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EC number: 921-577-3 | CAS number: 1174918-60-5
- 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:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1996-10-09 to 1997-02-21
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- This study is classified as reliable without restriction because it is in compliance with OECD principles of GLP and E.U. Council Decision on GLP, as well as the European Community Dangerous Substance Directive (67/548/EEC), Methods of Determination of Toxicity, Annex VIII.
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Deviations:
- yes
- Remarks:
- Protocol deviations were noted and were not expected to affect the overall study results.
- Qualifier:
- according to guideline
- Guideline:
- other: EC, Annex VIII, Sub-chronic inhalation toxicity, 1988
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Pentane
- EC Number:
- 203-692-4
- EC Name:
- Pentane
- Cas Number:
- 109-66-0
- Molecular formula:
- C5H12
- IUPAC Name:
- pentane
- Details on test material:
- - Name of test material (as cited in study report): n-pentane
- Substance type: C5 alphatics
- Physical state: liquid
- Analytical purity: 97.4%
- Expiration date of the lot/batch: 5 years from date of received (i.e., June, 2001 and December, 2001)
- Storage condition of test material: room temperature
- Other: The testing laboratory was stated to have analyzed for stability, identity, strength, purity, and composition of the test material, but the information was not provided in the study report.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl: CDBR
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Inc., Kignstone Facility, Stone Ridge, New York
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: males: 229.8 to 255.8 grams; females: 184.8 to 213.4 grams
- Housing: individually housed in suspended stainless steel and wire mesh cages with absorbent paper below during study period and individually housed in 1.5 cubic meter statinless steel and glass whole body inhalation chambers during exposure
- Diet (e.g. ad libitum): ad libitum during nonexposure periods
- Water (e.g. ad libitum): ad libitum during nonexposure periods
- Acclimation period: 12 days
ENVIRONMENTAL CONDITIONS
- Temperature (°F): 64 to 72 °F
- Humidity (%): 30 to 70%
- Photoperiod (hrs dark / hrs light): 12 hours dark and 12 hours light
IN-LIFE DATES: From: 1996-11-18 To:1997-02-21
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Remarks on MMAD:
- MMAD / GSD: not reported
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: vapor generator into a whole body inhalation chamber (1.5 cubic meter)
- Source and rate of air: air flow rate was 300 litres per minute
- Temperature, humidity, pressure in air chamber: 66 to 72°F, 40 to 70% relative humidity, under slightly negative pressure to the room
- Air flow rate: 300 litres per minute
TEST ATMOSPHERE
- Brief description of analytical method used: Hourly measurements from five different locations in the chamber were made by on-line gas chromatography.
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- analytical concentrations for the 5000; 10,000; and 20,000 mg/m3 concentrations were as follows: 5097±79; 10,203±151; and 20,483±734 mg/m3
- Duration of treatment / exposure:
- 6 hours a day plus chamber equilibrium time (theoretically=23 minutes)
- Frequency of treatment:
- 5 days a week for 13 weeks; males had three additional treatments during the 14th week and females had four additional treatments
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5097±79, 10,203±151, and 20,483±734 mg/m3
Basis:
analytical conc.
- No. of animals per sex per dose:
- 10 animals/sex/dose
- Control animals:
- yes
- Details on study design:
- - Dose selection rationale: Doses were selected based on a range finding study with concentrations up to 21,000 mg/m3 without any noted effects.
- Positive control:
- not reported
Examinations
- Observations and examinations performed and frequency:
- DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: daily prior to exposure, once a day on nonexposure days, during the first and sixth hour of exposure
BODY WEIGHT: Yes
- Time schedule for examinations: prior to study initiation, weekly thereafter, and at study termination
FOOD CONSUMPTION:
- Food consumption for each animal determined: Yes, specified in grams
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: prior to study initiation and during the final week of the study
- Dose groups that were examined: all dose groups
HAEMATOLOGY: Yes
- Time schedule for collection of blood: at terminal sacrifice
- Anaesthetic used for blood collection: Yes, IP injection of sodium pentobarbital
- Animals fasted: Yes
- How many animals: all 40 animals
- Parameters checked in table were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: at terminal sacrifice
- Animals fasted: Yes
- How many animals:all 40 animals
- Parameters checked in table were examined.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No
- Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes (see table) - Other examinations:
- The following organs were weighed: adrenals, brain, epididymis, kidneys, liver, lungs plus trachea, prostate, seminal vesicles (with coagultion gland), spleen, testes or ovaries, thymus, and uterus.
- Statistics:
- Bartlett's test for equal variance (p<0.01); parametric procedures included a one-way ANOVA with F distribution followed by Dunnett's test and a standard regression analysis for linear response (p<0.05 and p<0.01); nonparametric proceduresincluded the Kruskal-Wallis test followed by Dunn's summed rank test and Jonckheere's test for monotonic trends (p<0.05 and p<0.01)
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:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not examined
- Behaviour (functional findings):
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- no effects observed
- Details on results:
- not reported
Effect levels
- Dose descriptor:
- NOAEC
- Effect level:
- 20 000 mg/m³ air (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: lack of any effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
There were sporadic statistically significant results. However, none of the results were considered clinically significant or related to treatment.
Applicant's summary and conclusion
- Conclusions:
- Inhalation exposure to n-pentane at concentrations ≤20,000 mg/m3 did not cause any observable adverse effects in male or female rats.
- Executive summary:
In a subchronic inhalation toxicity study, n-pentane was administered to 10 rats/sex/concentration by whole body exposure at analytical concentrations of 5097±79; 10,203±151; or 20,483±734 mg/m3 6 hours a day, 5 days a week for 13 weeks. Animals were sacrificed in the fourteenth week after 3 (males) or 4 (females) exposures. There were no treatment-related effects observed for clinical signs, body weight, food consumption, hematology, clinical chemistry, ophthalmology, gross pathology, organ weights, or histopathology. This study is classified as reliable without restrictions because it is in compliance with OECD principles of GLP and E.U. Council Decision on GLP, as well as the European Community Dangerous Substance Directive (67/548/EEC), Methods of Determination of Toxicity, Annex VIII. In addition the study was performed according to OECD 413 guidelines.
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