Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.73 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12.5
Modified dose descriptor starting point:
NOAEC
Value:
71.6 mg/m³
Explanation for the modification of the dose descriptor starting point:
The NOAEL is based on Aluminum and thus it was converted to the relevant dose for the dossier compound, BPyrAl2Cl7, taking the molar masses into account: i.e.: NOAEL = 5 mg Al/kg bw (Molar mass = 27 g/mol); Molar Mass of BPyrAl2Cl7 / Molar Mass of Al / Molar Mass Al equivalents = 8,12; NOAEL (corrected) = 5 mg Al /kg bw *8.12 = 40.6 mg BPyrAl2Cl7 / kg bw. Taking a standard body weight of 70 kg/person, a standard breathing volume of 10 m3 / per 8 hours shift (worker) and an AF of 4 for the allometric scaling (default rat - human) into account yields a NAEC human of 71 mg/m3 as point of departure.
AF for dose response relationship:
1
Justification:
Standard factor for using NOAEL as starting point
AF for differences in duration of exposure:
1
Justification:
Standard Factor for long term studies (full lifecycle covering the most sensitive life stages)
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable for oral to inhalation extrapolation [ECHA default, Chapter R8 guidance].
AF for other interspecies differences:
2.5
Justification:
[ECHA default, Chapter R8 guidance].
AF for intraspecies differences:
5
Justification:
[ECHA default, Chapter R8 guidance].
AF for the quality of the whole database:
1
Justification:
Lowest NOAEL of any degradation product was taken into account
AF for remaining uncertainties:
1
Justification:
Lowest NOAEL of any degradation product was taken into account
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:
high hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Route of original study:
Dermal
DNEL related information
Explanation for the modification of the dose descriptor starting point:

The test material is corrosive, therefore no threshold is derived.

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:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population