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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
DNEL (Derived No Effect Level)
Value:
18 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
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 <0.1%/inhalation absorption human <0.1%)
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 was conducted 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
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 100 (oral absorption rat <0.1%/dermal absorption human <0.001%)
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 LD and LC50 values greater than 5000 mg/kg bw and 5 mg/L respectively. It is not irritating to either skin or eyes and has no sensitising potential. On this basis no acute DNELs, either for systemic or local effects were considered necessary.

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

In a fully compliant OECD 422 study, the overall NOAEL for the study was 300 mg/kg bw/day based on kidney pathology (bilateral cortical tubular necrosis and/or diffuse cortical basophilic tubules) seen in 2/10 females only at the limit dose of 1000 mg/kg. No adverse effects were seen in males for systemic toxicity and in both males and females for reproduction, fertility and development of offspring up to and including the limit dose of 1000 mg/kg bw/day. This study was used for setting long-term systemic DNELs.  No local effects concerns were raised by the OECD 422 study.

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/m3 total inhalable and/or with a respirable fraction no greater than 3 mg/m3, depending on the member state.

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 neodymium oxide(see Section 3.5 of the IUCLID dosiser).