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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
75
Modified dose descriptor starting point:
NOAEC
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
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no-threshold effect and/or no dose-response information available

Workers - Hazard for the eyes

Additional information - workers

Long-term exposure - systemic effects

Dermal DN(M) EL

DNEL derivation is based on a 28 -day toxicity study by oral administration to rats (Rokh, 2010). The starting dose for DNEL calculation was a NOAEL higher than 1000 mg/kg/day for systemic toxicity.

Considering the chemical composition of the substance ,a default oral and dermal absorption of 100% is assumed.

The application of assessment factors of 2.5 for remaining interspecies differences, 4 for allometric scaling, 5 for intraspecies differences and 6 for exposure duration from sub-acute to chronic leads to a DNEL higher than 3.3 mg/kg bw for long-term dermal exposure - systemic effects.

Inhalation (DN(M)EL

DNEL derivation is based on a 28 -day toxicity study by oral administration to rats (Rokh, 2010). The starting dose for DNEL calculation was a NOAEL higher than 1000 mg/kg/day for systemic toxicity.

Considering the chemical composition of the substance, a default oral and inhalation absorption of 100% is assumed.

The equivalent NAEC (8h) derived for workers is 1763 mg/m3 (1000 mg/kg x 1/0.38 m3/kg x 6.7 m3/10 m3) after correction for difference between respiratory rates under standard conditions and under conditions of light activity and exposure conditions.

The application of assessment factors of 2.5 for remaining interspecies differences, 5 for intraspecies differences and 6 for exposure duration from sub-acute to chronic leads to a DNEL of 23.5 mg/m3 for long-term inhalation exposure - systemic effects.

General Population - Hazard via inhalation 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

Local 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 via dermal 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

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

Additional information - General Population

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