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Toxicological information

Repeated dose toxicity: other routes

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Administrative data

Endpoint:
short-term repeated dose toxicity: other route
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well-documented publication meeting basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Parenteral nutrition with short- and long-chain triglycerides: triacetin reduces atrophy of small and large bowel mucosa and improves protein metabolism in burned rats.
Author:
Karlstad, M.D. et al.
Year:
1992
Bibliographic source:
Am J Clin Nutr., 55(5):1005-11.

Materials and methods

Principles of method if other than guideline:
The goal of this study was to determine if the partial replacement of long-chain triglyceride (LCT) calories with triacetin in a parenteral-nutrition regimen would be beneficial with respect to improving kinetics and energy metabolism and small and large bowel integrity after burn injury.
GLP compliance:
not specified
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Triacetin
- Source: Sigma Chemical Co, St. Louis, USA
- Analytical purity: no data

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Taconic Farms, Germantown, NY, USA.
- Housing: individually in wire-bottom cages
- Diet (e.g. ad libitum): Liposyn II (Abbott Laboratories, IL, USA) was used as the source of LCTs.

Administration / exposure

Route of administration:
intravenous
Duration of treatment / exposure:
7 days after burn injury
Frequency of treatment:
delivery rate: 2.1 mL/h

Results and discussion

Results of examinations

Details on results:
Parenteral nutrition with 50% triacetin and 50% LCTs promoted a positive nitrogen balance similar to that of 100% LCTs, increased protein in rectus muscle and liver, smaller and more numerous mucosal cells in jejunum and colon, and increased colonic mucosal weight compared with the other groups. Triacetin did not appreciably affect whole-body and tissue leucine kinetics. The equicaloric provision of triacetin and LCTs improved protein utilization and structural components of the small and large bowel and reduced the development of intestinal mucosal atrophy associated with conventional parenteral nutrition in burn injury.
No deaths or evidence of overt toxicity (irritability, somnolence, diarrhea) to the parenteral regimens were observed.
Body weight loss in all groups after 7 d of parenteral nutrition was presumably due to a loss of body mass and an increase in evaporative water loss from the burn wound.

Effect levels

Dose descriptor:
NOAEL
Basis for effect level:
other: Triacetin might be of benefit as a replacement of long-chain triglycerides in parenteral nutrition after burn injuries.
Remarks on result:
not determinable
Remarks:
no NOAEL identified

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Triacetin might be of benefit as a replacement of long-chain triglycerides in parenteral nutrition after burn injuries.