Registration Dossier
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EC number: 203-777-6 | CAS number: 110-54-3
- 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: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1980
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because there was no GLP statement provided, and limited data on methods were reported, but the study seemed to be well-conducted.
Data source
Reference
- Reference Type:
- publication
- Title:
- A comparative study on the neurotoxicity of n-pentane, n-hexane, and n-heptane in the rat
- Author:
- Takeuchi, Y, Ono, Y, Hisanaga, N, Kitoh, J, and Sugiura, Y
- Year:
- 1 980
- Bibliographic source:
- British Journal of Industrial Medicine, 37, 241-247
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 7 rats were exposed to 3000 ppm of hexane vapors for 12 hrs a day for 16 weeks. Body weights and conduction velocity of the peripheral nerve of the tail was measured at 0, 4, 8, 12 and 16 weeks. At the end of the exposure period, two animals were sacrificed and the nerve tissue examined.
- GLP compliance:
- not specified
- Limit test:
- yes
Test material
Reference
- Name:
- Unnamed
- Type:
- Constituent
- Details on test material:
- - Name of test material (as cited in study report): n-hexane
- Analytical purity: 99%
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 308 +/- 18 g
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 23.5-24.5
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Temperature, humidity, pressure in air chamber: 23.5-24.5 degree C, 41-61% humidity
TEST ATMOSPHERE
- Brief description of analytical method used: gas detector measurements were taken daily, liquid chromatography measurements were taken twice weekly - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- gas detector measurements were taken daily, liquid chromatography measurements were taken twice weekly
- Duration of treatment / exposure:
- 16 weeks
- Frequency of treatment:
- daily, 12 hrs per day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
3000 ppm
Basis:
no data
- No. of animals per sex per dose:
- 7
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Dose selection rationale: not provided
- Rationale for animal assignment (if not random): not provided
- Rationale for selecting satellite groups: not provided
- Post-exposure recovery period in satellite groups: not provided
- Section schedule rationale (if not random): not provided
Examinations
- Observations and examinations performed and frequency:
- BODY WEIGHT: Yes
- Time schedule for examinations: 0, 4, 8, 12, and 16 weeks after start of exposure
OTHER: The conduction velocity of the peripheral nerve of the tail was measured at 0, 4, 8, 12 and 16 weeks - Sacrifice and pathology:
HISTOPATHOLOGY: Yes, 2 rats were sacrificed at the end of 16 weeks, and their gastrocnemius and soleus muscles, dorsal trunk of the tail nerve, and the tibial nerve examined.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- effects observed, treatment-related
- Food consumption and compound intake (if feeding study):
- not examined
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- not examined
- Ophthalmological findings:
- not examined
- Haematological findings:
- not examined
- Clinical biochemistry findings:
- not examined
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- effects observed, treatment-related
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- not examined
- Details on results:
- CLINICAL SIGNS AND MORTALITY
Two animals died during the study. One animal died 1 day before the end of the exposure period, and one animal died three days before the end of the exposure period.
BODY WEIGHT AND WEIGHT GAIN
Body weight gain was significantly reduced at 4 weeks after start of exposure, and remained depressed for the rest of the experiment.
NEUROBEHAVIOUR
Unsteady gait was observed in one animal at 10 weeks exposure, and in 4 animals at 12 weeks. 2 animals at this time point also showed foot drop. At 16 weeks exposure, the five surviving rats had unsteady gait, and two had foot drop. All animals had muscular atrophy at this time point.
HISTOPATHOLOGY: NON-NEOPLASTIC
There were paranodal swellings in the myelinated fibers of the tibial nerve and dorsal trunk of the tail nerve. There were an excessive number of neurofilaments, vesicles, multivesicular bodies, mitochondria, myelin figures, and dense bodies in the paranodal axoplasm and no neurotubules. Denervated neuromuscular junctions in the muscles were observed. Muscle fibers were of irregular shape and size, and had an increased number of nuclei, and had disordered myofilaments, zig-zagging of the z-band, and invaginations of the plasma membrane.
OTHER FINDINGS
The motor nerve conduction velocity (MCV) was significantly less than controls by 4 weeks of exposure. MCVs could not be measured in 2 animals after 16 weeks due to nerve damage. Distal latencies (DL) were signficantly prolonged after 4 weeks of exposure, and could not be measured in 2 aminals at 16 weeks of exposure.
Effect levels
- Dose descriptor:
- LOAEC
- Effect level:
- 3 000 ppm
- Sex:
- male
- Basis for effect level:
- other: neurotoxicology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The LOAEC for sub-chronic exposure to hexane vapors was 3000 ppm based on reduced body weight gain, mortality and neurological effects.
- Executive summary:
In this study, 7 rats were exposed to 3000 ppm of hexane vapors for 12 hrs a day for 16 weeks. Body weights and conduction velocity of the peripheral nerve of the tail was measured at 0, 4, 8, 12 and 16 weeks. At the end of the exposure period, two animals were sacrificed and the nerve tissue examined. Two animals died before the end of the exposure period. All animals showed reduced weight gain after 4 weeks of exposure. Neurological effects were seen beginning at 10 weeks exposure. Motor nerve conduction velocity and distal latency were significantly affected after 4 weeks exposure. Examination of neural tissue showed damage to the tibial nerve and dorsal trunk of the tail nerve. The LOAEC for sub-chronic exposure was 3000 ppm.
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