Imidazole

Toxicity to reproduction: other studies

Administrative data

Endpoint:

toxicity to reproduction: other studies

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:

Imidazoles suppress rat testosterone secretion and testicular interstitial fluid formation in vivo

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

Principles of method if other than guideline:

Increasing single doses of imidazole (10-300 mg/kg bw) were adminstered to rats (10 male rats per group) via subcutaneous injection and samples of serum an testicular interstitial fluid were investigated at a single time point (after 2 hours).

GLP compliance:

no

Type of method:

in vivo

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:

- Name of test material (as cited in study report): Imidazole (Sigma Chemical Company (St. Louis))

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: originally derived from Harlan Sprague-Dawley, Inc. (Indianapolis, IN) rats
- Age at study initiation: Adult (60 days old) or adolescent (42 days old)

Administration / exposure

Route of administration:

subcutaneous

Vehicle:

physiological saline

Analytical verification of doses or concentrations:

not specified

Duration of treatment / exposure:

Single

Frequency of treatment:

Once

Duration of test:

2 hours

Doses / concentrations

Remarks:

Doses / Concentrations:
10 – 300 mg/kg (122–4407 mmol/kg)
Basis:
nominal conc.

Control animals:

yes, concurrent vehicle

Statistics:

ANOVA followed by post hoc analysis with Fisher’s protected least-significant difference tests was used to determine significant differences between groups as described previously (Adams ML, Little PJ, Bell B, Cicero TJ. Alcohol affects rat testicular interstitial fluid volume and testicular secretion of testosterone and bendorphin. J Pharmacol Exp Ther 1991; 258:1008–1014.). The level of significance was set at p < 0.05.

Results and discussion

Observed effects

Imidazole decreased serum testosterone in a dose-dependent manner at 2 h after treatment. Imidazole dose-dependently also decreased TIF testosterone concentrations, TIF volume, and LH secretion.