Imidazole

Additional toxicological data

Administrative data

Endpoint:

additional toxicological information

Type of information:

experimental study

Adequacy of study:

disregarded due to major methodological deficiencies

Reliability:

3 (not reliable)

Rationale for reliability incl. deficiencies:

other: see 'Remark'

Remarks:

Investigative non-guideline study. With regard to hazard assessment, the findings reported by Adams et al. (1998) are considered to be of limited relevance because the subcutaneous injection does not represent a relevant exposure route. In addition, the precise s.c. injection site is not indicated in the publication, only one time point (2 hours after treatment) was studied and no microscopical examination of the testes was performed.

Data source

Reference

Reference 1

Reference Type:

publication

Title:

(1998) Imidazoles suppress|rat testosterone secretion and testicular interstitial fluid|formation in vivo. Biol Reproduction 59: 248-254

Author:

Adams ML, Meyer ER and Cicero TJ

Year:

1998

Bibliographic source:

Biol Reproduction 59: 248-254

Reference 2

Title:

No information

Author:

also cited in OECD SIDS Dossier Imidazole, Final August 2005

Materials and methods

Type of study / information:

Type: other: testosterone secretion

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Imidazole

EC Number:

206-019-2

EC Name:

Imidazole

Cas Number:

288-32-4

Molecular formula:

C3H4N2

IUPAC Name:

1H-imidazole

Details on test material:

imidazole: Sigma Chemical Company (St. Louis)

Results and discussion

Any other information on results incl. tables

 reported that imidazole suppressed the two major regulating aspects of testicular function (testosterone secretion and TIF formation) at 30 mg/kg bw and higher and can suppress LH secretion regulating systems in the pituitary in rats at 300 mg/kg bw. The authors concluded that the findings support the hypothesis that imidazoles can suppress male reproductive function. With regard to hazard assessment, the findings reported by Adams et al. (1998) are considered to be of limited relevance because the subcutaneous injection does not represent a relevant exposure route. In addition, the precise s.c. injection site is not indicated in the publication, only one time point (2 hours after treatment) was studied and no microscopical examination of the testes was performed. By contrast, there was no indication of any adverse effect on male reproductive organs and sperm quality in the 90-day oral gavage study according to OECD TG 408 mentioned  It was reported that imidazole suppressed the two major regulating aspects of testicular function (testosterone secretion and TIF formation) at 30 mg/kg bw and higher and can suppress LH secretion regulating systems in the pituitary in rats at 300 mg/kg bw. The authors concluded that the findings support the hypothesis that imidazoles can suppress male reproductive function. With regard to hazard assessment, the findings reported by Adams et al. (1998) are considered to be of limited relevance because the subcutaneous injection does not represent a relevant exposure route. In addition, the precise s.c. injection site is not indicated in the publication, only one time point (2 hours after treatment) was studied and no microscopical examination of the testes was performed. By contrast, there was no indication of any adverse effect on male reproductive organs and sperm quality in the 90-day oral gavage study according to OECD TG 408 mentione


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It was reported that imidazole suppressed the two major regulating aspects of testicular function (testosterone secretion and TIF formation) at 30 mg/kg bw and higher and can suppress LH secretion regulating systems in the pituitary in rats at 300 mg/kg bw. The authors concluded that the findings support the hypothesis that imidazoles can suppress male reproductive function. With regard to hazard assessment, the findings reported by Adams et al. (1998) are considered to be of limited relevance because the subcutaneous injection does not represent a relevant exposure route. In addition, the precise s.c. injection site is not indicated in the publication, only one time point (2 hours after treatment) was studied and no microscopical examination of the testes was performed. By contrast, there was no indication of any adverse effect on male reproductive organs and sperm quality in the 90-day oral gavage study according to OECD TG 408 mentioned above.

Applicant's summary and conclusion

Conclusions:

With regard to hazard assessment, the findings reported by Adams et al. (1998) are considered to be of limited relevance because the subcutaneous injection does not represent a relevant exposure route. In addition, the precise s.c. injection site is not indicated in the publication, only one time point (2 hours after treatment) was studied and no microscopical examination of the testes was performed. By contrast, there was no indication of any adverse effect on male reproductive organs and sperm quality in the 90-day oral gavage study according to OECD TG 408 mentioned above.

Executive summary:

It was reported that imidazole suppressed the two major regulating aspects of testicular function (testosterone secretion and TIF formation) at 30 mg/kg bw and higher and can suppress LH secretion regulating systems in the pituitary in rats at 300 mg/kg bw. The authors concluded that the findings support the hypothesis that imidazoles can suppress male reproductive function. With regard to hazard assessment, the findings reported by Adams et al. (1998) are considered to be of limited relevance because the subcutaneous injection does not represent a relevant exposure route. In addition, the precise s.c. injection site is not indicated in the publication, only one time point (2 hours after treatment) was studied and no microscopical examination of the testes was performed. By contrast, there was no indication of any adverse effect on male reproductive organs and sperm quality in the 90-day oral gavage study according to OECD TG 408 mentioned above.