Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
9.8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECHA REACH guidance and ECETOC Technical Report No. 110
Overall assessment factor (AF):
45
Modified dose descriptor starting point:
LOAEC
DNEL value:
441 mg/m³
Explanation for the modification of the dose descriptor starting point:
Although no inhalation exposure is foreseen, a DNEL has been derived because the granulometry of the substance indicate the presence of an inhalable fraction
AF for dose response relationship:
3
Justification:
The starting point is not the dose without adverse effectes, but it is the lowest toxic dose, considered therefore as a LOAEL
AF for differences in duration of exposure:
2
Justification:
The study has been performed during 26 weeks
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric factor is needed in a route to route extrapolation from an oral value to an inhalation value
AF for other interspecies differences:
2.5
Justification:
As no allometric factor has been used, an assessment factor for other interspecies differences has been chosen
AF for intraspecies differences:
3
Justification:
An assessment factor of 3 has been chosed for differences between workers, according to ECETOC guidance
AF for the quality of the whole database:
1
Justification:
The available information have been judged reliable enough to perform a proper hazard evaluation of the substance
AF for remaining uncertainties:
1
Justification:
The available information have been judged sufficient to the hazard evaluation of the substance
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:
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:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - workers

In deriving the appropriate DNELs for the quantitative assessment of systemic toxicity effects, the TDLo form the oral sub-chronic toxicity study has been used. The TDLo value has been reported as the total dose administered to animals during the treatment, therefore the TDLo reported in the study has been divided by the days of exposure in order to approximate the TDLo per day. This value has been considered equivalent to a LOAEL for this study. The Lowest-Observed-Adverse-Effect-Levels from the sub-chronic oral study (500 mg/kg bw/day) has been used in the DNEL derivation for the systemic effects after inhalation exposure. For dermal effects after acute exposure, a qualitative approach has been used in order to evaluate the results of the QSAR study, which indicates that bile acids are potentially irritant and therefore have been classified as Skin Irrit. 2, H315 and Eye Irrit. 2, H319. The derivation of DNEL via inhalation route has been performed according to a precautionary point of view, indeed workers exposure to the substance is unlikely or not significant (see Section 9).

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:
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:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
low hazard (no threshold derived)

Additional information - General Population

Ursodeoxycholic acidis a intermediate intended to be used only at industrial sites, under controlled conditions. No significant or unlikely exposure of the general population is expected (See Section 9).