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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
141 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):
12.5
Modified dose descriptor starting point:
NOAEC
Value:
1 763 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation toxicity data are available; inhalation DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d, correcting for breathing rate (/0.38) and activity (*0.67) results in a corrected starting point (inhalation NOAEC) of 1763 mg/m3. Correction for the extent of oral absorption and inhalation absorption is not required as oral absorption is likely to represent the worst case.
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
1
Justification:
Not required: available studies are of up to chronic duration
AF for interspecies differences (allometric scaling):
1
Justification:
Not required: already accounted for
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value (worker)
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information
DNEL derivation method:
ECHA REACH Guidance

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:
1.7 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):
50
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dermal toxicity data are available; dermal DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d results in a corrected starting point (dermal NOAEL) of 1000 mg/kg bw/d.
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
1
Justification:
Not required: available studies are of up to chronic duration
AF for interspecies differences (allometric scaling):
4
Justification:
Default value (rat study)
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
5
Justification:
Default value (worker)
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value
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

Inhalation DNEL values

No inhalation toxicity data are available; inhalation DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d, correcting for breathing rate (/0.38) and activity (*0.67) results in a corrected starting point (inhalation NOAEC) of 1763 mg/m3. Correction for the extent of oral absorption and inhalation absorption is not required as oral absorption is likely to represent the worst case. Individual Assessment Factors of 1 (for dose-response relationship), 1 (for exposure duration), 1 (for allometric factors), 2.5 (for other intraspecies differences), 5 (for interspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) results in an overall Assessment Factor of 12.5. Application of the overall Assessment Factor to the corrected starting point results in a long-term systemic inhalation DNEL of 141 mg/m3.

The substance is of very low acute toxicity. In the absence of a hazard, an acute inhalation systemic DNEL is not derived.

The substance is not an irritant. In the absence of a hazard, local inhalation DNELs are not derived.

Dermal DNEL values

No dermal toxicity data are available; dermal DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d results in a corrected starting point (dermal NOAEL) of 1000 mg/kg bw/d. Correction for the extent of oral absorption and dermal absorption is not required as oral absorption is likely to represent the worst case. Individual Assessment Factors of 1 (for dose-response relationship), 1 (for exposure duration), 4 (for allometric factors), 2.5 (for other intraspecies differences), 5 (for interspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) results in an overall Assessment Factor of 50. Application of the overall Assessment Factor to the corrected starting point results in a long-term systemic dermal DNEL of 20 mg/kg bw/d.

The substance is of very low acute toxicity. In the absence of a hazard, an acute dermal systemic DNEL is not derived.

The substance is not an irritant. In the absence of a hazard, local dermal DNELs are not derived.

General Population - 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):
25
Modified dose descriptor starting point:
NOAEC
Value:
870 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation toxicity data are available; inhalation DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d, correcting for breathing rate (/1.15) results in a corrected starting point (inhalation NOAEC) of 870 mg/m3.
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
1
Justification:
Not required: available studies are of up to chronic duration
AF for interspecies differences (allometric scaling):
1
Justification:
Not required: already accounted for
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value (general population)
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value
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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
10 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:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dermal toxicity data are available; dermal DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d results in a corrected starting point (dermal NOAEL) of 1000 mg/kg bw/d.
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
1
Justification:
Not required: available studies are of up to chronic duration
AF for interspecies differences (allometric scaling):
4
Justification:
Default value (rat)
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value (general population)
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value
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:
10 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:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not required
AF for dose response relationship:
1
Justification:
Default value
AF for differences in duration of exposure:
1
Justification:
Not required: available studies are of up to chronic duration
AF for interspecies differences (allometric scaling):
4
Justification:
Default value
AF for other interspecies differences:
2.5
Justification:
Default value
AF for intraspecies differences:
10
Justification:
Default value (general population)
AF for the quality of the whole database:
1
Justification:
Default value
AF for remaining uncertainties:
1
Justification:
Default value
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

Inhalation DNEL values

No inhalation toxicity data are available; inhalation DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d, correcting for breathing rate (/1.15) results in a corrected starting point (inhalation NOAEC) of 870 mg/m3. Correction for the extent of oral absorption and inhalation absorption is not required as oral absorption is likely to represent the worst case. Individual Assessment Factors of 1 (for dose-response relationship), 1 (for exposure duration), 1 (for allometric factors), 2.5 (for other intraspecies differences), 10 (for interspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) results in an overall Assessment Factor of 5. Application of the overall Assessment Factor to the corrected starting point results in a long-term systemic inhalation DNEL of 141 mg/m3.

The substance is of very low acute toxicity. In the absence of a hazard, an acute inhalation systemic DNEL is not derived.

The substance is not an irritant. In the absence of a hazard, local inhalation DNELs are not derived.

Dermal DNEL values

 

No dermal toxicity data are available; inhalation DNELs are therefore derived using the oral toxicity data as a starting point. There is no evidence of adverse toxicological effects from the available dataset at dose levels of up to and including the limit dose of 1000 mg/kg bw/d in studies of up to chronic duration; this dose level is therefore used a starting point for DNEL derivation. Using the oral NOAEL of 1000 mg/kg bw/d results in a corrected starting point (dermal NOAEL) of 1000 mg/kg bw/d. Correction for the extent of oral absorption and dermal absorption is not required as oral absorption is likely to represent the worst case. Individual Assessment Factors of 1 (for dose-response relationship), 1 (for exposure duration), 4 (for allometric factors), 2.5 (for other intraspecies differences), 10 (for interspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) results in an overall Assessment Factor of 100. Application of the overall Assessment Factor to the corrected starting point results in a long-term systemic DNEL of 10 mg/kg bw/d.

The substance is of very low acute toxicity. In the absence of a hazard, an acute dermal systemic DNEL is not derived.

The substance is not an irritant. In the absence of a hazard, local dermal DNELs are not derived.

 

Oral DNEL values

Oral DNELs are derived using the oral toxicity data as a starting point.  Individual Assessment Factors of 1 (for dose-response relationship), 1 (for exposure duration), 4 (for allometric factors), 2.5 (for other intraspecies differences), 10 (for interspecies differences), 1 (for database quality) and 1 (for remaining uncertainties) results in an overall Assessment Factor of 100. Application of the overall Assessment Factor to the corrected starting point results in a long-term oral systemic DNEL of 10 mg/kg bw/d.

The substance is of very low acute toxicity. In the absence of a hazard, an acute oral systemic DNEL is not derived.

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