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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
22.73 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):
1
Modified dose descriptor starting point:
NOAEC
Value:
5 mg/m³
Explanation for the modification of the dose descriptor starting point:
No hazard data via the inhalation route available.
AF for dose response relationship:
1
Justification:
NOAEL used as POD
AF for differences in duration of exposure:
1
Justification:
not required, human data
AF for interspecies differences (allometric scaling):
1
Justification:
not required, human data
AF for other interspecies differences:
1
Justification:
not required, human data
AF for intraspecies differences:
1
Justification:
not required, human data
AF for the quality of the whole database:
1
Justification:
key studies are of high quality
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
24.39 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):
50
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No hazard data via the dermal route available.
AF for dose response relationship:
1
Justification:
NOAEL used as POD
AF for differences in duration of exposure:
1
Justification:
chronic study available
AF for interspecies differences (allometric scaling):
4
Justification:
default value according to ECHA guidance
AF for other interspecies differences:
2.5
Justification:
default value according to ECHA guidance
AF for intraspecies differences:
5
Justification:
default value according to ECHA guidance
AF for the quality of the whole database:
1
Justification:
key study is of high quality
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:
medium hazard (no threshold derived)

Additional information - workers

For further information on the DNEL derivation, please refer to the attached document in IUCLID section 7.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
11.36 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):
1
Modified dose descriptor starting point:
NOAEC
Value:
2.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
No hazard data via the inhalation route available.
AF for dose response relationship:
1
Justification:
NOAEL used as POD
AF for differences in duration of exposure:
1
Justification:
not required, human data
AF for interspecies differences (allometric scaling):
1
Justification:
not required, human data
AF for other interspecies differences:
1
Justification:
not required, human data
AF for intraspecies differences:
1
Justification:
not required, human data
AF for the quality of the whole database:
1
Justification:
key studies are of high quality
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:
12.2 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
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No hazard data via the dermal route available.
AF for dose response relationship:
1
Justification:
NOAEL used as POD
AF for differences in duration of exposure:
1
Justification:
chronic study available
AF for interspecies differences (allometric scaling):
4
Justification:
default value according to ECHA guidance
AF for other interspecies differences:
2.5
Justification:
default value according to ECHA guidance
AF for intraspecies differences:
10
Justification:
default value according to ECHA guidance
AF for the quality of the whole database:
1
Justification:
key study is of high quality
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:
3.77 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):
1
Modified dose descriptor starting point:
NOAEL
Value:
0.83 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL used as POD
AF for differences in duration of exposure:
1
Justification:
not required, human data
AF for interspecies differences (allometric scaling):
1
Justification:
not required, human data
AF for other interspecies differences:
1
Justification:
not required, human data
AF for intraspecies differences:
1
Justification:
not required, human data
AF for the quality of the whole database:
1
Justification:
key studies are of high quality
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

For further information on the DNEL derivation, please refer to the attached document in IUCLID section 7.