Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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:
hazard unknown (no 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:
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. human
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:
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:
no hazard identified

Additional information - workers

The UVCB substance WS400151 did show toxic effects in a subacute oral toxicity study and correspondingly, a DNEL for systemic effects has been derived. In addition, WS400151 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.

General Population - 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:
hazard unknown (no 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

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
AF for interspecies differences (allometric scaling):
4
Justification:
rat vs human
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
AF for interspecies differences (allometric scaling):
4
Justification:
rat vs human
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:
no hazard identified

Additional information - General Population

The UVCB substance WS400151 did show toxic effects in a subacute oral toxicity study and correspondingly, a DNEL for systemic effects has been derived. In addition, WS400151 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.