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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
30 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
5
Modified dose descriptor starting point:
NOAEC
Value:
152 mg/m³
Explanation for the modification of the dose descriptor starting point:

Systemic effects

AF for dose response relationship:
1
Justification:
the NOAEL was at least 250 mg/kg bw
AF for differences in duration of exposure:
1
Justification:
chronic (2-year) study
AF for interspecies differences (allometric scaling):
1
Justification:
has already been done at the correction in sRV
AF for other interspecies differences:
1
Justification:
hardly absorbed and not metabolized
AF for intraspecies differences:
5
Justification:
standard assessment factor
AF for the quality of the whole database:
1
Justification:
many studies available
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 mg/m³
DNEL related information
DNEL derivation method:
other: expert judgement
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
62 500 mg/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):
20
Modified dose descriptor starting point:
NOAEL
Value:
1 250 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

systemic effects

AF for dose response relationship:
1
Justification:
NOAEL is at least 250 mg/kg bw
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
allomteric scaling
AF for other interspecies differences:
1
Justification:
hardly absorbed and not metabolized
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
1
Justification:
many studies available
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

See at justification and comments

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.5 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
Value:
75 mg/m³
Explanation for the modification of the dose descriptor starting point:

systemic effects

AF for dose response relationship:
1
Justification:
NOAEL is at least 250 mg/kg bw
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
has already been done at the correction in sRV
AF for other interspecies differences:
1
Justification:
hardly absorbed and not metabolized
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
many studies available
AF for remaining uncertainties:
1
Justification:
no remaning uncertainties
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 mg/m³
DNEL related information
DNEL derivation method:
other: expert judgement
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
31 250 mg/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):
40
Modified dose descriptor starting point:
NOAEL
Value:
1 250 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

systemic effects

AF for dose response relationship:
1
Justification:
NOAEL at least 250 mg/kg bw
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling
AF for other interspecies differences:
1
Justification:
hardly absorbed and not metabolized
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
many studies available
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral 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:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

systemic effects

AF for dose response relationship:
1
Justification:
NOAEL at least 250 mg/kg bw
AF for differences in duration of exposure:
1
Justification:
chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling
AF for other interspecies differences:
1
Justification:
remaining differences in case of systemic effects
AF for intraspecies differences:
10
Justification:
general population
AF for the quality of the whole database:
1
Justification:
many studies available
AF for remaining uncertainties:
1
Justification:
no reamining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

See at justification and comments