Registration Dossier
Registration Dossier
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EC number: 224-675-8 | CAS number: 4443-26-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.1 mg/m³
- Most sensitive endpoint:
- effect on fertility
DNEL related information
- Overall assessment factor (AF):
- 25
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.9 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
DNEL related information
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Systemic long-term DNEL for dermal contact:
Starting point: NOAEL from reprotox study with 90d exposure duration: NOAEL = 30 mg/kg bw/d.
Correcting of the starting point: correct for difference in absorption between dermal and oral route and for difference between absorption through rat or human skin: corrected NOAEL = oral rat NOAEL * (ABS oral-rat / ABS dermal-human)
-- ABS derm-human = ca. 30% (from in vitro skin absorption study)
-- ABS oral-rat = ca. 90% (from different ADME studies in rats)
Corrected dose descriptor: corrected NOAEL = 30 mg/kg bw/d * (0.90/0.30) = 90 mg/kg bw/d
Assessment factors:
-- Allometric scaling (including "non-calorimetric differences"): 4 * 2,5 (ECHA default)
-- Intra-species differences: 5 (ECHA default for workers)
-- Duration of exposure: 2 (ECHA default for sub-chronic to chronic)
-- Dose-response relationship: 1 (ECHA default)
-- Quality of whole database: 1 (ECHA default)
Overall assessment factor: 100
DNEL: 90 mg/kg bw/d / 100 = 0.9 mg/kg bw/d
Systemic long-term DNEL for inhalation route:
Starting point: NOAEL from reprotox study with 90d exposure duration: NOAEL = 30 mg/kg bw/d.
Correcting of the starting point: convert NOAEL to NOAEC:
NOAEC = [NOAEL / 0.38 m3/kg bw] * [6.7 m3 / 10 m3] = 52.90 mg/m3
Corrected dose descriptor: corrected NOAEC = [NOAEL / 0.38 m3/kg bw] * [6.7 m3/ 10 m3] = 52.90 mg/m3
Assessment factors:
-- Oral-to-inhalation extrapolation: 1 (deviation from ECHA default due to the fact that in the toxicokinetics studies it is shown that oral absorption is high (> 90%) and fast).
-- Allometric scaling (only "non-calorimetric differences"): 2,5 (ECHA default)
-- Intra-species differences: 5 (ECHA default for workers)
-- Duration of exposure: 2 (ECHA default for sub-chronic to chronic)
-- Dose-response relationship: 1 (ECHA default)
-- Quality of whole database: 1 (ECHA default)
Overall assessment factor: 25
DNEL: 52.90 mg/m3 / 25 = 2.1 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/m³
- Most sensitive endpoint:
- effect on fertility
DNEL related information
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.45 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.15 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
DNEL related information
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Systemic long-term DNEL for dermal contact:
Starting point: NOAEL from reprotox study with 90d exposure duration: NOAEL = 30 mg/kg bw/d.
Correcting of the starting point: correct for difference in absorption between dermal and oral route and for difference between absorption through rat or human skin: corrected NOAEL = oral rat NOAEL * (ABS oral-rat / ABS dermal-human)
-- ABS derm-human = ca. 30% (from in vitro skin absorption study)
-- ABS oral-rat = ca. 90% (from different ADME studies in rats)
Corrected dose descriptor: corrected NOAEL = 30 mg/kg bw/d * (0.90/0.30) = 90 mg/kg bw/d
Assessment factors:
-- Allometric scaling (including "non-calorimetric differences"): 4 * 2,5 (ECHA default)
-- Intra-species differences: 10 (ECHA default for general population)
-- Duration of exposure: 2 (ECHA default for sub-chronic to chronic)
-- Dose-response relationship: 1 (ECHA default)
-- Quality of whole database: 1 (ECHA default)
Overall assessment factor: 200
DNEL: 90 mg/kg bw/d / 200 = 0.45 mg/kg bw/d
Systemic long-term DNEL for inhalation route:
Starting point: NOAEL from reprotox study with 90d exposure duration: NOAEL = 30 mg/kg bw/d.
Correcting of the starting point: convert NOAEL to NOAEC:
NOAEC = [NOAEL / 1.15 m3/kg bw] = 26.09 mg/m3
Corrected dose descriptor: corrected NOAEC = [NOAEL / 1.15 m3/kg bw] = 26.09 mg/m3
Assessment factors:
-- Oral-to-inhalation extrapolation: 1 (deviation from ECHA default due to the fact that in the toxicokinetics studies it is shown that oral absorption is high (> 90%) and fast)
-- Allometric scaling (only "non-calorimetric differences"): 2,5 (ECHA default)
-- Intra-species differences: 10 (ECHA default for general population)
-- Duration of exposure: 2 (ECHA default for sub-chronic to chronic)
-- Dose-response relationship: 1 (ECHA default)
-- Quality of whole database: 1 (ECHA default)
Overall assessment factor: 50
DNEL: 26.09 mg/m3 / 50 = 0.5 mg/m3
Systemic long-term DNEL for oral route:
Starting point: NOAEL from reprotox study with 90d exposure duration: NOAEL = 30 mg/kg bw/d.
Correcting of the starting point: not required
Assessment factors:
-- Allometric scaling (including "non-calorimetric differences"): 4 * 2,5 (ECHA default)
-- Intra-species differences: 10 (ECHA default for general population)
-- Duration of exposure: 2 (ECHA default for sub-chronic to chronic)
-- Dose-response relationship: 1 (ECHA default)
-- Quality of whole database: 1 (ECHA default)
Overall assessment factor: 200
DNEL: 30 mg/kg bw/d / 200 = 0.150 mg/kg bw/d
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