Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Justifications for a read-across from data of fumaric acid to succinic acid:

# Fumaric acid (FA) and succinic acid (SA) are chemically analogous substances distinguished only by a double bond in the fumaric acid.

# Both anions of the substances, succinate and fumarate, are naturally occurring substances that are elements of the citric acid cycle. Fumarate is the successor of succinate in this cycle.

# Both substances have similar characteristics: Melting temperature: FA: 287 °C; SA: 185 °C. Water solubility: FA: 7 g/L; SA: 83 g/L. Partition coefficient (logPow): FA: 0.46; SA: -059. Acute toxicity (LD50oral,rat): FA: 9300 mg/kg; SA: >6700 mg/kg. Eye irritation: FA: Xi R36; SA: Xi R41.

# DEREK, a knowledge-based systemt o detect toxicity alerts, which is repeatedly cited in the Guidance on information requirements and chemical safety assessment, Chapter R.6 "QSARs and grouping of chemicals" was applied to succinic acid and also to fumaric acid. DEREK did not find any substructures in its database that fired an alert that would predict succinic acid to be toxic or reproductive toxic. Also for the chemically analogous substance fumaric acid no indications for toxicity were detected.

Short description of key information:
Succinic acid: Negative data from two Ames tests (1984, 2001), two in vitro chromosome aberration tests with Chinese hamster fibroblasts (1984, 2001), one test on clastogenic effects on primary root tips of Vicia faba (1984) and one Ames like investigation (plate test and suspension assay, 1975).
Fumaric acid (read-across): Negative data from two Ames tests (1988, 2006) and two Mouse lymphoma tests (2006, 2010).

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Negative results were obtained in all in vitro tests. No classification is derived from the results of these tests.