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EC number: 219-006-1 | CAS number: 2312-35-8
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 26th July 1991 to 2nd September 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OTS 798.1175 (Acute Oral Toxicity)
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Propargite
- EC Number:
- 219-006-1
- EC Name:
- Propargite
- Cas Number:
- 2312-35-8
- Molecular formula:
- C19H26O4S
- IUPAC Name:
- propargite
- Test material form:
- liquid
- Details on test material:
- - Name of test material (as cited in study report): Omite® Technical
- Stability under test conditions: at least one year at room temperature
- Storage condition of test material: sealed container at room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Inc., Portage, Michigan, USA
- Age at study initiation: young adult
- Weight at study initiation: 203-278 g
- Fasting period before study: yes (approximately 18-20 hours)
- Housing: individual suspended wire-mesh cages
- Diet: Purina® Certified Rodent Chow® #5002 ad libitum
- Water: tap water ad libitum
- Acclimation: 7 days minimum
ENVIRONMENTAL CONDITIONS
- Temperature: 70-75 ºF
- Humidity: 54-86 %
- Photoperiod: 12 hours light/12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- RATIONAL FOR THE SELECTION OF THE STARTING DOSE
- A range-finding study was conducted in which groups of one male and one female were dosed at levels of 500, 1000, 2000, 3500 and 5000 mg/kg. The male dosed at 2000 mg/kg, the female dosed at 3000 mg/kg and all animals dosed at 5000 mg/kg died. Both animals dosed at 500 and 1000 mg/kg survived. Based on these results 2000 mg/kg was selected as the first dose level on the definitive study.
- Three groups of five male and five female rats were administered single doses at levels of 2000, 2800 and 3920 mg/kg. Dose levels were selected using a progression of 1.4. - Doses:
- 2000, 2800 and 3920 mg/kg bw (dose volumes of 1.8, 2.57 and 3.6 mL/kg respectively)
- No. of animals per sex per dose:
- Five
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical observations at 1, 3 and 4 hours post-dose and twice daily thereafter; body weights at days -1, 0, 7 and 14 (and at death)
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 2 800 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 2 511 - <= 3 122
- Mortality:
- All mortalities occurred in the second week of the study (days 6- 11), during which the combined mortality was 0/10, 5/10 and 10/10 in the 2000, 2800 and 3920 mg/kg bw groups, respectively (see Table 1).
- Clinical signs:
- other: All animals displayed various signs of urogenital staining/matting. Abnormal defecation was observed in 28 animals, while 20 animals exhibited decreased urination. Hypoactivity was observed for 23 animals. The hindpaws and/or forepaws were red/swollen in
- Gross pathology:
- Findings of gross necropsy on animals that died during the study, included stomach abnormalities (thickened mucosa and red areas/contents), intestinal abnormalities (distended red with contents), reddened adrenal glands, red lungs, reddened pituitary, dark red prostate and red streaks in the bladder.
Any other information on results incl. tables
Table 1: Mortality
Dose level (mg/kg bw) | Male mortality | Female mortality | Total mortality |
2000 | 0/5 | 0/5 | 0/10 |
2800 | 4/5 | 1/5 | 5/10 |
3920 | 5/5 | 5/5 | 10/10 |
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified in accordance with EU criteria
- Conclusions:
- The acute oral LD50 of the test material in rats was calculated to be 2800 mg/kg (95 % C.I. 2511-3122 mg/kg).
- Executive summary:
The test material was administered once orally via gastric intubation to groups of five male and five female fasted albino rats at dose levels of 2000, 2800 and 3920 mg/kg. Mortality, clinical observations, body weights and gross necropsy findings were evaluated.
Clinical findings were generally noted throughout the study and in all dose groups. All animals had various urogenital staining. The majority of the animals had abnormal defecation and swollen hindpaw(s) and/or forepaw(s). The urogenital area appeared swollen on the majority of females. Essentially all males had a red and swollen penis and prepuce and the majority of animals in the 2000 and 2800 mg/kg groups had necrotic areas on the scrotum. Hypoactivity, wet and/or dried material on the forepaw(s), dried red material around the mouth, decreased urination and a red and swollen mouth were noted for approximately two-thirds of the animals. More than one-half of the animals had hair loss at the base of the tail. Approximately one-third of the animals had red and swollen ears and hypothermia. Eight animals were hypersensitive to the touch. Other clinical findings included rales, scabbing of the right and/or left ear, dried red material around the eye(s), ataxia, moist alopecia on the forepaw(s) and/or hindpaw(s), dried red abdominal staining, dehydration, prostration and greenish discolouration of the tissues in the urogenital area.
No mortality was observed in the 2000 mg/kg group. Five and ten deaths were observed in the 2800 and 3920 mg/kg groups respectively.
Twenty-four animals lost weight from day 0 to day 7; all surviving animals gained weight during the second week of the study.
G.I. abnormalities were noted for 14/15 animals that died and were considered to be due to the irritative properties of the test material. Dark red or reddened adrenal glands, a typical agonal or stress-related change, were observed for six animals that died. Five animals had bright red lungs and three animals were icteric. Other findings observed for one animals included a reddened pituitary gland, a dark red prostate gland and dark red streaks on the urinary bladder. 14/15 animals that died had external matting. Reddened forepaw(s) and/or hindpaw(s) were observed on six animals. Two animals had reddened ear(s) and a red and swollen penis. Scabbing on the forepaw and hair loss were each noted for one animal.
External surface findings were noted on all animals that were terminally necropsied. Various scabbing, hair loss and swelling were noted for approximately two-thirds of the animals. Approximately one-third of the animals had reddened hindpaw(s) and/or forepaw(s). Red nasal matting and a thickened mucosa in the stomach were noted for two animals each. One 2800 mg/kg male had small, soft testes. No other significant changes were observed at terminal necropsy.
The LD50 was determined to be 2800 mg/kg (95 % C.I. 2511-3122 mg/kg).
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