Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.41 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
4 320
Modified dose descriptor starting point:
LOAEC
Value:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:
according to ECHA and ECETOC guidelines; there is no evidence that route-to-route extrapolation cannot be applied.
AF for dose response relationship:
8
Justification:
LOAEL based on clinical signs observed in an acute oral toxicity study
AF for differences in duration of exposure:
18
Justification:
assuming chronic exposure of the worker
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand for inhalation
AF for other interspecies differences:
1
Justification:
according to ECETOC guideline
AF for intraspecies differences:
3
Justification:
according to ECETOC guideline
AF for the quality of the whole database:
10
Justification:
acute studies available only
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
0.12 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
17 280
Modified dose descriptor starting point:
LOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not needed, as dermal study is starting point.
AF for dose response relationship:
8
Justification:
LOAEL based on clinical signs observed in an acute dermal toxicity study
AF for differences in duration of exposure:
18
Justification:
assuming chronic exposure of the worker
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
according to guideline
AF for intraspecies differences:
3
Justification:
according to guideline
AF for the quality of the whole database:
10
Justification:
acute studies available only
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.22 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
9
Dose descriptor:
other: LOAEL
AF for dose response relationship:
3
Justification:
extrapolation LOAEL to NOAEL
AF for differences in duration of exposure:
1
Justification:
local effect
AF for interspecies differences (allometric scaling):
1
Justification:
local effect
AF for other interspecies differences:
1
Justification:
according to guideline
AF for intraspecies differences:
3
Justification:
difference in sensitivity among workers
AF for the quality of the whole database:
1
Justification:
no additional assessment factor required
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.22 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
9
Dose descriptor starting point:
other: LOAEL
AF for dose response relationship:
3
Justification:
extrapolation LOAEL to NOAEL
AF for interspecies differences (allometric scaling):
1
Justification:
local effect
AF for other interspecies differences:
1
Justification:
local effect
AF for intraspecies differences:
3
Justification:
difference in sensitivity among workers
AF for the quality of the whole database:
1
Justification:
no additional assessment factor required
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties

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:
0.12 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
7 200
Modified dose descriptor starting point:
LOAEC
Value:
869 mg/m³
Explanation for the modification of the dose descriptor starting point:
according to ECHA and ECETOC guidelines; there is no evidence that route-to-route extrapolation cannot be applied.
AF for dose response relationship:
8
Justification:
LOAEL based on clinical signs observed in an acute oral toxicity study
AF for differences in duration of exposure:
18
Justification:
assuming chronic exposure of the general population
AF for interspecies differences (allometric scaling):
1
Justification:
no correction for caloric demand for inhalation
AF for other interspecies differences:
1
Justification:
according to ECETOC guideline
AF for intraspecies differences:
5
Justification:
according to ECETOC guideline
AF for the quality of the whole database:
10
Justification:
acute studies available only
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.07 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
28 800
Modified dose descriptor starting point:
LOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not needed, as dermal study is starting point.
AF for dose response relationship:
8
Justification:
LOAEL based on clinical signs observed in an acute dermal toxicity study
AF for differences in duration of exposure:
18
Justification:
assuming chronic exposure of the general population
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
according to ECETOC guideline
AF for intraspecies differences:
5
Justification:
according to ECETOC guideline
AF for the quality of the whole database:
10
Justification:
acute studies available only
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.3 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
15
Dose descriptor:
other: LOAEL
AF for dose response relationship:
3
Justification:
extrapolation from LOAEL to NOAEL
AF for differences in duration of exposure:
1
Justification:
local effect, according to ECETOC guideline
AF for interspecies differences (allometric scaling):
1
Justification:
local effect, according to ECETOC guideline
AF for other interspecies differences:
1
Justification:
no additional assessment factor required
AF for intraspecies differences:
5
Justification:
according to ECETOC guideline
AF for the quality of the whole database:
1
Justification:
no additional assessment factor required
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.3 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
15
Dose descriptor starting point:
other: LOAEL
AF for dose response relationship:
3
Justification:
extrapolation from LOAEL to NOAEL
AF for interspecies differences (allometric scaling):
1
Justification:
local effect, according to ECETOC guideline
AF for other interspecies differences:
1
Justification:
no additional assessment factor required
AF for intraspecies differences:
5
Justification:
according to ECETOC guideline
AF for the quality of the whole database:
1
Justification:
no additional assessment factor required
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.07 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC guidance (Technical Report No. 110, October 2010)
Overall assessment factor (AF):
28 800
Modified dose descriptor starting point:
LOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
not applicable, as starting point is oral toxicity study.
AF for dose response relationship:
8
Justification:
LOAEL based on clinical signs observed in an acute dermal toxicity study
AF for differences in duration of exposure:
18
Justification:
assuming chronic exposure of the general population
AF for interspecies differences (allometric scaling):
4
Justification:
rat to human
AF for other interspecies differences:
1
Justification:
according to ECETOC guideline
AF for intraspecies differences:
5
Justification:
according to ECETOC guideline
AF for the quality of the whole database:
10
Justification:
Acute studies available only
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
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