Registration Dossier

Toxicological information

Additional toxicological data

Currently viewing:

Administrative data

Endpoint:
additional toxicological information
Type of information:
other: review
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: only secondary literature: GRAS notification from Select Committee of Food and Drug Administration

Data source

Reference
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1975

Materials and methods

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Any other information on results incl. tables

Triacetin, acetooleins, acetostearins Triacetin and two types of acetooleins have been found to be without toxic effects in long-term feeding tests in rats at levels that were several orders of magnitude greater than those to which consumers are exposed. Three types of acetostearins have been found to be without toxic effects in long-term feeding tests in rats at levels up to 5 g per kg per day. This contrasts with an estimated human consumption of a fraction of a milligram per kg per day. It is recognized that at an even higher feeding level (10 g per kg per day) male rats developed testicular atrophy and female rats, uterine discoloration. However, such a level which would amount to 50 g or more for an infant and 600 g for an adult per day, is vastly higher than would be possible in the consumption of foods to which acetostearins are added for functional purposes. In light of the available scientific information the Select Committee concludes that: There is no evidence in the available information on triacetin, acetooleins, and acetostearins that demonstrates or suggests reasonable grounds to suspect a hazard to the public when they are used at levels that are now current or that might reasonably be expected in the future.

Applicant's summary and conclusion

Conclusions:
There is no evidence in the available information on triacetin that demonstrates or suggests reasonable grounds to suspect a hazard to the public.