Safety assessment of a novel ingredient for removable chewing gum.
Rev7 is an indigestible gum polymer used for the manufacturing of chewing gum. It allows for the formulation of chewing gum with low adhesion; thus can be readily removed from surfaces such as sidewalks, clothing, carpets and furniture. In a toxicological safety assessment, Rev7 was found to be non-mutagenic in the AMES assay. The highest concentration tested in a mouse lymphoma thymidine kinase locus gene mutation assay induced a slight but biologically relevant increase in mutations under non-metabolic activation conditions after 24h. Because of this finding, a mouse micronucleus assay was performed, and the test article was found to be negative for inducing chromosomal damage. A 28-day repeated oral toxicity study resulted in a NOAEL of 80,000 ppm; the highest concentration tested. Rev7 was found to be free from contaminants such as heavy metals, monomers, and solvents. Lastly, Rev7 did not demonstrate skin-sensitizing properties in the murine local lymph node assay.
Farber
T M
TM
Toxicology Advisory Services, 11430 Strand Drive, Rockville, MD 20852, USA.
Clewell
A E
AE
Endres
J R
JR
Hauswirth
J
J
Van Gemert
M
M
Schauss
A G
AG
Sheane
C A
CA
D000818:Animals; D002084:Butylated Hydroxytoluene / Q000032:analysis; D002638:Chewing Gum / Q000633:toxicity*; D004912:Erythrocytes / Q000187:drug effects / Q000648:ultrastructure; D005260:Female; D023441:Local Lymph Node Assay; D008297:Male; D019216:Metals, Heavy / Q000032:analysis; D051379:Mice; D015162:Micronucleus Tests; D009152:Mutagenicity Tests; D011108:Polymers / Q000627:therapeutic use*; D051381:Rats; D017207:Rats, Sprague-Dawley; D012449:Safety; D012486:Salmonella typhimurium / Q000187:drug effects / Q000235:genetics; D012997:Solvents / Q000032:analysis; D013386:Succinates / Q000627:therapeutic use*; D013937:Thymidine Kinase / Q000187:drug effects / Q000235:genetics
D002638:Chewing Gum; D019216:Metals, Heavy; D011108:Polymers; D012997:Solvents; D013386:Succinates; D002084:Butylated Hydroxytoluene; D013937:Thymidine Kinase