Evaluation of the OECD 421 reproductive toxicity screening test protocol using butyl benzyl phthalate (BBP)

Piersma, AH; Verhoef, A; Dortant, PM

HERO ID

678930

Reference Type

Journal Article

Subtype

Abstract

Year

1995

Language

English

HERO ID 678930
Material Type Abstract
In Press No
Year 1995
Title Evaluation of the OECD 421 reproductive toxicity screening test protocol using butyl benzyl phthalate (BBP)
Authors Piersma, AH; Verhoef, A; Dortant, PM
Journal Teratology
Volume 51
Issue 6
Page Numbers 28A
Abstract The OECD421 reproductive toxicity screening test was designed to provide initial information on possible effects on reproduction and/or development, for prioritization of more elaborate reproductive toxicity testing. The method was not designed to provide definitive claims of no effects and in addition, due to its limited dimensions, statistical analyses are not applicable. It is important to validate the protocol with known reproductive toxicants. BBP affects both fertility parameters and development of the conceptus, and thus enables the simultaneous study of the sensitivity of both these segments of the reproductive cycle, as represented in the OECD421 protocol. BBP in corn oil was given daily by gavage at 5 mL/kg bw to WU rats of 10-11 weeks of age in four dosage groups (0, 250, 500 and 1000 mg/kg bw/day) at 10 males and 10 females per group. The OECD421 protocol (final draft document, January 1993) was used. Briefly, after dosing of both sexes by gavage for 14 days, males and females were paired (1:1) and allowed to mate for a maximum of 14 days. Daily dosing was continued. Males were necropsied after a total dosage period of 29 days. Females and pups were killed and necropsied at postpartum day 6. Pups were counted, sexed, weighed and examined for external malformations on days 1 and 6 after birth, and decapitated. Body weights and food consumption were determined weekly except for the mating period. No clinical signs of toxicity were seen. At the high dose, effects were found on bw gain and food consumption, on spermatogenesis, time to conception, pregnancy rate, postimplantation survival, and litter size and weight. Food consumption and pup weight were slightly affected at 500 mg/kg also. No malformations were observed. Effects and effective dosages were as expected on the basis of literature data. Therefore, the OECD421 test correctly scores BBP as a reproductive toxicant. General conclusions on the usefulness of the test awaits further evaluation with other compounds.
Wosid BCI:BCI199598534448
Is Certified Translation No
Dupe Override No
Conference Location Dublin, Ireland
Conference Name 23rd Annual Conference of the European Teratology Society Joint Meeting with the Irish Society for Toxicology
Conference Date September 4-7, 1995
Comments Journal: 23RD ANNUAL CONFERENCE OF THE EUROPEAN TERATOLOGY SOCIETY JOINT MEETING WITH THE IRISH SOCIETY FOR TOXICOLOGY ISSN:
Is Public Yes
Language Text English
Keyword Pregnancy; Rats; Animal; Male; Female; Phthalic Acids TOXICITY; Dose-Response Relationship; Drug; Reproduction DRUG EFFECTS; Abnormalities; Drug-Induced; Fetus DRUG EFFECTS; 85-68-7; No cas rn
Is Qa No
Relationship(s)
  • Is related to other part(s): 675379