Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
44 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECEOTC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
18
Modified dose descriptor starting point:
NOAEC
Value:
793 mg/m³
Explanation for the modification of the dose descriptor starting point:
There is no indication that route-to-route extrapolation can not be applied.
AF for dose response relationship:
1
Justification:
Not relevant, NOAEL is available
AF for differences in duration of exposure:
6
Justification:
From sub-acute to chronic exposure for the workers
AF for interspecies differences (allometric scaling):
1
Justification:
allometric scaling rat human included in dose descriptor starting point
AF for other interspecies differences:
1
Justification:
not relevant
AF for intraspecies differences:
3
Justification:
differences in sensitivity amongst workers
AF for the quality of the whole database:
1
Justification:
Not relevant, reliable studies and all endpoints required are covered adequately.
AF for remaining uncertainties:
1
Justification:
Not relevant (no remaining uncertainties)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.25 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
72
Modified dose descriptor starting point:
NOAEL
Value:
450 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
There is no indication that route to route extrapolation cannot be applied.
AF for dose response relationship:
1
Justification:
Not relevant, NOAEL is available
AF for differences in duration of exposure:
6
Justification:
From sub-acute to chronic exposure for workers
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
Not relevant
AF for intraspecies differences:
3
Justification:
Differences in sensitivity amongst workers
AF for the quality of the whole database:
1
Justification:
Not relevant, reliable studies and all endpoints required are covered adequately.
AF for remaining uncertainties:
1
Justification:
Not relevant (no remaining uncertainties)
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:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
30
Modified dose descriptor starting point:
NOAEC
Value:
391 mg/m³
Explanation for the modification of the dose descriptor starting point:
There is no indication that route to route extrapolation cannot be applied.
AF for dose response relationship:
1
Justification:
Not relevant, NOAEL is available
AF for differences in duration of exposure:
6
Justification:
From sub-acute to chronic exposure for the general population
AF for interspecies differences (allometric scaling):
1
Justification:
allometric scaling rat human included in dose descriptor starting point
AF for other interspecies differences:
1
Justification:
not relevant
AF for intraspecies differences:
5
Justification:
differences in sensitivity amongst general population
AF for the quality of the whole database:
1
Justification:
Not relevant, reliable studies and all endpoints required are covered adequately.
AF for remaining uncertainties:
1
Justification:
not relevant
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.75 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
450 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
There is no indication that route to route extrapolation cannot be applied.
AF for dose response relationship:
1
Justification:
Not relevant, NOAEL is available
AF for differences in duration of exposure:
6
Justification:
From sub-acute to chronic exposure for general population
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
not relevant
AF for intraspecies differences:
5
Justification:
Differences in sensitivity amongst general population
AF for the quality of the whole database:
1
Justification:
Not relevant, reliable studies and all endpoints required are covered adequately.
AF for remaining uncertainties:
1
Justification:
not relevant
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.75 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
450 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not relevant
AF for dose response relationship:
1
Justification:
Not relevant, NOAEL is available
AF for differences in duration of exposure:
6
Justification:
From sub-acute to chronic exposure for general population
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
not relevant
AF for intraspecies differences:
5
Justification:
Differences in sensitivity amongst general population
AF for the quality of the whole database:
1
Justification:
Not relevant, reliable studies and all endpoints required are covered adequately.
AF for remaining uncertainties:
1
Justification:
not relevant
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population