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EC number: 250-196-9 | CAS number: 30433-91-1
Toxicological information
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From 17 March 1994 to 16 September 1994
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: A well documented not GLP study according to OECD guideline
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 995
- Report date:
- 1995
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
Test material
- Reference substance name:
- Thiophene-2-ethylamine
- EC Number:
- 250-196-9
- EC Name:
- Thiophene-2-ethylamine
- Cas Number:
- 30433-91-1
- Molecular formula:
- C6H9NS
- IUPAC Name:
- 2-(2-thienyl)ethanamine
- Reference substance name:
- 2-Thiopheneethanamine
- IUPAC Name:
- 2-Thiopheneethanamine
- Test material form:
- other: liquid
- Details on test material:
- - Name of test material (as cited in study report): SR 26825
- Lot/batch No.: 4SNL001
Constituent 1
Constituent 2
Test animals
- Species:
- rat
- Strain:
- other: OFA-SD (IOPS Caw)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Credo
- Age at the beginning of the treatment: approximately 5 weeks
- Weight at the beginning of the treatment: male: 115 to 184 g - female: 122 to 152 g
- Fasting period before treatment: food was withdrawn 18 hours before treatment and redistributed approximately 4 hours after treatment
- Housing: rats were housed 2 or 3 of a same group to stainless steel cages (891cm² x 18 cm).
- Diet: UAR AO4C diet
- Water: tap water
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature: 22°C (+/- 2°C)
- Humidity: between 40 and 70%
- Air changes: 10 to 11 times per hour without recycling
- Photoperiod: 12/24-hour light cycle
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: in a 0.6% methylcellulose aqueous solution
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 0.6% in methylcellulose aqueous solution
- Administration volume: 10 mL/kg
Dose levels were selected in view of available information on the test compound. - Doses:
- Dose levels: 0, 125, 200, 250, 500 and 2000 mg/kg
- No. of animals per sex per dose:
- 5 animals per sex per dose
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 15 days
- Frequency of observations and weighing:
Clinical signs: daily observations
Body weight: day 1 (on the day of treatment) and on day 3, day 8 and day 15.
- Post-mortem macroscopic examination was performed in the animals found dead during the study.
- Surviving animals were sacrificed by an intraperitoneal injection of pentobarbital sodium followed by exsanguination and subjected to a macroscopic examination at the end of observation period.
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LD0
- Effect level:
- 200 other: mg/kg
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 200 - <= 250 other: mg/kg
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD100
- Effect level:
- 500 other: mg/kg
- Based on:
- test mat.
- Mortality:
- No mortality occurred for the dose levels: 0, 125 and 200 mg/kg
At 250 mg/kg: 3 males (of 5) and 3 females (of 5) died 3h30 following treatment
At 500 mg/kg: 3 males died in the first hour and 2 other males died, 3h30 following treatment. As for the females, 4 died in the first hour and 1 died, 3h30 following treatment.
At 2000 mg/kg: 2 males died 30 minutes following treatment and the other 3 males died 45 minutes following treatment. As for the females, the 5 animals died 30 minutes following treatment.
Mortality occurred very soon after treatment. - Clinical signs:
- other: >= 125 mg/kg: Ptyalism (day 1) >= 200 mg/kg: Prostration (day 1) in surviving animals a few hours after treatment >= 250 mg/kg: Decubitus, tremors, clonic convulsions (day 1) 2000 mg/kg: Piloerection (on day 1 in 3 males only)
- Gross pathology:
- Observations after necropsy:
- Animals found dead:
>= 250 mg/kg: Intestine and stomach: hemorrhagic contents in all animals; Lungs: non collapsed mostly at 250 mg/kg; Dried blood on the muzzle (3/6 at 250 mg/kg, 8/10 at 500 mg/kg)
>= 500 mg/kg: Liver: slightly pale in all animals
2000 mg/kg: Stomach (glandular area): red spots in all animals
- Animals sacrificed on day 15: No treatment-related changes
Applicant's summary and conclusion
- Conclusions:
- The maximal non lethal dose is 200 mg/kg in male and female rats. LD50 is between 200 and 250 mg/kg. No intersex differences were noted.
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