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:
DNEL (Derived No Effect Level)
Value:
0.024 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
300
Modified dose descriptor starting point:
NOAEL
Value:
7.1 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
well performed guideline conform oral repeat dose study
AF for dose response relationship:
1
Justification:
well performed guideline conform oral repeat dose study
AF for differences in duration of exposure:
6
Justification:
subacute vs. chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
rat vs. man
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
5
Justification:
for workers
AF for the quality of the whole database:
1
Justification:
well performed guideline conform oral repeat dose study
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

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

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - workers

A subacute oral toxicity study was not performed with the UVCB substance WS400101 but read-across from the respective study performed with the UVCB substance WS400151 was made. The toxic effects observed in the subacute oral toxicity study are due to octadecenylamine which is present in both substances at approx. the same level. A DNEL for systemic effects resulting from dermal exposure has been derived although the effects observed in the gastro-intestinal tract are considered local effects rather than systemic effects.

In addition, WS400101 showed skin-sensitizing potential in a local lymph node assay in mice. Therefore, dermal contact - the most likely route of exposure - has to be avoided. Exposure by inhalation is not expected because the substance has a very low vapour pressure, is highly viscous at room temperature and decomposes before boiling.

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:
DNEL (Derived No Effect Level)
Value:
0.012 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Value:
7.1 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
well performed guideline conform oral repeat dose study
AF for dose response relationship:
1
Justification:
well performed guideline conform oral repeat dose study
AF for differences in duration of exposure:
6
Justification:
subacute vs. chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
rat vs. man
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
for general population
AF for the quality of the whole database:
1
Justification:
well performed guideline conform oral repeat dose study
AF for remaining uncertainties:
1
Justification:
no uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

Local effects

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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.012 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
Value:
7.1 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
well performed guideline conform oral repeat dose study
AF for dose response relationship:
1
Justification:
well performed guideline conform oral repeat dose study
AF for differences in duration of exposure:
6
Justification:
subacute vs. chronic exposure
AF for interspecies differences (allometric scaling):
4
Justification:
rat vs. man
AF for other interspecies differences:
2.5
Justification:
remaining differences
AF for intraspecies differences:
10
Justification:
for general population
AF for the quality of the whole database:
1
Justification:
well performed guideline conform oral repeat dose study
AF for remaining uncertainties:
1
Justification:
no uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

A subacute oral toxicity study was not performed with the UVCB substance WS400101 but read-across from the respective study performed with the UVCB substance WS400151 was made. The toxic effects observed in the subacute oral toxicity study are due to octadecenylamine which is present in both substances at approx. the same level. A DNEL for systemic effects resulting from dermal and oral exposure has been derived although the effects observed in the repeat dose oral study in the gastro-intestinal tract are considered local effects rather than systemic effects.

In addition, WS400101 showed skin-sensitizing potential in a local lymph node assay in mice. Therefore, dermal contact - the most likely route of exposure - has to be avoided. Exposure by inhalation is not expected because the substance has a very low vapour pressure and decompsoes before boiling.