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Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.53 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
176.32 mg/m³
Explanation for the modification of the dose descriptor starting point:

correction calculation: 200x (1/0.38) x (1/2) x (6.7/10)

AF for dose response relationship:
1
Justification:
NOAEL was used for DNEL derivation hence, AF of 1 was used for dose-response issues
AF for differences in duration of exposure:
4
Justification:
Based on the fact that NOAEL was derived from the Reproduction/Developmental Toxicity Screening Test ( OECD TG 421) the assessment factor of 4 was used (duration of the study was ca 50 days).
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not used for inhalation route.
AF for other interspecies differences:
2.5
Justification:
Additional factor of 2.5 for other interspecies differences was considered
AF for intraspecies differences:
5
Justification:
default assessment factor of 5 for workers was used
AF for the quality of the whole database:
1
Justification:
Based on the quality of data available, AF of 1 was used
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL was used for DNEL derivation hence, AF of 1 was used for dose-response issues
AF for differences in duration of exposure:
4
Justification:
Based on the fact that NOAEL was derived from the Reproduction/Developmental Toxicity Screening Test ( OECD TG 421) the assessment factor of 4 was used (duration of the study was ca 50 days).
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling rat to human
AF for other interspecies differences:
2.5
Justification:
Additional factor of 2.5 for other interspecies differences was considered
AF for intraspecies differences:
5
Justification:
default assessment factor of 5 for workers was used
AF for the quality of the whole database:
1
Justification:
Based on the quality of data available, AF of 1 was used
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:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.87 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
87 mg/m³
Explanation for the modification of the dose descriptor starting point:

correction calculation: 200 x (1/1.15) x (1/2)

AF for dose response relationship:
1
Justification:
NOAEL was used for DNEL derivation hence, AF of 1 was used for dose-response issues
AF for differences in duration of exposure:
4
Justification:
Based on the fact that NOAEL was derived from the Reproduction/Developmental Toxicity Screening Test ( OECD TG 421) the assessment factor of 4 was used (duration of the study was ca 50 days).
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
Additional factor of 2.5 for other interspecies differences was considered
AF for intraspecies differences:
10
Justification:
A default assessment factor of 10 was used, based on the fact that general population cover susceptible subgroups - the very young, the very old, and the very ill
AF for the quality of the whole database:
1
Justification:
Based on the quality of data available, AF of 1 was used
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:
0.5 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL was used for DNEL derivation hence, AF of 1 was used for dose-response issues
AF for differences in duration of exposure:
4
Justification:
Based on the fact that NOAEL was derived from the Reproduction/Developmental Toxicity Screening Test ( OECD TG 421) the assessment factor of 4 was used (duration of the study was ca 50 days).
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor of 4 for allometric scalling from rat to human was used for dermal NOAEL
AF for other interspecies differences:
2.5
Justification:
Additional factor of 2.5 for other interspecies differences was considered
AF for intraspecies differences:
10
Justification:
A default assessment factor of 10 was used, based on the fact that general population cover susceptible subgroups - the very young, the very old, and the very ill
AF for the quality of the whole database:
1
Justification:
Based on the quality of data available, AF of 1 was used
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:
0.5 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
200 mg/kg bw/day
AF for dose response relationship:
1
Justification:
NOAEL was used for DNEL derivation hence, AF of 1 was used for dose-response issues
AF for differences in duration of exposure:
4
Justification:
Based on the fact that NOAEL was derived from the Reproduction/Developmental Toxicity Screening Test ( OECD TG 421) the assessment factor of 4 was used (duration of the study was ca 50 days).
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor of 4 for allometric scalling from rat to human was used
AF for other interspecies differences:
2.5
Justification:
Additional factor of 2.5 for other interspecies differences was considered
AF for intraspecies differences:
10
Justification:
A default assessment factor of 10 was used, based on the fact that general population cover susceptible subgroups - the very young, the very old, and the very ill
AF for the quality of the whole database:
1
Justification:
Based on the quality of data available, AF of 1 was used
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population