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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
27.9 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
18
Modified dose descriptor starting point:
NOAEC
Value:
502.3 mg/m³
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for other interspecies differences:
1
Justification:
AF for interspecies differences is not required for inhalation
AF for intraspecies differences:
3
Justification:
intraspecies differences for workers
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
167.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
3
Dose descriptor:
NOAEC
AF for differences in duration of exposure:
1
Justification:
subacute to chronic - local effects
AF for other interspecies differences:
1
Justification:
AF for interspecies differences is not required for inhalation
AF for intraspecies differences:
3
Justification:
intraspecies differences for workers
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
24
Modified dose descriptor starting point:
NOAEL
Value:
120 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
For route to route extrapolation an assessment factor of 1 is taken into account as no information on dermal absorption is available.
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for other interspecies differences:
4
Justification:
interspecies difference for rat
AF for intraspecies differences:
3
Justification:
intraspecies differences for workers
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

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:
DNEL (Derived No Effect Level)
Value:
8.33 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEC
Value:
250 mg/m³
AF for differences in duration of exposure:
6
Justification:
subacute to chronic
AF for other interspecies differences:
1
Justification:
interspecies differences are not relevant for inhalation
AF for intraspecies differences:
5
Justification:
differences for the general public
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
5
Dose descriptor:
NOAEC
AF for differences in duration of exposure:
1
Justification:
subacute to chronic - local effects
AF for other interspecies differences:
1
Justification:
interspecies differences are not relevant for inhalation
AF for intraspecies differences:
5
Justification:
differences for the general public
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Value:
120 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
For route to route extrapolation an assessment factor of 1 is taken into account as no information on dermal absorption is available.
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for other interspecies differences:
4
Justification:
interspecies differences for rat
AF for intraspecies differences:
5
Justification:
intraspecies differences for general population
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
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 hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC assessment factors
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Value:
120 mg/kg bw/day
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for other interspecies differences:
4
Justification:
interspecies differences for rat
AF for intraspecies differences:
5
Justification:
intraspecies differences for general population
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population