Registration Dossier
Registration Dossier
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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
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EC number: 482-120-7 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- yes
- Remarks:
- The first animal was dosed at 300 mg/kg, rather than a step below the estimated LD50 as indicated in the protocol; Systemic observations and a.m. mortality checks were not recorded for Animal 2/F on one day during the study; Animal 6/F was fasted only for
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- EPA 40 CFR parts 792 and 160, FDA 21 CFR 58
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): c-4000
- Physical state: liquid
- Analytical purity: >99%
- Purity test date: 2007-02-26
- Lot/batch No.: jyc0367
- Expiration date of the lot/batch: 2007-08-26
- Stability under test conditions: stable
- Storage condition of test material: room temperature and humidity
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
Administration / exposure
- Route of administration:
- other: oral by syringe
- Vehicle:
- unchanged (no vehicle)
- Doses:
- 300, 500 and 2000 mg/kg
- No. of animals per sex per dose:
- 1 female animal dosed at 300 mg/kg
1 female animal dosed at 550 mg/kg
1 female animal dosed at 1750 mg/kg
5 female animals dosed at 2000 mg/kg - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Toxicity and pharmacological effects: 1/2, 1, 2 and 4 hours postdose and once daily for 14 days
Mortality: twice daily
Body weight: immediately pretest, weekly and at termination
- Necropsy of survivors performed: yes
- Other examinations performed: Gross pathology. The contents of the abdominal and thoracic cavities were examined in situ for gross pathology
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- All animals survived 300, 550, 1750 or 2000 mg/kg as a single oral dose
- Clinical signs:
- other: There were no abnormal physical signs noted during the observation period
- Other findings:
- Necropsy: four animals appeared normal at necropsy. Mottled kidneys and adrenals appearing larger than normal were noted in the rat dosed at 1750 mg/kg. Red areas on the thymus or a large red spot on the thymus were noted in two animals dosed at 2000 mg/kg. A red capsule (~2 mm) was found attached to abdominal fat in the animal dosed at 300 mg/kg; this finding does not appear to be due to the toxic effects of the test article. A bifurcated spleen was also noted in this same animal, however, this abnormality is probably not due to the toxic effects of the test article.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- All animals survived 300, 550, or 2000 mg/kg as a single oral dose
The LD50 of C-4000 is greater than 2000 mg/kg in female rats
No classification needed for acute toxicity - Executive summary:
In an acute oral toxicity study, groups of eight healthy, non pregnant female Wistar albino rats were given a single oral dose of c-4000 (>99%)at doses of 300, 550, 1750 or 2000 mg/kg bw and observed for 14 days.
Oral LD50>2000 mg/kg bw
No mortality occurred. Limit test
C-4000 is of low Toxicity based on the LD50in females.
There were no major treatment related clinical signs, necropsy findings or changes in body weight.
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.
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