A recent toxicological study has examined the dodecanedioic acid safety profile to determine its suitability for human consumption. Dodecanedioic acid (DDDA), often marketed as Metabolyte™, is an odd-chain dicarboxylic acid that researchers are investigating for its metabolic benefits. This comprehensive assessment included multiple genotoxicity assays and a 28-day repeat-dose oral toxicity evaluation in Wistar rats.

Genotoxicity and Systemic Observations

The researchers utilized a bacterial reverse mutation assay along with both in vitro and in vivo mammalian chromosomal tests. According to the results, Metabolyte™ showed no mutagenic potential in any of the genotoxicity models. This suggests that the compound does not pose a primary risk of genetic damage under the tested conditions. However, the 28-day oral study revealed significant physiological changes at higher dosage levels.

Dodecanedioic Acid Safety Profile and Organ Toxicity

During the repeated-dose study, rats received doses ranging from 3250 mg/kg to 13,100 mg/kg body weight per day. While histological examinations did not show direct lesions, biochemical markers pointed toward potential organ dysfunction. Specifically, high-dose groups displayed altered electrolyte levels, including decreased sodium and chloride in males and increased calcium and phosphorous in females. These shifts often indicate underlying kidney malfunction. Furthermore, male rats in the highest dose group exhibited significant increases in triglycerides and bile acids, alongside altered ALT levels, suggesting liver stress.

Female rats in the high-dose categories also showed significant alterations in motor activity and increased alkaline phosphatase levels. Consequently, changes in the absolute and relative weights of the liver and kidney were detected in females receiving 13,100 mg/kg/day. Despite these findings at extreme doses, the study established a clear threshold for safety.

Determining the NOAEL

The investigators concluded that the No Observed Adverse Effect Level (NOAEL) for sodium dodecanedioate is 3250 mg/kg body weight per day. At this specific concentration, there were no toxicologically relevant treatment-related findings in either male or female rats. Therefore, while dodecanedioic acid appears safe at lower doses, excessive intake may compromise hepatorenal health.

FAQs

Is dodecanedioic acid safe for long-term use?

Studies indicate that dodecanedioic acid is safe at established No Observed Adverse Effect Levels (NOAEL). However, very high doses in animal models have shown markers of liver and kidney stress, suggesting that sticking to recommended metabolic dosages is crucial.

Does dodecanedioic acid cause genetic mutations?

No, multiple genotoxicity tests, including the Ames test and chromosomal aberration assays, have confirmed that dodecanedioic acid is not mutagenic.

Disclaimer: This content is for informational and educational purposes only. It does not constitute medical advice or a professional recommendation. Always consult with a qualified healthcare professional regarding the safety and efficacy of dietary supplements. Refer to the latest local and national guidelines for clinical practice.

References

1. Sharma D et al. Safety Assessment of Dodecanedioic Acid (Dodecanedioic Acid Disodium Salt) Using Genotoxicity and Repeated 28-day Oral Toxicological Evaluation. Int J Toxicol. 2026 Mar 13. doi: 10.1177/10915818261431749. PMID: 41823950.
2. Mingrone G. Dodecanedioic acid: a metabolic fuel with a potential role in the treatment of diabetes. Am J Physiol Endocrinol Metab. 2006 Nov;291(5):E1051-8.
3. Compound Solutions. Introducing Metabolyte™: The Fifth Macronutrient for Metabolic Health. 2023.