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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
23.3 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):
75
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 750 mg/m³
Explanation for the modification of the dose descriptor starting point:

Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (route-to-route extrapolation).

AF for dose response relationship:
1
Justification:
Lowest NOAEL chosen for DNEL-derivation.
AF for differences in duration of exposure:
6
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for interspecies differences (allometric scaling):
1
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health. (interspecies difference is included in the calculation by correcting the respiratory volumes of rat and man, AF = 4).
AF for other interspecies differences:
1
Justification:
No additional AF for interspecies differences assumed in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for intraspecies differences:
5
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for the quality of the whole database:
1
Justification:
Guideline study. Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for remaining uncertainties:
2.5
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.3 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Since a dermal absoprtion of 100% was assumed the orally derived dose descriptor starting point does not need to be modified. Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.

AF for dose response relationship:
1
Justification:
Lowest NOAEL chosen for DNEL-derivation.
AF for differences in duration of exposure:
6
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for other interspecies differences:
1
Justification:
No additional AF for interspecies differences assumed in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for intraspecies differences:
5
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for the quality of the whole database:
1
Justification:
Guideline study. Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for remaining uncertainties:
2.5
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
low hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.8 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:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
875 mg/m³
Explanation for the modification of the dose descriptor starting point:

Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health (route-to-route extrapolation).

AF for dose response relationship:
1
Justification:
Lowest NOAEL chosen for DNEL-derivation.
AF for differences in duration of exposure:
6
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for interspecies differences (allometric scaling):
1
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health. (interspecies difference is included in the calculation by correcting the respiratory volumes of rat and man).
AF for other interspecies differences:
1
Justification:
No additional AF for interspecies differences assumed in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for intraspecies differences:
10
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for the quality of the whole database:
1
Justification:
Guideline study. Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for remaining uncertainties:
2.5
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.7 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Since a dermal absoprtion of 100% was assumed the orally derived dose descriptor starting point does not need to be modified. Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.

AF for dose response relationship:
1
Justification:
Lowest NOAEL chosen for DNEL-derivation.
AF for differences in duration of exposure:
6
Justification:
Guideline study. Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for interspecies differences (allometric scaling):
4
Justification:
Guideline study. Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for other interspecies differences:
1
Justification:
No additional AF for interspecies differences assumed in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for intraspecies differences:
10
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for the quality of the whole database:
1
Justification:
Guideline study. Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for remaining uncertainties:
2.5
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
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:
DNEL (Derived No Effect Level)
Value:
1.7 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point does not need to be modified.

AF for dose response relationship:
1
Justification:
Lowest NOAEL chosen for DNEL-derivation.
AF for differences in duration of exposure:
6
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for interspecies differences (allometric scaling):
4
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for other interspecies differences:
1
Justification:
No additional AF for interspecies differences assumed in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for intraspecies differences:
10
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for the quality of the whole database:
1
Justification:
Guideline study. Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
AF for remaining uncertainties:
2.5
Justification:
Assessment factors in accordance with Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population