Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
136.68 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
15
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
2 050 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point NOAEL (Dermal rat 13 week repeat dose study); x [6.7/10 {light work ventilation rate}] x [1/0.38{adjust for human inhalation rate from dermal}] x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}] = 2050 mg/m3

AF for dose response relationship:
1
Justification:
Not required; starting point was a NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA R.8 value)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not required
AF for other interspecies differences:
2.5
Justification:
Interspecies rat to human (ECHA R.8 value)
AF for intraspecies differences:
3
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not required
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:
48.45 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
24
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 163 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point (13 week dermal rat study); x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}] = 1163 mg/kg/day

AF for dose response relationship:
1
Justification:
Not required; starting point was a NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA R.8 value)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA guidance R.8 value
AF for other interspecies differences:
1
Justification:
Not required
AF for intraspecies differences:
3
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not required
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:
28.89 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
722 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point NOAEL (Dermal rat 13 week repeat dose study); x 5 days per week adjusted [5/7{days/week}] x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}] x [1/1.15 {Allometric scaling rat to human and dermal to inhalation}] = 14.5 mg/m3

AF for dose response relationship:
1
Justification:
Not required; starting point was a NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA R.8 value)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not required
AF for other interspecies differences:
2.5
Justification:
Interspecies rat to human (ECHA R.8 value)
AF for intraspecies differences:
5
Justification:
ECETOC intraspecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not required
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:
5.19 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
208 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point (13 week dermal rat study); x 7 days per week adjusted [7/5 {days/week}] x 6 hours per day adjusted [6/24{hours/day}] x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}]  = 207 mg/kg/day

AF for dose response relationship:
1
Justification:
Not required; starting point was a NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic (ECHA R.8 value)
AF for interspecies differences (allometric scaling):
4
Justification:
Interspecies rat to human (ECHA R.8 value)
AF for other interspecies differences:
1
Justification:
Not required
AF for intraspecies differences:
5
Justification:
ECETOC intrapsecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not required
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:
5.19 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
208 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point (13 week dermal rat study); x 7 days per week adjusted [7/5 {days/week}] x 6 hours per day adjusted [6/24{hours/day}] x [1/0.43 {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}]  = 207 mg/kg/day

AF for dose response relationship:
1
Justification:
Not required; starting point was a NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic, ECHA R.8 value
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA guidance R.8 value
AF for other interspecies differences:
1
Justification:
Not required
AF for intraspecies differences:
5
Justification:
ECETOC intrapsecies AF
AF for the quality of the whole database:
1
Justification:
Reliable study available
AF for remaining uncertainties:
1
Justification:
Not required
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