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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEC
Value:
3 500 mg/m³
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
700 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Value:
35 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
35 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
700 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
100 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEL
Value:
5 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.125 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
1
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
20
Dose descriptor starting point:
other: NOAEL
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
1
Justification:
REACH default factor
AF for intraspecies differences:
5
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
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:
17.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEC
Value:
3 500 mg/m³
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
350 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEC
Value:
35 000 mg/m³
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor:
NOAEC
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
350 mg/m³
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
5 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Extrapolated from oral GLP compliant study, therefore regarded as a reliable 1:1 ratio.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.062 mg/cm²
Most sensitive endpoint:
repeated dose toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
80
Dose descriptor:
other: NOAEL
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
1
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.25 mg/cm²
Most sensitive endpoint:
acute toxicity
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
40
Dose descriptor starting point:
other: NOAEL
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
1
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
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:
2.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Value:
500 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable as GLP compliant oral study used.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for differences in duration of exposure:
2
Justification:
REACH default factor
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
50 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
5 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable as GLP compliant oral study used.
AF for dose response relationship:
1
Justification:
Klimisch 1 oral study used.
AF for interspecies differences (allometric scaling):
4
Justification:
REACH default factor
AF for other interspecies differences:
2.5
Justification:
REACH default factor
AF for intraspecies differences:
10
Justification:
REACH default factor
AF for the quality of the whole database:
1
Justification:
No problem with quality; GLP compliant study.
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties.

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population