Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
27.34 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:
50 mg/kg bw/day
Modified dose descriptor starting point:
other: NOEC
Value:
205 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point NOEL (rat dermal development toxicity study); x [1/0.43 {RVM}] x [1/0.38{convert to inhal dose}] x [6.7/10 {light work ventilation rate}] = 205 mg/m3

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 differences (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:
2 229.76 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:
1 560 mg/m³
Modified dose descriptor starting point:
other: NOEC
Value:
16 723 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point NOEC (Rat acute inhalation Tox study); x adjusted for duration [240/15 {minutes exposure}] x [6.7/10 {light work ventilation rate}]  = 16,723 mg/m3

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 AF (ECHA R.8)
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:
2.42 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:
25 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
58.14 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point NOAEL (90 day 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}]

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
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:
high 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:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.04 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:
25 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
41.53 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point NOAEL (90 day 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} x 5/7 {adjustment for days/week exposure}]

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
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 requried
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population