Registration Dossier

Diss Factsheets

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

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:
no hazard identified
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)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

  Effect Route DNEL Dose Descriptor Modified Dose Descriptor and Assessment Factors
Acute Exposure Systemic Dermal (a)    
Inhalation (a)    
Local Dermal (b)    
Inhalation (a)    
Long-Term Exposure Systemic  Dermal (a)    
Inhalation (a)    
Local Dermal (b)    
Inhalation (a)    

a) No hazard identified for this route (data available)

b) The data do not allow setting a DNEL.

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:
no hazard identified
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:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
19 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: REACH guidance with modification of some factors
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

  Effect Route DNEL Dose Descriptor Modified Dose Descriptor and Assessment Factors
Acute Exposure Systemic Dermal (a)    
Inhalation (a)    
Local Dermal (b)    
Inhalation (a)    
Long-Term Exposure Systemic  Dermal (a)    
Inhalation (a)    
Oral 19 mg/kg/24h 750 mg/kg (NOAEL – 21-week daily oral gavage study based on significant decrease in body weight for females (deemed biologically meaningful) No modification of dose descriptor was needed since study incorporated daily exposures. A total assessment factor of 40 was applied for inter- and intraspecies differences and for overall duration of exposure. 
Local Dermal (b)    
Inhalation (a)    

a) No hazard identified for this route (data available)

b) The data do not allow setting a DNEL.

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