Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

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

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

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.