Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: - | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.49 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 12.3 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 10 mg/kg bw /day was derived based on a subchronic oral repeated dose toxicity study in rats available for the source substance Fe(Na)EDDHA (Novartis Crop Protection AG, 1998). This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/0.38 m³/kg/day, the absorption rates (based on the ECHA Guidance R.8 the inhalative absorption is considered to be higher by a factor of 2 than the oral absorption as worst-case assumption) and the standard respiratory volume in humans/ worker respiratory volume (6.7 m³ (8 h) / 10 m³ (8 h)) and the correction factor between human and experimental exposure conditions of workers (5 working days vs. 7 days continuous exposure) of 1.4.
NOAEC corrected = 10 mg/kg bw/day * 1/0.38 m³/kg/day * 0.5 * (6.7 m³/10 m³) * 1.4 = 12.3 mg/m³
- Justification:
- Default
- Justification:
- Default for sub-chronic to chronic
- Justification:
- No allomoetric scaling needed extrapolating oral-to-inhalation
- Justification:
- Default
- Justification:
- Default for workers
- Justification:
- sufficient quality of the database
- Justification:
- no remaining uncertainties
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:
- DNEL (Derived No Effect Level)
- Value:
- 1.4 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 140 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 10 mg/kg bw /day was derived based on a subchronic oral repeated dose toxicity study in rats available for the source substance Fe(Na)EDDHA (Novartis Crop Protection AG, 1998). This value was converted into the corrected dermal NOAEL taking into account the absorption rates (based on the physicochemical properties and toxicological profile, an oral absorption rate of 100 %, and a dermal absorption rate of 10 % are assumed as worst-case assumptions) and the correction factor between human and experimental exposure conditions of workers (5 working days vs. 7 days continuous exposure) of 1.4.
NOAEL corrected = 10 mg/kg bw/day * 100/10 * 1.4 = 140 mg/kg bw/day
- Justification:
- Default
- Justification:
- Default for sub-chronic to chronic
- Justification:
- Default for rats
- Justification:
- Default
- Justification:
- Default for workers
- Justification:
- sufficient quality of the database
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 87 µg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4.35 mg/m³
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 10 mg/kg bw /day was derived based on a subchronic oral repeated dose toxicity study in rats available for the source substance Fe(Na)EDDHA (Novartis Crop Protection AG, 1998). This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/1.15 m³/kg/day and the absorption rates (based on the ECHA Guidance R.8 the inhalative absorption is considered to be higher by a factor of 2 than the oral absorption as worst-case assumption).
NOAEC corrected = 10 mg/kg bw/day * 1/1.15 m³/kg/day * 0.5 = 4.3 mg/m³
- Justification:
- Default
- Justification:
- Default for sub-chronic to chronic
- Justification:
- not needed for inhalation endpoint as already included in the corrected starting point
- Justification:
- Default
- Justification:
- Default for general population
- Justification:
- sufficient quality of the database
- Justification:
- no remaining uncertainties
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 100 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 10 mg/kg bw /day was derived based on a subchronic oral repeated dose toxicity study in rats available for the source substance Fe(Na)EDDHA (Novartis Crop Protection AG, 1998). This value was converted into the corrected dermal NOAEL taking into account the absorption rates (based on the physicochemical properties and toxicological profile, an oral absorption rate of 100 %, and a dermal absorption rate of 10 % are assumed as worst-case assumptions).
NOAEL corrected = 10 mg/kg bw/day * 100/10 = 100 mg/kg bw/day
- Justification:
- Default
- Justification:
- Default for sub-chronic to chronic
- Justification:
- Default for rats
- Justification:
- Default
- Justification:
- Default for general population
- Justification:
- sufficient quality of the database
- Justification:
- No remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 50 µg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 10 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
A NOAEL of 10 mg/kg bw /day was derived based on a subchronic oral repeated dose toxicity study in rats available for the source substance Fe(Na)EDDHA (Novartis Crop Protection AG, 1998). This value does not have to be corrected as the oral absorption rate of rats and humans are considered to be identical (100 % as worst-case assumption).
- Justification:
- Default
- Justification:
- default for sub-chronic to chronic
- Justification:
- Default for rats
- Justification:
- Default
- Justification:
- Default for general information
- Justification:
- sufficient quality of the database
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
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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