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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.82 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):
75
Modified dose descriptor starting point:
other: NOAEL
Value:
61.71 mg/m³
Explanation for the modification of the dose descriptor starting point:
Assuming 50% absorption for oral-rat and 100% for inhalation-human. The oral NOAEL of 70 mg/kg bw/d (dosing regime: 5 days/week) is concerted to a NOAEL by dividing by 0.38 and by multiplying by 0.67 according to ECHA Guidance.
AF for dose response relationship:
1
Justification:
corrected NOAEL of 61.71 mg/m3 is used as a starting point.
AF for differences in duration of exposure:
6
Justification:
based on an oral 28 days study (subacute to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
default as 1 since no allometric scaling needed for oral to inhalation.
AF for other interspecies differences:
2.5
Justification:
no substance specific data are available.
AF for intraspecies differences:
5
Justification:
for workers the default factor of 5 is used.
AF for the quality of the whole database:
1
Justification:
available data of the substance fulfilling scientic princle is used.
AF for remaining uncertainties:
1
Justification:
no further uncertainities to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.82 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
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)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.23 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):
300
Modified dose descriptor starting point:
NOAEL
Value:
70 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Assuming 100% absorption for both routes (oral and dermal) in both species (rat and human).
AF for dose response relationship:
1
Justification:
NOAEL is used as a starting point
AF for differences in duration of exposure:
6
Justification:
based on an oral 28 days study (subacute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
rat was used in the test.
AF for other interspecies differences:
2.5
Justification:
no substance specific data are avaiable.
AF for intraspecies differences:
5
Justification:
for workers the default factor of 5 is used.
AF for the quality of the whole database:
1
Justification:
available data of the substance fulfilling scientic princle is used.
AF for remaining uncertainties:
1
Justification:
no further uncertainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.23 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.15 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):
150
Modified dose descriptor starting point:
other: NOEAL
Value:
21.93 mg/m³
Explanation for the modification of the dose descriptor starting point:
Assuming 50% absorption for oral-rat and 100% for inhalation-human. The oral NOAEL of 50 mg/kg bw/d (dosing regime: 7 days/week) is concerted to a NOAEL by dividing by 1.14 (24h) according to ECHA Guidance.
AF for dose response relationship:
1
Justification:
NOAEL is used as a starting point.
AF for differences in duration of exposure:
6
Justification:
based on an oral 28 days study (subacute to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
default as 1 since no allometric scaling needed for oral to inhalation.
AF for other interspecies differences:
2.5
Justification:
no substance specific data are available.
AF for intraspecies differences:
10
Justification:
for general population the default factor of 10 is used.
AF for the quality of the whole database:
1
Justification:
available data of the substance fulfilling scientic princle is used.
AF for remaining uncertainties:
1
Justification:
no further uncertainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.15 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
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)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.08 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Assuming 100% absorption for both route in both species, the oral NOAEL of 50 mg/kg bw/d (dosing regime: 7 days/week) is concerted to a NOAEL by dividing by 0.38 according to ECHA Guidance.
AF for dose response relationship:
1
Justification:
NOAEL is used as a starting point.
AF for differences in duration of exposure:
6
Justification:
based on an oral 28 days study (subacute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
rat was used in the test.
AF for other interspecies differences:
2.5
Justification:
no substance specific data are available.
AF for intraspecies differences:
10
Justification:
For general population the default factor of 10 is used.
AF for the quality of the whole database:
1
Justification:
available data of the substance fulfilling scientic princle is used.
AF for remaining uncertainties:
1
Justification:
no further uncertainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.08 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
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:
0.08 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):
600
Modified dose descriptor starting point:
NOAEL
Value:
50 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
no route-to-route extrapolation
AF for dose response relationship:
1
Justification:
NOAEL is used as a starting point.
AF for differences in duration of exposure:
6
Justification:
based on an oral 28 days study (subacute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
rat was used in the test.
AF for other interspecies differences:
2.5
Justification:
no substance specific data are available-
AF for intraspecies differences:
10
Justification:
for general population the default factor of 5 is used.
AF for the quality of the whole database:
1
Justification:
availabe data of the substance fulfilling scientic princle is used.
AF for remaining uncertainties:
1
Justification:
no further uncertainties to be taken into account.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.08 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population