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Diss Factsheets
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EC number: 219-835-9 | CAS number: 2549-53-3
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 977
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: "Appraisal of the safety of chemicals in foods , drugs and cosmetics, FDA"
- Principles of method if other than guideline:
- Method: according to Appraisal of the safety of chemicals in foods, drugs and cosmetics; FDA (1959)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-Propenoic acid, 2-methyl-, C12-16-alkyl esters
- EC Number:
- 292-094-7
- EC Name:
- 2-Propenoic acid, 2-methyl-, C12-16-alkyl esters
- Cas Number:
- 90551-76-1
- IUPAC Name:
- 2-Propenoic acid, 2-methyl-, C12-16-alkyl esters
- Test material form:
- liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: SPF Wistar rats, Zucht Winkelmann, Paderborn, Germany
- Age at study initiation: no data
- Weight at study initiation: 160 - 180 g
- Fasting period before study: 16 hours
- Housing: single housing
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22°C
- Humidity (%): 45 - 55 %
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- - Maximum dose volume applied: 3.6 ml
- Rationale for the selection of the starting dose: preliminary study for range finding - Doses:
- 20.0 ml/kg
- No. of animals per sex per dose:
- 5f/5m per dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighting: 20 min, 1h, 3h, 24h, 7d, 14d
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, organ weights, histopathology, other: reflexes, emotions, consciousness, central
symptoms, autonomous functions, tone
Results and discussion
- Preliminary study:
- No further information mentioned in the study report.
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 17 500 mg/kg bw
- Remarks on result:
- other: 14 days LD50
- Mortality:
- No mortality was observed in both test groups during the observation time of 14 days.
- Clinical signs:
- other: Methacrylic acid ester 12.6 caused decresed activity, disturbance in coordination, diuresis and piloreaction. These symptoms were seen 30 minutes after application of the test substance and persisted for approximately 3 hours. After that time all animals
- Gross pathology:
- No pathological effects during the test period and observation time of 14 days.
Any other information on results incl. tables
Weight development:
group/ number of animals | mean initial weight | mean weight after 14 -days |
I 5m/5f | 168.0 g | 248.0 g |
II 5m/5f | 173.0 g | 194.5 g |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- GHS no category.
- Conclusions:
- According to the test result: LD50(14days) > 17500 mg/kg bw the test substance Methacrylic acid ester 12.6 has to be classified as nontoxic in respect of its acute oral toxicity.
- Executive summary:
In an acute oral toxicity study, groups of fasted male and female SPF Wistar rats were given a single oral dose of Methacrylic acid ester 12.6 at a dose of 20.0 ml/kg/bw and observed for 14days.
Oral LD50Combined = > 20.0 ml/kg bw equals > 17500 mg/kg bw (95% C.I. not available)
GHS Category 5 ranges from 2000 -5000 mg/kg bw and represents the lowest hazard category for classifying the acute oral toxicity of a chemical substance. ("Criteria for hazard Category 5 are intended to enable the identification of the test substancese which are of relatively low acute toxicity hazard but which, under certain circumstances may present a danger to vulnerable populations". (OECD guideline 425 annex 4)).
Methacrylic acid ester 12.6 is of very low oral toxicity after oral administration based on this LD50test in males and females.
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