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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Acute/short term exposure
Hazard assessment conclusion:
no data available: testing technically not feasible
DNEL related information

Workers - Hazard via dermal 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:
no-threshold effect and/or no dose-response information available
DNEL related information

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

Inhalation and dermal routes of Green liquor sludge exposure are relevant for worker exposure. DNEL for dermal route cannot be derived, since GLS is irritant to the skin and there are no dose-response data for skin effects.

GLS showed no repeated dose oral toxicity (NOAEL > 2000 mg/kg (dry wt.) > 5000 mg/kg (wet wt.) ) in the tested exposure range

(Dry weigtht to wet weight conversation in the year 2010 reference samples: dry matter 46,7%, water 53.3%)

Therefore the DNEL value for long-term inhalation systemic derived by route-to-route (oral-inhal) extrapolation is unrealistically high. In practice sparingly soluble dusts may cause adverse effects in the lung which can be explained by overload phenomena.

As given in the CSA R8 guidance for exposure to dust, it should be considered whether a derived DNEL for inhalation may have to be lowered. The general dust limits of 10 mg/m3 for the inhalable airborne fraction and 3 mg/m3 for the respirable airborne fraction are used when setting Occupational Exposure Limits in many countries. For non-soluble inert dusts, if the derived DNEL for inhalation is above these dust limits, the general dust limits should apply for exposure scenarios with exposure to dust.

GLS is irritant to skin and corrosive to eyes and the oral to inhalation extrapolation is therefore not a suitable method for DNEL derivation. In addition to the alkaline character of the dust, it may contain 6 % wt manganese oxide (ca. 4% Mn). Manganese is known to have systemic effects and the OEL values for inhalation route are given.

Manganese (Mn) and calcium hydroxide (Ca(OH)2) are the components that may cause the main health risks, since the concentrations are remarkably high.

There are also some potentially hazardous trace constituents present in GLS (Ni, Cd, PAH...), but the concentrations are so low that these constituents have no remarkable or triggering influence on DNEL values.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.16 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: DNEL for general population is derived based on OEL value 5 mg/m3
Overall assessment factor (AF):
30
Acute/short term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.16 mg/m³
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.16 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
Overall assessment factor (AF):
30

General Population - Hazard via dermal 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:
exposure based waiving
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
exposure based waiving
Acute/short term exposure
Hazard assessment conclusion:
exposure based waiving
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

Exposure of general population to GLS is expected to be very low or insignificant, since GLS has no consumer uses. However, inhalation is a relevant route for GLS dust generated in professional uses such as the use as construction material (earth works). The DNEL derivation is based on the occupational value 5 mg/m3 inhalable GLS dust (same value for local and systemic effects).

Extrapolation from 8 hr to 24 hr exposure from worker DNEL systemic and local for inhalation route has been carried out.

In addition the default assessment factor 10 for intraspecies differences is used for the inhalation route. This factor is typically suggested for the general population representing all age groups, including children and elderly. A combined assessment factor 30 was used for worker DNEL in order to get the long term inhalation local and systemic DNELs.