Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1
Modified dose descriptor starting point:
NOAEC
DNEL value:
100 mg/m³
Explanation for the modification of the dose descriptor starting point:
not necessary: data from inhalation exposure route
Justification:
not applicable
Justification:
not applicable
AF for interspecies differences (allometric scaling):
1
Justification:
Data obtained upon occupational exposure
Justification:
not applicable
Justification:
not applicable
Justification:
not applicable
Justification:
not applicable
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 mg/m³
Most sensitive endpoint:
neurotoxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1
Modified dose descriptor starting point:
NOAEC
DNEL value:
100 mg/m³
Explanation for the modification of the dose descriptor starting point:
not necessary: data from inhalation exposure route
Justification:
not applicable
AF for interspecies differences (allometric scaling):
1
Justification:
Data obtained upon occupational exposure
Justification:
not applicable
Justification:
not applicable
Justification:
not applicable
Justification:
not applicable

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1
Dose descriptor:
NOAEC
Justification:
not applicable
Justification:
not applicable
AF for interspecies differences (allometric scaling):
1
Justification:
Data obtained upon occupational exposure
Justification:
not applicable
Justification:
not applicable
Justification:
not applicable
Justification:
not applicable
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1
Dose descriptor starting point:
NOAEC
Justification:
not applicable
AF for interspecies differences (allometric scaling):
1
Justification:
Data obtained upon occupational exposure
Justification:
not applicable
Justification:
not applicable
Justification:
not applicable
Justification:
not applicable

Workers - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

For detailed data on DNEL/DMEL, please, refer Chemical Safety Assessment Report (CSR).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Explanation for the modification of the dose descriptor starting point:
not necessary: data from inhalation exposure route
Justification:
not applicable
AF for differences in duration of exposure:
10
Justification:
for long-term effects (life-time)
AF for interspecies differences (allometric scaling):
1
Justification:
Data obtained upon occupational exposure
Justification:
not applicable
AF for intraspecies differences:
10
Justification:
to consider sensitivity differences within human population
Justification:
not applicable
Justification:
not applicable
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Explanation for the modification of the dose descriptor starting point:
not necessary: data from inhalation exposure route
Justification:
not applicable
AF for interspecies differences (allometric scaling):
1
Justification:
Data obtained upon occupational exposure
Justification:
not applicable
AF for intraspecies differences:
10
Justification:
to consider sensitivity differences within human population
Justification:
not applicable
Justification:
not applicable

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor:
NOAEC
Justification:
not applicable
AF for differences in duration of exposure:
10
Justification:
for long-term effects (life-time)
AF for interspecies differences (allometric scaling):
1
Justification:
Data obtained upon occupational exposure
Justification:
not applicable
AF for intraspecies differences:
10
Justification:
to consider sensitivity differences within human population
Justification:
not applicable
Justification:
not applicable
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Dose descriptor starting point:
NOAEC
Justification:
not applicable
AF for interspecies differences (allometric scaling):
1
Justification:
Data obtained upon occupational exposure
Justification:
not applicable
AF for intraspecies differences:
10
Justification:
to consider sensitivity differences within human population
Justification:
not applicable
Justification:
not applicable

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.7 µg/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):
1 000
Modified dose descriptor starting point:
NOAEL
DNEL value:
7.7 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not necessary: data from oral exposure route
AF for interspecies differences (allometric scaling):
10
Justification:
to consider difference from animal toxicity data to human data
AF for intraspecies differences:
10
Justification:
to consider sensitivity differences within human population
AF for remaining uncertainties:
10
Justification:
applied to consider severity of toxicity effects
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

For detailed data on DNEL/DMEL, please, refer Chemical Safety Assessment Report (CSR).