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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.12 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
Dose descriptor starting point:
other: NOEL
Value:
0.38 mg/m³
Modified dose descriptor starting point:
other: NOEC
Value:
18.4 mg/m³
Explanation for the modification of the dose descriptor starting point:

DNEL derivation method: ECHA REACH Guidance

Dose descriptor starting point: NOEL

Modified dose descriptor starting point: NOEC

Modification of starting point:

Oral NOELrat× (1/0.38 m3/kg bw) × (6.7 m3/10m3) × (50% /100%) = 20.9 × 2.63 × 0.67 × 0.5

Inhalation NOEChuman= 18.4 mg/m3

In the absence of route-specific information on the starting route, ECHA guidance recommends a conservative approach for oral to inhalation extrapolation by the inclusion of a default factor of 2 (i.e. the absorption percentage for the starting route is half that of the end route). Therefore, the starting point has been modified by assuming 50% oral absorption and 100% for inhalation.

Overall Assessment Factor: 150

AF for dose response relationship:
1
Justification:
(Predicted NOEL)
AF for differences in duration of exposure:
6
Justification:
(Default value- subchronic to chronic)
AF for interspecies differences (allometric scaling):
1
Justification:
(Not applicable for inhalation)
AF for other interspecies differences:
1
Justification:
(Adressed by modification of starting point)
AF for intraspecies differences:
5
Justification:
(Default value for workers)
AF for the quality of the whole database:
2
Justification:
(Robust QSAR prediction of oral NOEL using database of chemicals with 28-day repeat dose data)
AF for remaining uncertainties:
2.5
Justification:
(Default value for systemic effects)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.34 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):
1 200
Dose descriptor starting point:
other: NOEL
Value:
20.9 mg/kg bw/day
Modified dose descriptor starting point:
other:
Value:
406.6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

DNEL derivation method: ECHA REACH Guidance

Dose descriptor starting point: NOEL

Modified dose descriptor starting point: NOEL

Modification of starting point:

Oral NOELrat× (100% /5.14%) = 20.9 × 19.5

Dermal NOELhuman= 406.6 mg/kg bw/day

AF for dose response relationship:
1
Justification:
(Predicted NOEL)
AF for differences in duration of exposure:
6
Justification:
(Default value for subacute to chronic)
AF for interspecies differences (allometric scaling):
4
Justification:
(Default value for rat to human)
AF for other interspecies differences:
1
Justification:
(Addressed by modification of starting point)
AF for intraspecies differences:
5
Justification:
(Default value for workers)
AF for the quality of the whole database:
4
Justification:
(Robust QSAR prediction of NOEL (Completeness and consistency) and dermal absorption (reliability of alternative data).)
AF for remaining uncertainties:
2.5
Justification:
(Default value)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

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:
no hazard identified
DNEL related information

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

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:
medium hazard (no threshold derived)

Additional information - General Population

No DNELs have been derived for general population as exposure does not occur during the lifecycle of the substance.

The substance is not used by consumers.