Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
18
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.6 mg/kg bw/day
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
90
Modified dose descriptor starting point:
LOAEL
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.1 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
9
Dose descriptor:
other: LOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.1 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
9
Dose descriptor starting point:
other: LOAEL

Workers - Hazard for the eyes

Additional information - workers

 Acute dermal, local effects

At 2000 mg/kg in the acute dermal toxicity study in rats skin effects were observed.

 

Modification of starting point:

 Males: LOEL in mg/cm2= (0.26 x 2000 mg/kg bw)/25 cm2= 20.8 mg/cm2

Females: LOEL in mg/cm2= (0.17 x 2000 mg/kg bw)/18 cm2= 18.9 mg/cm2

 

The lowest value of 18.9 mg/cm2 is taken.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.6 mg/kg bw/day
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
LOAEL
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.26 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
15
Dose descriptor:
other: LOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.26 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
Overall assessment factor (AF):
15
Dose descriptor starting point:
other: LOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Acute dermal, local effects

at 2000 mg/kg in the acute dermal toxicity study in rats skin effects were observed.

 

Modification of starting point:

Males: LOEL in mg/cm2= (0.26 x 2000 mg/kg bw)/25 cm2= 20.8 mg/cm2

Females: LOEL in mg/cm2= (0.17 x 2000 mg/kg bw)/18 cm2= 18.9 mg/cm2

 

The lowest value of 18.9 mg/cm2is taken.