Registration Dossier
Registration Dossier
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EC number: 200-074-6 | CAS number: 50-98-6
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: BASF method, similar to OECD 402; non GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 434 (Acute Dermal Toxicity - Fixed Dose Procedure)
- Principles of method if other than guideline:
- Method: BASF test
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Ephedrine hydrochloride
- EC Number:
- 200-074-6
- EC Name:
- Ephedrine hydrochloride
- Cas Number:
- 50-98-6
- Molecular formula:
- C10H15NO.ClH
- IUPAC Name:
- 2-(methylamino)-1-phenylpropan-1-ol hydrochloride
- Reference substance name:
- (-)-Ephedrin hydrochlorid
- IUPAC Name:
- (-)-Ephedrin hydrochlorid
- Test material form:
- solid - liquid: suspension
- Details on test material:
- - Name of the test substance: (-)-Ephedrin hydrochlorid
- Batch-no.: 96509
- Substance type: powder
Constituent 1
Constituent 2
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 a.d. Riss, FRG
- Age at study initiation: no data
- Weight at study initiation: 200-300 g
- Housing: single housing, stainless steel wire mesh cages, type DK-III (Becker & Co., Castrop-Rauxel, FRG).
- Diet: Kliba-Labordiaet 343, klingentalmuehle AG, CH-4303 Kaiseraugst, Switzerland, ad libitum
- Water: tap water ad libitum
- Acclimation period: at least 1 week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-24
- Humidity (%): 30 - 70
- Photoperiod (hrs dark / hrs light): 12 /12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: about 50 cm x cm
REMOVAL OF TEST SUBSTANCE
- Washing : with warm water
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 4 mL/kg bw
- Concentration: 50% (w/v)
- Constant volume or concentration used: yes - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations: Recording of signs and symptoms several times on the day of application, at least once each workday. Check for moribund and dead animals twice each workday and once on holidays.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Mortality:
- No mortalities were observed.
- Clinical signs:
- other: Findings for male and female animals: slight erythema and edema (score 1) on the day of application. These signs had fully disappeared untill day 7.
- Gross pathology:
- No abnormalities were observed.
Applicant's summary and conclusion
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