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Diss Factsheets
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EC number: 478-210-0 | CAS number: 69901-75-3
- 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:
- 2006-10-02 to 2007-04-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study performed according to OECD Guideline 423 (Acute Oral Toxicity - Acute Toxic Class Method) and EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method) without deviations.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 007
- Report date:
- 2007
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Remarks:
- The testing facility indicated that the protocol was followed without deviation.
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Department of Health of the Government of the United Kingdom
- Test type:
- other: Acute Oral Toxicity
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): VRT-126016
- Molecular formula (if other than submission substance): Not applicable
- Molecular weight (if other than submission substance): Not applicable
- Smiles notation (if other than submission substance): Not applicable
- InChl (if other than submission substance): Not applicable
- Structural formula attached as image file (if other than submission substance): Not applicable
- Substance type: No data
- Physical state: White powder
- Analytical purity: 99.8%
- Impurities (identity and concentrations): No data
- Composition of test material, percentage of components: No data
- Isomers composition: No data
- Purity test date: 2006-02-02
- Lot/batch No.: Lot I-4107-6-02-02/ Batch No. 25719
- Expiration date of the lot/batch: 2008-02-01
- Other: Store at room temperature
Test animals
- Species:
- rat
- Strain:
- other: CD (Crl:CD BR)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, England
- Age at study initiation: 8 to 12 weeks
- Weight at study initiation: 175 to 209 g
- Fasting period before study: Overnight prior to and approximately 4 hours after exposure to test substance
- Housing: Housed in groups of three rats of the same sex
- Diet (e.g. ad libitum): Standard rodent diet (Rat and Mouse No. 1 Maintenance Diet), ad libitum
- Water (e.g. ad libitum): Potable water taken from the public supply, ad libitum
- Acclimation period: 5 days before treatment
ENVIRONMENTAL CONDITIONS
- Temperature (deg C): 19 to 23 deg C
- Humidity (%): 40 to 70%
- Air changes (per hr): No data
- Photoperiod: 12 hours continuous light and 12 hours continuous dark per 24 hours
IN-LIFE DATES
- From: 2006-10-05 to 2007-11-09
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: aqueous methylcellulose
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 1%
- Amount of vehicle (if gavage): 10 mL/kg body weight
- Justification for choice of vehicle: No data
- Lot/batch no. (if required): No data
- Purity: No data
MAXIMUM DOSE VOLUME APPLIED
- 10 mL/kg body weight
DOSAGE PREPARATION (if unusual)
- Not applicable
CLASS METHOD
- Rationale for the selection of the starting dose: OECD Guideline 423 - Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 3 females/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed soon after dosing and at frequent intervals for the remainder of Day 1. On subsequent days, animals were observed once in the morning and again at the end of the experimental day (with the exception of Day 15 – morning only). The nature and severity, where appropriate, of the clinical signs and the time were recorded at each observation. The weight of each rat was recorded on Days 1 (prior to dosing), 8 and 15. Individual weekly bodyweight changes and group mean bodyweights were calculated.
- Necropsy of survivors performed: Yes
- Other examinations performed: Cages of rats were checked at least twice daily for any mortalities. All animals were subject to a macroscopic examination which consisted of opening the cranial, thoracic and abdominal cavities. The macroscopic appearance of all examined organs was recorded. - Statistics:
- no data
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- There were no deaths during the study.
- Clinical signs:
- Clinical signs of reaction to treatment observed in animals dosed at 2000 mg/kg comprised hunched posture, abnormal gait (unsteady), piloerection and urine staining (perigenital area). In addition, underactivity seen in four females, partially closed eyelids in two females, reduced body temperature in two females, loose faeces and irregular breathing were observed in one female. These signs were first noted approximately from one to three hours after dosing. Recovery of animals, as judged by external appearance and behaviour, was complete by Day 4 or 5.
- Body weight:
- A bodyweight loss was noted for one animal (No. I8) dosed at 2000 mg/kg on Day 15. A low bodyweight gain was noted for one female (No. I4) on Day 15 dosed at 300 mg/kg and one female (No. I10) on Day 15 dosed at 2000 mg/kg. All other animals were considered to have achieved satisfactory bodyweight gains throughout the study.
- Gross pathology:
- No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15.
- Other findings:
- No data
Any other information on results incl. tables
Not applicable
Applicant's summary and conclusion
- Conclusions:
- The acute median lethal oral dose (LD50) to rats of the test substance was demonstrated to be greater than 2000 mg/kg bodyweight.
The test substance is included in Category 5 or unclassified, according to the Globally Harmonised System (GHS), (United Nations, 2005). - Executive summary:
Not applicable
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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