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EC number: 219-785-8 | CAS number: 2530-85-0
- 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: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 14.08.1989 to 08.09.1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted specifically to identify whether an aerosol of the test substance induced laryngeal granulomas. While this study does not meet standards of the current guidelines in terms of the diversity of the examinations conducted, it is a well conducted study that achieves its objective.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The objective of this study was to confirm the development of laryngeal granulomas in rats following short-term repeated inhalation exposures to 3-trimethoxysilylpropyl methacrylate-hydrolysate aerosol.
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 3-trimethoxysilylpropyl methacrylate
- EC Number:
- 219-785-8
- EC Name:
- 3-trimethoxysilylpropyl methacrylate
- Cas Number:
- 2530-85-0
- Molecular formula:
- C10H20O5Si
- IUPAC Name:
- 3-trimethoxysilylpropyl methacrylate
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Kingston, NY.
- Age at study initiation: 41 days
- Weight at study initiation: Males: 130-131 grams
- Fasting period before study: none
- Housing: One or two per cage in stainless steel wire mesh cages
- Diet (e.g. ad libitum): Ad libitum (except during exposure)
- Water (e.g. ad libitum): Ad libitum (except during exposure)
- Acclimation period: Two days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16.5-21 °C
- Humidity (%): 45-77 %
- Air changes (per hr): No data
- Photoperiod (hrs dark / hrs light): 12 hours dark / 12 hours light
IN-LIFE DATES: From: 14.08.1989 To: 08.09.1989
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: distilled water
- Remarks on MMAD:
- MMAD / GSD: 2.65 microns with standard deviation of 1.74.
- Details on inhalation exposure:
- The inhalation chambers were constructed from stainless steel and glass windows for animal observations. The volume was approximately 1330 litres, and the airflow was approximately 300 litres/minutes (13.5 air changes/hour). Temperature and relative humidity measurements were recorded at least twelve times per exposure.
A 2% solution of 3-(trimethoxysilyl)propyl methacrylate hydrolysate was metered from a piston pump into an atomiser. The atomiser was inserted into the top of the inhalation chamber turret where the liquid aerosol was dispersed throughout the chambers by filtered chamber supply air.
The particle size distribution was measured using a TSI Aerodynamic Particle Sizer and a 20:1 diluter. These determinations were made once per day for the duration of the study (except on day 3 due to equipment failure). - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Chamber concentrations of 3-(trimethoxysilyl)propyl methacrylate hydrolysate were determined by gravimetric methods. Four samples were obtained each day.
- Duration of treatment / exposure:
- 4 weeks (19 days of exposure over a 4-week period, 18 days of exposure for satellite group)
- Frequency of treatment:
- 6 hours/day, 5 days/week
Doses / concentrationsopen allclose all
- Dose / conc.:
- 143 mg/m³ air
- Dose / conc.:
- 150 mg/m³ air
- No. of animals per sex per dose:
- 15 males rats/treated group; 15 male rats/control group
5 animals from each group were designated to a satellite group for further ultrastructural evaluation of the larynges (this was cancelled) - Control animals:
- yes, concurrent no treatment
- Details on study design:
- A group of 15 male Fischer 344 rats was exposed 6 hours per day for 19 days of exposure (18 days of exposure for the satellite group) over a 4-week period to an aerosol of 3-(trimethoxysilyl)propyl methacrylate hydrolysate (3-(trimethoxysilyl)propyl methacrylate hydrolysate; gamma-methacryloxypropyltrimethoxysilane hydrolysate; CAS: 2530-85-0) at a target concentration of 150 mg/m3. A control group of 15 male rats was exposed with the same exposure regimen to filtered air only. Five animals of the control and 3-(trimethoxysilyl)propyl methacrylate hydrolysate exposure groups were assigned to a satellite group for possible ultrastructural evaluation of the larynges, but not subsequently evaluated.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Preceding and following each exposure. On non-exposure days, animals were observed once per day.
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: At the time of body weight collection and just preceding sacrifice.
BODY WEIGHT: Yes
- Time schedule for examinations: All animals were weighed on the morning prior to initiation of the first exposure. Then weekly during the four week exposure period and immediately preceding sacrifice.
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No
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: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes a full necropsy was performed.
HISTOPATHOLOGY: Yes, of gross lesions, larynx, lungs, trachea, nasal turbinates and kidneys. - Statistics:
- The data for continuous, parametric variables were intercompared for the exposure and control groups by use of Levene's test for homogeneity of variances and by t-tests.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- The only exposure-related clinical sign, observed in most of the animals, was perinasal encrustation.
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Description (incidence and severity):
- Decreases in body weight gain were observed for the 3-(trimethoxysilyl)propyl methacrylate-hydrolysate exposure group during the first two weeks of the study.
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Nasal crust around the nares of the 3-(trimethoxysilyl)propyl methacrylate-hydrolysate exposed rats was the only gross lesion noted at necropsy.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Upon histological examination, changes were noted within the respiratory tracts of the3-(trimethoxysilyl)propyl methacrylate-hydrolysate exposed rats. Cytoplasmic hyalinization was observed within the olfactory mucosa of the nasal cavity. In addition, squamous metaplasia and foci of minimal to mild granulomatous laryngitis (laryngeal granulomas) were present within the larynges of 3-(trimethoxysilyl)propyl methacrylate-hydrolysate exposed rats. These findings concur with microscopic changes observed in previous 3-(trimethoxysilyl)propyl methacrylate-hydrolysate aerosol studies.
- Histopathological findings: neoplastic:
- not examined
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 143 mg/m³ air
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Laryngeal granulomas developed.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- In a four week aerosol inhalation study, not conducted according to any guideline but in compliance with GLP, a LOAEL was concluded to be 143 mg/m3 in males, based on the development of laryngeal granulomas.
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