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Diss Factsheets
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EC number: 700-403-8 | 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 425 (Acute Oral Toxicity: Up-and-Down Procedure)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- up-and-down procedure
- Limit test:
- yes
Test material
- Details on test material:
- - Purity: not reported as such
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Sprague-Dawley derived, albino.
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Age at study initiation: 10-11 weeks
- Weight at study initiation: 193-219 g
- Fasting period before study: yes; overnight prior to dosing
- Housing: singly in suspended stainless steel caging with mesh floors. Litter paper was placed beneath the cage and was changed at least 3 times per week.
- Diet (e.g. ad libitum): ad libitum except for fasting period prior to dosing; food was returned to the rats approximately 3-4 hours after dosing
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 16-23 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-22°C
- Humidity (%): 39-71% The humidity was above the targeted upper limit for one day during the study. A portable dehumidifier was used to decrease the humidity levels during this time.
- Air changes (per hr): Not Reported
- Photoperiod (hrs dark / hrs light): 12-hour light/dark cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- MAXIMUM DOSE VOLUME APPLIED: Not Reported
- Doses:
- 175, 550, 1750, 5000 mg/kg
- No. of animals per sex per dose:
- One female each at dose levels of 175, 550 or 1,750 mg/kg and 3 females at 5,000 mg/kg.
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: All animals were observed for mortality, signs of gross toxicity, and behavioural changes approximately one hour post-dosing and during the first several hours post-dosing and at least once daily thereafter for 14 days after dosing.
-Frequency of weighing: prior to administration (initial) and again on Days 7 and 14 (termination) following dosing.
- Necropsy of survivors performed: yes, on all animals at terminal sacrifice. Tissues and organs of the thoracic and abdominal cavities were examined. - Statistics:
- The Acute Oral Toxicity (Guideline 425) Statistical Program (Weststat, version 1.0, May 2001) was used for all data analyses including: dose progression selections, stopping criteria determinations and/or LD50 and confidence limit calculations.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 other: mg/kg bw ( >1000 mg/kg based on ~20% solids content)
- Mortality:
- No deaths occurred.
- Clinical signs:
- All animals appeared active and healthy. There were no signs of gross toxicity, adverse pharmacologic effects, or abnormal behaviour.
- Body weight:
- All animals gained body weight during the study.
- Gross pathology:
- No gross abnormalities were noted for any of the rats at necropsy.
Any other information on results incl. tables
The aqueous dispersion of the test substance (~ 20% solids and ~80% water) was administered directly without correction for active ingredients since the product does not exist as solids alone and is always transported and used as the aqueous dispersion. The material was not toxic via the oral route of exposure as evidenced by the LD50 of > 5000 mg/kg. This is equivalent to an approximate LD50 of > 1000 mg a.i./kg of solids.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- LD50 (female rats) > 5000 mg/kg. This is equivalent to an approximate LD50 of > 1000 mg a.i./kg of solids.
- Executive summary:
Following the Up and Down procedure, a single dose of test substance was administered by oral gavage to 1 fasted female rat each at a dose of 175, 550, or 1750 mg/kg and to 3 fasted female rats at a dose of 5000 mg/kg. The rats were observed for mortality, body weight effects, and clinical signs for 14 days after dosing. All rats were necropsied to detect grossly observable evidence of organ or tissue damage. No deaths occurred. All animals appeared active and healthy and gained weight over the 14-day observation period. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the 14-day observation period. Under the conditions of this study, the oral LD50 for the test substance is greater than 5000 mg/kg for female rats.
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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