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Diss Factsheets
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EC number: 925-292-5 | 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:
- sub-chronic toxicity: oral
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- 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:
- The Relative Neurotoxicity of methyl-n-butyl ketone, n-hexane, and their metabolites
- Author:
- Krasavage, WJ, O'Donoghue, JL, DiVincenzo, GD, and Terhaar, CJ
- Year:
- 1 980
- Bibliographic source:
- Toxicology and Applied Pharmacology, 52, 433-441
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- 5 male rats were exposed to concentrations of 6.60, 13.2, and 46.2 mmol/kg bw (568, 1135, 3973 mg/kg) by oral gavage for 90 to 120 days. During the exposure, the rats were examined for body weight, clinical signs, mortality, and neurological effects. Animals were sacrificed after exhibiting hindlimb paralysis, or the end of the exposure period. After sacrifice, a histopathological examination was done on the testes, epididymis, and nerve tissue of the animals.
- GLP compliance:
- no
Test material
- Reference substance name:
- N-hexane
- EC Number:
- 203-777-6
- EC Name:
- N-hexane
- Cas Number:
- 110-54-3
- Molecular formula:
- C6H14
- IUPAC Name:
- hexane
- Details on test material:
- - Name of test material (as cited in study report): n-hexane
- Analytical purity: 99%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD (SD) BR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River COBS
- Weight at study initiation: 214.5 +/- 17.1 g
- Housing: singly in wire cages
- Diet (e.g. ad libitum): Purina Laboratory Chow, ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- not specified
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- once daily for 90 days, except for animals at the 46.2 mmol/kg dose which were treated for 120 days
- Frequency of treatment:
- 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
6.6, 13.2, and 46.2 mmol/kg (568, 1135, 3973 mg/kg)
Basis:
- No. of animals per sex per dose:
- 5 males
- Control animals:
- yes, sham-exposed
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
- Cage side observations: toxicity and general condition changes in posture, gait, and toe pinch
DETAILED CLINICAL OBSERVATIONS: Yes / No / No data
- Time schedule:
BODY WEIGHT: Yes
- Time schedule for examinations: twice weekly
FOOD CONSUMPTION:
- Food consumption: Yes
- Time schedule for examinations: twice weekly
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / No data
- Time schedule for examinations:
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: daily
- Battery of functions tested: changes in posture, gait, and toe pinch
- Sacrifice and pathology:
- HISTOPATHOLOGY: Yes, testes, epididymis, and nerve tissue were 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 specified
- 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 rats in the 13.2 mmol/kg group and one in the 46.2 mmol/kg group died immediately after intubation. Only the 46.2 mmol/kg dose produced hindlimb paralysis in 90 days.
BODY WEIGHT AND WEIGHT GAIN
Body weight gain was reduced after 3 weeks of exposure at all dose levels. This reduction in body weight followed a reduction in food consumption. Significant and dose dependant weight reduction was seen in the 13.2 and 46.2 mmol/kg groups.
NEUROBEHAVIOUR
Hindlimb paralysis was seen in the 46.2 mmol/kg dose animals an average of 101.3 +/- 9. 4 days after start of exposure.
HISTOPATHOLOGY: NON-NEOPLASTIC
The 46.2 mmol/kg dose produced multifocal axonal swellings, adaxonal myelin infolding, and paranodal myelin retraction. Atrophy of the germinal epithelium was also seen in the testes of animals at this dose level.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 6.6 other: mmol/kg bw
- Sex:
- male
- Dose descriptor:
- NOAEL
- Effect level:
- 13.2 other: mmol/kg bw
- Sex:
- male
- Basis for effect level:
- other: neurological effects
- Dose descriptor:
- LOAEL
- Effect level:
- 46.2 other: mmol/kg bw
- Sex:
- male
- Basis for effect level:
- other: neurological effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Neurological effects were only seen at the highest dose level after an average of 101.3 days of exposure. The LOAEL for neurological effects is 46.2 mmol/kg bw (37973 mg/kg), and the NOAEL is 13.2 mmol/kg bw (1135 mg/kg). Reduced body weight gain was seen at all three dose levels, however was only considered treatment related in the 13.2 and 46.2 mmol/kg bw groups. The NOAEL is therefore 6.60 mmol/kg bw.
- Executive summary:
This study examined the effect of oral exposure to the test substance n-hexane. 5 male rats were exposed to concentrations of 6.60, 13.2, and 46.2 mmol/kg bw (568, 1135, 3973 mg/kg) by oral gavage for 90 to 120 days. During the exposure, the rats were examined for body weight, clinical signs, mortality, and neurological effects. Animals were sacrificed after exhibiting hindlimb paralysis, or the end of the exposure period. After sacrifice, a histopathological examination was done on the testes, epididymis, and nerve tissue of the animals. Neurological effects were only seen at the highest dose level after an average of 101.3 days of exposure. The LOAEL for neurological effects is 46.2 mmol/kg bw (37973 mg/kg), and the NOAEL is 13.2 mmol/kg bw (1135 mg/kg). Reduced body weight gain was seen at all three dose levels, however was only considered treatment related in the 13.2 and 46.2 mmol/kg bw groups. The NOAEL is therefore 6.60 mmol/kg bw.
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