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Diss Factsheets
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EC number: 482-100-8 | 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:
- Between 15 May 2007 and 6 June 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP study conduct in accoradance with existing guidelines with none or no significant deficiencies
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2007
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Test material form:
- other: Pale amber coloured solid block
- Details on test material:
- Description: Pale amber coloured solid block
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Female Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rats (Charles River (UK) Ltd, Margate, Kent, UK) were randomly allocated to cages and acclimated for a period of at least five days. Following random selection animals were given a unique number and marked with indelible ink. The number was also written on a cage card. Animals were eight to twelve weeks of age at the start of the study and bodyweight variation did not exceed ± 20% of the initial mean bodyweight of any previously dosed animal(s). Animals were housed in groups of up to four in suspended solid-floor polypropylene cages furnished with woodflakes. Except for an overnight fast immediately before dosing and for approximately three to four hours after dosing, free access to mains drinking water and food (Certified Rat and Mouse Diet) was allowed throughout the study. Diet, drinking water and bedding were routinely analysed and were considered not to contain any contaminants that would reasonably be expected to affect the purpose or integrity of the study. Temperature and relative humidity were set to achieve limits of 19 to 25°C and 30 to 70%, respectively. Any occasional deviations from these targets were considered not to have affected the purpose or integrity of the study. The air exchange rate was at least fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light (06:00 to 18:00) and twelve hours darkness. Animals were provided environmental enrichment items that were considered not to contain any contaminant of a level that might have affected the purpose or integrity of the study.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- Based on the results of a sighting test at a dose level of 2000 mg/kg via gavage, an additional four fasted female animals were given a single oral gavage dose of test material, as a solution in arachis oil BP, at a dose level of 2000 mg/kg bodyweight. The volume administered to each animal was calculated according to its fasted bodyweight at the time of dosing. Clinical observations were made 1/2, 1, 2, and 4 hours after dosing and subsequently once daily for fourteen days. Morbidity and mortality checks were made twice daily. Individual bodyweights were recorded on Day 0 (the day of dosing) and on Days 7 and 14. All animals were subjected to gross necropsy at the end of the observation period, consisting of an external examination and opening of the abdominal and thoracic cavities. Any observed macroscopic abnormalities was recorded.
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 1 animal for the sighting study; 4 animals for the main study.
- Control animals:
- no
- Statistics:
- Not applicable
Results and discussion
- Preliminary study:
- No mortality was observed in the sighting study.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No mortality, clinical signs of systemic toxicity, body weight effects, or abnormal necropsy findings were observed.
- Mortality:
- None
- Clinical signs:
- None
- Body weight:
- None
- Gross pathology:
- None
- Other findings:
- None
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the results of this study, this substance does not require classification under EU Regulation (EC) No. 1272/2008 for acute oral toxicity.
- Executive summary:
Test Guidance
OECD 420 Fixed dose method
Method and materials
The acute toxicity of this substance was evaluated in rats. Following acclimation, a sighting test at a dose level of 2000 mg/kg via gavage was conducted with one animal. Based on the absence of mortality, an additional four fasted female animals were given a single oral gavage dose of test material, as a solution in arachis oil BP, at a dose level of 2000 mg/kg bodyweight.
Results
No mortality, clinical signs of systemic toxicity, body weight effects, or abnormal necropsy findings were observed. The LC50 (oral) > 2000 mg/kg.
Conclusion
Based on the results of this study, this substance does not require classification under EU Regulation (EC) No. 1272/2008 for acute oral toxicity.
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