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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
69.792 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):
25
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 744.792 mg/m³
Explanation for the modification of the dose descriptor starting point:

NOAEL derived from 90-days oral study (according to OECD 408 under GLP)

AF for dose response relationship:
1
Justification:
NOAEL as starting point
AF for differences in duration of exposure:
2
Justification:
subchronic (90-day) study
AF for interspecies differences (allometric scaling):
1
Justification:
according to ECHA Guidance document Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for other interspecies differences:
2.5
Justification:
according to ECHA Guidance document Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for intraspecies differences:
5
Justification:
according to ECHA Guidance document Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for the quality of the whole database:
1
Justification:
good quality of the database
AF for remaining uncertainties:
1
Justification:
There were no remaining uncertainties.
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:
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:
10 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):
100
Dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL derived from 90-days oral study (according to OECD 408 under GLP)

AF for dose response relationship:
1
Justification:
NOAEL as starting point
AF for differences in duration of exposure:
2
Justification:
subchronic (90-day) study
AF for interspecies differences (allometric scaling):
4
Justification:
according to ECHA Guidance document Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for other interspecies differences:
2.5
Justification:
according to ECHA Guidance document Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for intraspecies differences:
5
Justification:
according to ECHA Guidance document Guidance on information requirements and chemical safety assessment, Chapter R.8
AF for the quality of the whole database:
1
Justification:
good quality of the database
AF for remaining uncertainties:
1
Justification:
There were no remaining uncertainties.
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:
low hazard (no threshold derived)
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:
low hazard (no threshold derived)
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:
low hazard (no threshold derived)
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