Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.82 mg/m³
Most sensitive endpoint:
repeated dose toxicity
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

Based on data available, DNELs for repeated dose toxicity (based on kidney and liver toxicity and haematological alteration) and reproductive toxicity (based on the fertility impairment as the sensitive endpoint) were calculated.

Despite the fact that DNELs calculated from reproductive toxicity screening study dose descriptors were lower than DNELs derived from repeated dose toxicity study, limit values based on repeated dose toxicity study were chosen as critical DNELs. This decision was based on the fact that uncertainty in the extrapolation of experimental data to the real human exposure situation – expressed in the form of assessment factors – from repeated dose toxicity study was much lower, if compared to uncertainty from reproductive toxicity screening study.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.7 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
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:
0.4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
400
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:
0.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
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

Based on data available, DNELs for repeated dose toxicity (based on kidney and liver toxicity and haematological alteration) and reproductive toxicity (based on the fertility impairment as the sensitive endpoint) were calculated.

Despite the fact that DNELs calculated from reproductive toxicity screening study dose descriptors were lower than DNELs derived from repeated dose toxicity study, limit values based on repeated dose toxicity study were chosen as critical DNELs. This decision was based on the fact that uncertainty in the extrapolation of experimental data to the real human exposure situation – expressed in the form of assessment factors – from repeated dose toxicity study was much lower, if compared to uncertainty from reproductive toxicity screening study.