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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.15 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
Value:
22.3 mg/m³
Explanation for the modification of the dose descriptor starting point:
Undertaken as described in REACH Guidance R.8
AF for dose response relationship:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for differences in duration of exposure:
6
Justification:
Default factor (subacute to chronic), in accordance with REACH Guidance R.8
AF for interspecies differences (allometric scaling):
1
Justification:
Default factor (scaling addressed in route to route extrapolation), in accordance with REACH Guidance R.8
AF for other interspecies differences:
2.5
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for intraspecies differences:
5
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for the quality of the whole database:
2
Justification:
In accordance with REACH Guidance R.8
AF for remaining uncertainties:
1
Justification:
Deafult factor, in accordance with REACH Guidance R.8
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.42 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Value:
253 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Undertaken as described in REACH Guidance R.8
AF for dose response relationship:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for differences in duration of exposure:
6
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for other interspecies differences:
2.5
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for intraspecies differences:
5
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for the quality of the whole database:
2
Justification:
In accordance with REACH Guidance R.8
AF for remaining uncertainties:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

DNEL derivation for each of the relevant endpoints was based on the most conservative value obtained. Thus, DNELs represent the worst – case secenario.

The default assessment factor of 4 was applied for allometric scaling from rat to human. For the remaining interspecies differences the default assessment factor of 2.5 was used as was the default assessment factor of 6 for extrapolation from subacute to chronic exposure. Finally, an assessment factor of 5 was applied for intraspecies differences (worker). As worker DNEL long term for dermal route and inhalation route was derived from the NOAEL long term oral, the same assessment factors (as detailed above) were applied in the calculations of the DNEL long term dermal/ inhalation.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.07 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEC
Value:
22 mg/m³
Explanation for the modification of the dose descriptor starting point:
Undertaken as described in REACH Guidance R.8
AF for dose response relationship:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for differences in duration of exposure:
6
Justification:
Default factor (subacute to chronic), in accordance with REACH Guidance R.8
AF for interspecies differences (allometric scaling):
1
Justification:
Default factor (scaling addressed in route to route extrapolation), in accordance with REACH Guidance R.8
AF for other interspecies differences:
2.5
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for intraspecies differences:
10
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for the quality of the whole database:
2
Justification:
In accordance with REACH Guidance R.8
AF for remaining uncertainties:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.21 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 200
Modified dose descriptor starting point:
NOAEL
Value:
253 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Undertaken as described in REACH Guidance R.8
AF for dose response relationship:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for differences in duration of exposure:
6
Justification:
Default factor (subacute to chronic), in accordance with REACH Guidance R.8
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for other interspecies differences:
2.5
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for intraspecies differences:
10
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for the quality of the whole database:
2
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for remaining uncertainties:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.021 mg/kg bw/day
Most sensitive endpoint:
developmental toxicity / teratogenicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 200
Modified dose descriptor starting point:
NOAEL
Value:
25.3 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Undertaken as described in REACH Guidance R.8
AF for dose response relationship:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for differences in duration of exposure:
6
Justification:
Default factor (subacute to chronic), in accordance with REACH Guidance R.8
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for other interspecies differences:
2.5
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for intraspecies differences:
10
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for the quality of the whole database:
2
Justification:
Default factor, in accordance with REACH Guidance R.8
AF for remaining uncertainties:
1
Justification:
Default factor, in accordance with REACH Guidance R.8
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

DNEL derivation for each of the relevant endpoints was based on the most conservative value obtained. Thus, DNELs represent the worst – case secenario.

The default assessment factor of 4 was applied for allometric scaling from rat to human. For the remaining interspecies differences the default assessment factor of 2.5 was used as was the default assessment factor of 6 for extrapolation from subacute to chronic exposure. Finally, an assessment factor of 10 was applied for intraspecies differences (general population). As DNEL long term for dermal route and inhalation route was derived from the NOAEL long term oral, the same assessment factors (as detailed above) were applied in the calculations of the DNEL long term dermal/ inhalation.