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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
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant guideline study, fully adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 414 (Prenatal Developmental Toxicity Study)
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.3700 (Prenatal Developmental Toxicity Study)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.31 (Prenatal Developmental Toxicity Study)
- GLP compliance:
- yes
- 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
- Details on test material:
- - Name of test material (as cited in study report): propene
- Chemical name: propene
- Physical state: colourless gas
- Analytical purity: 99.53%
- Lot/batch No.: from Tank B 41
- Stability under test conditions: No changes were detected by gas chromatography over the in life phase of the study
- Storage condition of test material: gas cylinders stored in suitable containment outside the building
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Germany
- Strain: Wistar rats (CrlGlxBrlHan:WI)
- Age at study initiation: 70-84 days old. Supplied on day 0 post coitum (= detection of vaginal plug / sperm)
- Weight at study initiation: 142.7-173.4 g
- Housing: Singly from day 0 - 20 post coitum in type DK III stainless steel wire mesh cages (height: 15 cm, length: 37.5 cm,
width: 21 cm; floor area about 800 cm²)
- Diet: Ground Kliba rat/mouse/hamster laboratory diet (Provimi Kliba SA, Kaiseraugst, Switzerland) ad libitum (except during exposure)
- Water: Tap water ad libitum (except during exposure)
ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24°C
- Humidity: 30-70%
- Photoperiod: 12hrs dark / 12hrs light
IN-LIFE DATES: From: 21 August 2001 To: 12 September 2001
Administration / exposure
- Route of administration:
- inhalation
- Type of inhalation exposure (if applicable):
- whole body
- Vehicle:
- other: conditioned air
- Details on exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus / Method of holding animals in test chamber: The animals were kept singly in wire cages located in a glass-steel inhalation chamber with a volume of 1.4 m³
- Method of conditioning air: Charcoal filtered air conditioned to 50% ± 20% relative humidity and 22°C ± 2°C.
- Source and rate of air: Air conditioned supply air at 28 ± 2 m³/h
- System of generation : For each concentration, the test substance was supplied at a constant rate via the flow meter to a thermostat-controlled vaporizer (25 ± 5°C). There it was mixed with conditioned supply air and passed into the supply air of the inhalation system, where it was further diluted to the desired concentration.
- Air flow rate: 5-8, 22-38 and 245-377 L/h for groups exposed to 200, 1000 and 10000 ppm respectively
TEST ATMOSPHERE
- Brief description of analytical method used: Gas chromatography (in groups exposed to propene the constancy of concentration in each inhalation chamber was continuously monitored using total hydrocarbon analyzers).
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- For target concentrations of 200, 1000 and 10,000 ppm, the measured concentrations were determined to be 199.5±4.1, 1002±25 and 10010±197 ppm respectively with a nominal concentration of 205.2, 947 and 11593 ppm respectively. No propene was detected in the samples from the control chamber atmosphere.
- Details on mating procedure:
- - Impregnation procedure: purchased timed pregnant
- Proof of pregnancy: [vaginal plug / sperm in vaginal smear] referred to as day 0 of pregnancy - Duration of treatment / exposure:
- 14 days
- Frequency of treatment:
- 6 hours/day
- Duration of test:
- day 6 through day 19 post coitum
- No. of animals per sex per dose:
- 25
- Control animals:
- yes, sham-exposed
- Details on study design:
- Sex: female
Examinations
- Maternal examinations:
- CAGE SIDE OBSERVATIONS: Yes
- Time schedule: twice daily
DETAILED CLINICAL OBSERVATIONS: Yes
- Time schedule: Once during the chamber adaptation (preflow) period, on study day 0 and on post-exposure observation days and at least 3 times on exposure days (before, during and after exposure).
BODY WEIGHT: Yes
- Time schedule for examinations: study days 0, 1, 3, 6, 8, 10, 13, 15, 17, 19 and 20 p.c
FOOD CONSUMPTION: Yes
- Time schedule for examinations: study days 0, 1, 3, 6, 8, 10, 13, 15, 17, 19 and 20 p.c
WATER CONSUMPTION AND COMPOUND INTAKE (if drinking water study): Yes / No / No data
- Time schedule for examinations: study days 0, 1, 3, 6, 8, 10, 13, 15, 17, 19 and 20 p.c
POST-MORTEM EXAMINATIONS: Yes
- Sacrifice on gestation day 20
- Organs examined: ovaries, uterus - Ovaries and uterine content:
- The ovaries and uterine content was examined after termination: Yes
Examinations included:
- Gravid uterus weight: Yes
- Number of corpora lutea: Yes
- Number of implantations: Yes
- Number of early resorptions: Yes
- Number of late resorptions: Yes
- Other: Conception rate and pre-and postimplantation losses were calculated - Fetal examinations:
- - External examinations: Yes: all per litter
- Soft tissue examinations: Yes: half per litter
- Skeletal examinations: Yes: half per litter
- Head examinations: No data - Statistics:
- Simultaneous comparison of all concentration groups with the control group using the Dunnett-test (2-sided). Pairwise comparison of each concentration group with the control group using FISHER'S EXACT test (one-sided) for the hypothesis of equal proportions. Pairwise comparison of each concentration group with the control group using the WILCOXON-test (one-sided) for the hypothesis of equal medians.
Results and discussion
Results: maternal animals
Maternal developmental toxicity
- Details on maternal toxic effects:
- Maternal toxic effects:no effects
Effect levels (maternal animals)
open allclose all
- Dose descriptor:
- NOAEC
- Effect level:
- 10 000 ppm (nominal)
- Basis for effect level:
- other: maternal toxicity
- Dose descriptor:
- NOAEC
- Effect level:
- 10 000 ppm (nominal)
- Basis for effect level:
- other: developmental toxicity
Results (fetuses)
- Details on embryotoxic / teratogenic effects:
- Embryotoxic / teratogenic effects:no effects
Effect levels (fetuses)
- Dose descriptor:
- NOAEC
- Effect level:
- 10 000 ppm (nominal)
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
There were no substance-related effects on
the dams concerning food and water consumption, body
weight, body weight change, uterine weights, corrected
body weight change, clinical and necropsy observations up to and
including a concentration of 10,000 ppm.
There were no differences of toxicological relevance between the control
and the substance exposed groups (200, 1,000 and 10,000 ppm) on the gestational
parameters, i.e. in conception rate, mean number of corpora lutea,
total implantations, resorptions and live foetuses, foetal sex ratio or
in the values calculated for the pre- and the postimplantation losses. No
substance-related differences were recorded for placental and foetal body
weights. The external, soft tissue and/or skeletal examinations of the
foetuses revealed no toxicological relevant differences between the control
and the substance-exposed groups.
Applicant's summary and conclusion
- Conclusions:
- The NOAEC for maternal and developmental toxicity to the Wistar rat is 10,000 ppm, a concentration of propene approaching the lower explosion limit.
- Executive summary:
Under the conditions of this prenatal developmental toxicity study, the inhalation exposure of pregnant Wistar rats to propene from implantation to one day prior to the expected day of parturition (days 6 - 19 p .c .) elicited no maternal toxicity at any tested concentration up to 10,000 ppm, which is in the range of the lower explosion limit . There were no substance-induced, concentration-related influences on the gestational parameters and no signs of prenatal developmental toxicity, especially no substanceinduced indications of teratogenicity . Based on these results, the no observed adverse effect concentration (NOEC) for prenatal developmental and maternal toxicity from exposure to propene is 10,000 ppm .
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