Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 286.4 mg/m³
Most sensitive endpoint:
neurotoxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance procedure but incorporating CONCAWE/ECETOC inter/intra species AF
Overall assessment factor (AF):
9
Dose descriptor starting point:
LOAEC
DNEL value:
4 320 mg/m³
Modified dose descriptor starting point:
LOAEC
DNEL value:
11 577.6 mg/m³
Explanation for the modification of the dose descriptor starting point:

60 mins exposure adjusted for duration of work [60/15 {mins of work} x 6.7/10 {light work ventilation rate}]

AF for dose response relationship:
3
Justification:
LOAEL adjusted to NOAEL using ECHA R.8 and ECETOC 'non-severe'.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not required
AF for other interspecies differences:
1
Justification:
Not applicable, human study
AF for intraspecies differences:
3
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable human dataset (only data available)
AF for remaining uncertainties:
1
Justification:
Not required

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
837.5 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance procedure but incorporating CONCAWE/ECETOC inter/intraspecies AF
Overall assessment factor (AF):
6
Dose descriptor:
NOAEC
DNEL value:
5 025 mg/m³
AF for dose response relationship:
1
Justification:
Not required, starting point was a NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic, ECHA R.8 value
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not required
AF for other interspecies differences:
1
Justification:
Effects at the membrane level such as chemical irritation are considered similar in all species
AF for intraspecies differences:
3
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not required
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 066.67 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance procedure but incorporating CONCAWE/ECETOC inter/intraspecies AF
Overall assessment factor (AF):
9
Dose descriptor starting point:
LOAEC
DNEL value:
9 600 mg/m³
AF for dose response relationship:
3
Justification:
Starting point LOAEL adjusted to NOAEL (ECHA R.8 value)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not required
AF for other interspecies differences:
1
Justification:
Not required; human study
AF for intraspecies differences:
3
Justification:
ECETOC intrapsecies AF
AF for the quality of the whole database:
1
Justification:
Reliable human dataset
AF for remaining uncertainties:
1
Justification:
Not required

Workers - Hazard via dermal route

Systemic effects

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

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 152 mg/m³
Most sensitive endpoint:
neurotoxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance procedure but incorporating Concawe/ECETOC inter/intra species AF
Overall assessment factor (AF):
15
Dose descriptor starting point:
LOAEC
DNEL value:
4 320 mg/m³
Modified dose descriptor starting point:
LOAEC
DNEL value:
17 280 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point 4320, 60 mins exposure adjusted for duration of work [60/15 {mins of work}] = 17280 mg/m3

AF for dose response relationship:
3
Justification:
LOAEL adjusted to NOAEL using ECHA R.8 and ECETOC 'non-severe'.
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not required
AF for other interspecies differences:
1
Justification:
Not applicable, human study
AF for intraspecies differences:
5
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not requried

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
178.57 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: 'ECHA REACH guidance procedure but incorporating CONCAWE/ECETOC intra/interspecies AF
Overall assessment factor (AF):
10
Dose descriptor:
NOAEC
DNEL value:
1 786 mg/m³
AF for dose response relationship:
1
Justification:
Not required, starting point was a NOAEL
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic; ECHA R.8 value
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not required
AF for other interspecies differences:
1
Justification:
Effects at the membrane level such as chemical irritation are considered similar in all species
AF for intraspecies differences:
5
Justification:
ECETOC intrapsecies AF
AF for the quality of the whole database:
1
Justification:
reliable study available
AF for remaining uncertainties:
1
Justification:
Not requried
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
640 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance procedure but incorporating CONCAWE/ECETOC intra/interspecies AF
Overall assessment factor (AF):
15
Dose descriptor starting point:
LOAEC
DNEL value:
9 600 mg/m³
AF for dose response relationship:
3
Justification:
Starting point LOAEL adjusted to NOAEL (ECHA R.8 value)
AF for interspecies differences (allometric scaling):
1
Justification:
Allomteric scaling not required
AF for other interspecies differences:
1
Justification:
Not required, human study
AF for intraspecies differences:
5
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable human dataset
AF for remaining uncertainties:
1
Justification:
Not required

General Population - Hazard via dermal route

Systemic effects

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