Registration Dossier

Administrative data

additional toxicological information
Type of information:
experimental study
Adequacy of study:
supporting study
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: No GLP compliance and no data on guidelines requirements compliance.

Data source

Reference Type:

Materials and methods

Type of study / information:
Short communication
Principles of method if other than guideline:
Enzyme assays to determine the induction of a disinfectant agent (containing IBA among others) on the liver microsomal mixed-function oxidase system of rats and rabbits.
GLP compliance:

Test material


Results and discussion

Applicant's summary and conclusion

Isobornylacetate induces the hepatic microsomal mixed-function oxidase system.
Executive summary:

In this study wasdetermined whether the mixed-function oxidase system of rats and rabbits housed in animal quarters treated with a new deodorizing/disinfectant agent (containing IBA, among others) was affected by this agent.

Male rats were placed in quarters which contained the deodorizing agent for a period ranging from 1 day to a maximum of 14 days. A number of hepatic microsomal parameters were studied after 1,2, 4, 7 and 14 days of treatment.

The control groups were housed in different animal rooms in the absence of the deodorizing agent.

No deaths were observed throughout the periods of exposure. All parameters were increased after treatment in rats, but not in rabbits. To determine which volatile component of thedeodorizing/disinfectant agent was enhancing the content of cytochrome P450 and the activities of NADPH cytochrome reductase and N-demethylase, various concentrations of alpha-terpineol or isobornyl acetate were injectedintraperitoneally for 3 days.Control groups were injected with isotonic solution of NaCl. The100 mg dose of isobornyl acetate per 100 g of body weight caused a 2.5-fold increase in cytochrome P-450 content, a 2.6 -fold increase in both N-demethylase activities and a 2.0 -fold increase in NADPH cytochrome c reductase activity.Based on these results, isobornylacetate induces the hepatic microsomal mixed-function oxidase system, therefore it is important the environmental control in which experimental animals are housed.