Registration Dossier
Registration Dossier
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Diss Factsheets
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EC number: 700-323-3 | CAS number: 908020-52-0
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, available as unpublished report, no restrictions, fully adequate for assessment.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Gotemba laboratory, Bozo Research Center Inc
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Details on test material:
- - Name of test material (as cited in study report): Perfluoro-3,6-dioxaoctanoic acid ammonium salt (EEA-NH4)
- Physical state: white powder
- Purity: 99%
- Lot/batch No.: #0709211
- Storage condition of test material: in an air tight container (shielded from light) in a cold dark place (measured temperature: 4 to 7 °C)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Atsugi breeding center, Charles River Japan
- Age at study initiation: 7 weeks
- Weight at study initiation: 256 - 281 g for males, 203 to 234 g for females
- Fasting period before study:
- Housing: Bracket type stainless steel wire mesh cages (Lead Engineering Co Ltd.)
- Diet (e.g. ad libitum): Free access to pelleted diet CRF-1
- Water (e.g. ad libitum): Free access to tap water (Gotemba city water) via water bottles
- Acclimation period: 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23 ± 3 °C
- Humidity (%): 50 ± 20%
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12 hours
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 42 cm2
- Type of wrap if used: Lint sheet (6 x 7 cm) covered with and fixed by elastic bandage
REMOVAL OF TEST SUBSTANCE
- Washing (if done): wiped with warm water and absorbent gauze
- Time after start of exposure: 24 hours
TEST MATERIAL
- Concentration (if solution): 500 mg / ml
- Constant volume or concentration used: yes
- For solids, paste formed: No - Duration of exposure:
- 24 hours
- Doses:
- 500 mg/kg bw, 1000 mg/kg bw and 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: 5 mins, 15mins, 30 mins, 1 hour, 2 hours, 4 hours, 6 hours, thereafter daily to 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- Not performed
Results and discussion
- Preliminary study:
- None
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: No deaths at highest dose used in study
- Mortality:
- No deaths occurred.
- Clinical signs:
- other: There were no abnormal clinical signs in any animal of either sex in either the control group, the test article groups or the control article group during the observation period. Skin irritation reactions, such as erythema, eschar and edema, were not obse
- Gross pathology:
- There were no abnormal macroscopic findings in the external appearance including the application site or the cranial, thoracic or abdominal organs / tissues in any animal in either sex in the test article groups, the control article group or the control group.
Applicant's summary and conclusion
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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