Registration Dossier
Registration Dossier
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EC number: 216-323-7 | CAS number: 1559-35-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.47 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 1.47 mg/m³
- Value:
- 1.47 mg/m³
- Explanation for the modification of the dose descriptor starting point:
DNEL Derivation
The starting point for the DNEL derivation was from an OECD 422 28-day repeat dose/reproductive screen, where the NOAEL was 500 mg/kg/day, the highest dose tested.
The derivation of theWorker long-term systemic inhalation DNELwas as follows.
- NOAEL of 500 mg/kg/day. Correct to an inhalation dose with a factor of 0.38 m3/kg. 500/0.38 = 1315 mg/m3.
- The value is then corrected for 50% bioavailability by the oral route. 1315 mg/m3/2 = 657.89 mg/m3.
- The value is then corrected for increased respiration for light work. 657*0.67 = 440.79.
- This value is then dived by the adjustment factor of 300 for a final DNEL of 1.47. The adjustment factors are as follows:
Intraspecies: 5
Allometric scaling 4
Interspecies 2.5
Subacute to chronic 6
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
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:
- 1.67 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 1.67 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1.67 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
DNEL Derivation
The derivation of theWorker long-term systemic Dermal DNELwas as follows.
- NOAEL of 500 mg/kg/day. Divide by a total adjustment factor of 300 for a DNEL of 1.67 mg/kg
- The adjustment factors are as follows:
Intraspecies: 5
Allometric scaling 4
Interspecies 2.5
Subacute to chronic 6
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 5
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:
- 0.36 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.36 mg/m³
- Value:
- 0.36 mg/m³
- Explanation for the modification of the dose descriptor starting point:
DNEL Derivation
The derivation of theGeneral Population long-term systemic inhalation DNELwas as follows.
- NOAEL of 500 mg/kg/day. Correct to an inhalation dose with a factor of 1.15 m3/kg. 500/1.15 = 474 mg/m3.
- The value is then corrected for 50% bioavailability by the oral route. 434 mg/m3/2 = 217 mg/m3.
- This value is then dived by the adjustment factor of 600 for a final DNEL of 0.36 The adjustment factors are as follows:
Intraspecies: 10
Allometric scaling 4
Interspecies 2.5
Subacute to chronic 6
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
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:
- 0.83 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.83 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.83 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
DNEL Derivation
The derivation of theGeneral Population long-term systemic Oral/Dermal DNELwas as follows.
- NOAEL of 500 mg/kg/day.
- Divide by a total adjustment factor of 300 for a DNEL of 0.83 mg/kg
- The adjustment factors are as follows:
Intraspecies: 10
Allometric scaling 4
Interspecies 2.5
Subacute to chronic 6
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
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:
- 0.83 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 0.83 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 0.83 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
DNEL Derivation
The derivation of theGeneral Population long-term systemic Oral/Dermal DNELwas as follows.
- NOAEL of 500 mg/kg/day.
- Divide by a total adjustment factor of 300 for a DNEL of 0.83 mg/kg
- The adjustment factors are as follows:
Intraspecies: 10
Allometric scaling 4
Interspecies 2.5
Subacute to chronic 6
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
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
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