Air changes (per hr): 15
- Photoperiod: 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- once daily, 7 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 61 mg/kg bw/day (actual dose received)
- Remarks:
- dose level corrected by density value
- Dose / conc.:
- 184 mg/kg bw/day (actual dose received)
- Remarks:
- dose level corrected by density value
- Dose / conc.:
- 1 228 mg/kg bw/day (actual dose received)
- Remarks:
- dose level corrected by density value
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: A project pilot study was performed in which 3 rats per sex were dosed with 61, 184, 1228 mg/kg bw/day for 5 days by oral gavage. No adverse effects were observed up to 1228 mg/kg bw/day.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Mortality and viability were checked twice daily. Clinical observations were performed once daily.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Before treatment and on days 8, 15, 22, and 28 detailed clinical observations were performed outside the home cage and a grading of effects was performed.
BODY WEIGHT: Yes
- Time schedule for examinations: On days 1, 8, 15, 22, and 28
Food consumption: Yes
- Time schedule: weekly
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: Yes
- Time schedule for collection of blood: prior to post mortem examination
- Anaesthetic used for blood collection: Yes (light ether anaesthesia)
- Animals fasted: Yes (maximum of 20 h)
- How many animals: all animals
- Parameters that were examined see table 1
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: prior to post mortem examination
- Animals fasted: Yes (maximum of 20 h)
- How many animals: all animals
- Parameters that were examined see table 1
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: during week 4 of treatment
- Dose groups that were examined: all animals
- Battery of functions tested: hearing ability/pupillary reflex/static righting reflex/grip strength/activity test - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes (all animals)
HISTOPATHOLOGY: Yes, slides of all organs and tissues collected from the control and high-dose group and gross lesions of all animals were examined (see table 2). Additionally, spleen (males) and thymus (male, female) were examined in the intermediate dose groups. - Statistics:
- Dunnett-test (many-to-one t-test) based on a pooled variance estimate (if normal distribution): comparison of the treated and control groups of each sex. Steel-test (many-to-one rank test; if no normal distribution). All tests were two-sided and in all cases p<0.05 was accepted as the lowest level of significance. Group means were calculated for continuous data and medians were calculated for discrete data (scores). Test statistics were calculated on the basis of exact values for means and pooled variances. Individual values, means and standard deviations may have been rounded off before printing.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- 1228 mg/kg bw: salivation (non adverse)
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- CLINICAL SIGNS AND MORTALITY
No mortality occurred. Salivation was observed in the animals of the high dose group but was not considered to be a sign of adverse systemic toxicity.
BODY WEIGHT AND WEIGHT GAIN
Slightly lower body weight gain was observed in the mid and high dose males, but was not statistically significant.
HAEMATOLOGY
Decrease of RBC, HB, relative number of lymphocytes and an increase of relative number of neutrophils in the female mid-dose group were considered to have occurred by chance, as there was no dose-response relationship and the values were within the historical control data.
CLINICAL CHEMISTRY
No treatment-related effects have been observed.
NEUROBEHAVIOUR
In two females of the mid-dose group the total motor activity was increased. Moreover, in one of these females the ratio between upper and lower sensor recordings was reverse to what is expected. These effects were considered to have occurred by chance because no corroborative findings in the animals and no dose-response relationship was observed.
ORGAN WEIGHTS
A decrease in the thymus/body weight ratio of high dose males was not supported by histological examination of the thymus. In view of the very small variation in the thymus weights of the male high dose group and the fact that all thymus weights were within the range of the historical control data, the toxicological significance of this effect was doubted.
GROSS PATHOLOGY AND HISTOPATHOLOGY
Thickening of the limiting ridge was observed in the stomach of 2/5 females of the high dose group. Microscopically a minimal squamous hyperplasia was observed. These effects were attributed to an irritative effect of the substance and are also commonly seen in gavage studies.
Effect levels
- Key result
- Dose descriptor:
- NOAEL
- Effect level:
- >= 1 228 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: no adverse effects observed up to and including the highest dose tested
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- A 28-day repeated dose toxicity study with the test material was perforemd according to OECD 407 and GLP. Administration of the test material up to and including the highest dose tested (1228 mg/kg bw/day) did not results in any substance-related adverse effects. Thus, a NOAEL of =1228 mg/kg bw/day is derived.
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