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EC number: 205-153-9 | CAS number: 134-71-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Non-GLP non-guideline study, available as unpublished report, limitations in design and/or reporting but otherwise adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride
- EC Number:
- 205-153-9
- EC Name:
- (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride
- Cas Number:
- 134-71-4
- Molecular formula:
- C10 H15 N O .Cl H
- IUPAC Name:
- (1-hydroxy-1-phenylpropan-2-yl)(methyl)azanium chloride
- Details on test material:
- - Name of the test substance used in the study report: DL-Ephedrin-HCl
- Test substance No.: 86/12
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Dr. K. Thomae GmbH, D-7950 Biberach, FRG
- Weight at study initiation: mean group weight females 179 - 190 g, males 179 - 199 g
- Fasting period before study: 16 h
- Housing: 5 animals per cage, stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG)
- Diet: ad libitum, Kliba-Labordiaet, Fa. Klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland
- Water: ad libitum, tap water
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 -24
- Humidity (%): 30 - 70
- Air: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- - The aqueous formulation corresponds to the physiologial medium.
- Form of administration: solution
- Administration volume (mL/kg): 10 - Doses:
- 215, 316, 464, 681, 1000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Signs and symptoms: Recording of signs and symptoms several times on the day of administration (at least once each working day). A check for moribund and dead animals was made twice each working day and once on public holidays.
- Necropsy of survivors performed: yes
- Pathology: Withdrawal of food 16 hours before sacrifice with CO2; then necropsy with gross-pathological examination. Necropsy of all animals that die as soon as possible. - Statistics:
- Test for homogeneity: Chi-square
Results and discussion
Effect levelsopen allclose all
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- 827 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 586 - 1 371
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- ca. 316 mg/kg bw
- Based on:
- test mat.
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 527 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 412 - 698
- Mortality:
- - No mortality observed in animals exposed to 215 mg/kg.
- 3 out of 10 animals died exposed to 316 mg/kg, within 1 day, all were female.
- 4 out of 10 animals died exposed to 464 mg/kg, within 1 day, all were female.
- 6 out of 10 animals died exposed to 681 mg/kg, within 1 day, 5 were female and 1 male.
- 9 out of 10 animals died exposed to 1000 mg/kg, within 1 day, 5 were female and 4 male. - Gross pathology:
- - Animals that died: general congestive hyperemia, liver grey-brown broadened lobular periphery in some animals.
- Sacrificed animals: no abnormalities observed
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of this test, the LD50 was determined to be ca. 316 and 827 mg/kg bw for female and male rats, respectively.
- Executive summary:
Five Wistar rats per sex per dose were exposed in a study similar to OECD 401 to 215, 316, 464, 681 or 1000 mg/kg bw of the test substance dissolved in water via oral gavage. After an observation period of 14 days the surviving animals were necropsied. Animals that died showed general congestive hyperemia and a grey-brown broadened lobular periphery liver in some animals. No abnormalities were detected in sacrificed animals. The LD50 was determined to be ca. 316 and 827 mg/kg bw for female and male rats, respectively.
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