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Registration Dossier
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EC number: 208-863-7 | CAS number: 544-17-2
Endpoint summary
Administrative data
Description of key information
A correlation between developmental toxicity (spontaneous abortion, neural tube defects) and low folate levels is seen in humans. Formate could further decrease folate levels, but the increment attributable to formates is considered to be low. Experimental animals have generally higher folate levels. They cope therefore better with formate, and developmental toxicity is not seen in experimental studies.
Additional information
Epidemiological studies from Germany, Sweden, and the US suggest a correlation between low folate levels in humans and in food, and increased incidences of spontaneous abortion and neural tube defects (spina bifida). The incidences decreased by 25-30% in the US after implementation of a folate supplementation program (George, 2002; Erickson, 2002; BfR, 2005.
No effect was seen with sodium formate in reproduction studies using rats and rabbits exposed to formate. In humans, the folate levels are apparently insufficient in the early stages of pregnancy. Exposure to formate would further lower formate levels and, therefore, increase the risk for developmental toxicity. The risk that is attributable to formate is considered to be low. The correlation appears to be plausible, but the available information is considered to be insufficient for classification. Minimisation of the formate exposure of the general population is, however, reasonable, and this may have been the driving force when formic acid and formate salts were removed from the European list of authorized food preservatives, since suitable alternative preservatives are available.
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