Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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
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
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
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).