Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

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

Constituent 1
Chemical structure
Reference substance name:
4-isopropylbiphenyl
EC Number:
230-420-1
EC Name:
4-isopropylbiphenyl
Cas Number:
7116-95-2
Molecular formula:
C15H16
IUPAC Name:
4-Isopropylbiphenyl
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