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Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

Due to its physico-chemical properties, the physiological role of its constituent ions, and its toxicological properties, exposure to NaHCO3 is considered not to induce systemic effects. This is supported by absence of any observed systemic effects in performed developmental toxicity studies, and the low acute toxicity observed. Furthermore, sodium bicarbonate rapidly dissociates into Na+ (sodium) and HCO3- (bicarbonate), when in contact with any body fluid. Sodium is an essential nutrient, present in vertebrates in relatively high levels under physiological conditions. Bicarbonate is a component of the extracellular buffer in the blood and the interstitial fluid of vertebrates, i.e. the bicarbonate buffer system. The uptake of sodium, via exposure to sodium bicarbonate via any route, is expected to be much less than the uptake of sodium via food (recommended daily dietary intake has been reported in the range of 3.1-6.0 g). In addition, sodium bicarbonate is regarded as "GRAS" by the FDA, and the EU has accepted the use as food additive and feed ingredient. The Joint FAO/WHO Expert Committee on Food Additives considered it not necessary to derive an Acceptable Daily Intake (ADI) for the food additive sodium bicarbonate (JECFA, 1965).

DNEL Long-term

For the determination of a DNEL long-term, no reliable repeated-dose studies were available (from which normally a critical effect NOAEL is used to derive a DNEL). After assessment of the physico-chemical, toxicokinetic and the normal physiological role of NaHCO3, it is concluded that these studies are not required. Therefore, the DNEL long term cannot be established and is considered not necessary.

DNEL Acute

A DNEL acute should be established for substances if an acute toxicity hazard (leading to classification and labelling) has been identified and a potential for high peak exposures exists. Since NaHCO3 has not been classified for any toxicological property, there is no need to look at the exposure scenarios. In addition, in the acute studies (oral and inhalation) no signs for local irritation effects were noted, nor were any other critical systemic effects described (LD50 derived were close or above the highest given doses). Therefore, sodium bicarbonate is considered to be of no toxicological concern, which renders a DNEL derivation not necessary.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Due to its physico-chemical properties, the physiological role of its constituent ions, and its toxicological properties, exposure to NaHCO3is considered not to induce systemic effects. This is supported by absence of any observed systemic effects in performed developmental toxicity studies, and the low acute toxicity observed. Furthermore, sodium bicarbonate rapidly dissociates into Na+ (sodium) and HCO3- (bicarbonate), when in contact with any body fluid. Sodium is an essential nutrient, present in vertebrates in relatively high levels under physiological conditions. Bicarbonate is a component of the extracellular buffer in the blood and the interstitial fluid of vertebrates, i.e. the bicarbonate buffer system. The uptake of sodium, via exposure to sodium bicarbonate via any route, is expected to be much less than the uptake of sodium via food (recommended daily dietary intake has been reported in the range of 3.1-6.0 g). In addition, sodium bicarbonate is regarded as "GRAS" by the FDA, and the EU has accepted the use as food additive and feed ingredient. The Joint FAO/WHO Expert Committee on Food Additives considered it not necessary to derive an Acceptable Daily Intake (ADI) for the food additive sodium bicarbonate (JECFA, 1965).

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