Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7 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):
10
Modified dose descriptor starting point:
NOAEC
DNEL value:
70.3 mg/m³
Explanation for the modification of the dose descriptor starting point:
Based on Guidance Document, Chapter R.8, Appendix R.8-2. A 10% absorption via oral vs. inhalation was assumed
AF for dose response relationship:
1
Justification:
Clear NOAEL value was assigned
AF for differences in duration of exposure:
2
Justification:
Extrapolation of sub-chronic to chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable, correction of oral to inhalation (rat to human) already performed
AF for other interspecies differences:
1
Justification:
Not applicable
AF for intraspecies differences:
5
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
The quality of the whole database was considered adequate
AF for remaining uncertainties:
1
Justification:
None identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4 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
DNEL value:
400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Assumed equivalent bioavailability between oral and dermal routes of exposure
AF for dose response relationship:
1
Justification:
A clear NOAEL value was assigned
AF for differences in duration of exposure:
2
Justification:
Extrapolation for sub-chronic to chronic toxicity
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for the rat
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
The quality of the whole database was considered adequate
AF for remaining uncertainties:
1
Justification:
None identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

Default procedures for the calculation of DNEL values were employed as described in the REACH technical guidance documents (Chapter 8).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.7 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):
20
Modified dose descriptor starting point:
NOAEC
DNEL value:
34.8 mg/m³
Explanation for the modification of the dose descriptor starting point:
Based on Guidance Document, Chapter R.8, Appendix R.8-2. A 10% absorption via oral vs. inhalation was assumed
AF for dose response relationship:
1
Justification:
Clear NOAEL value was assigned
AF for differences in duration of exposure:
2
Justification:
Extrapolation of sub-chronic to chronic study
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable, correction of oral to inhalation (rat to human) already performed
AF for other interspecies differences:
1
Justification:
Not applicable
AF for intraspecies differences:
10
Justification:
Default
AF for the quality of the whole database:
1
Justification:
The quality of the whole database was considered adequate
AF for remaining uncertainties:
1
Justification:
None identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
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):
200
Modified dose descriptor starting point:
NOAEL
DNEL value:
400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Assumed equivalent bioavailability between oral and dermal routes of exposure
AF for dose response relationship:
1
Justification:
A clear NOAEL value was assigned
AF for differences in duration of exposure:
2
Justification:
Extrapolation of sub-chronic to chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for the rat
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
The quality of the whole database was considered adequate
AF for remaining uncertainties:
1
Justification:
None identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
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):
200
Modified dose descriptor starting point:
NOAEL
DNEL value:
400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable
AF for dose response relationship:
1
Justification:
A clear NOAEL value was assigned
AF for differences in duration of exposure:
2
Justification:
Extrapolation of sub-chronic to chronic study
AF for interspecies differences (allometric scaling):
4
Justification:
Default value for the rat
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value
AF for the quality of the whole database:
1
Justification:
The quality of the whole database was considered adequate
AF for remaining uncertainties:
1
Justification:
None identified
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

Default procedures for the calculation of DNEL values were employed as described in the REACH technical guidance documents (Chapter 8).