Registration Dossier
Registration Dossier
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EC number: 201-069-1 | CAS number: 77-92-9
Toxicological Summary
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
- Explanation for the modification of the dose descriptor starting point:
It is not considered appropriate to derive DN(M)ELs for this substance.
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- low hazard (no threshold derived)
Additional information - workers
The calculation of DNELs for citric acid is considered to be unnecessary because:
1. Citric acid is naturally present in common fruit and vegetables, which means there is a long history of human exposure; it has been estimated that maximum daily intake of citric acid can reach up to 500 mg/kg/day. (OECD SIDS 2001) In addition citric acid is an intermediate in the human metabolic pathway (WHO Food Additives, Series 5, 1973).
2. Citric acid is a permitted EU Food Additive and, according to the JECFA (Joint Expert Committee on Food Additives of the WHO/ FAO), these products may be used without limitation, according to Good Manufacturing Practice (JECFA, summary of evaluations, citric acid, 1973).
3. The US Food and Drug Administration also classifies citric acid as GRAS (Generally Recognized as Safe) food ingredients (www.accessdata.fda.gov,1977).
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:
- low hazard (no threshold derived)
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:
- low hazard (no threshold derived)
Additional information - General Population
The calculation of DNELs for citric acid and its salts is considered to be unnecessary because:
1. Citric acid is naturally present in common fruit and vegetables, which means there is a long history of human exposure; it has been estimated that maximum daily intake of citric acid can reach up to 500 mg/kg/day. (OECD SIDS 2001) In addition citric acid is an intermediate in the human metabolic pathway (WHO Food Additives, Series 5, 1973).
2. Citric acid is a permitted EU Food Additive and, according to the JECFA (Joint Expert Committee on Food Additives of the WHO/ FAO), these products may be used without limitation, according to Good Manufacturing Practice (JECFA, summary of evaluations, citric acid, 1973).
3. The US Food and Drug Administration also classifies citric acid as GRAS (Generally Recognized as Safe) food ingredients (www.accessdata.fda.gov,1977).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
