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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
3.52 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:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
264 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8

AF for dose response relationship:
1
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for differences in duration of exposure:
6
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for interspecies differences (allometric scaling):
1
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for other interspecies differences:
2.5
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for intraspecies differences:
5
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for the quality of the whole database:
1
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for remaining uncertainties:
1
Justification:
According to ECHA 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:
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):
300
Dose descriptor starting point:
NOAEL
Value:
300 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
3 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8

AF for dose response relationship:
1
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for differences in duration of exposure:
6
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for interspecies differences (allometric scaling):
4
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for other interspecies differences:
2.5
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for intraspecies differences:
5
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for the quality of the whole database:
1
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for remaining uncertainties:
1
Justification:
According to ECHA 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:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

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:
0.86 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:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
130 mg/m³
Explanation for the modification of the dose descriptor starting point:

According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8

Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
Justification:
According to ECHA 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:
5 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:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
3 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8

AF for dose response relationship:
1
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for differences in duration of exposure:
6
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for interspecies differences (allometric scaling):
4
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for other interspecies differences:
2.5
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for intraspecies differences:
10
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for the quality of the whole database:
1
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for remaining uncertainties:
1
Justification:
According to ECHA 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:
medium 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:
0.5 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:
300 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

no modification done

AF for dose response relationship:
1
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for differences in duration of exposure:
1
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for interspecies differences (allometric scaling):
1
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for other interspecies differences:
1
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for intraspecies differences:
1
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for the quality of the whole database:
1
Justification:
According to ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.8
AF for remaining uncertainties:
1
Justification:
According to ECHA 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:
low hazard (no threshold derived)

Additional information - General Population