In vitro hydrolysis studies with propylene glycol alginate in simulated gastric juice and simulated intestinal juice showed no hydrolysis in simulated gastric juice, while intestinal juice hydrolyzed 25% in 4 hr, 65% in 12 hr and 80% in 24 hr ... .
Fifty individuals known to be allergic to numerous substances were tested intradermally with various dilutions of propylene glycol alginate. Fifty other individuals without an allergic history or family history of allergy were used as controls. Eleven individuals showed slight to moderate skin reactions (8 in test group, 3 in control group). When five of those showing the greatest reactions (all in test group) were fed propylene glycol alginate three showed mild allergic reactions which were duplicated in repeated tests. Three control individuals, who showed very slight skin reactions, did not react to oral admin of propylene glycol alginate ... .
Five healthy male volunteers received 175 mg propylene glycol alginate/kg bw/day orally for 7 days, followed by 200 mg/kg bw/dy for a further 16 days. The daily doses were consumed in three measured portions at intervals each day. ... The treatment period was preceded by a 7 day initial control period. ... At day 3 of the initial control period, on the last day of the 23-day treatment period and on the last day of the 7 day recovery period the following parameters were examined: fasting blood glucose, plasma insulin, breath hydrogen concn, hematological parameters ... and biochemical parameters. ... Routine urinalysis was carried out during the initial control wk and during the third wk of treatment. Five day fecal collections were made during days 2-6 of the initial control period and during days 16-20 of the treatment period. ... No allergic reactions were observed. Propylene glycol alginate exerted no significant effects on fecal parameters. ... Fecal transit time was constant in 3 volunteers, increased in one and decreased in one. Fecal total and individual volatile fatty acids and total and individual bile acids did not show changes. Fecal total neutral sterols and cholesterol decreased in each volunteer. Hematological, biochemical and urinary parameters did not show significant changes ... .
HOST-MEDIATED ASSAY OF PROPYLENE GLYCOL ALGINATE DID NOT PRODUCE MUTAGENIC RESPONSE FOR SACCHAROMYCES CEREVISIAE. NO MUTAGENIC RESPONSE DEMONSTRATED IN IN VITRO TESTS ON SALMONELLA TYPHIMURIUM.
WHEN PROPYLENEGLYCOL (14)C ALGINATE OR (14)C PROPYLENEGLYCOL ALGINATE...DOSED TO MICE, UNHYDROLYZED ESTER & ALGINATE RESIDUE...UNABSORBED FROM GI TRACT... HYDROLYZED PROPYLENEGLYCOL...ABSORBED...METABOLIZED & ELIMINATED... SINGLE DOSE OF 1 G/KG...EXCRETED IN FECES...IN 5 DAYS...
来源:Hazardous Substances Data Bank (HSDB)
吸收、分配和排泄
在单次给药5克/千克后,5天后直肠中仍有微量标签存在。
...AFTER A /SINGLE/ DOSE OF 5 G/KG, TRACES OF LABEL WERE STILL PRESENT IN RECTUM /AFTER 5 DAYS/.
Five g of propylene glycol alginate/kg bw (as a 10% aq soln), labeled with (14)C in the alginate moiety, or 1 g of propylene glycol alginate/kg bw (as a 5% aq soln), labeled with (14)C in the propylene glycol moiety, was admin as a single dose to mice (8/group) by gavage. Absorption, distribution and excretion of radioactivity were followed from 1 hr to 5 days after admin by whole body autoradiography. Some, but not all, of the label (labeled in the propylene glycol moiety) in a single dose of 1 g propylene glycol alginate/kg bw was absorbed. The unabsorbed portion was excreted in the feces within 3 days while the absorbed radioactivity was distributed rapidly over the whole body, was concn in the liver and was completely removed from all tissues in 3-4 days. These findings are consistent with the fate of absorbed radioactivity from labeled free propylene glycol and its metabolites. Five days after admin of 5 g propylene glycol alginate (labeled in the alginate moiety)/kg bw traces of radioactivity were still noted in the rectum. It was concluded that released propylene glycol was absorbed and metabolized by the usual pathways (to acetate, lactate or glycogen) and had disappeared completely from the body after 5 days. The alginate moiety and the unhydrolyzed propylene glycol alginate were not absorbed from the GI tract, but excreted in the feces ... .