Registration Dossier

Administrative data

Workers - Hazard via inhalation 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:
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:
7 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):
100
Dose descriptor starting point:
NOAEL
Value:
700 mg/kg bw/day
AF for dose response relationship:
1
Justification:
well performed guideline conform oral repeat dose study
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
man vs. rat
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 uncertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
14 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):
50
Dose descriptor starting point:
NOAEL
Value:
700 mg/kg bw/day
AF for dose response relationship:
1
Justification:
well performed guideline conform oral repeat dose study
AF for interspecies differences (allometric scaling):
4
Justification:
man vs. rat
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 uncertainties

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

In a subchronic oral toxicity study performed with the UVCB substance WS400402 no adverse toxic effects were observed up to the highest dose level of 700 mg/kg/day. Accordingly, the DNEL for systemic toxicity was calculated starting from this dose level. In a local lymph node assay in mice, WS400402 exhibited a strong skin-sensitizing potential. Therefore, dermal contact has to be avoided. Additionally, the substance is corrosive to eyes. Exposure via inhalation is unlikely because the substance has a very low vapour pressure and is a viscous liquid.

General Population - Hazard via inhalation 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:
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:
3.5 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):
200
Dose descriptor starting point:
NOAEL
Value:
700 mg/kg bw/day
AF for dose response relationship:
1
Justification:
well performed guideline conform oral repeat dose study
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
man vs. rat
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:
DNEL (Derived No Effect Level)
Value:
7 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):
100
Dose descriptor starting point:
NOAEL
Value:
700 mg/kg bw/day
AF for dose response relationship:
1
Justification:
well performed guideline conform oral repeat dose study
AF for interspecies differences (allometric scaling):
4
Justification:
man vs. rat
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

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:
3.5 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):
200
Dose descriptor starting point:
NOAEL
Value:
700 mg/kg bw/day
AF for dose response relationship:
1
Justification:
well performed guideline conform oral repeat dose study
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
man vs. rat
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 unvertainties
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7 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):
100
Dose descriptor starting point:
NOAEL
Value:
700 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 interspecies differences (allometric scaling):
4
Justification:
man vs. rat
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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
high hazard (no threshold derived)

Additional information - General Population

In a subchronic oral toxicity study performed with the UVCB substance WS400402 no adverse toxic effects were observed up to the highest dose level of 700 mg/kg/day. Accordingly, the DNEL for systemic toxicity was calculated starting from this dose level. In a local lymph node assay in mice, WS400402 exhibited a strong skin-sensitizing potential. Therefore, dermal contact has to be avoided. Additionally, the substance is corrosive to eyes. Exposure via inhalation is unlikely because the substance has a very low vapour pressure and is a viscous liquid.