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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
1969
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

Constituent 1
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

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