Registration Dossier
Registration Dossier
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EC number: 401-540-3 | CAS number: 84632-65-5
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 11.75 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 75
- 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:
- 3.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 300
- 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
WORKER
Acute/Short-term Exposure: Systemic effects
Acute/Short-term Exposure: Local effects
The ECHA guidance (Chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified as an acute toxicity hazard. As PR 254 is not classified as an acute toxicity hazard, no acute DNEL needs to be calculated.
Long Term Exposure: Systemic Effects
DN(M)EL-Worker
From the available studies, a NOAEL for sub-acute repeated dose toxicity study (OECD 407) is used as the starting point for DNEL calculations.
Dermal DN(M)EL
Starting point: NOAEL 1000 mg/kg bw/day fromsub-acuterepeated dose toxicity study
Differences in absorption Abs (oral-rat) / Abs (dermal-human): 1
Corrected NOAEL: 1000 mg/kg bw/day
Interspecies differences: Allometric scaling: 4
Remaining interspecies differences: 2.5
Intraspecies differences: 5
Differences in duration of exposure (sub-acute to chronic): 6
Dose response and endpoint specific/severity issues: 1
Quality of database: 1
Overall factor (product of individual factors): 300
=>Worker DNEL long-term for dermal route-systemic: 3.33 mg/kg bw/day
Inhalation DN(M)EL
Starting point: NOAEL 1000 mg/kg bw/day fromsub-acuterepeated dose toxicity study
Respiratory volume rat (sRV) (worker (8 h): 1/0.38): 2.632
Differences in respiratory volume (default factor "light activity worker"): 0.67
Differences in absorption Abs (oral-rat) / Abs (inhalation-human): 0.5
=>Corrected NOAEC: 881.72 mg/m3
Interspecies differences: Allometric scaling: 1
Remaining interspecies differences: 2.5
Intraspecies differences: 5
Differences in duration of exposure (sub-acute to chronic): 6
Dose response and endpoint specific/severity issues: 1
Quality of database: 1
Overall factor (product of individual factors): 75
=>Worker DNEL long-term for inhalation route-systemic: 11.75 mg/m3
Long-Term: Local Effects
No specific local effects resulting from long term exposure have been identified. Adherence to the long term DNEL for systemic effects is sufficient to protect against any local effects.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.898 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 150
- 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:
- 1.66 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- 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:
- 1.66 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 600
- 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
GENERAL POPULATION
Acute/Short-term Exposure: Systemic effects
Acute/Short-term Exposure: Local effects
The ECHA guidance (Chapter R.8 of the Guidance on Information Requirements and Chemical Safety Assessment) indicates that acute DNELs do not need to be calculated for substances that are not classified as an acute toxicity hazard. As PR 254 is not classified as an acute toxicity hazard, no acute DNEL needs to be calculated.
Long Term Exposure: Systemic Effects
DNEL General Population
From the available studies, a NOAEL for sub-acute repeated dose toxicity study (OECD 407) is used as the starting point for DNEL calculations.
Oral DN(M)EL
Starting point: NOAEL 1000 mg/kg bw/day fromsub-acuterepeated dose toxicity study
Interspecies differences: Allometric scaling: 4
Remaining interspecies differences: 2.5
Intraspecies differences: 10
Differences in duration of exposure (sub-acute to chronic): 6
Dose response and endpoint specific/severity issues: 1
Quality of database: 1
Overall factor (product of individual factors): 600
=>General population DNEL long-term for oral route-systemic: 1.666 mg/kg bw/day
Dermal DN(M)EL
Starting point: NOAEL 1000 mg/kg bw/day from oral route
Differences in absorption Abs (oral-rat) / Abs (dermal-human): 1
Corrected NOAEL: 1000 mg/kg bw/day
Interspecies differences: Allometric scaling: 4
Remaining interspecies differences: 2.5
Intraspecies differences: 10
Differences in duration of exposure (sub-acute to chronic): 6
Dose response and endpoint specific/severity issues: 1
Quality of database: 1
Overall factor (product of individual factors): 600
=> General population DNEL long-term for dermal route-systemic: 1.666 mg/kg bw/day
Inhalation DN(M)EL
Starting point: NOAEL 1000 mg/kg bw/day from oral route
Respiratory volume rat (sRV) (general population (24 h): 1/1.15): 0.8696
Differences in absorption Abs (oral-rat) / Abs (inhalation-human): 0.5
=>Corrected NOAEC: 434.8 mg/m3
Interspecies differences: Allometric scaling: 1
Remaining interspecies differences: 2.5
Intraspecies differences: 10
Differences in duration of exposure (sub-acute to chronic): 6
Dose response and endpoint specific/severity issues: 1
Quality of database: 1
Overall factor (product of individual factors): 150
=>General populationDNEL long-term for inhalation route-systemic: 2.898 mg/m3
Long-term local effects
No specific local effects resulting from long term exposure have been identified. Adherence to the long term DNEL for systemic effects is sufficient to protect against any local effects.
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