Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 687-691-8 | CAS number: 709031-43-6
- 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:
- December 2002
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Principles of method if other than guideline:
- Two groups of three male rats were given the test article as a single dose on DAy 1 by oral gavage at dose levels of 200 mg/kg. The study director requested that the first group to be dosed should be females, but males were dosed , in error. This mistake was not noticed until a second group of males had been dosed). Subsequently a group of three male and three female fasted rats were given the test article as single dose by oral gavage at a dose level of 2000 mg/kg.
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid - liquid: suspension
- Remarks:
- migrated information: dispersion
- Details on test material:
- Batch number ZD48725 LOT 002 (Dispensary number 0683/02-1340
Test animals
- Species:
- rat
- Strain:
- other: Crl: WI(GIx/BRL/Han)BR
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Methylcellulose
- Details on oral exposure:
- The test article was dispersed in 1% w/v methylcellulose. The formulated concentrations were calculated from the selected dose level and the dose volume 20 mL/Kg
- Doses:
- 200 mg/kg
2000 mg/kg - No. of animals per sex per dose:
- 2 groups of three fasted male rats were treated at 200 mg/kg
1 group of three female and three male fasted rats were treated at 2000 mg/kg - Control animals:
- no
- Details on study design:
- Two groups of three male rats were given the test article as a single dose on DAy 1 by oral gavage at dose levels of 200 mg/kg. The study director requested that the first group to be dosed should be females, but males were dosed , in error. This mistake was not noticed until a second group of males had been dosed). Subsequently a group of three male and three female fasted rats were given the test article as single dose by oral gavage at a dose level of 2000 mg/kg. The test article was dispersed in 1% w/v methylcellulose and administered at a dose volume of 20 ml/kg. All animals were killed on DAy 15 and subsequently underwent a full necropsy.
Results and discussion
- Mortality:
- There were no deaths folloiwng a sinle oral dose of BMS 528235-01 among male rats dosed at 200 mg/kg or among rats of both sexes dosed at 2000 mg/kg
- Clinical signs:
- Signs of reaction to treatment were limited to a single incidence of tachypnoea observed in one male dosed at 2000 mg/kg at 1 hour observation. This had resolved by teh 2 hour observation and is not considered to be of toxicological significance.
- Body weight:
- All rats achieved body weight gains during the first and second weeks of the study. The overall body weight gains of males dosed at 2000 mg/kg tended to be slightly lower than those seen in males dosed at 200 mg/kg. The body weight gains in animals dosed at 200 mg/kg ranged beteeen 35 adn 45'; the three animals dosed at 2000 mg/kg gained 31, 21, adn 42g, respectively. Body weight gains in the females also tended to be low (12, 14 adn 15g respectively). These variations in body weight gain are considered to be of equivocal toxicological significance.
- Gross pathology:
- No macrosocopic changes were observed for animals killed on Day 15
Any other information on results incl. tables
Dose Level (mg/kg) | Mortality Ratio - Male | Mortality Ratio - Female |
200 | 0/6 | - |
2000 | 0/3 | 0/3 |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Following a single oral administration of BMS 528235-01 to rats, the acute median lethal oral dose was found to exceed 2000 mg/kg
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.