Registration Dossier

Administrative data

Endpoint:
additional toxicological information
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The GLP-study was not conducted according to any guidelines but the report contains sufficient data to permit a meaningful evaluation of study results.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1983
Report Date:
1983

Materials and methods

Type of study / information:
In laboratory animals, increased liver mixed-function oxidase (MFO) activities and alterations in liver morphology are considered as two of the more sensitive indicators of polychlorinated biphenyls (PCB) exposure. Since the potential of chlorinated biphenyls to cause these effects has been considered to be dependent on the degree as well as position of chlorination, the purpose of this study was to compare the effects of biphenyl, monochlorobiphenyls (MCB's) and PCB mixtures on liver MFO activity and histopathology in male rats.
Test guideline
Qualifier:
no guideline available
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Biphenyl
- Physical state: not specified in the report
- Analytical purity: Biphenyl - 100%,
- Impurities (identity and concentrations): not specified in the report
- Composition of test material, percentage of components: not specified in the report
- Isomers composition: not specified in the report
- Purity test date: not specified in the report
- Lot/batch No.: Biphenyl-OCR564:86
- Stability under test conditions: not specified in the report
- Storage condition of test material: not specified in the report

Results and discussion

Applicant's summary and conclusion

Conclusions:
Based on the conditions of the study, it was concluded that there are marked differences between the biological activities of chlorinated biphenyls in male rats and that monochlorobiphenyls (MCB's) and biphenyl were found to be less potent than typical polychlorinated biphenyls mixtures as inducing agents of hepatic MFO enzymes.