Registration Dossier

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.