Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
insufficient hazard data available (further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
28.58 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor:
other: EC3
AF for dose response relationship:
1
Justification:
default AF; clear EC3
AF for differences in duration of exposure:
1
Justification:
not relevant; local effect
AF for interspecies differences (allometric scaling):
1
Justification:
see overall interspecies AF
AF for other interspecies differences:
10
Justification:
proposed AF in ECHA guidance
AF for intraspecies differences:
5
Justification:
default AF for workers
AF for the quality of the whole database:
1
Justification:
default AF
AF for remaining uncertainties:
1
Justification:
Vehicle/matrix effects (not relevant); moderate potency (i.e. EC3 >2% w/v)
Acute/short term exposure
Hazard assessment conclusion:
other toxicological threshold
Value:
28.58 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Dose descriptor starting point:
other: EC3
AF for dose response relationship:
1
Justification:
default AF; clear EC3
AF for interspecies differences (allometric scaling):
1
Justification:
see overall interspecies AF
AF for other interspecies differences:
10
Justification:
proposed AF in ECHA guidance
AF for intraspecies differences:
5
Justification:
default AF for workers
AF for the quality of the whole database:
1
Justification:
default AF
AF for remaining uncertainties:
1
Justification:
Vehicle/matrix effects (not relevant); moderate potency (i.e. EC3 >2% w/v)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

Consumers are not exposed to unreacted p-PP