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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:
By inhalation
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor:
NOAEC
Value:
3.95 mg/m³
Justification:
This factor is applied because the dose-descriptor starting point is a NOAEC.
Justification:
Local effects on the respiratory tract are related to the deposited dose per unit of surface area. Below a certain concentration the clearance capacity of the lungs is not overwhelmed and the lungs retain the ability to clear the deposited substance. Therefore, time scaling is not appropriate as the lung effects are mainly driven by the exposure concentration.
Justification:
AF not used for inhalation.
Justification:
No additional assessment factor is added for interspecies extrapolation from rodent to human, since the respiratory rate of rats (0.29 m3/kg-day according to Pauluhn (2010)) leads to a greater lung tract burden compared to humans (0.14 m3/kg-day), thus the effects observed in rats are exaggerated and provide a “built in” safety margin. 
Justification:
A factor of 5 is applied for worker DNELs.
Justification:
The key study is considered as a reliable study with a klimisch score of 1 and the database is complete and robust.
Justification:
No other assessment factor is applied.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
DNEL related information

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:
By inhalation
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

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:
By inhalation
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Dose descriptor:
NOAEC
Value:
3.95 mg/m³
Justification:
This factor is applied because the dose-descriptor starting point is a NOAEC.
Justification:
Local effects on the respiratory tract are related to the deposited dose per unit of surface area. Below a certain concentration the clearance capacity of the lungs is not overwhelmed and the lungs retain the ability to clear the deposited substance. Therefore, time scaling is not appropriate as the lung effects are mainly driven by the exposure concentration.
Justification:
AF not used for inhalation.
Justification:
No additional assessment factor is added for interspecies extrapolation from rodent to human, since the respiratory rate of rats (0.29 m3/kg-day according to Pauluhn (2010)) leads to a greater lung tract burden compared to humans (0.14 m3/kg-day), thus the effects observed in rats are exaggerated and provide a “built in” safety margin. 
Justification:
A factor of 10 is applied for general population DNELs.
Justification:
The key study is considered as a reliable study with a klimisch score of 1 and the database is complete and robust.
Justification:
No other assessment factor is applied.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
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:
Dermal
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population