Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
26.3 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: assessment based on the IOEL for hydrochloric acid (8 mg/m3 (8 h TWA) in Commission Directive 2000/39/EC).
Overall assessment factor (AF):
1
Dose descriptor:
other: based on Occupational Exposure Limit (OEL) for HCl (8 h TWA).
Value:
8 mg/m³
AF for dose response relationship:
1
Justification:
Not required as assessment based on OEL.
AF for differences in duration of exposure:
1
Justification:
Not required as assessment based on OEL.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required as assessment based on OEL.
AF for other interspecies differences:
1
Justification:
Not required as assessment based on OEL.
AF for intraspecies differences:
1
Justification:
Not required as assessment based on OEL.
AF for the quality of the whole database:
1
Justification:
Not required as assessment based on OEL.
AF for remaining uncertainties:
1
Justification:
Not required as assessment based on OEL.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
49.3 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: based on the indicative Short-Term Exposure Limit (STEL) for HCl.
Overall assessment factor (AF):
1
Dose descriptor starting point:
other: based on the STEL for HCl.
Value:
15 mg/m³
AF for dose response relationship:
1
Justification:
Not required as assessment based on STEL.
AF for interspecies differences (allometric scaling):
1
Justification:
Not required as assessment based on STEL.
AF for other interspecies differences:
1
Justification:
Not required as assessment based on STEL.
AF for intraspecies differences:
1
Justification:
Not required as assessment based on STEL.
AF for the quality of the whole database:
1
Justification:
Not required as assessment based on STEL.
AF for remaining uncertainties:
1
Justification:
Not required as assessment based on STEL.

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
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
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

Although a hazard assessment has been conducted for the respective endpoints for the general population, there is no potential for exposure of consumers via any route to trichloro(hexadecyl)silane.