Registration Dossier

Administrative data

Endpoint:
acute toxicity: other routes
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Documentation insufficient for assessment, only meeting abstract available; study subject does not correspond to REACH information requirements

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1975

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
After intraperitoneal application of single or multiple doses of gamma-methyl-4-phenylmandelic acid, a major metabolite of 4-isopropylbiphenyl, development of renal lesions was investigated. Renal lesions were also observed after application of 4-isopropylbiphenyl.
GLP compliance:
no
Remarks:
pharmacological programme

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): 4-isopropylbiphenyl major metabolite, gamma-4-phenylmandelic acid
- no further information

Test animals

Species:
other: rats and dogs
Strain:
not specified
Sex:
not specified

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
not specified
Doses:
single of multiple doses of 250 mg/kg bw
No. of animals per sex per dose:
no data

Results and discussion

Effect levels
Remarks on result:
other: Increase in relative kidney weights; progressive alterations in function and structure of the kidney; time sequential changes of cortical tubules (4-8 h), collecting tubules (8-24 h) and papilla (24-48h)
Mortality:
no data
Clinical signs:
Increase in urine volume, serum creatinine, blood urea nitrogen, urine glutamic-oxalacetic transaminase, relative kidney weights, and decrease in urine specific gravity
Gross pathology:
Progressive alterations in function and structure of the kidney: papillary edema, dillated collecting tubules, degeneration and necrosis; dillated tubules contained precipitated proteins and minerals
Other findings:
- Histopathology: time sequential changes of cortical tubules (4-8 h), collecting tubules (8-24 h) and papilla (24-48h)
- Potential target organs: kidney

Applicant's summary and conclusion