Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
19.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
19.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
Acute/short term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.8 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Additional information - workers

The inhalation DNEL for acute toxicity is unnecessary to be derived because no acute toxicity hazard (leading to C&L) has been identified and there is not a potential for high peak exposures. For the inhalation, dermal and oral exposure routes, ‘short-term’ exposures will be assessed using the long-term DNELs.

In relation to repeated dose toxicity, a NOAEL of 1000 mg/kg bw/day was derived from a 28-day study in which male and female rats were dosed with BDP at concentrations of up to 1000 mg/kg bw/day (assuming 83%, 20% and 100% absorption by the oral, dermal and inhalation route respectively).

In line with Guidance on Information Requirements and Chemical Safety Assessment (2008), the overall AF for oral and dermal repeated dose toxicity is 300. This is established by taking into account an interspecies factor of 10 (4 for metabolic size differences × 2.5 for sensitivity differences), an intraspecies factor of 5, and a further factor of 6 to allow for subacute to chronic extrapolation. The overall AF for inhalation repeated dose toxicity which should be applied to the corrected NOAEC (1000 mg/kg bw/day/3/kg/day×0.83 ×6.7 m3/3) is 75. This is established by taking into account an interspecies factor of 2.5 (for sensitivity differences), an intraspecies factor of 5, and a further factor of 6 to allow for subacute to chronic extrapolation.

In line with Guidance on Information Requirements and Chemical Safety Assessment (2008), the overall AF forreproductivetoxicity is50. This is established by taking into account an interspecies factor of 10 (4 for metabolic size differences × 2.5 for sensitivity differences)andan intraspecies factor of 5.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC

Local effects

Long term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
Acute/short term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.9 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.9 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.6 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL

General Population - Hazard for the eyes

Additional information - General Population

The inhalation DNEL for acute toxicity is unnecessary to be derived because no acute toxicity hazard (leading to C&L) has been identified and there is not a potential for high peak exposures. For the inhalation, dermal and oral exposure routes, ‘short-term’ exposures will be assessed using the long-term DNELs.

In relation to repeated dose toxicity, a NOAEL of 1000 mg/kg bw/day was derived from a 28-day study in which male and female rats were dosed with BDP at concentrations of up to 1000 mg/kg bw/day (assuming 83%, 20% and 100% absorption by the oral, dermal and inhalation route respectively).

In line with Guidance on Information Requirements and Chemical Safety Assessment (2008), the overall AF for oral and dermal repeated dose toxicity is 600. This is established by taking into account an interspecies factor of 10 (4 for metabolic size differences × 2.5 for sensitivity differences), an intraspecies factor of 10, and a further factor of 6 to allow for subacute to chronic extrapolation. The overall AF for inhalation repeated dose toxicity which should be applied to the corrected NOAEC (1000 mg/kg bw/day/3/kg/day×0.83) is 150. This is established by taking into account an interspecies factor of 2.5 (for sensitivity differences), an intraspecies factor of 10, and a further factor of 6 to allow for subacute to chronic extrapolation.

In line with Guidance on Information Requirements and Chemical Safety Assessment (2008), the overall AF forreproductivetoxicity is100. This is established by taking into account an interspecies factor of 10 (4 for metabolic size differences × 2.5 for sensitivity differences)andan intraspecies factor of 10.