Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
8.4 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
6
Dose descriptor starting point:
NOAEL
Value:
50.3 mg/m³
AF for dose response relationship:
1
Justification:
(ECHA guidance R.8)
AF for differences in duration of exposure:
6
Justification:
subacute versus chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not relevant for local effects (ECHA guidance R.8)
AF for other interspecies differences:
1
Justification:
Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122 p.85)
AF for intraspecies differences:
1
Justification:
Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122 p.85-86)
AF for the quality of the whole database:
1
Justification:
default assessment factor for studies performed according to OECD and GLP (ECHA guidance R.8)
AF for remaining uncertainties:
1
Justification:
default assessment factor (ECHA guidance R.8)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.6 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
6
Dose descriptor:
NOAEC
Value:
10.3 mg/m³
AF for dose response relationship:
1
Justification:
(ECHA guidance R.8)
AF for differences in duration of exposure:
36
Justification:
subacute versus chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not relevant for local effects (ECHA guidance R.8)
AF for other interspecies differences:
1
Justification:
Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122 p.85)
AF for intraspecies differences:
1
Justification:
Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122 p.85-86)
AF for the quality of the whole database:
1
Justification:
default assessment factor for studies performed according to OECD and GLP (ECHA guidance R.8)
AF for remaining uncertainties:
1
Justification:
default assessment factor (ECHA guidance R.8)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
53.1 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
other: LC50
Value:
5 310 mg/m³
AF for dose response relationship:
100
Justification:
A default AF of 100 is suggested (ECHA guidance R.8)
AF for interspecies differences (allometric scaling):
1
Justification:
Allometric scaling not relevant for local effects (ECHA guidance R.8)
AF for other interspecies differences:
1
Justification:
Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122 p.85)
AF for intraspecies differences:
1
Justification:
Rats are more susceptible to lung overloading of PSP compared to humans (ECETOC TR No. 122 p.85-86)
AF for the quality of the whole database:
1
Justification:
default assessment factor for studies performed according to OECD and GLP (ECHA guidance R.8)
AF for remaining uncertainties:
1
Justification:
default assessment factor (ECHA guidance R.8)

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population