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EC number: 451-160-7 | CAS number: 17913-76-7
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 24.7 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 617 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- 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:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 7 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 700 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 5
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- 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:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
DNELs based on NOAEL of 500 mg/kg bw/d obtained in the subchronic study/one generation with rats
Hazard conclusions for workers
Route |
Type of effect |
Hazard conclusion |
Most sensitive endpoint |
Inhalation
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 24.7mg/m³
|
effect on fertility (Oral)
|
Dermal
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 7mg/kg bw/day
|
effect on fertility (Oral)
|
Correction factors:
Correction for differences in respiratory volume (workers): 2.63
Correction for differences in bioavailability (oral -> inhalation): 0.5
Correction for light activity at work: 0.67
Correction for differences between human and experimental exposure conditions (workers): 1.4
Inhalation Systemic effects - Long-term
DNEL derivation method: ECHA REACH Guidance
Dose descriptor starting point:NOAEL
Overall Assessment Factor:25
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):1 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:5 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Dermal Systemic effects - Long-term
DNEL derivation method: ECHA REACH Guidance
Dose descriptor starting point:NOAEL
Overall Assessment Factor:100
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):4 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:5 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
DNELs based on NOAEL of 200 mg/kg bw/d obtained in the subchronic study with beagle dogs
Hazard conclusions for workers
Route |
Type of effect |
Hazard conclusion |
Most sensitive endpoint |
Inhalation
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 28.9mg/m³
|
repeated dose toxicity (Oral)
|
Dermal
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 8mg/kg bw/day
|
repeated dose toxicity (Oral)
|
Correction factors:
Correction for differences in respiratory volume (workers): 7.69
Correction for differences in bioavailability (oral -> inhalation): 0.5
Correction for light activity at work: 0.67
Correction for differences between human and experimental exposure conditions (workers): 1.4
Inhalation Systemic effects - Long-term
DNEL derivation method:
Dose descriptor starting point:NOAEL
Modified dose descriptor starting point:NOAEC
Overall Assessment Factor:25
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):1 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:5 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Dermal Systemic effects - Long-term
DNEL derivation method:
Dose descriptor starting point:NOAEL
Modified dose descriptor starting point:NOAEL
Overall Assessment Factor:35
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):1.4 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:5 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Similar DNELs were obtained with both starting points.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.35 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:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 218 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- 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:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
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:
- 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:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- 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:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
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:
- 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:
- 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Default (DNEL calculator)
- AF for dose response relationship:
- 1
- Justification:
- Default (DNEL calculator)
- AF for differences in duration of exposure:
- 2
- Justification:
- Default (DNEL calculator)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default (DNEL calculator)
- AF for other interspecies differences:
- 2.5
- Justification:
- Default (DNEL calculator)
- AF for intraspecies differences:
- 10
- Justification:
- Default (DNEL calculator)
- AF for the quality of the whole database:
- 1
- Justification:
- Default (DNEL calculator)
- 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:
- low hazard (no threshold derived)
Additional information - General Population
DNELs based on NOAEL of 500 mg/kg bw/d obtained in the subchronic study/one generation with rats
Hazard conclusions for the general population
Route |
Type of effect |
Hazard conclusion |
Most sensitive endpoint |
Inhalation
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 4.35mg/m³
|
effect on fertility (Oral)
|
Dermal
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 2.5mg/kg bw/day
|
effect on fertility (Oral)
|
Oral
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 2.5mg/kg bw/day
|
effect on fertility (Oral)
|
Correction factors:
Correction for differences in respiratory volume (general population): 0.78
Correction for differences in bioavailability (oral -> inhalation): 0.5
Correction for differences between human and experimental exposure conditions (general population): 1
Inhalation Systemic effects - Long-term
DNEL derivation method: ECHA REACH Guidance
Dose descriptor starting point:NOAEL
Overall Assessment Factor:50
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):1 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:10 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Dermal Systemic effects - Long-term
DNEL derivation method: ECHA REACH Guidance
Dose descriptor starting point:NOAEL
Overall Assessment Factor:200
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):4 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:10 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Oral Systemic effects - Long-term
DNEL derivation method: ECHA REACH Guidance
Dose descriptor starting point:NOAEL
Overall Assessment Factor:200
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):4 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:10 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
DNELs based on NOAEL of 200 mg/kg bw/d obtained in the subchronic study with beagle dogs
Hazard conclusions for the general population
Route |
Type of effect |
Hazard conclusion |
Most sensitive endpoint |
Inhalation
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 5mg/m³
|
repeated dose toxicity (Oral)
|
Dermal
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 2.86mg/kg bw/day
|
repeated dose toxicity (Oral)
|
Oral
|
Systemic effects - Long-term
|
DNEL (Derived No Effect Level) 2.86mg/kg bw/day
|
repeated dose toxicity (Oral)
|
Correction factors:
Correction for differences in respiratory volume (general population): 2.5
Correction for differences in bioavailability (oral -> inhalation): 0.5
Correction for differences between human and experimental exposure conditions (general population): 1
Inhalation Systemic effects - Long-term
DNEL derivation method:
Dose descriptor starting point:NOAEL
Modified dose descriptor starting point:NOAEC
Overall Assessment Factor:50
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):1 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:10 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Dermal Systemic effects - Long-term
DNEL derivation method:
Dose descriptor starting point:NOAEL
Modified dose descriptor starting point:NOAEL
Overall Assessment Factor:70
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):1.4 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:10 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Oral Systemic effects - Long-term
DNEL derivation method:
Dose descriptor starting point:NOAEL
Modified dose descriptor starting point:NOAEL
Overall Assessment Factor:70
AF for dose response relationship:1 (Default (DNEL calculator))
AF for difference in duration of exposure:2 (Default (DNEL calculator))
AF for interspecies differences (allometric scaling):1.4 (Default (DNEL calculator))
AF for other interspecies differences:2.5 (Default (DNEL calculator))
AF for intraspecies differences:10 (Default (DNEL calculator))
AF for the quality of the whole database:1 (Default (DNEL calculator))
Similar DNELs were obtained with both starting points.
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