Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.352 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
26.44 mg/m³
Explanation for the modification of the dose descriptor starting point:

Inhalatory NOAEC= 30 mg/kg bw/day*(1/0.38 m3/kg/d)*0.67*(ABSoral/ABSinh.) = 26.44 mg/m3

Differences in absorption Abs (oral-rat) / Abs (inhalation-human): 0.5

 

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
3
Justification:
Subchronic
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
2
Justification:
The predicted NOAEL value for UV-1084 is derived from the read-across 90 day study from TBBC. The default assessment factor of 1 is increased to 2 in the DNEL derivation to account for uncertainty in the quality of the whole database, based on the available repeated dose toxicity study and supporting toxicokinetic data. This modification should be sufficient to account for any uncertainty. The overall quality of the database is high.
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
Explanation for the modification of the dose descriptor starting point:

Acute inhalation toxicity is waived according to column 2 of ANNEX VIII of REACH regulation. The test substance has very low vapor pressure so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and no acute inhalation test was performed. No acute DNEL-inhalation needs to be calculated.

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:
0.1 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
Dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal NOAEL=30 mg/kg bw/day*( ABSoral/ABSdermal) = 30 mg/kg bw/day                                                                                                                                         Differences in absorption Abs (oral-rat) / Abs (dermal-human): 1

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
3
Justification:
Subchronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
5
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
2
Justification:
The predicted NOAEL value for UV-1084 is derived from the read-across 90 day study from TBBC. The default assessment factor of 1 is increased to 2 in the DNEL derivation to account for uncertainty in the quality of the whole database, based on the available repeated dose toxicity study and supporting toxicokinetic data. This modification should be sufficient to account for any uncertainty. The overall quality of the database is high.
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:
high hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)

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:
DNEL (Derived No Effect Level)
Value:
0.086 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
13.02 mg/m³
Explanation for the modification of the dose descriptor starting point:

Inhalation NOAEC= 30 mg/kg bw/day*(1/1.15 m3/kg/d)*(ABSoral/ABSinh.)

Differences in absorption Abs (oral-rat) / Abs (inhalation-human): 0.5

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
3
Justification:
Subchronic
AF for interspecies differences (allometric scaling):
1
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
2
Justification:
The predicted NOAEL value for UV-1084 is derived from the read-across 90 day study from TBBC. The default assessment factor of 1 is increased to 2 in the DNEL derivation to account for uncertainty in the quality of the whole database, based on the available repeated dose toxicity study and supporting toxicokinetic data. This modification should be sufficient to account for any uncertainty. The overall quality of the database is high.
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:
0.05 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
Dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal NOAEL=30 mg/kg bw/day*( ABSoral/ABSdermal)                                                                                                                                                                 Differences in absorption Abs (oral-rat) / Abs (dermal-human): 1  

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
3
Justification:
Subchronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
2
Justification:
The predicted NOAEL value for UV-1084 is derived from the read-across 90 day study from TBBC. The default assessment factor of 1 is increased to 2 in the DNEL derivation to account for uncertainty in the quality of the whole database, based on the available repeated dose toxicity study and supporting toxicokinetic data. This modification should be sufficient to account for any uncertainty. The overall quality of the database is high.
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:
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:
0.05 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
Dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
30 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No modification required

AF for dose response relationship:
1
Justification:
Default (DNEL calculator)
AF for differences in duration of exposure:
3
Justification:
Subchronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default (DNEL calculator)
AF for other interspecies differences:
2.5
Justification:
Default (DNEL calculator)
AF for intraspecies differences:
10
Justification:
Default (DNEL calculator)
AF for the quality of the whole database:
2
Justification:
The predicted NOAEL value for UV-1084 is derived from the read-across 90 day study from TBBC. The default assessment factor of 1 is increased to 2 in the DNEL derivation to account for uncertainty in the quality of the whole database, based on the available repeated dose toxicity study and supporting toxicokinetic data. This modification should be sufficient to account for any uncertainty. The overall quality of the database is high.
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 for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population