Registration Dossier
Registration Dossier
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EC number: 202-163-5 | CAS number: 92-52-4
Direct observations: clinical cases, poisoning incidents and other
Administrative data
- Endpoint:
- direct observations: clinical cases, poisoning incidents and other
- Type of information:
- other: case study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well-described and detailed case study
Data source
Reference
- Reference Type:
- publication
- Title:
- Reversible Hepatotoxic Effects of Diphenyl: Report of a Case and a Review of the Literature
- Author:
- Carella G, Bettolo PM
- Year:
- 1 994
- Bibliographic source:
- Journal of Occupational Medicine 36, 575-576
Materials and methods
- Study type:
- clinical case study
- Endpoint addressed:
- repeated dose toxicity: oral
- repeated dose toxicity: dermal
Test guideline
- Qualifier:
- no guideline required
- GLP compliance:
- no
Test material
- Reference substance name:
- Biphenyl
- EC Number:
- 202-163-5
- EC Name:
- Biphenyl
- Cas Number:
- 92-52-4
- Molecular formula:
- C12H10
- IUPAC Name:
- 1,1'-biphenyl
- Details on test material:
- Patient was exposed to diphenyl-impregnated paper.
Constituent 1
Method
- Subjects:
- - Number of subjects exposed: 1
- Sex: female
- Age: 46
- Demographic information: Italy
- Other: no alcohol or drug abuse or taken hepatotoxic medication, no transfusions, no multiple sexual partners - Route of exposure:
- dermal
- oral
- Reason of exposure:
- unintentional, occupational
- Exposure assessment:
- not specified
Results and discussion
- Clinical signs:
- General clinical condition was good.
Moderate hepatomegaly was noted and confirmed by ultrasound. Elevation in serum transaminases, alkaline phosphatase, GGT and neutrophilic leukocytosis. Hepatitis B markers were negative. A liver biopsy showed a polymorphic inflammatory infiltrate with some eosinophils in the portal and lobular regions consistent with the picture of chronic persistent hepatitis. In the past, the patient had reported episodes of periodic asthenia accompanied by a rise in transaminases.
Approximately 3 years earlier the patient had stopped working in citrus packing and all symptoms had returned to normal.
Applicant's summary and conclusion
- Conclusions:
- The pathogenesis of liver damage in the patient can be attributed to both skin absorption of diphenyl due to prolonged contact with the packing paper and perhaps also to digestive absorption.
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