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EC number: 271-865-1 | CAS number: 68610-44-6
- 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:
- 24 September 2004 - 03 December 2004
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Reference substance name:
- 2-Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide
- EC Number:
- 271-865-1
- EC Name:
- 2-Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide
- Cas Number:
- 68610-44-6
- Molecular formula:
- not applicable, as UVCB substance
- IUPAC Name:
- 2-Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide
- Test material form:
- solid
- Remarks:
- gummy solid at 25 °C
- Details on test material:
- - Color: Slight Pale Yellow Color
- Expiry date: August 2005
- Storage conditions: Room temperature
- Batch: R-0469-203-15
- Analytical purity: 82.9%
- Impurities: 17.1%
Constituent 1
- Specific details on test material used for the study:
- The purity was taken into account for the preparation of the formulations
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Janvier (Le Genest-Saint-Isle, France)
- Females nulliparous and non-pregnant
- Age at study initiation: approximately 8 weeks old
- Weight at study initiation: mean 193g (+/- 4g)
- Fasting period before study: animals were fasted for an overnight period of approximately 18 hours before dosing, but with free access to water
- Housing: in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm)
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 5 days before the beginning of the study
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22
- Humidity (%): 30 to 70
- Air changes (per hr): aproximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12 h / 12 h
IN-LIFE DATES:
First treatment: 5 october 2004
Experimental completion date (necropsy of the last animal): 26 October 2004
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Purified water prepared by the Testing Faciilty (reverse osmosis)
DOSE VOLUME APPLIED: 20mL/kg
RATIONALE FOR THE SELECTION OF THE DOSE:
Based on the information on the toxic potential of the test item, mortality was not expected. Therefore a limit test at 2000 mg/kg was conducted.
After the first assay with 3 females, no death occurred at the dose level of 2000 mg/kg. Then the results were confirmed in three other females. - Doses:
- Limit test at 2000 mg/kg
- No. of animals per sex per dose:
- 6 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations (clinical sign and mortality): frequently during the hours following admiistration of the test item, and then, at least once a day
- Frequency of weighing: just before administration on Day 1, and then on day 8 and 15.
- Necropsy: on day 15
- Macroscopy examinations of the main organs as soon as possible after death (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any organs with obvious abnormalities)
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No death occurred during the study
- Clinical signs:
- other: Hypoactivity and piloerection in all animals, and dyspnea in 3/6 females, were noted on day 1 only. No other clinical signs were noted during the study.
- Gross pathology:
- No apparent abnormalities were observed
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the experimental conditions, the oral LD50 of the test item is higher than 2000 mg/kg in female rats.
- Executive summary:
The test item was evaluated in 6 female rats according to the OECD 423 guideline.
The test item, prepared in water, was administered by gavage under a volume of 20 mL/kg, at the dose level of 2000 mg/kg.
Mortality, clinical signs and body weight gain were checked for a period of 14 days.
No death was observed during the study.
Hypoactivity and piloerection in all animals, and dyspnea in 3/6 females were noted on day 1 only. No other clinical signs were observed.
The body weight gain was slightly reduced in 4/6 females during the second week of the study compared to CIT historical control data.
At necropsy, no apparent abnormalities were observed in any animal.
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