Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 221-950-4 | CAS number: 3290-92-4
- 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: dermal
Administrative data
- Endpoint:
- short-term repeated dose toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- June 1978
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study well documented ; it is a range-finding study of the 90-week dermal carcinogenicity study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- A dermal toxicity study was performed to assess dermal irritation caused by TMPTMA. Albino rabbits (5/sex/dose) were treated one daily, five days per week for two weeks for a total of 10 treatments. After 15 days, six/animals/group (3 abraded and 3 non-adraded, regardless sex) were sacrified and 30 days after the onset of treatment (two weeks after the last treatment) the remaining animals (4/group) were sacrified.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Propylidynetrimethyl trimethacrylate
- EC Number:
- 221-950-4
- EC Name:
- Propylidynetrimethyl trimethacrylate
- Cas Number:
- 3290-92-4
- Molecular formula:
- C18H26O6
- IUPAC Name:
- 2,2-bis[(methacryloyloxy)methyl]butyl methacrylate (non-preferred name)
- Test material form:
- other: clear liquid
- Details on test material:
- - Name of test material (as cited in study report): Trimethylolpropane trimethacrylate (TMPTMA)
-Storage: at room temperature
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Maland Breeding Farms, Inc. Hewitt, New jersey
- Age at study initiation: no data
- Weight at study initiation: males : mean 2.5 kg (2.3-3.0), females mean = 2.5 kg (2.2-2.9)
- Fasting period before study:no data
- Housing: Individually housed in suspended stain-less steel caging.
- Diet (e.g. ad libitum): Purina Rabbit chow, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: at least one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%):no data
- Air changes (per hr):no data
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- open
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- On the day prior to the first treatment, the hair was clipped from the back of each rabbit, over an area large enough to accomodate the dose volume. Clipping was repeated at necessary throughout the study. The skin of half the animals (3M and 2F or 2M and 3F) was abraded over the area of exposure using an inverted clipper head prior to the first treatment and twice weekly thereafter. The abrasions were deep enough to penetrate the stratum corneum, but no to disturb the dermis.
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 2 weeks
- Frequency of treatment:
- daily, 5/week
Doses / concentrations
- Dose / conc.:
- 300 mg/kg bw/day
- No. of animals per sex per dose:
- 5 rabbits/ sex
- Control animals:
- yes
- Details on study design:
- Treatment was accomplished by dispensing the dose volume from a disposable syringe onto the animal's back and spreading it evenly over the area of exposure. Doses volumes were based on the most recent weekly body weights. Each animal was fitted with a plastic collar, designed to prevent ingestion of the test material, which was worn throughout the study. No dressings was applied to the teatment site.
- Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS& DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily
DERMAL IRRITATION : yes
- Time schedule for examinations: daily
BODY WEIGHT: Yes
- Time schedule for examinations: pretest, weekly during treatment and terminally
FOOD CONSUMPTION: no
WATER CONSUMPTION: no
OPHTHALMOSCOPIC EXAMINATION: no
HAEMATOLOGY: no
CLINICAL CHEMISTRY: no
URINALYSIS: no
NEUROBEHAVIOURAL EXAMINATION: no - Sacrifice and pathology:
- Complete postmortem examination for animals dying spontaneoulsy or killed in a moribund conditions.
- Other examinations:
- no
- Statistics:
- no
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Dermal irritation:
- effects observed, treatment-related
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- 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
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- no effects observed
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Irritation only
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- Control group : In this non-treated control group, half the animals were abraded and all wore callars and were clipped as needed throughout the study. Slight or very slight erythema and desquamation were observed in some animals on single occasions (Days 5 and 6 or 7 only). No unusual in-life signs were noted. All animals exhibited weight gains over the study period.
Treated group (TMPTMA): Slight erythema occurred in some or all animals during the two-week treatment period. Some animals (one to four) also exhibited slight edema during the first ten days of study but not subsequently. Desquamation, generally slight, occurred in the majority of animals during the second week noted in a few animals on single occasions during the treatment period. None of the rabbits treated with TMPTMA exhibited necrotic skin or eschar formation. No consistent patterns of unusual in-life signs occurred. One female exhibited a very slight weight loss.
Microscopic examination of selected tissues obtained from animals treated for two weeks with the test material revealed no evidence of a systemic effect of any of the materials administered. However, minimal to mild irritation was present in skin samples from rabbits treated with TMPTMA.
Examination of tissues from rabbits held for two weeks after treatment revealed no evidence of a systemic effect of the test material. Only minimal epithelial hyperplasia and hyperkeratosis was present in rabbits which received TMPTMA.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Remarks:
- (systemic effects)
- Effect level:
- 300 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical signs
- gross pathology
- histopathology: non-neoplastic
- mortality
- Dose descriptor:
- LOAEL
- Remarks:
- (local effects)
- Effect level:
- 300 mg/kg bw/day
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- dermal irritation
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Animals were exposed to a single dose-level of 300 mg/kg bw/d of TMPTMA for 2 weeks, with or without a recovery period of 2 weeks.
The NOAEL for systemic effects is 300 mg/kg bw/d based on the absence of adverse treatment-related effects on investigated parameters at this dose-level.
No NOAEL could be determined for local effects as dermal irritation was observed at 300 mg/kg bw/d, which is therefore the LOAEL. - Executive summary:
TMPTMA was applied to the backs of albino rabbits (5/sex/group). Rabbits were treated daily, five days per week, for two weeks (for a total of 10 treatments). Six treated animals were sacrified after two weeks and the remaining four animals were held for an additional two weeks during which no treatment was performed prior sacrifice.
Animals treated with TMPTMA (300 mg/kg/d) exhhibited signs of slight dermal irritation with no eschar formation or necrotic skin. No consistent pattern of unusual in-life signs occurred. One female exhibited a very slight weight loss.
Microscopic examination of selected tissues obtained from animals treated for two weeks with the test material revealed no evidence of a systemic effect of any of the materials administered. However, minimal to mild irritation was present in skin samples from rabbits treated with TMPTMA. Examination of tissues from rabbits held for two weeks after treament revealed no evidence of a systemic effect of the test material. Only minimal epithelial hyperplasia and hyperkeratosis was present in rabbits which received TMPTMA.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.