Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
47 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
Modified dose descriptor starting point:
NOAEC
Value:
3 526 mg/m³
Explanation for the modification of the dose descriptor starting point:
The NOAEC of inhalation is derived from the NOAEC of repeated dose oral test. According to REACH R.8 Figure R. 8-3, corrected inhalatory NOAEC = oral NOAEL * (1/sRVrat) * (ABSoral-rat/ABSinh-rat) * (ABSinh-rat/ABSinh-human) *(sRVhuman/wRV). sRVrat = 0.38 mg/m3; ABSoral-rat/ ABSinh-rat = 2; ABSin-rat/ABSinh-humna=1; sRV human/ wRV = 0.67.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
In the inhalation, allmetric scaling is not taken into account.
AF for other interspecies differences:
2.5
Justification:
Other difference
AF for intraspecies differences:
5
Justification:
Worker
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
3.3 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
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The NOAEC of dermal is derived from the NOAEC of repeated dose oral test. According to REACH R.8, corrected dermal NOAEC = oral NOAEL * (ABSoral-rat/ABSdermal-rat)*(ABSdermal-rat/ABSdermal-human). ABSoral-rat/ ABSdermal-rat = 1; ABSdermal-rat/ ABSdermal-human = 1.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Rat to human
AF for other interspecies differences:
2.5
Justification:
Other difference
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

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:
11.6 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
Modified dose descriptor starting point:
NOAEC
Value:
1 739 mg/m³
Explanation for the modification of the dose descriptor starting point:
The NOAEC of inhalation is derived from the NOAEC of repeated dose oral test. According to REACH R.8 Figure R. 8-3, corrected inhalatory NOAEC = oral NOAEL * (1/sRVrat) * (ABSoral-rat/ABSinh-rat)* (ABSinh-rat/ABSinh-human). sRVrat = 1.15 mg/m3; ABSoral-rat/ ABSinh-rat = 2; ABSin-rat/ABSinh-humna=1.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
1
AF for other interspecies differences:
2.5
Justification:
Other difference
AF for intraspecies differences:
10
Justification:
Consumer
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
1.7 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
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The NOAEC of dermal is derived from the NOAEC of repeated dose oral test. According to REACH R.8, corrected dermal NOAEC = oral NOAEL * (ABSoral-rat/ABSdermal-rat)*(ABSdermal-rat/ABSdermal-human). ABSoral-rat/ ABSdermal-rat = 1; ABSdermal-rat/ ABSdermal-human = 1.
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
Justification:
Other differences
AF for intraspecies differences:
10
Justification:
Consumer
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.7 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
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The NOAEC of oral is derived from the NOAEC of repeated dose oral test. According to REACH R.8, corrected oral NOAEC = oral NOAEL * (ABSoral-rat/ABSoral-human). ABS oral-rat/ABS oral-human = 1
AF for dose response relationship:
1
AF for differences in duration of exposure:
6
Justification:
Subacute to chronic
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
Justification:
Other differences
AF for intraspecies differences:
10
Justification:
Consumer
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population