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EC number: 203-894-2 | CAS number: 111-67-1
- 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 from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable without restrictions because it was GLP compliant and was generally conducted according to OECD 408 guidelines.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 994
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- yes
Test material
- Reference substance name:
- Pent-1-ene
- EC Number:
- 203-694-5
- EC Name:
- Pent-1-ene
- Cas Number:
- 109-67-1
- Molecular formula:
- C5H10
- IUPAC Name:
- pent-1-ene
- Details on test material:
- This substance is very similar in structure to the substance being registered.
- Name of test material (as cited in study report): 1-Pentene
- Molecular formula (if other than submission substance): C5H10
- Substance type: C5 alpha olefin
- Physical state: Liquid
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: Animal Centre of RRL
- Age at study initiation: 8 weeks
- Weight at study initiation: Males: 62.4 to 73.9 grams; Females: 60.1 to 78.4 grams
- Fasting period before study: No fasting
- Housing: Groups of four
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18 to 22°C
- Humidity (%): 38 to 69%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark / 12 hrs light
IN-LIFE DATES: From: 1993-9-14 To: 1993-12-14
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- cotton seed oil
- Details on oral exposure:
- PREPARATION OF DOSING SOLUTIONS: Mixed with vehicle; volumes ranged from 0.35 millilitre to 2.00 millilitres, adjusted for weight.
VEHICLE
- Concentration in vehicle: 280 mg/mL - Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- Daily, 5 out of every 7 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1000 mg/kg bw/day
Basis:
no data
- No. of animals per sex per dose:
- 12
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Not detailed
- Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: 4 times daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Pretest and 13 weeks
BODY WEIGHT: Yes
- Time schedule for examinations: Weekly
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: Pretest and 13 weeks
- Dose groups that were examined: Control and 1000 mg/kg bw
HAEMATOLOGY: Yes
- Time schedule for collection of blood: 13 weeks
- Anaesthetic used for blood collection: No data
- Animals fasted: No
- How many animals: All animals
- Parameters checked in Table 1 were examined.
CLINICAL CHEMISTRY: Yes
- Time schedule for collection of blood: 13 weeks
- Animals fasted: No
- How many animals: All animals
- Parameters checked in Table 2 were examined.
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Parameters checked in Table 3 were examined. - Other examinations:
- Mean organ mass, as determined at post mortem examinations.
- Statistics:
- All test group results were analyzed to determine if they were significantly different from the control animals.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Mortality:
- mortality observed, treatment-related
- Body weight and weight changes:
- no effects observed
- 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:
- 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:
- not examined
- Details on results:
- There were no clinical signs related to treatment. There were no treatment-related changes in body weight, ophthalmology, haematology, clinical chemistry, organ weights, gross pathology, or histopathology.
CLINICAL SIGNS AND MORTALITY: During week 2, one male was sacrificed prematurely, due to accidental dosing of the test substance into the lungs. Seven males exhibited signs of skin injury during the treatment period, possibly caused during the dosing procedure. One female was sacrificed prematurely during week 6 due to a partially ruptured oesophagus, and one female died on day 33, showing severe centrilobular congestion and an enlarged heart with severe pericarditis and haemopericardium. These signs were determined to be unrelated to treatment.
BODY WEIGHT AND WEIGHT GAIN: No treatment-related effects were observed.
OPHTHALMOSCOPIC EXAMINATION: No treatment-related effects were observed.
HAEMATOLOGY: Platelet counts were somewhat higher in the treatment groups for both sexes, but not significantly when compared to historical data.
CLINICAL CHEMISTRY: No treatment-related effects were observed.
ORGAN WEIGHTS: No treatment-related effects were observed.
GROSS PATHOLOGY: Centrilobular hepatic congestion was observed in all the animals that died or were subjected to euthanasia, and was determined to be agonal and unrelated to the treatment.
HISTOPATHOLOGY: NON-NEOPLASTIC: Individual abnormal findings were unrelated to the test substance, or incidental. No treatment-related effects were observed.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects and clinical signs; mortality; body weight; ophthalmoscopic examination; haematology; clinical chemistry; gross pathology; organ weights; histopathology
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- There were no clinical signs related to treatment. There were no treatment-related changes in body weight, ophthalmology, haematology, clinical chemistry, organ weights, gross pathology, or histopathology. The NOAEL for this study is considered to be 1000 mg/kg/day.
- Executive summary:
Justification for Read Across
Several criteria justify the use of the read across approach to fill data gaps for Category C isomerised olefins using 1-pentene as an analog. Category C is comprised of isomerised olefins with a range of carbon numbers; 1-pentene is a C5 alpha olefin. Studies indicate that changing carbon number, location of the double bond, or addition of branching does not measurably alter the mammalian health endpoints. Additionally, an acute inhalation study for 1-pentene showed that the toxicity concerns through this route of exposure are relatively low; toxicity concerns for Category C isomerised olefins are also low for acute oral and dermal exposure. 1-Pentene’s chemical structure, according to the Cramer classification scheme, also indicates that it is relatively non-toxic. This point is observed in a 90-day repeated dose oral exposure study, in which rats were dosed up to 1000 mg/kg/day (limit dose). 1-Pentene did not induce any chemical related affects in any of the treated animals. As a result, all of the above information indicates a low hazard potential for human health for both compounds. There do not appear to be any toxicological differences between 1-pentene and Category C isomerised olefins. Therefore, read across between 1 -pentene and Category C isomerised olefins can be justified.
In a 90-day oral toxicity study, 1-pentene in cottonseed oil was administered to twelve Sprague-Dawley rats/sex/dose at dose levels of 0 (vehicle control) or 1000 mg/kg/day (limit dose) via gavage, 5 days a week for 13 weeks.
Two animals were euthanized and morbidity was subsequently associated with accidental dosing into the lungs or a ruptured oesophagus. One treated female died on day 33 with severe centrilobular congestion and an enlarged heart with severe percarditis and haemopericardium. There were no clinical signs related to treatment. There were no treatment-related changes in body weight, ophthalmology, haematology, clinical chemistry, organ weights, gross pathology, or histopathology. Based on the results presented above, it can be concluded that the test material administered orally for 90 days in a limit test did not induce any chemical related affects in any of the treated animals. Hence, the NOAEL for this study is considered to be 1000 mg/kg/day.
This study received a Klimisch score of 1 and is classified as reliable without restrictions because it was GLP compliant and was generally conducted according to OECD 408 guidelines. This study will influence the DNEL(s).
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