Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
141 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:
141 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:
20 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:
20 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

When calculating DNELs according to Chapter R.8 of Guidance on Information Requirements and Chemical Safety Assessment (2008) the overall AFs for oral and dermal repeated dose toxicity are 200 (for general population) and 100 (for workers). This is established by taking into account an interspecies factor of 10 (4 for metabolic rate differences × 2.5 for remaining differences), an intraspecies factor of 10 (for general population) and 5 (for workers), and a further factor of 2 to allow for subchronic to chronic extrapolation. The overall AFs for inhalation repeated dose toxicity which should be applied to the corrected NOAECs (2,000 mg/kg bw/day/0.38 m3/kg/day × 6.7 m3/10 m3 and 2,000 mg/kg bw/day/1.15 m3/kg/day) are 25 (for workers) and 50 (for general population) respectively. This is established by taking into account an interspecies factor of 2.5 (for remaining differences), an intraspecies factor of 5 (for workers) and 10 (for general population), and a further factor of 2 to allow for subchronic to chronic extrapolation.

The overall AFs for developmental toxicity are 100 (for general population) and 50 (for workers). This is established by taking into account an interspecies factor of 10 (4 for metabolic rate differences × 2.5 for remaining differences) and an intraspecies factor of 10 (for general population) and 5 (for workers).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
34 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
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
34 mg/m³
Most sensitive endpoint:
repeated dose toxicity
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:
10 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
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
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:
10 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
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

When calculating DNELs according to Chapter R.8 of Guidance on Information Requirements and Chemical Safety Assessment (2008) the overall AFs for oral and dermal repeated dose toxicity are 200 (for general population) and 100 (for workers). This is established by taking into account an interspecies factor of 10 (4 for metabolic rate differences × 2.5 for remaining differences), an intraspecies factor of 10 (for general population) and 5 (for workers), and a further factor of 2 to allow for subchronic to chronic extrapolation. The overall AFs for inhalation repeated dose toxicity which should be applied to the corrected NOAECs (2,000 mg/kg bw/day/0.38 m3/kg/day × 6.7 m3/10 m3 and 2,000 mg/kg bw/day/1.15 m3/kg/day) are 25 (for workers) and 50 (for general population) respectively. This is established by taking into account an interspecies factor of 2.5 (for remaining differences), an intraspecies factor of 5 (for workers) and 10 (for general population), and a further factor of 2 to allow for subchronic to chronic extrapolation.

The overall AFs for developmental toxicity are 100 (for general population) and 50 (for workers). This is established by taking into account an interspecies factor of 10 (4 for metabolic rate differences × 2.5 for remaining differences) and an intraspecies factor of 10 (for general population) and 5 (for workers).