Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
18 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):
30
Modified dose descriptor starting point:
NOAEC
Value:
529 mg/m³
Explanation for the modification of the dose descriptor starting point:
300 mg/kg/day x 1/0.38 x 6.7/10 x 1 (oral absorption rat <1%/inhalation absorption human <1%) = 529 mg/m3
AF for dose response relationship:
1
Justification:
None required. A clear NOAEL is available
AF for differences in duration of exposure:
6
Justification:
Default factor for extrapolation from subacute to chronic duration
AF for interspecies differences (allometric scaling):
1
Justification:
Not required after initial conversion of starting point from oral to inhalation
AF for other interspecies differences:
1
Justification:
TK data for another rare earth indicate that there are not likely to be any remaining differences between species.
AF for intraspecies differences:
5
Justification:
Default factor for variation between individual workers
AF for the quality of the whole database:
1
Justification:
None required. The data available is to internationally recognised guidelines and GLP
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
30 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
300 mg/kg/day x 1(oral absorption rat <1%/dermal absorption human <0.01%)
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The substance is not acutely toxicity via the oral or inhalation routes, with LD50 and LC50 values greater than 5000 mg/kg bw and 5 mg/L, respectively. It is not irritating to skin or eyes and has no sensitising potential. There were no effects in the GLP compliant OECD 422 study (klimisch 1) that would indicate there was a potential for adverse local effects. On this basis no acute DNELs, either for systemic or local effects were considered necessary.

Based on a complete set of in vitro genotoxicity studies, it is concluded that the substance has no genotoxic properties.

In a fully GLP compliant OECD 422 study (Klimisch 1), the overall NOEL for the study was 300 mg/kg bw/day based on increased incidence of clinical signs observed at 1000 mg/kg bw/day around the time of parturition and reduced bodyweight gain (36.7%) during days 1-4 of lactation at 1000 mg/kg. This study was used for setting long-term systemic DNELs.  The male systemic NOAEL was 1000 mg/kg (based on no findings that could be considered adverse). 

It should also be noted that long term worker systemic inhalation DNEL derived above is higher than the OEL for non-specific nuisance dust, frequently specified as10 mg/m3total inhalable and/or with a respirable fraction no greater than 3 mg/m3, depending on the member state.

The material is not hazardous via the dermal route.

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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal 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:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral 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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

In accordance ECHA guidance (Chapter R.5:Adaptation of information requirements) no general population DNELs are set because there are no uses that would result in significant exposure of the general public to erbium oxide(see IUCLID dossier Section 3.5).