Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
22.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical Report N°86 and 110
Overall assessment factor (AF):
24
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
PoD NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic exposure duration
AF for other interspecies differences:
4
Justification:
Rat to human
AF for intraspecies differences:
3
Justification:
Worker
AF for the quality of the whole database:
1
Justification:
experimental study (guideline study)
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:
12.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical report n°86 & 110
Overall assessment factor (AF):
24
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEL
AF for dose response relationship:
1
Justification:
PoD: NOAEL
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic exposure duration
AF for other interspecies differences:
4
Justification:
Rat to human
AF for intraspecies differences:
3
Justification:
Worker
AF for the quality of the whole database:
1
Justification:
experimental study (guideline study)
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

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:
6.52 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical report n°86 & 110
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
PoD: NOAEL
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic exposure duration
AF for other interspecies differences:
4
Justification:
Rat to human
AF for intraspecies differences:
5
Justification:
General Population
AF for the quality of the whole database:
1
Justification:
experimental study (guideline study)
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:
7.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical report n°86 & 110
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
AF for dose response relationship:
1
Justification:
PoD: NOAEL
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic exposure duration
AF for other interspecies differences:
4
Justification:
Rat to human
AF for intraspecies differences:
5
Justification:
General Population
AF for the quality of the whole database:
1
Justification:
experimental study (guideline study)
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical report n°86 & 110
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEL
AF for dose response relationship:
1
Justification:
PoD: NOAEL
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic exposure duration
AF for other interspecies differences:
4
Justification:
Rat to human
AF for intraspecies differences:
5
Justification:
General Population
AF for the quality of the whole database:
1
Justification:
experimental study (guideline study)
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