Registration Dossier

Administrative data

Endpoint:
hepatotoxicity
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1978

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Analysis of plasma bilirubin concentration, glutamic pyruvic transaminase (GPT) activity, and hepatioc triglyceride concentration 24 h after i.p. injection of test material. Blood was collected by aortic puncture in heparin-treated syringes.
GLP compliance:
not specified
Type of method:
in vivo
Endpoint addressed:
not applicable

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
liquid

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
corn oil
Analytical verification of doses or concentrations:
not specified
Duration of treatment / exposure:
single injection
Post exposure period:
24h
Doses / concentrations
Dose / conc.:
150 mg/kg bw/day (nominal)
Remarks:
1.5 mmol/kg were reproted
No. of animals per sex per dose:
5
Control animals:
yes

Results and discussion

Details on results:
Benzonitrile is not hepatotoxic to rats under conditions of this study at doses of 1.5 mmol/kg.

Applicant's summary and conclusion

Conclusions:
Benzonitrile is not hepatotoxic to rats under conditions of this study at doses of 1.5 mmol/kg.
Executive summary:

Benzonitrile is not hepatotoxic to rats under conditions of this study at doses of 1.5 mmol/kg.