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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
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: - | 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:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non GLP-Study, no informations on Guideline followed in report.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- no
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- solid: crystalline
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Male Crl:CD®(SD)IGS BR rats were received from Charles River Laboratories, Inc., Raleigh,
North Carolina. Rats were housed singly in stainless steel, wire-mesh cages suspended above
cage boards. Each rat was assigned a unique identification number which was recorded on a card
affixed to the cage. The rats were tail-marked, using a water-insoluble marker, with the last 3
digits of the animal number. PMI Nutrition International, Inc. Certified Rodent LabDiet® 5002
and water were available ad libitum.
As specified in the Haskell Laboratory animal health and environmental monitoring program, the
following procedures are performed periodically to ensure that contaminant levels are below
those that would be expected to impact the scientific integrity of the study:
• Water samples are analyzed for total bacterial counts, and the presence of coliforms, lead,
and other contaminants.
• Feed samples are analyzed for total bacterial, spore, and fungal counts.
• Samples from freshly washed cages and cage racks are analyzed to ensure adequate sanitation
by the cagewashers.
Certified animal feed is used, guaranteed by the manufacturer to meet specified nutritional
requirements and not to exceed stated maximum concentrations of key contaminants, including
specified heavy metals, aflatoxin, chlorinated hydrocarbons, and organophosphates. The
presence of these contaminants below the maximum concentration stated by the manufacturer
would not be expected to impact the integrity of the study.
The animal health and environmental monitoring program is administered by the attending
laboratory animal veterinarian. Evaluation of these data did not indicate any conditions that
affected the validity of the study.
Rats were quarantined, weighed, and observed for general health for 6 days. Animal rooms were
maintained on a timer-controlled, 12-hour light/12-hour dark cycle. Environmental conditions of
the rooms were targeted for a temperature of 23 ± 1°C and relative humidity of 50 ± 10%.
Excursions outside these ranges were of small magnitude and/or brief duration and did not
adversely affect the validity of the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- The test substance was suspended in corn oil and administered to 1 rat per dose rate by
intragastric intubation. The volumes administered were calculated based on the suspension
concentration and body weights collected on the day of dosing. Doses administered ranged from
2300 to 11,000 mg/kg of body weight in increments of approximately 50%. Additionally, 1 rat
was dosed at 670 mg/kg. The dosing day was test day 1; postexposure day 14 was test day 15.
Following administration of the test substance, rats were observed for clinical signs of toxicity. - Doses:
- 670, 2300, 3400, 5000, 7500, and 11,000 mg/kg
- No. of animals per sex per dose:
- 1
- Control animals:
- no
- Details on study design:
- The rats were weighed and observed daily until signs of toxicity subsided, and then at least 3
times a week throughout the 14-day observation period. Observations for mortality and signs of
illness, injury, or abnormal behavior were made daily throughout the study. Pathology
examinations of test animals were not performed.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 5 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No deaths occurred during the study.
- Clinical signs:
- The rat dosed at 7500 mg/kg exhibited wet chin on the day of dosing and yellow stained perineum on test day 2. The rat dosed at 11,000 mg/kg exhibited lung noise on the day of dosing. No other clinical signs were observed.
- Body weight:
- No biologically important body weight losses occurred during the study.
- Gross pathology:
- Pathology examinations of test animals were not performed.
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- Under the conditions of this study, the oral ALD for H-25286 was greater than 11,000 mg/kg of body weight. This substance is considered to be very low in toxicity (ALD greater than 5000 mg/kg) when administered as a single oral dose to male 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.
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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