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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
60 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
60 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC

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:
3.9 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.9 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL

Workers - Hazard for the eyes

Additional information - workers

Workers:

Dermal exposure (workers):

The starting value is the NOAEL derived from the 90 day dermal study. The NOAEL was 390 mg/kg.

The assessment factor is calculated as follows:

Interspecies factor: 2.5

Allometric scaling: 4.0

Intra species factor for workers: 5

Exposure duration (subchronic – chronic): 2 

Total assessment factor: 100

 

Inhalation exposure (workers):

The starting value is the NOAEL derived from the chronic dog study. NOAEL was 300 mg/kg.

To convert this into a NAEC for workers the following calculation is applied:

300 /1.4 x 70 /10 m3 = 1500 (NAEC worker 8 h)

Interspecies factor: 2.5

Intra species factor for workers: 5

AF of 2 for route to route extrapolation from oral to inhalation

Total assessment factor: 25

 

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
15 mg/m³
DNEL related information
Overall assessment factor (AF):
50
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
15 mg/m³
DNEL related information
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.57 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
35
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.57 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
35
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

Oral exposure (general population):

The starting value is the NOAEL derived from the chronic oral study. The NOAEL was 300 mg/kg.

The assessment factor is calculated as follows:

Interspecies factor: 2.5

Allometric scaling: 1.4

Intra species factor for general population: 10 

Total assessment factor: 35

 

 

Dermal exposure (general population):

The starting value is the NOAEL derived from the 90 day dermal study. The NOAEL was 390 mg/kg.

The assessment factor is calculated as follows:

Interspecies factor: 2.5

Allometric scaling: 4.0

Intra species factor for general population: 10

Exposure duration (subchronic – chronic): 2 

Total assessment factor: 200

 

 

 

Inhalation exposure (general population):

 

The starting value is the NOAEL derived from the chronic dog study. NOAEL was 300 mg/kg.

To convert this into a NAEC for workers the following calculation is applied:

300 /1.4 x 70 /50 m3 = 750 (NAEC general population 24 h)

Interspecies factor: 2.5

Intra species factor for general population: 10

AF of 2 for route to route extrapolation from oral to inhalation

Total assessment factor: 50