Registration Dossier
Registration Dossier
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EC number: 484-350-3 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 49 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 13.9 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Workers - Hazard for the eyes
Additional information - workers
In the absence of systemic effects after acute exposure to the substance and in addition that no classification is applicable for acute toxicity, no acute systemic DNELs will be derived. Local effects were noted after acute dermal exposure, however in the skin irritation study the skin effects did not result in a classification. Therefore it is considered justified not to derive an acute local DNEL. Local DNELs after oral exposure for the general population are not required and therefore not derived. Workers are not exposed orally.
The following DNELs will be derived for workers:
Systemic:
Long-term inhalation workers
Long-term dermal workers
Route-to-route extrapolation
Necessary for systemic inhalation and dermal DNELs, since only oral toxicity data are available. The following values are considered for absorption (based on toxicokinetic assessment): For oral and dermal absorption 50% is used and inhalation absorption is 100%.
Starting point for DNEL derivation: NOAEL ≥ 1000 mg/kg bw/day from a subacute oral study in rats.The DNELs for human exposure are derived according to the ECETOC guidance (Technical Report No. 110, October 2010).
DNEL long-term, dermal systemic effects
Route-to-route extrapolation:
Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 1000 * 50/50 = 1000 mg/kg bw
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 3
- Exposure duration: 6 (assuming chronic worker exposure)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 72
Based on the above, the long-term DNEL for systemic effects after dermal worker exposure is set at 13.9 mg/kg bw/day.
DNEL long-term, inhalation systemic effects
Route-to-route extrapolation:
Inhalation NOAEL = oral NOAEL * ABSoral-rat/ABSinh-human = 1000 * 50/100 = 500 mg/kg bw
Corrected inhalatory NAEC = 500 * 1/0.38 * 6.7 m3/10 m3= 882 mg/m3
Safety factors:
- Interspecies extrapolation: 1
- Intraspecies extrapolation: 3
- Exposure duration: 6 (assuming chronic worker exposure)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 18
Based on the above, the long-term DNEL for systemic effects after inhalation exposure of the worker, is set at 49 mg/m3.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.3 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- no-threshold effect and/or no dose-response information available
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
In the absence of systemic effects after acute exposure to the substance and in addition that no classification is applicable for acute toxicity, no acute systemic DNELs will be derived. Local effects were noted after acute dermal exposure, however in the skin irritation study the skin effects did not result in a classification. Therefore it is considered justified not to derive an acute local DNEL. Local DNELs after oral exposure for the general population are not required and therefore not derived.
The following DNELs will be derived for the general population:
Systemic:
Long-term oral general population
Long-term inhalation general population
Long-term dermal general population
Route-to-route extrapolation
Necessary for systemic inhalation and dermal DNELs, since only oral toxicity data are available. The following values are considered for absorption (based on toxicokinetic assessment): For oral and dermal absorption 50% is used and inhalation absorption is 100%.
Starting point for DNEL derivation: NOAEL ≥ 1000 mg/kg bw/day from a subacute oral study in rats.The DNELs for human exposure are derived according to the ECETOC guidance (Technical Report No. 110, October 2010).
DNEL long-term, dermal systemic effects
Route-to-route extrapolation:
Dermal NOAEL = oral NOAEL * ABSoral-rat/ABSderm-human = 1000 * 50/50 = 1000 mg/kg bw
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 5
- Exposure duration: 6 (assuming chronic exposure of the general population)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 120
Based on the above, the long-term DNEL for systemic effects after dermal exposure of the general population is set at 8.3 mg/kg bw/day.
DNEL long-term, inhalation systemic effects
Route-to-route extrapolation:
Inhalation NOAEL = oral NOAEL * ABSoral-rat/ABSinh-human = 1000 * 50/100 = 500 mg/kg bw
Corrected inhalatory NAEC = 500 * 1/1.15= 435 mg/m3
Safety factors:
- Interspecies extrapolation: 1
- Intraspecies extrapolation: 5
- Exposure duration: 6 (assuming chronic exposure of the general population)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 30
Based on the above, the long-term DNEL for systemic effects after inhalation exposure of the general population, is set at 14.5 mg/m3.
DNEL long-term, oral systemic effects
Safety factors:
- Interspecies extrapolation: 4
- Intraspecies extrapolation: 5
- Exposure duration: 6 (assuming chronic exposure of the general population)
- Dose response: 1
- Quality of the data base: 1
Total safety factor: 120
Based on the above, the long-term DNEL for systemic effects after oral exposure of the general population is set at 8.3 mg/kg bw/day.
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