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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 473-130-2 | 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
Endpoint summary
Administrative data
Description of key information
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 16, 2006 to May 31, 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to OECD Guideline 423, EPA OPPTS 870.1100 and EU Method B.1tris, in compliance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1100 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CRL:(WI) BR
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles river (Europe) laboratories inc. Toxi coop Ltd. 1103 Budapest, Cserkesz u. 90.
- Date of receipt: April 26, 2006
- Age at study initiation: Young, adult rats, 8-12 weeks old
- Body weight range at treatment: 190 g to 208 g
- Hygienic level at arrival: SPF
- Sex: Female, nulliparous and non-pregnant.
- Housing: Type II polypropylene/polycarbonate, 3 animals / cage
- Bedding: Laboratory bedding
- Diet: Ssnif SM R/M-Z+H complete diet for rats and mice, ad libitum
- Water: Tap water from municipal supply from 500 mL bottle, ad libitum
- Animal health: Only healthy animals were used for the test. The veterinarian certified healthy status.
- Acclimation period: 20 and 21d
- Animal identification: Numbers on the tail written with a marker pen. The cages were identified by cards, with information about study code, sex, dose group, cage number and individual animal numbers
ENVIRONMENTAL CONDITIONS
- Temperature: 22±3°C
- Relative humidity: 30-70%
- Photoperiod: 12 h light/dark cycle
- Ventilation: 8-12 air exchanges/h by central air-condition system
IN-LIFE DATES: From: To: May 16, 2006 to May 31, 2006 - Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Batch No: 2364-1005
- Expiry date: October 31, 2006
- Storage: At room temperature
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
PREPARATION OF THE TEST SUBSTANCE: For treatment the test substance was applied in a concentration of 200 mg/mL in Distilled water. Formulations were prepared just before the administration and stirred with a magnetic stirrer up to end of the treatment.
Justification of the dose:
Starting dose was selected on the basis of available data of similar compounds. The LD50 value was expected to be above 2,000 mg/kg bw. A limit test was performed at 2,000 mg/kg bw dose.
Three female animals were treated with a dose level of 2,000 mg/kg bw of test substance in the first step. All animals survived; so three further animals were dosed at 2,000 mg/kg bw dose level next day, as the second step. No mortality occurred in either step, therefore the test was finished meeting the stopping criteria of guidelines. - Doses:
- 2,000 mg/kg bw
- No. of animals per sex per dose:
- 3 females/group
- Control animals:
- not specified
- Details on study design:
- Procedure
-A single oral administration - followed by a 14 d observation period - was performed by gavage.
-On the day before each treatment the animals were fasted. The food but not water was withheld during an overnight period.
-Animals were weighed just before the treatment. The test substance was administered by oral gavage in the morning hours. The food was given back 3 h after the treatment. A constant treatment volume of 10 mL/kg bw was applied.
OBSERVATIONS
Clinical Observations
Careful clinical observation was made 15 and 30 minutes, 1 h, 2 h, 3 h, 4 h, 6 h after the treatment and once each day for 14 d thereafter.
Individual observations were performed on the skin, fur, eyes, mucous membranes, respiratory, circulatory, autonomic and central nervous system, somatomotor activity and behaviour pattern as well. Particular attention was directed to the observation of tremors, convulsions, salivation, diarrhoea, lethargy, sleep and coma.
Body Weight Measurement
The body weight was recorded on Day 0 (shortly before the treatment), then on Days 7 and 14 with a precision of 1g.
NECROPSY
Gross necropsy was performed in each experimental animal terminally. Animals were sacrificed by exsanguination under pentobarbital anaesthesia. After the examination of the external appearance the cranial, thoracic and the abdominal cavities were opened, the organs and the tissues were observed. Abnormalities were recorded on post mortem data sheets. - Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- Test substance caused no mortality in female CRL:(WI) BR rats after a single oral (by gavage) administration of 2,000 mg/kg bw.
- Clinical signs:
- other: No animals showed clinical symptom on the day of the treatment and the following 14 d observation period in either groups. The physical condition and behaviour of animals were considered normal during the whole experiment.
- Gross pathology:
- No macroscopic alterations related to the toxic effect of test substance were found at necropsy. The pinprick-sized haemorrhages (3/3 and 3/3) observed in the lungs were due to the termination procedures and exsanguination. Hydrometra due to the sexual cycle of animals is a common observation in experimental rats (0/3, 2/3).
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the study conditions, the oral LD50 was found to be >2,000 mg/kg bw in rats.
- Executive summary:
A study was conducted to assess the acute oral toxicity of the test substance in female CRL:(WI) BR rats according to OECD Guideline 423, EPA OPPTS 870.1100 and EU Method B.1tris, in compliance with GLP.
Groups of three female rats received a single oral (gavage) dose of 2,000 mg/kg bw in a first and second step respectively. A concentration of 200 mg/mL of test substance was prepared with distilled water and administered by gavage at a volume of 10 mL/kg bw.
No mortality occurred, no clinical symptoms were found, no effect on body weight was observed and no significant macroscopic abnormalities were seen at necropsy.
Under the study conditions, the oral LD50 was found to be >2,000 mg/kg bw in rats.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
A study was conducted to assess the acute oral toxicity of the test substance in female CRL:(WI) BR rats according to OECD Guideline 423, EPA OPPTS 870.1100 and EU Method B.1tris, in compliance with GLP. Groups of three female rats received a single oral (gavage) dose of 2,000 mg/kg bw in a first and second step respectively. A concentration of 200 mg/mL of test substance was prepared with distilled water and administered by gavage at a volume of 10 mL/kg bw. No mortality occurred, no clinical symptoms were found, no effect on body weight was observed and no significant macroscopic abnormalities were seen at necropsy. Under the study conditions, the oral LD50 was found to be >2,000 mg/kg bw in rats (Szakonyi, 2006).
Justification for selection of acute toxicity – oral endpoint
Guideline-compliant study conducted according to GLP.
Justification for classification or non-classification
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.