Disodium adipate

Endpoint summary

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

There are no data available for disodium adipate. 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.

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

Animal data:

"There is only one sensitisation study available and it produced no evidence of a sensitising action but its reliability can not be fully assigned. Groups of 10 guinea pigs were given series of four sacral intradermal injections, one each week over a three-week period, which consisted of 0.1 ml of a 1.0 % solution of adipic acid (99.99 %) in water. Following a two-week rest period, the test animals were challenged for sensitisation by applying, and lightly rubbing in, approximately 0.05 ml of a 50 % and 25 % suspension of the test material in propylene glycol on the shaved intact shoulder skin. A group of 10 previously unexposed animals received similar applications at the time of challenge to provide direct comparison of the challenge reactions on the skin of similar age. The compound produced very mild to no skin irritation to previously unexposed guinea pigs and did not cause sensitisation (Haskell 1974). The study design does not accord to modern guidelines because the number of animals per group was low, no data were presented to justify the induction concentration used, no adjuvant was used, and no positive control or historical data were presented."

Human data:

"Despite the wide use of adipic acid, only very few cases of skin or respiratory tract reactions are reported: A positive patch test reaction to adipic acid (probably 1 % in alcoholic solution) was reported in a 51-year-old machine repairman with a 3- to 4-year history of work-related dermatitis of the hands and other exposed sites when working with powders in the synthesis of polyesters (Guin 2001). Delayed cutaneous hypersensitivity to adipic acid was reported in a patch test (100 %) with a laboratory worker in a factory producing polyester resins. No further details are available in this case (Malten and Zielhuis 1964)."

Updated relevant information:

Potential sensitization was investigated in a Guinea pig maximization test according to OECD TG 406 with a mixture of dicarboxylic acids containing 23.8% adipic acid, 50.9% glutaric acid and 18.6% succinic acid. Ten guinea pigs received 0.1% test compound in 0.9% NaCl in the presence of Freud's complete adjuvant during the intradermal induction and 10% test compound during the following dermal induction after application of 10% sodium lauryl sulfate to induce local irritation. The challenge was performed with 5% test compound for 24 hours and skin reaction was evaluated 24 and 48 hours after removal of the dressing.

After the challenge application, no cutaneous reactions were observed in the animals of the control group. In the treatment group, a discrete erythema was observed in 1/10 animals at the 24-hour reading and in another animal at the 48-hour reading. Dryness of the skin was also observed in 1/10 animals at the 48-hours reading only. The authors concluded that the test item is not sensitizing should not be considered as a skin sensitizer.

Migrated from Short description of key information:
There are no data available for disodium adipate. Adipic acid is not sensitizing.

Respiratory sensitisation

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (not sensitising)

Additional information:

There are no data available for disodium adipate.

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

"Despite the wide dispersive use of adipic acid, only very few cases of skin or respiratory tract sensitisation reactions are reported in humans. Overall, sensitisation is not expected for adipic acid."

Migrated from Short description of key information:
no valid animal data available

Justification for classification or non-classification

Disodium adipate is considered to be not sensitizing; no classification is required according to the EU classification criteria 67/548/EWG and regulation no. 1272/2008 (GHS).