Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.12 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:
other: NOEL
Value:
0.38 mg/m³
Modified dose descriptor starting point:
other: NOEC
Value:
18.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

DNEL derivation method: ECHA REACH Guidance

Dose descriptor starting point: NOEL

Modified dose descriptor starting point: NOEC

Modification of starting point:

Oral NOELrat× (1/0.38 m3/kg bw) × (6.7 m3/10m3) × (50% /100%) = 20.9 × 2.63 × 0.67 × 0.5

Inhalation NOEChuman= 18.4 mg/m3

In the absence of route-specific information on the starting route, ECHA guidance recommends a conservative approach for oral to inhalation extrapolation by the inclusion of a default factor of 2 (i.e. the absorption percentage for the starting route is half that of the end route). Therefore, the starting point has been modified by assuming 50% oral absorption and 100% for inhalation.

Overall Assessment Factor: 150

AF for dose response relationship:
1
Justification:
(Predicted NOEL)
AF for differences in duration of exposure:
6
Justification:
(Default value- subchronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
(Not applicable for inhalation)
AF for other interspecies differences:
1
Justification:
(Adressed by modification of starting point)
AF for intraspecies differences:
5
Justification:
(Default value for workers)
AF for the quality of the whole database:
2
Justification:
(Robust QSAR prediction of oral NOEL using database of chemicals with 28-day repeat dose data)
AF for remaining uncertainties:
2.5
Justification:
(Default value for systemic effects)
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:
DNEL (Derived No Effect Level)
Value:
0.34 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 200
Dose descriptor starting point:
other: NOEL
Value:
20.9 mg/kg bw/day
Modified dose descriptor starting point:
other:
Value:
406.6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

DNEL derivation method: ECHA REACH Guidance

Dose descriptor starting point: NOEL

Modified dose descriptor starting point: NOEL

Modification of starting point:

Oral NOELrat× (100% /5.14%) = 20.9 × 19.5

Dermal NOELhuman= 406.6 mg/kg bw/day

AF for dose response relationship:
1
Justification:
(Predicted NOEL)
AF for differences in duration of exposure:
6
Justification:
(Default value for subacute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
(Default value for rat to human)
AF for other interspecies differences:
1
Justification:
(Addressed by modification of starting point)
AF for intraspecies differences:
5
Justification:
(Default value for workers)
AF for the quality of the whole database:
4
Justification:
(Robust QSAR prediction of NOEL (Completeness and consistency) and dermal absorption (reliability of alternative data).)
AF for remaining uncertainties:
2.5
Justification:
(Default value)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium 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:
medium hazard (no threshold derived)

Additional information - General Population

No DNELs have been derived for general population as exposure does not occur during the lifecycle of the substance.

The substance is not used by consumers.