Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
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):
300
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
Value:
19.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEC

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
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:
DNEL (Derived No Effect Level)
Value:
19.5 mg/cm²
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.8 % in mixture (weight basis)
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Dose descriptor starting point:
other: NOAEL

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 aforeseeablepotential for high peak exposures.

NOAEL(C)swere corrected based on the28-day study in which male and female rats were dosedorallywith BDP, resulting in NOAEL 1,000mg/kg bw/day, byassuming 83%, 20% and 100% absorption by the oral, dermal and inhalation route respectively.

When calculation of DNELs, according toChapter R.8ofGuidance 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 intra-species factor of 5, and a further factor of 6 to allow for sub-acute to chronic extrapolation. The overall AF for inhalation repeated dose toxicity which should be applied to the corrected NOAEC (1,000 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 intra-species factor of 5, and a further factor of 6 to allow for sub-acute to chronic extrapolation.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.8 ng/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
600
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):
600
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
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

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

When calculation of DNELs, according toChapter R.8ofGuidance 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 intra-species factor of 10, and a further factor of 6 to allow for sub-acute to chronic extrapolation. The overall AF for inhalation repeated dose toxicity which should be applied to the corrected NOAEC (1,000 mg/kg bw/day//kg/day × 0.83) is 150. This is established by taking into account an interspecies factor of 2.5 (for sensitivity differences), an intra-species factor of 10, and a further factor of 6 to allow for sub-acute to chronic extrapolation.