Disodium adipate

Endpoint summary

Additional information

The IUCLID dataset and the present Human Health Hazard Assessment is based on the recent OECD/ICCA evaluation of adipic acid. For all systemic endpoints the hazards identified and discussed in the OECD SIDS Initial Assessment Report for adipic acid in 2004 are cited and additional updated relevant information is given in a separate heading. In aqueous media, disodium adipate and adipic acid acid dissociate into the corresponding anion (1,6-hexandioic acid ion) and the sodium ion and hydrogen ion (proton), respectively. Systemic toxicity of adipic acid and its disodium salt are thought to be an effect of the di-carboxylate ion rather than of the sodium ion or the hydrogen ion (proton), which are normal constituents in living systems and have no relevant toxicological properties at relevant doses. Therefore data on adipic acida are taken to evaluate the systemic toxicity of disodium adipate.

Adipic acid possesses eye and respiratory tract irritation based on the acidic character. Since disodium adipate is neutral in aqueous solutions no read-across between the disodium salt and the acid is appropriate for local effects. In vitro corrosion and irritation studies are performed for the disodium salt and indicate that this compound is not irritating.

There are no toxicokinetic data available for disodium adipate.The OECD SIDS Initial Assessment Report for adipic acid in 2004 indicates:

Non-human information:

Hazards identified by OECD/ICCA high production volume chemicals program in 2004:

"After oral administration by gavage of radioactive adipic acid to fasted rats up to 70 % of the dose was exhaled as CO2. In the urine the parent compound adipic acid and metabolic products identified as urea, glutamic acid, lactic acid, beta-ketoadipic acid and citric acid were found (percentages not specified). Adipic acid was metabolized by beta-oxidation in a similar fashion as fatty acids and acetate was a metabolite of adipic acid. Radioactive glycogen was isolated in experiments where glycogen formation in the liver was encouraged by oral administration of glucose together with radioactive adipic acid (Rusoff et al. 1960). When adipic acid or its sodium salt was administered to non fasted rats, rabbits and one dog 18 – 71 % of the doses were excreted in the urine. Breath was not analyzed in these studies (Mori 1918; Bernhard and Andreae 1937; Enders 1941). In an oral 28-day subacute study in rats excretion of adipic acid was similar from day 1 to 28, indicating that adipic acid did not accumulate during the treatment. Breath was not analyzed, (Enders 1941). It is unclear whether the methods of detection in these early studies were reliable."

Updated relevant information:

None

Human information

Hazards identified by OECD/ICCA high production volume chemicals program in 2004:

"Adipic acid was orally administered to humans to investigate compound excretion. The highest dose administered in one volunteer was 70 g over 10 days. 3 other persons took 19 to 23.4 g over up to 9 days. 15 - 75 % of the adipic acid dose was found unchanged in the urine after oral administration of up to 7 g of adipic acid over up to 10 days to 7 volunteers. Breath was not analyzed, and it is unclear whether the methods of detection used were reliable (Weitzel 1942 and 1947)."

Updated relevant information:

None

Conclusion:

In limited studies in animals and humans it was shown that adipic acid is absorbed after oral administration, partially metabolized to various metabolites and CO2 which are excreted via urine and breath, resp.