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Diss Factsheets
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EC number: 443-940-0 | 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
- Study period:
- From May. 28, 2002 to Aug. 29, 2002
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted according to EU Method B.1 tris in compliance with GLP
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Details on test material:
- - Name of test material (as cited in study report): Reaktiv-Scharlach F01-0467
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: HSD: Sprague Dawley SD
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HARLAN WINKELMANN, Gartenstr. 27, D-33178 Borchen
- Age at study initiation: 6-10 wk
- Weight at study initiation: 201± 9.2g (males); 186± 6.1 g (females)
- Fasting period before study: Yes, 16 h
- Housing: Transparent macroIon cages (type 4) on soft wood granulate in groups of 3 animals
- Diet (e.g. ad libitum): ssnif R/M-H (V 1534), ad libitum
- Water (e.g. ad libitum): Tap water in plastic bottles, ad libitum
- Acclimation period: At least 5 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±3 °C
- Humidity (%): 50±20 °C
- Photoperiod (hrs dark / hrs light): 12 h dark/12 h light
IN-LIFE DATES: From: May. 28, 2002 To: Jun. 12, 2002
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Sesame oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 % suspension in sesame oil
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION (if unusual): Test substance was suspended in the stated concentration in sesame oil and distributed homogeneously by means of a magnetic stirrer.
The stability and the homogeneity of the test substance in the vehicle was determined by analytical methods.
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: Was tested only at a dose level of 2000 mg/kg body weight (limit test) according to toxicity data of related compounds - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3 animals/sex/dose
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 d
- Frequency of observations and weighing: Symptoms were recorded twice every day (in the morning and in the afternoon), on weekends
and public holidays only once. The animals were weighed weekly.
- Necropsy of survivors performed: yes; animals were killed by carbon dioxide
asphyxiation, dissected and examined for macroscopically visible changes.
- Other examinations performed: clinical signs, body weight- Yes
Results and discussion
- Preliminary study:
- No
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: -
- Mortality:
- No mortalities occurred during the whole study
- Clinical signs:
- other: Red discolored urine was observed in all animals on the first day of the study and on Day 2 in the male animals. From Day 3 until the end of the study no symptoms were observed.
- Gross pathology:
- No gross pathology changes observed
- Other findings:
- None
Any other information on results incl. tables
None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the test conditions, the acute oral LD50 of the test substance was found to be >2,000 mg/kg in Sprague-Dawley SD rats.
- Executive summary:
A study was conducted to assess the acute oral toxicity of test substance in Sprague-Dawley CD rats according EU Method B.1 tris in compliance with GLP.
Following a range-finding study, a group of 10 fasted rats (three males and three females) were given a single oral dose of the test substance as a 20 % suspension in sesame oil, at a dose level of 2,000 mg/kg. The animals were observed for 14 d after the day of dosing and were then killed and subjected to gross pathological examination. There were no mortalities in the study. Red discolored urine was observed in all animals on the first day of the study and on Day 2 in the male animals. From Day 3 until the end of the study no symptoms were observed. Two female animals showed a reduced body weight gain in wk 2. In all other animals the development of body weight was not impaired. No abnormalities were noted at necropsy.
Under the test conditions, the acute oral LD50 of the test substance was found to be >2,000 mg/kg in Sprague-Dawley CD 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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