Registration Dossier

Administrative data

Endpoint:
genetic toxicity in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
Not reported
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
documentation insufficient for assessment

Data source

Referenceopen allclose all

Reference Type:
publication
Title:
Depleted Uranium Health Effects: Transformation, Mutagenicity, and Carcinogenicity
Author:
Miller AC
Year:
1998
Bibliographic source:
AFRRI Special Publication 98-3: 11-13
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:
Studies with depleted uranium embedded animals were reviewed to help assess the risk for carcinogenesis and mutagenesis from depleted uranium embedded fragments. Animals with tantalum embedded fragments served as a control.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified
Details on test material:
- Name of test material (as cited in study report): tantalum implants

Results and discussion

Any other information on results incl. tables

Studies with depleted uranium embedded animals demonstrated that increased tissue uranium content was associated with aberrant activation of several of the oncogenes and tumour suppressor genes associated with preneoplastic lesions and human carcinogenesis. Specific point mutations in these genes have also been identified. In contrast, tissues from animals with tantalum implants did not show this aberrant oncogene pattern. Oncoproteins and tumour suppressor proteins were also found in the serum of animals with depleted uranium pellets. These proteins were not detected in serum from animals implanted with tantalum.

Applicant's summary and conclusion

Conclusions:
Tissues from animals with tantalum implants did not show an aberrant oncogene pattern. Oncoproteins and tumour suppressor proteins were not detected in serum from animals implanted with tantalum.
Executive summary:

Studies to help assess the risk for carcinogenesis and mutagenesis from depleted uranium embedded fragments were conducted, with tantalum serving as a control. The studies with depleted uranium embedded animals demonstrated that increased tissue uranium content was associated with aberrant activation of several of the oncogenes and tumour suppressor genes associated with preneoplastic lesions and human carcinogenesis. Specific point mutations in these genes were also identified. In contrast, tissues from animals with tantalum implants did not show this aberrant oncogene pattern. Oncoproteins and tumour suppressor proteins were also found in the serum of animals with depleted uranium pellets. These proteins were not detected in serum from animals implanted with tantalum.