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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
45 µg/m³
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3 125
Modified dose descriptor starting point:
T25
Value:
141 mg/m³
Explanation for the modification of the dose descriptor starting point:
T25 of 57 mg/kg/d (rat, oral) corrected to T25 (workers, inhalation) according to ECHA Guidance R8 Appendix R8-6 and R8-7
AF for dose response relationship:
2.5
Justification:
T25 used
AF for differences in duration of exposure:
1
Justification:
103 weeks rat study
AF for interspecies differences (allometric scaling):
2.5
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
10
Justification:
point of comparison
AF for remaining uncertainties:
10
Justification:
nature of carcinogenic process
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.24 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor:
NOAEC
AF for differences in duration of exposure:
2
Justification:
13 wk study
AF for interspecies differences (allometric scaling):
1
Justification:
inhalation study in rat
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.72 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
8.33
Dose descriptor starting point:
NOAEC

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
12.76 µg/kg bw/day
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
12 500
Modified dose descriptor starting point:
T25
Value:
159.6 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
See ECHA Guidance R8 page 21 (oral = dermal)
AF for dose response relationship:
2.5
Justification:
T25 used
AF for differences in duration of exposure:
1
Justification:
103 weeks oral study
AF for interspecies differences (allometric scaling):
10
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
AF for the quality of the whole database:
10
Justification:
point of comparison
AF for remaining uncertainties:
10
Justification:
nature of carcinogenic process
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.24 µg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor:
other: NOAEL
AF for differences in duration of exposure:
5
Justification:
45d study in rat (oral)
AF for interspecies differences (allometric scaling):
1
Justification:
local effects
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
5
Justification:
workers
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
6.72 µg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
8.33
Dose descriptor starting point:
other: NOAEL

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
4 µg/m³
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
6 250
Modified dose descriptor starting point:
T25
Value:
24.8 mg/m³
Explanation for the modification of the dose descriptor starting point:
T25 of 57 mg/kg/d (rat, oral) corrected to T25 for consumers at 24hr/day via multiplication with 1/1.15 and 1/2 (ECHA Guidance)
AF for dose response relationship:
2.5
Justification:
T25 used
AF for differences in duration of exposure:
1
Justification:
103 wk rat study
AF for interspecies differences (allometric scaling):
2.5
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
consumers
AF for the quality of the whole database:
10
Justification:
point of comparison
AF for remaining uncertainties:
10
Justification:
nature of carcinogenic process
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
By inhalation
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.06 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor:
NOAEC
AF for differences in duration of exposure:
2
Justification:
13wk study
AF for interspecies differences (allometric scaling):
1
Justification:
inhalation study
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
consumers
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.18 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
16.67
Dose descriptor starting point:
NOAEC

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
2.3 µg/kg bw/day
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25 000
Modified dose descriptor starting point:
T25
Value:
57 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
See Guidance R8 page 21 (oral = dermal)
AF for dose response relationship:
2.5
Justification:
T25 used
AF for differences in duration of exposure:
1
Justification:
103 week study
AF for interspecies differences (allometric scaling):
10
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
consumers
AF for the quality of the whole database:
10
Justification:
point of comparison
AF for remaining uncertainties:
10
Justification:
nature of carcinogenic process
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.12 µg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor:
other: NOAEL
AF for differences in duration of exposure:
5
Justification:
45d study (rat, oral)
AF for interspecies differences (allometric scaling):
1
Justification:
local effects
AF for other interspecies differences:
1
AF for intraspecies differences:
10
Justification:
consumers
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.36 µg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
Overall assessment factor (AF):
16.67
Dose descriptor starting point:
other: NOAEL

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DMEL (Derived Minimum Effect Level)
Value:
2.3 µg/kg bw/day
Most sensitive endpoint:
carcinogenicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25 000
Modified dose descriptor starting point:
T25
Value:
57 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
See ECHA Guidance R8 Appendix R8-6 and R8-7
AF for dose response relationship:
2.5
Justification:
T25 used
AF for differences in duration of exposure:
1
Justification:
103 weeks oral rat study
AF for interspecies differences (allometric scaling):
10
Justification:
ECHA Guidance
AF for other interspecies differences:
1
Justification:
ECHA Guidance
AF for intraspecies differences:
10
Justification:
consumers
AF for the quality of the whole database:
10
Justification:
point of comparison
AF for remaining uncertainties:
10
Justification:
nature of carcinogenic process
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

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