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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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
Value:
4 320 mg/m³
Modified dose descriptor starting point:
LOAEC
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
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
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
Value:
4 320 mg/m³
Modified dose descriptor starting point:
LOAEC
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
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
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