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Diss Factsheets
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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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- 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
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 985
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- Deviations:
- not specified
- GLP compliance:
- no
- 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:
- TEST ANIMALS
- Source: Frederick Cancer Research Centre
- Age at study initiation: weanling
- Weight at study initiation: mean bw per group for males 78-84 g; mean bw per group for females 60-63 g
- Fasting period before study: none
- Housing: Individually housed in stainless steel mesh cages
- Diet: Wayne Lab-Blox® (Allied Mills, Inc., Chicago, IL, USA); freely available except during inhalation exposure
- Water: tap water available ad libitum
- Acclimation period: 8 days
ENVIRONMENTAL CONDITIONS
- Temperature: not reported
- Humidity: not reported
- Air changes: not reported
- Photoperiod: 12 hrs dark /12 hrs light
IN-LIFE DATES: From: 27 May 1977 To: 1 September 1977
Administration / exposure
- Route of administration:
- inhalation: gas
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: air
- Details on inhalation exposure:
- All test chambers received clean, dry chamber supply air, 24 hours/day, at the top of each chamber. The test material was metered into the chamber air so that it was well mixed with incoming air by turbulence. A dual-bank switching type manifold (Matheson Gas Products, Joliet, IL, USA) provided a continuous supply of gas.
- Analytical verification of doses or concentrations:
- not specified
- Details on analytical verification of doses or concentrations:
- only reported for 2-year studies
- Duration of treatment / exposure:
- 14 weeks
- Frequency of treatment:
- 6 hours/day, 5 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 625, 1250, 2500, 5000 and 10,000 ppm
Basis:
nominal conc.
- No. of animals per sex per dose:
- 9-11/sex/group
- Control animals:
- yes
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: daily
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: Yes
- Time schedule for examinations: day 0 and then weekly
FOOD CONSUMPTION: No
FOOD EFFICIENCY: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: No
HAEMATOLOGY: No
CLINICAL CHEMISTRY: No
URINALYSIS: No
NEUROBEHAVIOURAL EXAMINATION: No - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes. The following tissues were examined: gross lesions, skin, mandibular lymph node, mammary gland, salivary gland, thigh muscle, sciatic nerve, sternebrae, vertebrae or femur including marrow, costochondral junction (rib), thymus, larynx and pharynx, trachea, lungs and bronchi, heart, thyroid gland, parathyroids, oesophagus, stomach, duodenum, jejunum, ileum, colon, caecum, rectum, mesenteric lymph node, liver, pancreas, spleen, kidneys and adrenal glands, urinary bladder, seminal vesicles/prostate/testes or ovaries/uterus, nasal cavity and nasal turbinates, brain, pituitary gland, spinal cord, eyes.
HISTOPATHOLOGY: Yes on above tissues from all controls, high dose and early deaths - 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 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.
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- 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:
- no effects observed
- Histopathological findings: non-neoplastic:
- no effects observed
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY: No compound related deaths or clinical signs were observed
BODY WEIGHT AND WEIGHT GAIN: The mean body weights of exposed male rats were 4%-12% higher throughout most of the study. Weight gains of exposed and control female rats were comparable. These differences were considered not to be dose related.
PATHOLOGY: No gross or microscopic pathologic effects (including no nasal cavity changes) were observed
Effect levels
- Key result
- Dose descriptor:
- NOAEC
- Effect level:
- 10 000 ppm (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: ( 17,200mg/m3), no deaths or clinical signs, no dose-related effects on bodyweight, no abnormalities detected at macroscopic or microscopic examination
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- This study demonstrates that propene is not toxic to rats exposed to concentrations up to 10,000 ppm for 14 weeks. These findings are consistent with the available human data.
- Executive summary:
Male and female Fischer 344 rats were exposed to gaseous prop-1 -ene for 6h/day 5 days a week for 14 weeks. After the exposure period, animal tissues were examined. No clinical signs or deaths were attribued to the compound. The mean body weights of exposed male rats were 4 -12% higher throughout most of the study, thr weight of exposed female rats was comparableto control females. The weight differences were not considered to be dose related.
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