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Diss Factsheets
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EC number: 442-080-3 | 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
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Test conducted according to internationally accepted testing procedures and according to the GLP.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Italia.
- Age at study initiation: no more than three months old.
- Weight at study initiation: 276-298 g (males) 223-225 g (females).
- Fasting period before study: 16 hours fasting before treatment.
- Housing: 5 animals/cage/sex.
- Acclimation period: 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature: 22 °C
- Humidity: 55 %
- Air changes: 12/20 per hrs, filtered on HEPA 99.97 %.
- Photoperiod: 12 hrs dark/12 hrs light.
- Water/feed: ad libitum; GLP 4RF21 top certificate pelleted diet, water filtered from the municipal water system.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 0.5 % Methocel water solution (w/v)
- Details on oral exposure:
- ADMINISTRATION
- Volume: 10 ml/kg
VEHICLE
- Amount of vehicle: 80 %
- Lot/batch no.: 348492/1 - Doses:
- 2000 mg/Kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: observation after 30 minute, 2, 4, 6 hours at the day 1; then twice a day. The animals were weighed twice before treatment and on days 3, 8 and 14.
- 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:
- No deaths occurred in both males and females.
- Clinical signs:
- No clinical changes were observed in the animals.
- Body weight:
- Body weights of both males and females were not affected by the test article administration.
- Gross pathology:
- At the autopsy carried out at the end of the observation period, no appreciable macroscopic findings were evident in any treated rat.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information according to the CLP Regulation Criteria used for interpretation of results: EU
- Conclusions:
- No death or clinical changes occurred in the animals. At the autopsy no appreciable macroscopic findings were evident in any animal. LD50 of the test item when administered to rats as a single dose by oral route is greater than 2000mg/Kg. At this dose the compound did not induce appreciable toxic signs ion the rat.
- Executive summary:
Test item was administered by gavage to Sprague Dawley Crl:CD(SD) BR rats at the limit dose of 2000 mg/Kg (5 males and 5 females). All rats were treated after a 16 hours fasting period and they were weighed twice before treatment and on days 3, 8 and 14.
Rats were observed for 14 day post-treatment period in order to evaluate the substance acute oral toxicity. At day 15 the rats were killed and autopsied.
No deaths or clinical changes were recorded and autopsy did not reveal any appreciable macroscopic finding.
Conclusion
LD50 > 2000 mg/kg bw
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