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Key value for chemical safety assessment

Effects on fertility

Additional information

Several pieces of information give a sufficient evidence that succinic acid need not to be investigated further for reproductive toxicity.

# Low toxicity and no effects on reproductive organs in a subchronic and a long-term toxicity study with administration of the monosodium salt of succinic acid.

# Read-across to the results with the chemical analogous substance fumaric acid gave no evidence of reproductive or developmental toxicity.

# DEREK, a knowledge-based systemr epeatedly 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 the chemically analogous substances fumaric acid and maleic 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 substances fumaric acid and maleic acid no indications for toxicity were detected.

# Succinic acid is a food additive on the Everything Added to Food in the United States (EAFUS) list and on the Generally Recognized As Safe (GRAS) list of the US FDA.

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:
No indications for a reproductive or developmental toxicity of succinic acid are available.

Effects on developmental toxicity

Description of key information
No indications for a reproductive or developmental toxicity of succinic acid are available.
Additional information

Several pieces of information give a sufficient evidence that succinic acid need not to be investigated further for reproductive toxicity.

# Low toxicity and no effects on reproductive organs in a subchronic and a long-term toxicity study with administration of the monosodium salt of succinic acid.

# The developmental effects of succinic acid and sodium succinate were investigated in chick embryos and that of fumaric acid in rats, guinea pigs and Drosophila cells, without detecting adverse effects.

# DEREK, a knowledge-based systemr epeatedly 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 the chemically analogous substances fumaric acid and maleic 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 substances fumaric acid and maleic acid no indications for toxicity were detected.

# Succinic acid is a food additive on the Everything Added to Food in the United States (EAFUS) list and on the Generally Recognized As Safe GRAS listof the US FDA.

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 to 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.

Justifications for a read-across from data of sodium succinate hexahydrate to succinic acid:

The read-across from the succinate to succinic acid seems justified, as both are well water soluble and will be in the ionised form in dilute aqueous solutions, to give the same anion.

Justification for classification or non-classification

No indications for a reproductive or developmental toxicity of succinic acid are available. No classification is therefore required.

Additional information

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