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EC number: 680-413-6 | CAS number: 217437-44-0
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 08 - 25 Jul 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 011
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted on 17 December 2001
- Deviations:
- no
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-[(3,5-dimethyl-1H-pyrazole-1-carbonyl)amino]ethyl 2-methylprop-2-enoate
- EC Number:
- 680-413-6
- Cas Number:
- 217437-44-0
- Molecular formula:
- C12H17N3O3
- IUPAC Name:
- 2-[(3,5-dimethyl-1H-pyrazole-1-carbonyl)amino]ethyl 2-methylprop-2-enoate
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan, INC.
- Females nulliparous and non-pregnant: not specified
- Age at study initiation: 8.5 to 9 weeks
- Fasting period before study: from the day prior to administration until 3 h after the administration
- Housing: individually in stainless steel cages with a stainless mesh floor (D38 cm × W24 cm × H18 cm)
- Diet: solid pellets Lab Diet #5002 (PMI Nutrition International), ad libitum
- Water: tap water, ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 50 ± 20
- Air changes (per hr): 12
- Photoperiod (hrs dark / hrs light): 12/12
Remarks on environmental conditions:
Between July 8 and 21 and July 23, 2011, the humidity in the animal room exceeded the upper control limit (70%) for 5 to 30 min per occasion, several times per day. (Abnormal humidity persisted for approximately 40 min on July 12 and 1.5 h on July 18.)
Humidity most frequently exceeded the limit on July 9 (26 episodes), and the highest humidity (79%) was observed on July 9, 14, and 18.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: carboxymethyl cellulose (CMC)
- Remarks:
- 1% aqueous solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20% (w/v)
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: The test substance was not homogeneously dispersible in distilled water; however, it was dispersible in 1% CMC.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
CLASS METHOD
- Rationale for the selection of the starting dose: In previous acute toxicity study performed on structurally similar derivates, no animals died at a dose of 300 mg/kg bw. As the test substance was not expected to cause animal deaths at 300 mg/kg bw, the initial dose was set at 2000 mg/kg bw in accordance with the guideline. - Doses:
- 2000 mg/kg bw (step 1 and 2)
- No. of animals per sex per dose:
- 6 (3 per step)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for clinical signs and behaviour within 30 min (0 h) and 1, 3 and 6 h after administration and further once daily for 14 days until terminal necropsy day. Body weight was measured immediately before administration (Day 0), and on Days 3, 7, and 14.
- Necropsy of survivors performed: yes
Results and discussion
Effect levelsopen allclose all
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- female
- Dose descriptor:
- LD50 cut-off
- Effect level:
- 2 500 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other:
- Remarks:
- accordint to OECD 423 (1 dead animal in step 1)
- Mortality:
- One animal of step 1 was found dead on Day 1.
- Clinical signs:
- other: Immediately after administration, prone position in 1/6 animals, eyelid closure in 2/6 animals, ptosis in 3/6 animals, and decreased locomotor activity in 1/6 animals were observed. At 1 h after administration, eyelid closure in 3/6 animals, ptosis in 1/6
- Gross pathology:
- Necropsy revealed a dark red area of the glandular stomach mucosa (adherence of blood-like substance) in the animal that died on Day 1 and redness of ileum mucosa and thinning of ileum mucosa in 2/5 animals sacrificed at Day 14 for terminal necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008
- Conclusions:
- In this acute oral toxicity study in female rats 1/6 animals died at 2000 mg/kg bw and thus the LD50 value was > 2000 mg/kg bw.
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