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EC number: 208-901-2
CAS number: 546-46-3
Starting point NOAEL 50 mg Zn 2+ /person/day from Human study
Assessment factor for route to route extrapolation oral to dermal: 2
(40% absorption inhalation/ 20% absorption oral)
NOAEL: 50 x 0.5= 25 mg Zn 2+ /person/day
Conversion to inhalative volume Worker 10 m3/ person (8 h, light
activities) 25 / 10 = 2.5 mg Zn 2+/m3
Starting point NOAEL 50 mg Zn 2+/person/day from Human study
Assessment factor for route to route extrapolation oral to dermal: 0.1 (2% absorption dermal/ 20% absorption oral)
NOAEL: 50 x 10 = 500 mg Zn 2+ /person/day
Conversion to mg/kg bw/d: 70 kg 500/70 = 7.14 mg Zn 2+/kg bw/d
The exposure of trizinc dicitrate is not expected to
differ significantly from the exposure to citric acid and zinc ions
separately in an aqueous matrix (oral and inhalation) and once absorbed.
While the dermal absorption of trizinc dicitrate is expected to be
neglegible due to the physico-chemical properties of the substance,
namely the low LogKow (<1). Therefore the toxicity of trizinc dicitrate
should be based on citric acid and zinc separately.
citric acid is a central constituent in cell metabolism and used as food
additive with an ADI “not quantified”. Therefore, it is not thought
appropriate or necessary to derive DNELs for this substance. Additional
information can be found in the Chemical Safety Report for the Citrates
Category (2010). Human data from Zinc supplement use are used as
starting point for DNEL derivation, in line with assessment performed by
EFSA and other risk assessment bodies like German MAK committee.
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.
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