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Diss Factsheets

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
publication
Title:
Safety evaluation of diethyl citrate and its impact on vascular calcification
Author:
Duan C-Y, Huang L-H, Guo D, Ouyang J-M, Han J and Gui B-S
Year:
2017
Bibliographic source:
Advances in Biological Sciences Research, Vol. 6, pages 62-67

Materials and methods

Test guideline
Guideline:
other: Up and down procedure
GLP compliance:
not specified
Limit test:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of diethyl hydrogen 2-hydroxypropane-1,2,3-tricarboxylate and ethyl dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate and triethyl citrate
EC Number:
904-139-6
Cas Number:
172820-60-9
Molecular formula:
not applicable, multi constituent substance
IUPAC Name:
Reaction mass of diethyl hydrogen 2-hydroxypropane-1,2,3-tricarboxylate and ethyl dihydrogen 2-hydroxypropane-1,2,3-tricarboxylate and triethyl citrate
Test material form:
liquid

Test animals

Species:
mouse
Strain:
not specified
Sex:
female

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
other: physiological saline
Doses:
7
No. of animals per sex per dose:
1
Control animals:
yes

Results and discussion

Effect levels
Sex:
female
Dose descriptor:
LC0
Effect level:
<= 9 900 mg/kg bw
Based on:
test mat.
Mortality:
None
Clinical signs:
Activity of the mice was not significantly reduced and no death occurred at dose levels of less than 6900 mg/kg body weight. At dose levels up to 9900 mg/kg, reduced activity, ataxia, slow and sluggish movement immediately occurred. Recovery occurred within 1 hour of dosing and no deaths occurred.
Body weight:
No effects
Gross pathology:
No significant lesions of the body tissues and organs were observed.

Applicant's summary and conclusion

Executive summary:

Administration of a single dose of diethyl citrate to the mouse by intraperitoneal administration resulted in no mortality at dose levels up to 9900 mg/kg body weight.