Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.353 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEL
DNEL value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
DNEL value:
53 mg/m³
Explanation for the modification of the dose descriptor starting point:

Lack of route-specific data

AF for dose response relationship:
1
Justification:
Reliable dose-response data used
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling already considered in dose descriptor conversion (route-to-route extrapolation)
AF for other interspecies differences:
2.5
Justification:
default for "other interspecies difference"
AF for intraspecies differences:
5
Justification:
Worker
AF for the quality of the whole database:
1
Justification:
Good quality data-set
AF for remaining uncertainties:
2
Justification:
Route-to-route extrapolation
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Route of original study:
Dermal
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
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

Oral to Inhalation Dose Descriptor Correction - NOAEC Long-term Systemic

Route-to-route extrapolation of the 28-day repeated dose toxicity study NOAEL via the oral route, to the inhalation route, was conducted in accordance with ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8).

Inhalatory NOAEClong-term= Systemic NOAELlong-termx (1/sRVrat) x (sRVhuman/wRV)

 Symbol  Parameter  Value/Reference
 Input      
 Systemic NOAELlong-term  Oral system NOAEL from 28-day repeat dose rat test  30 mg/kg bw/day
 sRVrat  standard Respiratory Volume - rat  0.38 m3/kg/day
 sRVhuman  standard Respiratory Volume - human  6.7 m3
 wRV  worker Respiratory Volume  10 m3
Output
 Inhalatory NOAEClong-term  Inhalatory NOAEClong-termestimate  53 mg/m3

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