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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
20.3 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance with assessment factors described below.
Overall assessment factor (AF):
6
Modified dose descriptor starting point:
NOAEC
Value:
122 mg/m³
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
2
Justification:
Default - Sub chronic to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
Inhalation study
AF for other interspecies differences:
1
Justification:
Based on justification and guidance provided in ECETOC Technical report 86
AF for intraspecies differences:
3
Justification:
Based on justification and guidance provided in ECETOC Technical report 86
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50.8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: See justification and comments
Overall assessment factor (AF):
2.4
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC

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:
2.9 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: Based on extrapolation of the inhalation DNEL (route to route extrapolation). See the justification and comments below.
Explanation for the modification of the dose descriptor starting point:

Based on assumption of 10m3 inhalation per shift, 70kg worker and 100% uptake

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:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

For the purposes of deriving the DNEL, the assessment factors published by ECEOC in their technical reports TR86 (2003) and TR110 (2010) are used. These are derived and underpinned by a comprehensive review of the scientific literature that is documented in the publication.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12.2 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance with assessment factors described below.
Overall assessment factor (AF):
10
Modified dose descriptor starting point:
NOAEC
Value:
122 mg/m³
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
2
Justification:
Default - sub-chronic to chronic extrapolation
AF for interspecies differences (allometric scaling):
1
Justification:
Default - inhalation study
AF for other interspecies differences:
1
Justification:
Based on justification and guidance provided in ECETOC Technical report 86
AF for intraspecies differences:
5
Justification:
Based on justification and guidance provided in ECETOC Technical report 86
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
30.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: See justification and comments below.
Overall assessment factor (AF):
7.5
DNEL extrapolated from long term DNEL
Modified dose descriptor starting point:
NOAEC

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:
1.4 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
other: Based on extrapolation of the inhalation DNEL (route to route extrapolation). See the justification and comments below.
Overall assessment factor (AF):
48
Modified dose descriptor starting point:
NOAEL
Explanation for the modification of the dose descriptor starting point:

Assuming 6.7m3 inhalation per 8hr exposure period, 60kg individual and 100% uptake.

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:
0.16 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance with assessment factors described below.
Overall assessment factor (AF):
120
Modified dose descriptor starting point:
NOAEL
Value:
20 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human extrapolation
AF for other interspecies differences:
1
Justification:
Based on justification and guidance provided in ECETOC Technical report 86
AF for intraspecies differences:
5
Justification:
Based on justification and guidance provided in ECETOC Technical report 86
AF for the quality of the whole database:
1
Justification:
Default
AF for remaining uncertainties:
1
Justification:
Default
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:
no hazard identified

Additional information - General Population

For the purposes of deriving the DNEL, the assessment factors published by ECEOC in their technical reports TR86 (2003) and TR110 (2010) are used. These are derived and underpinned by a comprehensive review of the scientific literature that is documented in the publication.