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Diss Factsheets
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EC number: 943-336-1 | 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 14 June 1991 to 16 July 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study conducted under GLP conditions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Perfluorohexane
- IUPAC Name:
- Perfluorohexane
- Details on test material:
- - Name of test material (as cited in study report): T-5333
- Lot/batch no.: 629
- Storage condition of test material: Test article was stored at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CDBR VAF/Plus
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Porage MI.
- Age at study initiation: about 5 weeks old
- Weight at study initiation: 144.2 to 195.5 g
- Housing: Individually except during 7 day acclimation period
- Diet (e.g. ad libitum): ad libitum Certified Rodent Chow #5002 meal (Purina Mills, Inc.)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 7 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25
- Humidity (%): 30 to 70
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From 14 June 1991 to 16 July 1991
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Analytical verification of doses or concentrations:
- no
- Details on analytical verification of doses or concentrations:
- Test article was dosed as received form the sponsor.
- Duration of treatment / exposure:
- 32 days
- Frequency of treatment:
- once daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Basis:
actual ingested
- No. of animals per sex per dose:
- 20 male, 20 female
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Low toxicity expected
- Rationale for animal assignment (if not random): Random
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Observed twice daily (a.m. and p.m.)
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Observed twice daily for mortality and moribundity and predose and apporximately 1.5 hours postdose for obvious indications of a toxic effect. At least once weekly, each animal was removed from its cage and examined.
BODY WEIGHT: Yes
- Time schedule for examinations: Recorded prior to randomization, on the first day of treatment, and weekly thereafter.
WATER CONSUMPTION AND COMPOUND INTAKE: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Evaluated during week 5.
- Anaesthetic used for blood collection: Yes (ketamine)
- Animals fasted: Yes
- How many animals: All animals
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: Week 5
- Animals fasted: Yes
- How many animals: All animals
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- no effects observed
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not examined
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- BODY WEIGHT AND WEIGHT GAIN: Weights and weight gains in the test groups were not significatly different than the control group
CLINICAL CHEMISTRY: No abnormal findings
NEUROBEHAVIOUR: No abnormal behaviors observed
ORGAN WEIGHTS: No abnormal organ-to-body weight percentages observed
GROSS PATHOLOGY: No effects observed
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- > 2 000 mg/kg bw (total dose)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- body weight and weight gain
- clinical biochemistry
- clinical signs
- gross pathology
- haematology
- histopathology: non-neoplastic
- mortality
- organ weights and organ / body weight ratios
- other: There were no test article related clinical observations or changes in body weights or food consumption noted for males or females. Oral administration of the test article had no effect on clinical pathology or anatomical pathology.
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
- System:
- other: There were no test article related clinical observations or changes in body weights or food consumption noted for males or females. Oral administration of the test article had no effect on clinical pathology or anatomical pathology.
Applicant's summary and conclusion
- Conclusions:
- Based on the results of this study, the no-observable-effect level for the test article in male and female rats was greater than 2000 mg/kg.
- Executive summary:
A 4 week oral toxicity study was conducted on the test article utilizing rats. 20 male and 20 female Crl:CDBR VAF/Plus rats were assigned at random to one control group and three treated groups (five/sex/group). The control group was given 0.9% sodium chloride at 1 mL/kg body weight. The test groups received 200, 1000, and 2000 mg/kg body weight at a volume of 0.104, 0.520, and 1.04 mL/kg respectively. The animals received their respective doses daily (A.M.) for a total of 32 days. Rats were observed twice daily (A.M. and P.M.) for mortality and moribundity and pre-dose and approximately 1.5 hours post-dose for obvious indications of a toxic effect. Blood samples were collected from all animals before terminal sacrifice for hematology and clinical chemistry analyses. After 4 weeks of treatment, the animals were fasted overnight, anesthetized with sodium pentobarbital, weighed, exsanguinated, and necropsied. All animals were examined macroscopically and selected tissues were weighed and preserved. Tissues from all animals in the control and high-dose groups were sectioned, stained, and examined microscopically. There were no test article related clinical observations or changes in body weights or food consumption noted for males or females. Oral administration of the test article had no effect on clinical pathology or anatomical pathology. Based on the results of this study, the no-observable-effect level/no-observable-adverse-effect level for the test article in male and female rats was greater than 2000 mg/kg as described in the study report. In the absence of any adverse findings, it can also be considered that the NOAEL is > 2000 mg/kg.
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