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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.73 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):
300
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
220 mg/m³
Explanation for the modification of the dose descriptor starting point:

In according to ECHA Practical Guide 14: How to prepare toxicological summaries in IUCLID and how to derive DNELs:

Inhalatory N(L)OAEC= oral N(L)OAEL*(1/0.38 m3 /kg/d)*0.67*(ABSoral/ABSinh.)

In according to ECHA Guidance on information requirements and chemical safety assessment Chapter R.8

50% (instead of 100%) adsorption is assumed for oral absorption, and 100% for inhalation

.

AF for dose response relationship:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (The starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Sub-acute study)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Animal specie of study is rat)
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for intraspecies differences:
5
Justification:
CHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for the quality of the whole database:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for remaining uncertainties:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
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:
8.33 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):
300
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Extrapolation route to route: the dermal absorption is negligible; the  absorption from the gastrointestinal tract occurs

AF for dose response relationship:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (The starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Sub-acute study)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Animal specie of study is rat)
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for intraspecies differences:
5
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for the quality of the whole database:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for remaining uncertainties:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
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:
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:
DNEL (Derived No Effect Level)
Value:
0.18 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):
600
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
108.7 mg/m³
Explanation for the modification of the dose descriptor starting point:

In according to Echa Practical Guide 14: How to prepare toxicological summaries in IUCLID and how to derive DNELs:

Inhalation N(L)OAEC= oral N(L)OAEL*(1/1.15 m3/kg/d)*(ABSoral/ABSinh.)

In according to Echa Guidance on information requirements and chemical safety assessment Chapter R.850% (instead of 100%) adsorption is assumed for oral absorption, and 100% for inhalation

AF for dose response relationship:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (The starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Sub-acute study)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Animal specie of study is rat)
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for intraspecies differences:
10
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for the quality of the whole database:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for remaining uncertainties:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
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:
DNEL (Derived No Effect Level)
Value:
4.17 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):
600
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
2 500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Extrapolation route to route: the dermal absorption is negligible; the  absorption from the gastrointestinal tract occurs

AF for dose response relationship:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (The starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Sub-acute study)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Animal specie of study is rat)
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for intraspecies differences:
10
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for the quality of the whole database:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for remaining uncertainties:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
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:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.42 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):
600
Dose descriptor starting point:
NOAEL
Value:
250 mg/kg bw/day
AF for dose response relationship:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (The starting point for the DNEL calculation is a NOAEL)
AF for differences in duration of exposure:
6
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Sub-acute study)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8 (Animal specie of study is rat)
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for intraspecies differences:
10
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for the quality of the whole database:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
AF for remaining uncertainties:
1
Justification:
ECHA Guidance: Guidance on information requirements and chemical safety assessment - Chapter R.8
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