Registration Dossier

Administrative data

Endpoint:
toxicity to reproduction: other studies
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP non-guideline study, published in peer reviewed literature

Data source

Reference
Reference Type:
publication
Title:
In vivo exposure of female rats to toxicants may affect oocyte quality.
Author:
Berger T and Horner CM
Year:
2003
Bibliographic source:
Reprod. Toxicol. 17, 273-281

Materials and methods

GLP compliance:
not specified
Type of method:
in vivo

Test material

Reference
Name:
Unnamed
Type:
Constituent

Results and discussion

Any other information on results incl. tables

The fertilisability of oocytes was investigated following a 2-week exposure to rats via drinking water to TAME. The preceding two weeks of the oocyte recovery, young female Sprague-Dawley rats (28-45 days) were treated with 0.3% TAME. Controls received drinking water only. The rats were induced to ovulate with gonadotropin. After treatment, the females were killed, oviducts were removed and the oocytes isolated and transferred to fertilisation medium. The Zona pellicuda was removed before insemination. Oocytes (in 100 μl) were inseminated with 10 μl of sperm diluted to either 7*10E6 or 0.5*10 E6 sperm/ml. Three replicates were inseminated with 7*10E6 sperm/ml and three replicates with 0.5*10 E6 sperm/ml. Following 20 hours of incubation at 37°C, oocytes were rinsed and transferred to cover slips for examination. TAME did not have an effect on the final weight of the females. The treatment did not have an effect on the oocytes fragility. However, the results showed that the fertilisability of the oocytes decreased after consumption of TAME. The percentage of fertilised oocytes was 84% in the control group and 64% in the one treated with TAME.

In vivo administered TAME seemed to have an inhibitory effect on the fertilisability of rat oocytes in vitro. However, this finding was not supported by the findings in the 2-generation reproductive toxicity study. Therefore, the significance of this observation fertility is left unknown.

Applicant's summary and conclusion