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EC number: 203-471-2 | CAS number: 107-19-7
- 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: oral
Administrative data
- Endpoint:
- sub-chronic toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1987
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study is scientifically valid and followed the principles of OPPTS Test Guideline 870.8700 for subchronic oral toxicity.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPPTS 870.8700 (Subchronic Oral Toxicity Test)
- Deviations:
- not applicable
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Prop-2-yn-1-ol
- EC Number:
- 203-471-2
- EC Name:
- Prop-2-yn-1-ol
- Cas Number:
- 107-19-7
- Molecular formula:
- C3H4O
- IUPAC Name:
- prop-2-yn-1-ol
- Details on test material:
- Test substance: propargyl alcohol (> 99% pure)
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- no details available
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Test Item was given as aqueous solution.
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 13 weeks
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 5, 15 or 50 mg/kg bw/day
Basis:
nominal in water
- No. of animals per sex per dose:
- 20 rats/sex/dose and control group
- Control animals:
- yes
- Details on study design:
- - 40 Animals (20/sex/dose group) were used
- Interim sacrifice of animals was peformed (10/sex/dose group)
- Recovery group was not included - Positive control:
- no
Examinations
- Observations and examinations performed and frequency:
- - CLINICAL SIGNS AND MORTALITY: yes
- BODY WEIGHT AND WEIGHT GAIN: yes
- OPHTHALMOSCOPIC EXAMINATION: yes
- CLINICAL CHEMISTRY / HAEMATOLOGY: yes
- ORGAN WEIGHTS: yes
- GROSS PATHOLOGY: yes
- HISTOPATHOLOGY: NON-NEOPLASTIC: yes - Sacrifice and pathology:
- Rats were sacrificed on days 91 or 92 after dosing.
Gross pathology and histopathology was performed. - Other examinations:
- none
- Statistics:
- not indicated
Results and discussion
Results of examinations
- Details on results:
- CLINICAL SIGNS AND MORTALITY:
Treatment-related mortality was reported in the 50 mg/kg dosage group, although the precise cause was not identified.
4 male rats of the 50 mg/kg dose group died. Animals belonging to this dose group showed marked salivation.
BODY WEIGHT AND WEIGHT GAIN:
The body weight of males of the highest dose group were significantly lower compared to the control group. In case of the females there was only a tendency towards lower body weights compared to the controls.
OPHTHALMOSCOPIC EXAMINATION:
The ophtalmological examination was without findings.
HAEMATOLOGY:
No changes in haematological parameters were reported in the rats of the 5 mg/kg dose group. In males of the highest dose group reduced values for haemoglobin, mean corpuscular haemoglobin (MCH) and mean corpuscular haemoglobin concentration (MCHC) were measured. In females of the highest dose group only reduced values for MCH and MCHC were observed. Neutrophil counts were significantly increased in males of the mid- and high-dose group (15 and 50 mg/kg bw/day). Hematological changes were seen in the mid- and high-dose animals and were considered to be treatment- related.
CLINICAL CHEMISTRY:
No changes in clinical pathology parameters were reported in the rats of the 5 mg/kg dosage group.
Enzyme changes characteristic of liver damage were seen in the mid- and high-dose animals. These changes included significantly increased ALAT, ASAT, LDH, and ALP serum activities. Moreover, decreased glucose, sodium, total cholesterol, total protein, albumin, globulin, and creatinine serum levels were seen, whereas inorganic phosphate and total bilirubin serum levels were significantly higher.
ORGAN WEIGHTS:
Treatment-related effects at the 15 mg/kg/day dose level included increased liver weights in both genders, increased kidney weights in females, and megalocytosis of the liver after 13 weeks of dosing.
GROSS PATHOLOGY
Macroscopic findings were confined to the liver (15 and 50 mg/kg bw) and the stomach (50 mg/kg bw).
HISTOPATHOLOGY: NON-NEOPLASTIC
Hepatocytic megalocytosis with a less prominent proliferation of the bile ducts and cytoplasmic vacuolation of hepatocytes was observed in all rats in the 50 mg/kg group dosed for 3 months, in all 15 mg/kg rats dosed for 3 months. In the low-dose group, megalocytosis was seen only in one rat treated for 3 months. Karyomegaly of renal tubular epithelial cells was reported to occur in a dose-response fashion in the mid- and high-dose groups, but not in the low-dosage group.
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 5 mg/kg bw/day (nominal)
- Sex:
- male/female
- Basis for effect level:
- other: effects on clinical chemistry, organ weight, histopathology at higher dose levels
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Executive summary:
Male and female Crl:CD(SD)BR rats (n=20/sex/group) were dosed orally (gavage) with 0, 5, 15 or 50 mg/kg bw of Propargyl alcohol (purity: >99%) (at 10 mL/kg in deionised water) daily for 13 weeks. Rats were sacrificed on days 91 or 92 after dosing. Parameters examined included clinical signs, body and organ weight changes, food consumption, ophthalmology, haematology, blood chemistry and histological evaluations. Treatment-related mortality was reported for 4/30 males in the high-dose group. The most prevalent clinical sign was salivation, occurring mainly at 50 mg/kg bw. Body weights were significantly lower in the high-dose animals. Haematological changes observed in the high-dose animals comprised decreased haemoglobin, MCV (also at 15 mg/kg bw), MCH, and mean corpuscular haemoglobin concentration (MCHC) values. Enzyme changes characteristic of liver damage were seen in the mid- and high-dose animals. These changes included significantly increased ALAT, ASAT, LDH, and ALP serum activities. Moreover, decreased glucose, sodium, total cholesterol, total protein, albumin, globulin, and creatinine serum levels were seen, whereas inorganic phosphate and total bilirubin serum levels were significantly higher. The haematological and blood chemistry changes were considered to be treatment-related. Absolute and relative liver and kidney weights were significantly increased in males and/or females at 15 and 50 mg/kg bw/day. At 5 mg/kg bw, mean absolute and relative liver weights were higher compared to controls, but statistical significance was not reached. Macroscopic findings were confined to the liver (15 and 50 mg/kg bw) and the stomach (50 mg/kg bw). Hepatocytic megalocytosis with a less prominent proliferation of the bile ducts and cytoplasmic vacuolation of hepatocytes was observed in the majority of rats in the mid- and high-dose groups. In the low-dose group, megalocytosis was seen only in one rat treated for 3 months. Karyomegaly of renal tubular epithelial cells was reported to occur in a dose-response fashion in the mid- and high-dose groups, but not in the low-dose group. Treatment-related effects at 15 mg/kg bw included increased liver weights in both genders, increased kidney weights in females, and megalocytosis of the liver after 13 weeks of dosing. The daily oral administration of 5 mg/kg bw/day of propynol produced no apparent treatment-related effects and hence this dose level was considered a NOAEL for subchronic oral exposure to Propargyl alcohol.
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