Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Repeated dose toxicity: other routes

Currently viewing:

Administrative data

Endpoint:
sub-chronic toxicity: other route
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
Not reported
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study data from literature relating to non-standard test methods. The experiment was conducted in accordance with accepted scientific principles.

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Depleted Uranium Distribution and Toxicology in a Rodent Model
Author:
Pellmar TC, Hogan JB, Benson KA & Landauer MR
Year:
1998
Bibliographic source:
AFRRI Special Publication 98(3): 7-9
Reference Type:
publication
Title:
Health Effects of Depleted Uranium Fragments
Author:
Armed Forces Radiobiology Research Institute
Year:
1998
Bibliographic source:
Livengood DR (ed) An Armed Forces Radiobiology Research Institute Workshop

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A study was conducted to investigate the toxicity associated with depleted uranium exposure. Rats were exposed to the metal through implantation; tantalum was selected to be a chemically inert control.
GLP compliance:
not specified
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tantalum
EC Number:
231-135-5
EC Name:
Tantalum
Cas Number:
7440-25-7
Molecular formula:
Ta
IUPAC Name:
tantalum
Test material form:
solid: pellets
Details on test material:
- Name of test material (as cited in study report): tantalum pellets

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
other: implantation
Vehicle:
unchanged (no vehicle)
Details on exposure:
Tantalum pellets were surgically implanted into the gastrocnemus muscle of both hindlimbs of the rats.
Duration of treatment / exposure:
Data were analysed at 30 days and 6 months after implantation.
Frequency of treatment:
A single surgical implantation procedure took place; the implanted tantalum remained in the test animals for 6 months.
Doses / concentrations
Remarks:
Doses / Concentrations:
Each animal had 20 1 x 2 mm tantalum pellets implanted.
Control animals:
yes, concurrent no treatment
Details on study design:
The study was conducted to evaluate kidney, behavioural and neural toxicity associated with implanted depleted uranium pellets. In addition, assess tissues were assessed for histological changes and uranium content.
Two control groups were used as part of this study: one was a completely non-surgical control group and the other was implanted with tantalum pellets.

Examinations

Observations and examinations performed and frequency:
Data were analysed at 30 days and 6 months after implantation.

-The distribution of uranium and tantalum were measured in tissues after 6 months.
-Changes in bodyweight were continually monitored for 28 weeks.
-Behavioural and neurotoxicity were evaluated through a functional observational battery, locomotor activity grip strength, passive-avoidance learning, peripheral nerve conduction velocity and hippocampal field potential recordings.

Results and discussion

Results of examinations

Body weight and weight changes:
no effects observed
Behaviour (functional findings):
no effects observed
Details on results:
Examination of the pellets in situ revealed no fibrous tissue adhering to the pellets after implantation with tantalum.
The distribution of the metals throughout the tissues was examined; after 6 months the levels of tantalum found were negligible.

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
During the course of the study, examination of the implanted pellets in situ revealed no fibrous tissue adhering to the tantalum pellets. No other effects with tantalum were recorded.
Executive summary:

A study was conducted to investigate the toxicity associated with depleted uranium exposure. Pellets of the metals were surgically implanted into the gastrocnemus muscle of both hindlimbs of male Sprague-Dawley rats. The implantation of tantalum was selected to be a chemically inert control, in addition to a non-surgical control group. Data were analysed at 30 days and 6 months after implantation.

Parameters investigated were kidney, behavioural and neural toxicity. Also, tissues were assessed for histological changes and uranium content.

Bodyweight was continually monitored for 28 weeks. Behavioural and neurotoxicity were evaluated through a functional observational battery, locomotor activity grip strength, passive-avoidance learning, peripheral nerve conduction velocity and hippocampal field potential recordings.

After 6 months the levels of tantalum found distributed through tissue were negligible. Examination of the pellets in situ revealed no fibrous tissue adhering to the pellets after implantation with tantalum. Bodyweight gain was as expected and comparable to the non-surgical control. No other effects were noted for the animals implanted with tantalum.