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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
1.47 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
Value:
1.47 mg/m³
Value:
1.47 mg/m³
Explanation for the modification of the dose descriptor starting point:

DNEL Derivation

The starting point for the DNEL derivation was from an OECD 422 28-day repeat dose/reproductive screen, where the NOAEL was 500 mg/kg/day, the highest dose tested.

 

The derivation of theWorker long-term systemic inhalation DNELwas as follows.  

- NOAEL of 500 mg/kg/day. Correct to an inhalation dose with a factor of 0.38 m3/kg. 500/0.38 = 1315 mg/m3. 

- The value is then corrected for 50% bioavailability by the oral route. 1315 mg/m3/2 = 657.89 mg/m3.

- The value is then corrected for increased respiration for light work.  657*0.67 = 440.79.

- This value is then dived by the adjustment factor of 300 for a final DNEL of 1.47. The adjustment factors are as follows:

 

               Intraspecies:                   5

               Allometric scaling            4

               Interspecies                      2.5

               Subacute to chronic       6

AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
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:
DNEL (Derived No Effect Level)
Value:
1.67 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
Value:
1.67 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1.67 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

DNEL Derivation

The derivation of theWorker long-term systemic Dermal DNELwas as follows.  

- NOAEL of 500 mg/kg/day. Divide by a total adjustment factor of 300 for a DNEL of 1.67 mg/kg

 

- The adjustment factors are as follows:

 

               

               Intraspecies:                   5

               Allometric scaling            4

               Interspecies                      2.5

               Subacute to chronic       6

AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.36 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
0.36 mg/m³
Value:
0.36 mg/m³
Explanation for the modification of the dose descriptor starting point:

DNEL Derivation

The derivation of theGeneral Population long-term systemic inhalation DNELwas as follows.  

- NOAEL of 500 mg/kg/day. Correct to an inhalation dose with a factor of 1.15 m3/kg. 500/1.15 = 474 mg/m3. 

- The value is then corrected for 50% bioavailability by the oral route. 434 mg/m3/2 = 217 mg/m3.

- This value is then dived by the adjustment factor of 600 for a final DNEL of 0.36 The adjustment factors are as follows:

 

               Intraspecies:                   10

               Allometric scaling            4

               Interspecies                      2.5

               Subacute to chronic       6

AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
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:
DNEL (Derived No Effect Level)
Value:
0.83 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
0.83 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
0.83 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

DNEL Derivation

The derivation of theGeneral Population long-term systemic Oral/Dermal DNELwas as follows.  

- NOAEL of 500 mg/kg/day. 

 

- Divide by a total adjustment factor of 300 for a DNEL of 0.83 mg/kg

 

- The adjustment factors are as follows:

 

               

               Intraspecies:                   10

               Allometric scaling            4

               Interspecies                      2.5

               Subacute to chronic       6

AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.83 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Dose descriptor starting point:
NOAEL
Value:
0.83 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
0.83 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

DNEL Derivation

The derivation of theGeneral Population long-term systemic Oral/Dermal DNELwas as follows.  

- NOAEL of 500 mg/kg/day. 

 

- Divide by a total adjustment factor of 300 for a DNEL of 0.83 mg/kg

 

- The adjustment factors are as follows:

 

               

               Intraspecies:                   10

               Allometric scaling            4

               Interspecies                      2.5

               Subacute to chronic       6

AF for differences in duration of exposure:
6
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population