Registration Dossier
Registration Dossier
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EC number: 200-517-3 | CAS number: 61-76-7
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: Publication published in a peer reviewed journal with limitations in design and/or reporting but otherwise adequate for assessment.
Data source
Reference
- Reference Type:
- publication
- Title:
- Toxizitatsunterschiede von Pharmaka bei subcutaner, intragastraler und intraduodenaler Applikation bei Ratten
- Author:
- Stockhaus, K. et. al.
- Year:
- 1 969
- Bibliographic source:
- Arch. Int. Pharmacodyn. 180:155 161.
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Three groups of five rats were exposed to phenylephrine under light anesthesia of 3-4 minutes duration by oral gavage. The LD50 and the confidence limits were calculated according to Litchfield and Wilcoxon.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- no
Test material
- Reference substance name:
- Phenylephrine
- EC Number:
- 200-424-8
- EC Name:
- Phenylephrine
- Cas Number:
- 59-42-7
- IUPAC Name:
- 3-[1-hydroxy-2-(methylamino)ethyl]phenol
- Details on test material:
- - Name of test material (as cited in study report): Phenylephrine
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: FW 49/Biberach
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: 150-160g
- Fasting period before study: 12 hours
- Diet: Altromin-R-standard feed
- Water: ad libitum
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- No. of animals per sex per dose:
- 5
- Statistics:
- The LD50 and the confidence limits were calculated according to Litchfield and Wilcoxon.
Results and discussion
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- 350 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- 208 - 288
Applicant's summary and conclusion
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