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EC number: 468-890-7 | 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:
- 2003-02-21 to 2003-06-23
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- adopted 17 December 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Version / remarks:
- 30 September 1996
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - Test system
Species: Rat, Wistar HsdCpb: WU, males (m) and females (f)
Age: approx. 6 to 8 weeks
Mean initial body weight at the start of the study: 177 g (range from 156 to 196 g).
- Identification and adaptation
Healthy young animals were allocated to the study group at least 7 days before dosing to allow for acclimatization.
The rats were identified by an ear tattoo.
- Housing and diet
The rats were housed in an air-conditioned room of about 25 m^2 in the institute. Lighting was controlled by a timer to provide a 12 hour light - 12 hour dark regime.
The rats were kept separately in type III Makrolon cages with a shelter, placed on mobile racks. Conventional softwood granulate was used
as the bedding. One day before treatment, and up to 24 hours after dosing, metal grids were placed above the softwood granulate.
The cages and the metal grids had been machine-cleaned before the start of the experimental part. The bedding was changed two times per
week.
Temperature and humidity were measured using a thermohygrograph. The room temperature during the experimental period was 22 °C
and the relative atmospheric humidity 44 to 68 %.
Diet was withheld from 17 hours before until up to 4 hours after treatment. At all other times food and tap water from Makrolon drinking
bottles were available to the rats ad libitum.
According to the specifications given by the manufacturer, the diet, Provimi Kliba 3433.0, had been checked by independent laboratories.
Analysis included qualitative and quantitative evaluation for heavy metals, aflatoxins, pesticides, and antibiotics.
The drinking water was periodically analyzed according to the German regulations for human drinking water.
The softwood granulate was analytically checked by independent laboratories.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Methocel K4M premium (hydroxypropyl methylcellulose)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 g/L
- Amount of vehicle (if gavage): 10 mL/kg bw
- Justification for choice of vehicle: standard vehicle for this type of studies
- Doses:
- 2000 mg/kg bw (limit test)
- No. of animals per sex per dose:
- 3 males / 3 females
- Control animals:
- no
- Details on study design:
- Observation for clinical symptoms
The behavior and general condition of all rats were monitored for at least 6 hours after administration and then checked daily.
Body weight
All animals were weighed before treatment and on days 2, 4, 6, 8, 11, 13, and 15 of the experimental part.
Pathology
All rats were sacrificed at the end of the experimental part by C02-asphyxia and subjected to a gross pathological investigation.
Statistics and evaluation
The body weight data recording and statistical evaluations were performed using a PC-program. The body weight development of each rat and group was determined. The group mean value was calculated for each measurement and printed on tables.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality observed. All rats survived the observation period.
- Clinical signs:
- No signs of toxicity were detected in the 3 male and 3 female rats after treatment with 2000 mg/kg of test material.
- Body weight:
- Body weight development of the treated rats was inconspicuous.
- Gross pathology:
- At necropsy no organ alterations were seen.
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to the results of this study in rats the test material is not toxic/harmful after acute oral administration i.e. the LD50 value (rat, oral) exceeds the limit dose of 2000 mg/kg body weight.
- Executive summary:
Purpose
The purpose of this assay was to provide information on possible health hazards for the test material and serve as a rational basis for risk assessment to the potential of acute oral toxicity of the test item in man.
Study design
This study was performed according to the OECD TG 423 ,,Acute toxic class method" (ATC).
Results
No signs of toxicity were detected in 3 male and 3 female rats after treatment and no rat died.
The gross pathological examination revealed no organ alterations.
Conclusions
According to the results of this study the test material can be allocated to ATC class 0 i.e. the LD50 value exceeds the limit dose of 2000 mg/kg body weight.
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