Registration Dossier

Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
other: report
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The data was obtained from a collection of reliable data which has been subject to peer-review and in which the original data sources are traceable.

Data source

Reference
Reference Type:
secondary source
Title:
Unnamed
Year:
2010

Materials and methods

Principles of method if other than guideline:
The data available on citric acid and the citrate salts has been assembled into one report.

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
Citric acid is a metabolic intermediate vital to the TCA respiration pathway found in all animal and plant cells. There is little evience that citric acid and the citrate salts have deleterious effects, even in large doses. Indeed there is some support for the fact that citric acid in the human diet is favourable by inhibiting the formation of calcium oxalate kidney and bladder stones. This statement is applicable to the citrate salts since once absorbed citrate salts will dissociate into citric acid and their counter-ion.