Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
16.4 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: 'ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
7.5
Dose descriptor starting point:
other: NOEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
other: NOEL
Value:
123 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point dermal NOEL adjusted for rat versus man absorption, conversion to inhalation [1/0.43 x 1/0.38 x 6.7/10 {light work ventilation rate}]

AF for dose response relationship:
1
Justification:
Not required: starting point was a NOEL
AF for differences in duration of exposure:
1
Justification:
Not required
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:
DNEL (Derived No Effect Level)
Value:
1 500.8 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
7.5
Dose descriptor starting point:
other: NOEC
Value:
1 050 mg/m³
Modified dose descriptor starting point:
other: NOEC
Value:
11 256 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point NOEC 4 hrs exposure adjusted for duration of work [240/15 {mins of work} x 6.7/10 {light work ventilation rate}]

AF for dose response relationship:
1
Justification:
Not required: starting point was a NOEC
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

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:
2.91 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 procedure but incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
24
Dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
69.8 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point NOAEL [1/0.43] {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}]

AF for dose response relationship:
1
Justification:
Not required: starting point was a NOAEL
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic
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:
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:
4.85 mg/m³
Most sensitive endpoint:
developmental toxicity / teratogenicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
other: NOEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
other: NOEL
Value:
60.7 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point dermal NOEL adjusted for rat versus man absorption, conversion to inhalation [1/0.43 x 1/1.15]

AF for dose response relationship:
1
Justification:
Not required: starting point was a NOEL
AF for differences in duration of exposure:
1
Justification:
Not required
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 intrapecies 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:
DNEL (Derived No Effect Level)
Value:
900.48 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance procedure but incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
12.5
Dose descriptor starting point:
other: NOEC
Value:
1 050 mg/m³
Modified dose descriptor starting point:
other: NOEC
Value:
11 256 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point NOEC 4 hrs exposure adjusted for duration of work [240/15 {mins of work} x 6.7/10 {light work ventilation rate}]

AF for dose response relationship:
1
Justification:
Not required: starting point was a NOEC
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

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:
1.25 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 procedure but incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
49.9 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point NOAEL x [5/7] {days/week exposure} x [1/0.43] {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}]

AF for dose response relationship:
1
Justification:
Not required: starting point was a NOAEL
AF for differences in duration of exposure:
2
Justification:
Sub-chronic 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 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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.25 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 procedure but incorporating ECETOC intraspecies AF
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
49.9 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point NOAEL x [5/7] {days/week exposure} x [1/0.43] {Adjust the human dermal uptake to rat with adjustment factor of 0.43 to account for increased rat absorption}]

AF for dose response relationship:
1
Justification:
Not required: starting point was a NOAEL
AF for differences in duration of exposure:
2
Justification:
Sub-chronic 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 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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population