Registration Dossier
Registration Dossier
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EC number: 208-901-2 | CAS number: 546-46-3
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.25 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 2
- Explanation for the modification of the dose descriptor starting point:
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
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- DNEL (Derived No Effect Level)
- Value:
- 3.57 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 2
- Explanation for the modification of the dose descriptor starting point:
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
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
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.
Furthermore, 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.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
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.
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