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Diss Factsheets
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EC number: 457-320-2 | CAS number: -
- 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:
- 15-May-2002 to 14-Jun-2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study, to GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): MRD-02-375
- Physical state: red viscous liquid
- Analytical purity: "the test substance, as received, was considered 'pure' substance"
- Expiration date of the lot/batch: April 2007
- Stability under test conditions: "the testing laboratory characterized the neat test substance and will determine its stability when the final characterization is performed"
- Storage condition of test material: room temperature
- Other: pH: 5
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl: CD (SD) IGSBR
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, NY
- Age at study initiation: 10-13 weeks
- Weight at study initiation: 217-257 g
- Fasting period before study: yes, overnight
- Housing: singly housed in suspended stainless steel and wire mesh cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7-22 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18-22
- Humidity (%): 30-70
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12 / 12
IN-LIFE DATES: From: 15-May-2002 To: 14-Jun-2002
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.5 g/ml (50% w/v)
- Amount of vehicle (if gavage): 4 ml/kg bw
- Justification for choice of vehicle: standard vehicle in toxicology studies; test substance is mixed with lubricant base oil in the final product
- Lot/batch no. (if required): Sigma, product number C8267, lot number 70K0 127
- Purity: no data
MAXIMUM DOSE VOLUME APPLIED: 4 ml/kg bw
DOSAGE PREPARATION (if unusual): "The test substance was mixed with the carrier to form a dosable mixture" - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 females tested
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
- viablility: twice daily Monday through Friday and once daily on weekends and holidays
- clinical observations: at 30 minutes, 1, 2, 4 and 6 hours after dosing and once per day thereafter for a total of 14 days
- body weight: on the day prior to dosing (pretest), on the day of dosing (day 0), on day 7 and on day 14
- Necropsy of survivors performed: yes
- Other examinations performed:
- clinical signs: the nature, onset, severity, and duration of toxicological signs
- body weights
- gross necropsy: performed on all animals; included an examination of the external surface of the body, all orifices, the cranial, thoracic and abdominal cavities and their contents - Statistics:
- Means and standard deviations of body weight and body weight change calculated by group and sex
Results and discussion
- Preliminary study:
- Not applicable
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- 0/5
- Clinical signs:
- Present in 2/5: wet rales were evident in one animal from the 1 hour observation through to day 2, and alopecia
of the trunk was seen in a rat on day 4 until study termination. Clinical signs were
not reported at the other observation periods for these
animals.
Absent in 3/5: all remaining animals were free of observable abnormalities throughout the study. - Body weight:
- All animals displayed increases in body weight over their initial values
- Gross pathology:
- Effects on organs: all animals were free of gross postmortem abnormalities with the exception of the one animal that displayed alopecia of the trunk
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In a GLP study conducted according to OECD guideline 425, the acute oral LD50 of EC# 457-320-2 was >2000 mg/kg bw (the limit dose) in female rats.
- Executive summary:
In a GLP study conducted according to OECD guideline 425, EC# 457-320-2 was administered by oral gavage to five female rats at 2000 mg/kg bw, the limit dose. The animals were observed for clinical signs of toxicity and body weights were recorded over a 14-day observation period. A gross necropsy examination was performed at study termination.
There were no deaths reported. Two animals exhibited clinical signs of toxicity: wet rales were evident in one animal from the 1-hour observation through to Day 2, and alopecia of the trunk was seen in a rat on Day 4 until study termination. There were no clinical signs in the remaining three animals and all rats displayed increased body weights over their initial values. All animals were free of gross postmortem abnormalities with the exception of the one rat that displayed alopecia of the trunk.
In conclusion, the acute oral LD50 of EC# 457-320-2 is >2000 mg/kg bw in female rats. In accordance with EU CLP regulations, the substance would not need to be classified as acutely toxic via the oral route.
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.
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