Registration Dossier

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.