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EC number: 204-062-1 | CAS number: 115-07-1
- 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
Toxicity to reproduction
Administrative data
- Endpoint:
- reproductive toxicity, other
- Remarks:
- other: combined repeated dose and carcinogenicity
- Type of information:
- experimental study
- Adequacy of study:
- supporting 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
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
- Principles of method if other than guideline:
- Method: other: NTP - 2 year Inhalation Study
- GLP compliance:
- not specified
- Limit test:
- no
Test material
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- - 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 159-169 g; mean bw per group for females 115-121 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); freely available except during inhalation exposure
- Water: tap water available ad libitum
- Acclimation period: 5 weeks
ENVIRONMENTAL CONDITIONS
- Temperature: Average of 70°F (during exposure 78 ± 2°F)
- Humidity: During non-exposure 54-57 % (during exposure 57 ± 7 %)
- Air changes: 20/hour
- Photoperiod: 12 hrs dark /12 hrs light
IN-LIFE DATES: From: 29 October 1979 To: 28 October 1981
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- other: air
- Details on 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. - Details on mating procedure:
- not applicable
- 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:
- Exposure period: 103 weeks
- Frequency of treatment:
- 6 hours/day, 5 days/week
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 5000, 10000 ppm
Basis:
nominal conc.
- Remarks:
- Doses / Concentrations:
0, 4985±274, 9891±515 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 for rats in the 2-year studies. Concentrations higher than 10000 ppm propene could not be selected because of the risk of explosion.
Examinations
- Parental animals: Observations and examinations:
- 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: Once per week for 14 weeks, once per month for 76 weeks and then biweekly thereafter.
FOOD CONSUMPTION: No
WATER CONSUMPTION: No - Postmortem examinations (parental animals):
- 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), 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: P0 (first parental generation)
Effect levels (P0)
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 10 000 ppm (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: (17,200 mg/m3) prostate/testes and ovaries/uterus
Overall reproductive toxicity
- Reproductive effects observed:
- not specified
Any other information on results incl. tables
The survival of exposed and control rats was comparable. Throughout most of the studies, mean body weights of exposed male and female rats were slightly lower (0-5%) than those of the controls, but the decrements were not concentration-related. No compound-related adverse clinical signs were observed.
Histopathological lesions in the reproductive system
|
exposure concentration (ppm) |
||||||
|
males |
females |
|||||
|
0 |
5000 |
10000 |
0 |
5000 |
10000 |
|
Prepuce |
inflammation suppurative |
1 |
|
|
|
|
|
|
abscess |
1 |
|
|
|
|
|
|
hyperplasia epithelial |
1 |
|
|
|
|
|
Preputial gland |
carcinoma |
|
1 |
2 |
|
|
|
|
inflammation suppurative |
1 |
1 |
|
|
|
|
Prostate |
inflammation |
3 |
1 |
|
|
|
|
|
inflammation suppurative |
13 |
9 |
2 |
|
|
|
|
hyperplasia |
2 |
1 |
1 |
|
|
|
|
hyperplasia focal |
4 |
5 |
2 |
|
|
|
Testis |
interstitial cell tumour |
37 |
36 |
33 |
|
|
|
|
mineralisation |
21 |
14 |
21 |
|
|
|
|
hyperplasia interstitial cells |
6 |
9 |
6 |
|
|
|
|
hyperplasia mesothelial |
|
|
1 |
|
|
|
|
atrophy |
38 |
38 |
38 |
|
|
|
Epididymis |
granuloma spermatic |
|
1 |
2 |
|
|
|
Mammary gland |
adenoma |
|
|
|
|
1 |
|
|
adenocarcinoma |
1 |
|
|
|
1 |
|
|
fibroadenoma |
|
1 |
|
9 |
11 |
6 |
|
galactocele |
2 |
|
|
3 |
3 |
7 |
|
hyperplasia |
|
|
|
28 |
30 |
25 |
|
hyperplasia |
18 |
26 |
27 |
|
|
|
Seminal vesicle |
inflammation suppurative |
6 |
15 |
12 |
|
|
|
Vagina |
endometrial stromal sarcoma |
|
|
|
|
1 |
|
Clitoral gland |
carcinoma |
|
|
|
|
2 |
|
Uterus |
leiomyosarcoma |
|
|
|
|
|
1 |
|
endometrial stromal polyp |
|
|
|
3 |
4 |
4 |
|
endometrial stromal sarcoma |
|
|
|
2 |
|
2 |
|
dilation |
|
|
|
|
|
1 |
|
inflammation suppurative |
|
|
|
|
1 |
3 |
Uterus / Endometrium |
hyperplasia cystic |
|
|
|
6 |
3 |
4 |
|
hyperplasia |
|
|
|
|
6 |
4 |
|
cysts |
|
|
|
4 |
5 |
3 |
Cervix |
inflammation suppurative |
2 |
|
|
|
|
|
Ovary |
cysts |
|
|
|
4 |
5 |
3 |
|
inflammation acute/chronic |
|
|
|
1 |
|
|
|
atrophy |
|
|
|
12 |
7 |
9 |
Applicant's summary and conclusion
- Conclusions:
- Reproductive organs from rats exposed to propene at concentrations of up to 10000 ppm for 2 years were evaluated histopathologically and there were no changes considered to be related to propene exposure.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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