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Diss Factsheets
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EC number: 435-940-4 | 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:
- 2000
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study with GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Supplier: Institut für Labortierkunde und -genetik, A-2325 Himberg, Austria.
Age: Approximately 8 weeks (males and females) at the time of the administration.
Body weight at the administration: 190 g for males, 154 g for females.
Room temperature: Average of 22 °C (continuous control and recording).
Relative humidity: Average of 56 % (continuous control and recording).
Air exchange: 12 per hour.
Light: Artificial light from 6 a.m. to 6 p. m.
Cages: Single caging in Makrolon cages type III (39 cm x 23 cm x 18 cm). Wire mesh lids.
Bedding material: Aspen wood chips
Environmental enrichment: Nibbling wood bricks (10 cm x 2 cm x 2 cm) and nesting material, both from the same material and source as the bedding material, were offered to the animals
Feed: Altromin 1324 forte, gamma irradiated with 25 kGy 60Co, ad libitum. Exception: The feed was withdrawn the evening before the administration of the test substance and was offered again about three hours afterwards.
Water: Tap water from an automatic watering system, ad libitum.
Acclimatisation: At least 5 days.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Details on oral exposure:
- A stomach intubation was performed. Dose volume: 10 mL/kg bw.
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males + 5 females
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Observations were performed within the periods 0- 0.5, 0.5 - 1, 1 - 2, 2- 4 and 4- 6 hours after administration of the test substance and then at least once a day for a total of 2 weeks.
- Frequency of weighing: Body weights were determined before the administration, 7 days p.a. and 14 days p.a.
- Necropsy of survivors performed: yes.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived until the scheduled termination of the study.
- Clinical signs:
- Observations in life
4/5 males and 4/5 females were normal during the whole observation period. Hunched posture in 1/5 males and females each noted 0.5 h p.a. is attributed as a sign of discomfort or of reduced well-being. - Body weight:
- Males and females: Body weights and body weight gain were inconspicuous in all animals in the first week. In the second week a low body weight gain was noted in 1/5 females.
- Gross pathology:
- Necropsy findings
No abnormal findings were made post mortem.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- No mortality, no relevant signs in life and at necropsy were detected. The LD50 is above 2000 mg/kg bw.
- Executive summary:
Methods and investigations were performed in accordance with the EU method B1., and the OECD Guideline 401, 1987.
The test substance, freshly suspended in corn oil, was administered once orally by stomach intubation to 5 male and 5 female Sprague Dawley rats. The dose was 2000 mg per kg body weight.
Investigations
• Body weights: before the administration, 7 and 14 days after the administration.
• Clinical observations: at least once per day.
• Necropsy: 14 days p.a.
No mortality, no relevant signs in life and at necropsy were detected. The LD50 is above 2000 mg/kg bw.
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