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EC number: 203-544-9 | CAS number: 108-03-2
- 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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP, guideline study
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- no
- Remarks:
- Not specified in report
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Draft Guidance Document for the Conduct of Skin Absorption Studies. OECD Environmental Health and Safety Publications Series on Testing and Assessment No. 28. (2002)
- Principles of method if other than guideline:
- Not applicable
- GLP compliance:
- yes
Test material
- Reference substance name:
- 1-nitropropane
- EC Number:
- 203-544-9
- EC Name:
- 1-nitropropane
- Cas Number:
- 108-03-2
- Molecular formula:
- C3H7NO2
- IUPAC Name:
- 1-nitropropane
- Details on test material:
- Source (non-radiolabel): Angus Chemical Company
Sopurce (radiolabel): Moravek Biochemicals, Inc. (Brea, California)
Non-radiolabel material had a purity of 99.5%.
Radiolabeled: radiochemical purity 99.1%, Sp. Act. 32 mCi/mmol
Constituent 1
- Radiolabelling:
- yes
- Remarks:
- [14C]1-nitropropane, was supplied by the sponsor and obtained from Moravek Biochemicals, Inc. (Brea, California) and assigned Haskell Laboratory Number 22705-101. The test substance had a radiochemical purity of 99.1% and a specific activity of 32 mCi/mm
Test animals
- Species:
- human
- Strain:
- other: Not applicable
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Samples of human cadaver skin from the National Disease Research Interchange (NDRI) were stored frozen at approximately -20°C until prepared for use. Samples were removed from donors within 24 hours of death and used within three months. Skin specimens selected for use were identified using a unique code (e.g., HCFA-26A = Human, Caucasian, Female, Abdomen sample 26-A).
Administration / exposure
- Type of coverage:
- other: Permeability coefficient experiment-donor chamber opening was occluded with a rubber stopper; for the short-term exposure experiments, the donor chamber opening was covered with a volatile organic trap.
- Vehicle:
- unchanged (no vehicle)
- Duration of exposure:
- Permeability coefficient experiment- 8 hours
Short-term exposure experiments- 10 and 60 minutes - Doses:
- Permeability coefficient experiment- 1200 μL/cm2
Short-term exposure experiments- 20 μL/cm2 - No. of animals per group:
- Permeability coefficient experiment- 6 skin replicates representing 3 human subjects
Short-term exposure experiments- 6 skin replicates/exposure time representing 3 human subjects - Control animals:
- no
- Details on study design:
- The permeability coefficient (Kp) and the short-term absorption rates at 10 and 60 minutes have been determined for 1-nitropropane using human abdominal skin from cadavers mounted in an in vitro static diffusion cell model. Human cadaver skin was heat-treated at approximately 60°C and the epidermis was peeled from the dermis and the section mounted onto an in vitro static diffusion cell, stratum corneum uppermost, with an exposure area of 0.64 cm2. Using a recirculating water bath system, the receptor fluid (0.9% saline) was maintained at 32°C. Following system equilibration, skin integrity was confirmed by electrical impedance (EI). The saline in the donor and receptor chambers was removed and discarded and the receptor chamber was filled with 0.9% saline fortified with 6% polyethoxyoleate (polyethylene glycol (PEG) 20 oleyl ether).
For the permeability coefficient experiment, an infinite dose of 1-nitropropane was applied to the epidermal surface, via the donor chamber, at a target rate of 1200 μL/cm2, to 6 skin replicates representing 3 human subjects, and the donor chamber opening was occluded with a rubber stopper. Serial receptor fluid samples were taken at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postapplication and analyzed for radioactivity by liquid scintillation counting. At the end of the 8- hour exposure, excess 1-nitropropane was removed and the skin washed with a 2% soap solution followed by rinsing with water. The receptor fluid was removed and discarded. The receptor and donor chambers were filled with 0.9% saline and an end of experiment integrity asssessment was determined using EI.
For the short-term exposure experiments, a finite dose of 1-nitropropane (20 μL/cm2) was applied to the epidermal surface, via the donor chamber, to 12 skin replicates representing 3 human subjects, and the donor chamber opening was covered with a volatile organic trap. At the end of the required exposure interval (10 minute and 60 minutes), 6 replicates each were terminated. At termination, the volatile trap was removed and extracted with ethanol. The skin surface was washed with a 2% soap solution, rinsed with water, and the receptor fluid was removed and retained for analysis. The receptor and donor chambers were filled with 0.9% saline and end of experiment integrity asssessment was taken using EI. The saline in both chambers was removed and the donor chamber was retained for analysis. The skin membrane was removed and placed into a glass vial for digestion. The receptor fluid and the skin were analyzed by liquid scintillation counting. - Details on in vitro test system (if applicable):
- See study design above
Results and discussion
- Signs and symptoms of toxicity:
- not examined
- Dermal irritation:
- not examined
- Absorption in different matrices:
- See "remarks on results" below
- Total recovery:
- Permeability Coefficient: Recovery of the applied radioactive dose was 83.3%.
10- and 60- Minute Short Term Penetration Rates: Recovery of the applied radioactive dose was 76.9 and 78.5% for the 10- and 60-minute exposure groups, respectively.
Percutaneous absorption
- Remarks on result:
- other: See "remarks on results" below
- Conversion factor human vs. animal skin:
- Not applicable
Any other information on results incl. tables
Based on the slope at steady-state (179.6 μg equiv/cm2/h) and the concentration of the applied dose of 1-nitropropane taken as its density (998,000 μg/cm3), the permeability coefficient was calculated to be 1.80 x 10-4 cm/h.
Following a 10-minute exposure to a finite application of 1-nitropropane, a total of 127.2 μg equivalents of 1-nitropropane were detected in the receptor fluid, with 5.40 μg equivalents in the skin. Based on the amount of 1-nitropropane in the receptor fluid and skin, an exposure area of 0.64 cm2, and an exposure time of 10 minutes (0.17 hours), the short-term penetration rate was calculated to be 1218.5 μg equiv/cm2/h.
Following a 60-minute exposure to a finite application of 1-nitropropane, a total of 108.5 μg equivalents of 1-nitropropane were detected in the receptor fluid and 6.00 μg equivalents in the skin. Based on the amount of 1-nitropropane in the receptor fluid and skin, an exposure area of 0.64 cm2, and an exposure time of one hour, the short-term penetration rate was calculated to be 178.9 μg equiv/cm2/h.
Applicant's summary and conclusion
- Conclusions:
- Based on the slope at steady-state (179.6 μg equiv/cm2/h) and the concentration of the applied dose of 1-nitropropane taken as its density (998,000 μg/cm3), the permeability coefficient was calculated to be 1.80 x 10-4 cm/h.
Following a 10-minute exposure to a finite application of 1-nitropropane, a total of 127.2 μg equivalents of 1-nitropropane were detected in the receptor fluid, with 5.40 μg equivalents in the skin. Based on the amount of 1-nitropropane in the receptor fluid and skin, an exposure area of 0.64 cm2, and an exposure time of 10 minutes (0.17 hours), the short-term penetration rate was calculated to be 1218.5 μg equiv/cm2/h.
Following a 60-minute exposure to a finite application of 1-nitropropane, a total of 108.5 μg equivalents of 1-nitropropane were detected in the receptor fluid and 6.00 μg equivalents in the skin. Based on the amount of 1-nitropropane in the receptor fluid and skin, an exposure area of 0.64 cm2, and an exposure time of one hour, the short-term penetration rate was calculated to be 178.9 μg equiv/cm2/h. - Executive summary:
None
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