Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.39 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):
225
Dose descriptor starting point:
LOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
LOAEC
Value:
88.16 mg/m³
Explanation for the modification of the dose descriptor starting point:

The corrected fose descriptor for inhalation for workers = (100 mg/kg bw/day) / (0.38 m^3/kg bw/day) × (6.7 m^3/10 m^3) × (1/2)* = 88.16 mg/m^3

*A default factor of 2 (i.e. the absorption percentage for the starting route is half that of the end route) for oral-to-inhalation extrapolation (ECHA, 2012).

AF for dose response relationship:
3
Justification:
The starting point is a LOAEL.
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable for inhalation.
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:
1
Justification:
Data available on the test substance appropriate for the tonnage band.
AF for remaining uncertainties:
2.5
Justification:
Default value.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Route of original study:
Oral
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:
1.11 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):
900
Dose descriptor starting point:
LOAEL
Value:
100 mg/kg bw/day
Modified dose descriptor starting point:
LOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The corrected dose descriptor for dermal for workers = (100 mg/kg bw/day) × (100 %/10 %) =1000 mg/kg bw/day

AF for dose response relationship:
3
Justification:
The starting point is a LOAEL.
AF for differences in duration of exposure:
6
Justification:
Sub-acute to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
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:
1
Justification:
Data available on the test substance appropriate for the tonnage band.
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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

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:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population

DNELs for general population are not appropriate to derive, as inhalation, dermal or oral exposure is not anticipated due to the use of the registered substance.