Registration Dossier

Diss Factsheets

Administrative data

Workers - 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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
sensitisation (skin)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

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:
no hazard identified
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:
3.8 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor:
LOAEC
Value:
750
AF for dose response relationship:
2
Justification:
EC3 value could be derived and additional uncertainties are covered with high interspecies differences assessment factor. While EC3 value can be considered a LOAEC, several publications argued it to be very close to a human NOAEC. Therefore, an assessment factor of 2 was considered adequate.
AF for differences in duration of exposure:
1
Justification:
complete induction timeframe is covered in the LLNA, furthermore differences in exposure conditions are covered in the skin sensitization specific assessment factors
AF for interspecies differences (allometric scaling):
1
Justification:
not required since the effect assessed is a local effect
AF for other interspecies differences:
10
Justification:
default assessment factor according to ECHA Guidance R.8
AF for intraspecies differences:
5
Justification:
default assessment factor according to ECHA Guidance R.8
AF for the quality of the whole database:
1
Justification:
Guideline, GLP study
AF for remaining uncertainties:
2
Justification:
Skin sensitization specific assessment factors:
AF for vehicle or matrix effect: 1 (for justification, please refer to attachment in IUCLID Chapter 13 and CSR)
AF for different exposure conditions: 2 (for justification, please refer to attachment in IUCLID Chapter 13 and CSR)
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.8 µg/cm²
Most sensitive endpoint:
sensitisation (skin)
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Dose descriptor starting point:
other: EC3
Value:
750
AF for dose response relationship:
2
Justification:
EC3 value could be derived and additional uncertainties are covered with high interspecies differences assessment factor. While EC3 value can be considered a LOAEC, several publications argued it to be very close to a human NOAEC. Therefore, an assessment factor of 2 was considered adequate.
AF for interspecies differences (allometric scaling):
1
Justification:
not required since the effect assessed is a local effect
AF for other interspecies differences:
10
Justification:
default assessment factor according to ECHA Guidance R.8
AF for intraspecies differences:
5
Justification:
default assessment factor according to ECHA Guidance R.8
AF for the quality of the whole database:
1
Justification:
Guideline, GLP study
AF for remaining uncertainties:
2
Justification:
Skin sensitization specific assessment factors:
AF for vehicle or matrix effect: 1 (for justification, please refer to attachment in IUCLID Chapter 13 and CSR)
AF for different exposure conditions: 2 (for justification, please refer to attachment in IUCLID Chapter 13 and CSR)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population