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Description of key information

Short description of key information on bioaccumulation potential result: 
low bioaccumulation potential based on study results:
- no retention of the test substance in organs examined
- the test substance was predominantly excreted via respiration.
Short description of key information on absorption rate:
The studies were performed prior to the adoption of OECD guidelines as well as the GLP regulations. Test facilities and authors of the studies are unknown but the content is comprehensible and the data obtained can provide information in the evaluation and the interpretation of toxicological data.

Key value for chemical safety assessment

Bioaccumulation potential:
low bioaccumulation potential

Additional information

The studies were performed to determine the excretion parameters of the C14 label on diallyl-diglycol carbonate (CR-39) into the urine, feces and respired carbon dioxide as well as disposition into the liver, kidney, thigh (site of injection), and remaining carcass following a single parenteral dose utilizing the guinea pigs. Rhesus monkey was also used in a study.

With the C14 label incorporated in the diethylene glycol moiety of the chemical, the excretion rates were obtained for parenteral administration in the two species.The urine and the feces of the guinea pigs contained an average total value of 67.7% and 27.4% of the C-14 label respectively. An average total value of 91.2% of the C14 label was found in the urine of rhesus monkey. The samples were collected daily for 11 days in the study with guinea pigs and for 5 days in the study with the rhesus monkey. The highest excretion rates were observed during the first 24 hours for both species.

However, with the C14 label in the allyl moiety of CR-39, no radioactivity could be detected in urine, feces or liver of guinea pigs following intramuscular injection. (The study was repeated with the same results; therefore the results were not technical errors). Since the diethylene glycol moiety is readily eliminated in urine and feces, the intact compound must rapidly dissociate/be metabolized and the two moieties follow different paths of elimination (or body retention) (refer to Research Proposal enclosed in the full study report included in Endpoint Basic toxicokinetics IUCLID file). The differences observed in the solubility of the diffrent labeled moieties (despite being the same intact chemical) might be the reason of very low excretion rates measured.

When only soluble fraction of the allyl-C14 labeled test substance was used in the "Elimination of 14C labeled Diallyl -Diglycol Carbonate in Guinea Pigs following a Single Parenteral Dose" study (1984), the excretion of the C14 label was found to occur predominantly via respiration (70.8% of injected dose) and the rates of excretion were also the highest within the first 24 hours. The time and frequency of sampling was daily for 7 days. The total recovery of C14 label was 100%.

The excretion rates in all studies were the highest during the first 24 hours.

Discussion on absorption rate:

Absorption rate (%) field is not applicable.

Carbon -14 labeled diallyl-diglycol carbonate (CR-39) was applied to the area of skin directly behind the ears of the guinea pigs and to the abdomen of rhesus monkeys. Percutaneous absorption of the test substance was determined by measurement of the total amount of the C14 label excreted into the urine. Two different C14 labeled test chemicals were tested.

With C14 label incorporated in diethylene glycol moiety of the test substance the excretion trates into the urine were high as with the C14 label incorporated in allyl moiety of the chemical. This applies to the both species tested . In case of diethylene glycol C14 labeled substance the urine of the guinea pigs contained an average corrected total value of 29.8% of the applied C14 label of the CR-39 and the urine of rhesus monkeys 55.3%. The highest elimination rates were observed within the first 24 hours. In case of allyl C14 labeled substance (only soluble fraction used in the study) only 17.6% of the applied dose was found in the urine of guinea pigs. No C14 was detected in the feces, site of application or in the carcasses of the animals. In all three dermal absorption studies the washing procedure of the skin after 24 hours of application removed a significant per cent of the applied dose. All calculated excretion values were corrected for incomplete urinary excretion with a parental excretion factor.

The excretion rates were the highest within the first 24 hours in all studies.