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Additional toxicological data

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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

Referenceopen allclose all

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
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

Constituent 1
Chemical structure
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.

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