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EC number: 270-752-4 | CAS number: 68477-71-4 A complex combination of hydrocarbons obtained from fractionation of catalytic cracked gas oil hydrocarbon stream and treated to remove hydrogen sulfide and other acidic components. It consists of hydrocarbons having carbon numbers in the range of C3 through C5, predominantly C4.
- 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:
- chronic toxicity: inhalation
- Remarks:
- combined repeated dose and carcinogenicity
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP; predates implementation of GLP and/or development of study guidelines but otherwise acceptable for assessment
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
- Reference Type:
- publication
- Title:
- Two-year inhalation toxicity study of propylene in F344/N rats and B6C3F1 mice.
- Author:
- Quest J, Tomaszewski J, Haseman J, Boorman G, Douglas J and Clarke W
- Year:
- 1 984
- Bibliographic source:
- Toxicol Appl Pharmacol 76, 288-295.
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 453 (Combined Chronic Toxicity / Carcinogenicity Studies)
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Propene
- EC Number:
- 204-062-1
- EC Name:
- Propene
- Cas Number:
- 115-07-1
- Molecular formula:
- C3H6
- IUPAC Name:
- prop-1-ene
- Reference substance name:
- propylene
- IUPAC Name:
- propylene
- Reference substance name:
- 1-propene
- IUPAC Name:
- 1-propene
- Details on test material:
- Purity 98.8-99.7%
Constituent 1
Constituent 2
Constituent 3
Test animals
- Species:
- mouse
- Strain:
- B6C3F1
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories (Portage, MI, USA)
- Age at study initiation: 9-10 weeks
- Weight at study initiation: mean bw per group for males 28-29 g; mean bw per group for females 22-23 g
- Fasting period before study: none
- Housing: Individually housed in stainless steel wire cages (Lab Products, Rochelle Pk, NJ, USA)
- Diet: Wayne Lab-Blox® (Allied Mills, Inc., Chicago, IL, USA); ad libitum except during inhalation exposure
- Water: tap water available ad libitum
- Acclimation period: 5 weeks
ENVIRONMENTAL CONDITIONS
- Temperature: Average of 70°F (equivalent to 21.1 C) (during exposure 75 ± 2°F) (equivalent to 23.9 C)
- Humidity: During non-exposure 54-57 % (during exposure 59 ± 8 %)
- Air changes: 20/hour
- Photoperiod: 12 hrs dark /12 hrs light
IN-LIFE DATES: From: 29 October 1979 To: 30 October 1981
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
Propene gas, at an operating pressure of 54 psi, was metered to the exposure chambers and diluted in the chamber fresh-air inlets. The animals were individually housed in mesh cages (6 cages/exposure chamber). Since the exposure chambers were being operated with concentrations of propene close to the lower explosive limit (LEL) of the gas (25% and 50% of the LEL), safety devices were incorporated in the polyethylene vapour hood (vented to the room exhaust) to minimize the hazard to animals and personnel in the event of a leak. The gas was then piped to a second hood containing four double-pattern metering valves. Since the upstream pressure to these valves was well regulated, these valves provided stable control of the gas flow rate and ultimately of the concentration in the chambers. To provide the proper chamber concentration, the valves were set and periodically checked, by matching the calculated with the actual flow measured by a bubble meter. From the double-pattern metering valves, the gas was piped to each exposure chamber. A shut-off valve at the entrance to the chamber permitted easy, rapid termination of gas flow. All materials in the gas distribution system were stainless steel, Teflon®, viton, or brass.
TEST ATMOSPHERE
The vapour concentration uniformity in the chamber was measured with a portable photoionization detector at 12 positions (2 positions, one at the front and one at the back, for each of the six animal cage units per chamber). The sample point was just above and about 10 cm in from the front or back centre of each cage unit. Propene concentrations in the exposure chambers, control chambers, and exposure room were automatically monitored approximately 10 times during each exposure day by gas chromatography. - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Throughout the studies, samples taken from the chambers several times each day indicated that average daily chamber concentrations were usually within 5 %-6 % of the target concentrations. However, wider variations in exposures were observed during the first 40 weeks of the studies as compared with the remainder of the studies.
Atmospheric samples were obtained from the control and 10000 ppm chambers during an exposure period during week 30 and were analyzed by gas chromatography. No peaks were observed in the air from the control chamber. Only those impurities present in the bulk propene at the pretest analysis were observed in the air from the 10000 ppm chamber - Duration of treatment / exposure:
- 103 weeks
- Frequency of treatment:
- 6 hours per day, 5 days per week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 5000, 10000 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0, 4999±285, 9957±533 ppm
Basis:
analytical conc.
- No. of animals per sex per dose:
- 50
- Control animals:
- yes, sham-exposed
- Details on study design:
- Dose selection rationale: No compound-related effects were seen in a 14 week inhalation study following exposure at 0, 625, 1250, 2500, 5000, or 10000 ppm. Based on these results even though no propene-related toxicity was observed, concentrations of 5000 and 10000 ppm propene were selected in the 2-year study. Concentrations higher than 10000 ppm propene could not be selected because of the risk of explosion.
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: Twice per day for signs of moribundity and mortality
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: once per month
BODY WEIGHT: Yes
- Time schedule for examinations: Once per week for 14 weeks, once per month for 76 weeks and then biweekly thereafter.
FOOD CONSUMPTION: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes. Complete necropsy examination performed on all animals.
HISTOPATHOLOGY: Yes. Complete histopathological examination performed on all animals. The following tissues were examined: gross lesions, skin, mandibular lymph node, mammary gland, sternebrae, vertebrae or femur including marrow, thymus, trachea (2 sections), lungs and bronchi, heart, thyroid gland, parathyroids, oesophagus, stomach, colon, small intestine, liver (2 sections), gall bladder, pancreas, spleen, kidneys and adrenal glands (2 sections), urinary bladder, prostate/testes (2 sections) or ovaries/uterus (2 sections), nasal cavity and nasal turbinates (3 sections), brain (3 sections), pituitary gland, and (if abnormal) spinal cord, eyes, and pharynx. - Statistics:
- The probability of survival was estimated by the product-limit procedure of Kaplan and Meier (1958). Statistical analyses for a possible dose-related effect on survival used the method of Cox (1972) for testing two groups for equality and Tarone's (1975) life table test for a dose-related trend. All reported P values for the survival analysis are two-sided.
The incidence of neoplastic or non-neoplastic lesions is given as the ratio of the number of animals bearing such lesions at a specific anatomic site to the number of animals in which that site was examined.
Three statistical methods are used to analyze tumour incidence data (Life table analysis, incidental tumour analysis and unadjusted analyses). The two that adjust for intercurrent mortality employ the classical method for combining contingency tables developed by Mantel and Haenszel (1959). Tests of significance included pairwise comparisons of high dose and low dose groups with chamber controls and tests for overall dose-response trends.
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):
- not examined
- Organ weight findings including organ / body weight ratios:
- not examined
- Gross pathological findings:
- not specified
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Histopathological findings: neoplastic:
- effects observed, treatment-related
- Details on results:
- CLINICAL SIGNS AND MORTALITY: No clinical signs were recorded. No significant differences in survival were observed between any groups of either sex.
BODY WEIGHT AND WEIGHT GAIN: After week 59, mean body weights of high concentration male mice were approximately 5% lower than those of the controls. Throughout the study, mean body weights of low concentration and control male mice and of exposed and control female mice were comparable.
HISTOPATHOLOGY - NON-NEOPLASTIC: Chronic focal inflammation of the kidneys occurred at increased incidences in male and female mice exposed at both concentrations and appeared to be related to propene exposure. The biological relationship of the renal effect to propene exposure is unknown.
HISTOPATHOLOGY - NEOPLASTIC: Haemangiosarcomas were found in one low dose male mouse (liver), two high dose male mice (spleen), and three high dose female mice (subcutis. spleen, and uterus). Haemangiomas were found in one low dose and in one high dose female mouse (liver). Vascular tumours were not found in control mice of either sex. The low incidences of vascular tumours and their occurrence in a variety of organs suggest
that they are not related to administration of propene.
The occurrence of uterine endometrial stromal polyps in female mice showed a positive trend (P≥0.05; 0/47; 0/47; 3/48); the incidence in the 10,000 ppm group was not significantly greater than that in the concurrent control group, but the incidence was higher than the mean historical control
rate (22/2411, 0.9%) and was within the range (0%-6%) observed in studies throughout the Carcinogenesis Program. The occurrence of endometrial stromal polyps in three high concentration female mice was not considered to be clearly related to exposure to propene.
The incidence of male mice with alveolar/bronchiolar adenomas or carcinomas (combined) occurred with a negative trend (P<0.05; 16/50; 4/49; 7/50), and the reduced incidences in both exposed groups were less than (P<0.05) that in the control group. The control incidence of these tumours in an inhalation study conducted concurrently at the same laboratory was similar (15/50), suggesting a possible exposure-related decrease. The biologic significance of this decrease in male mice is difficult to assess; the incidences seen in these control and exposed animals are within the range of incidences (2%-34%; mean, 16.7%) observed in control male mice in other studies throughout the Carcinogenesis Program.
Effect levels
- Dose descriptor:
- LOAEC
- Effect level:
- 5 000 ppm
- Sex:
- male/female
- Basis for effect level:
- other: see 'Remark'
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Chronic focal inflammation of the kidneys was reported at an increased incidence in low concentration and high concentration mice of each sex. Refer to subsequent expert evaluation. Hard G (2001). Expert Report on Renal Histopathological Changes in Mouse and Rat Inhalation Studies with Propene.
- Executive summary:
Toxicology and carcinogenesis studies of propene (greater than 99% pure) were conducted by exposing groups of 50 B6C3F1 mice of each sex to propene in air by inhalation at concentrations of 5000 or 10000 ppm, 6 hours per day, 5 days per week, for 103 weeks. Other groups of 50 mice of each sex received air only on the same schedule and served as chamber controls. The highest concentration of propene that was considered safe was 10000 ppm because of the risk of explosion that can occur at higher concentrations
The survival of exposed and control mice was comparable. After week 59 of the study, mean body weights of 10000 ppm male mice were usually slightly lower (5%) than those of the controls, whereas those in other exposed groups of male and female mice were generally comparable with those of the controls. No compound-related adverse clinical signs were observed.
A NOAEC was not reported. Chronic focal inflammation of the kidneys was reported with an increased incidence in low concentration and high concentration mice of each sex however subsequent expert re-evaluation was reported by Hard, G (2001) and concluded that kidney effects were not treatment-related.
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