Safety evaluation of a barrier cream.
A barrier cream containing propylene glycol, silica, xylene, dioctyl adipate and amyl acetate was applied topically for 3 months in 3 species of animal. Patch tests were carried out in human volunteers up to 72 h. The cream produced slight erythema in rats, guinea pigs and rabbits, but the irritation indices remained within safe limits. Histologically, mild focal thickening and moderate thickening of stratum corneum were observed in rats and guinea pigs, respectively, after 3 months of daily application. Patch testing in human volunteers indicated that the barrier cream is reasonably safe for human use.
Gupta
B N
BN
Industrial Toxicology Research Centre, Lucknow, India.
Shanker
R
R
Viswanathan
P N
PN
Mathur
A K
AK
Shukla
L
L
Singh
A
A
D000272:Adipates / Q000008:administration & dosage / Q000009:adverse effects; D000287:Administration, Topical; D000818:Animals; D003877:Dermatitis, Contact / Q000209:etiology; D009783:Dermatitis, Occupational / Q000517:prevention & control*; D003879:Dermatologic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D004341:Drug Evaluation; D005260:Female; D006168:Guinea Pigs; D006801:Humans; D008297:Male; D009824:Ointments; D010328:Patch Tests; D000439:Pentanols / Q000008:administration & dosage / Q000009:adverse effects; D011409:Propylene Glycols / Q000008:administration & dosage / Q000009:adverse effects; D011817:Rabbits; D051381:Rats; D012822:Silicon Dioxide / Q000008:administration & dosage / Q000009:adverse effects; D014992:Xylenes / Q000008:administration & dosage / Q000009:adverse effects
D000272:Adipates; D003879:Dermatologic Agents; D009824:Ointments; D000439:Pentanols; D011409:Propylene Glycols; D014992:Xylenes; C013966:dioctyl adipate; D012822:Silicon Dioxide; C005716:amyl acetate