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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Only abstract available

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Abstracts Thirty-Third Annual Meeting American College of Clinical Pharmacology October 3-5, 2004, Litchfield Park (Phoenix), Arizona - Prolonged sympathic stimulation with oral choline and urinar yexcretion of histamine and catecholamines in the rat
Author:
Salazar-Rodriguez M, Sosa A, Campos HA
Year:
2004
Bibliographic source:
J Clin Pharmacol 2004 44: 1185/1203
Reference Type:
publication
Title:
Abstracts Thirty-Third Annual Meeting American College of Clinical Pharmacology October 3-5, 2004, Litchfield Park (Phoenix), Arizona -Sympathic stimulation with oral choline fails to increase urinary histamine excretion in spontaneously hypertensive rats
Author:
Sosa A, Salazar-Rodriguez M, Losada M, Campos HA
Year:
2004
Bibliographic source:
J Clin Pharmacol 2004 44: 1185/1203

Materials and methods

Principles of method if other than guideline:
The study originally aimes to examine urinary excretion, determination of toxic effects of the compounds were side-observations. Rats were administered orally by gavage the test compound on three consecutive days.
GLP compliance:
not specified
Test type:
other: 3d intermittend gavage
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Choline
EC Number:
200-535-1
EC Name:
Choline
Cas Number:
62-49-7
Molecular formula:
C5H14NO
IUPAC Name:
2-hydroxy-N,N,N-trimethylethanaminium
Constituent 2
Reference substance name:
choline chloryde
IUPAC Name:
choline chloryde
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): choline / choline chloryde

Test animals

Species:
rat
Strain:
other: Sprague-Dawley / spontaneously hypertensive rats (SHR), Sprague-Dawley and Wistar
Sex:
not specified
Details on test animals or test system and environmental conditions:
TEST ANIMALS

Sprague-Dawley rats
- Sex: male
- Weight at study initiation: 300-400 g
- Housing: individually in metabolic cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Sprague-Dawley / spontaneously hypertensive rats (SHR), Sprague-Dawley and Wistar
- Sex: unknown
- Weight at study initiation: 250-300 g
- Housing: individually in metabolic cages
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Details on oral exposure:
Rats were administered orally with destilled water, 4mL/kg, for 3 days. Days 4, 5 and 6 choline (20 mmole each) in the same volume was administered daily by the same route. Days 7, 8 and 9, water was again administered orally.
Doses:
20 mmole/kg (i.e. 2.79 g/kg bw) each on three consecutive days, resulting in an total amount of 8.37 g/kg bw.
Control animals:
yes
Details on study design:
- Duration of observation period following administration: at least 3 days
- Other examinations performed: urinary analysis

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD0
Effect level:
>= 2 790 mg/kg bw
Based on:
test mat.
Remarks on result:
other: given on three consecutive days, hence LD0 can be calculated as intermittent total dose to 8.37 g/kg bw
Mortality:
none

Applicant's summary and conclusion

Interpretation of results:
practically nontoxic
Remarks:
Criteria used for interpretation of results: EU
Conclusions:
Although only abstracts are available and hence the reliability is not assessable, the results are consistent with the data provided in the key study, so the LD0 ≥ 2.79 g/kg bw resp. LD0 ≥ 8.37 g/kg (three consecutive days, intermittent gavage) obtained in this study can be used to support the classification of being practically nontoxic as stated in the key study.
Executive summary:

Male Sprague-Dawley rats resp. spontaneously hypertensive rats (SHR), Sprague-Dawley and Wistar rats were administered orally on each three consecutive days 20 mmole (i.e. 2.79 g/kg bw) of Choline chloride, which results in a total, intermittent dose of 8.37 g/kg bw. No mortalities were observed, so the LD0 was found to be LD0 ≥ 2.79 g/kg bw resp. LD0 ≥ 8.37 g/kg (three consecutive days, intermittent gavage), and hence Choline chloride can be considered to practically nontoxic.