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Toxicological information

Developmental toxicity / teratogenicity

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Administrative data

Endpoint:
developmental toxicity
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
other: The study was well conducted but the treatment was performed by ip injection. This route of administration is hardly extrapolable to the normal conditions of use of a chemical.
Cross-reference
Reason / purpose:
reference to other study

Data source

Reference
Reference Type:
publication
Title:
Developmental Anomalies: Mutational Zygote Exposure
Author:
Generoso WM, Rutledge JC, Aronson J
Year:
1990
Bibliographic source:
Banbury report 34: 311-319

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Exposure of the dams by ip injection at at 4 days before mating or 1, 6, 9 or 25 hours after mating. after mating. Uterine analysis done on the 17th day.
GLP compliance:
no
Limit test:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Supplier Aldrich Chemical Co

Test animals

Species:
mouse
Strain:
other: (C3H/R1 X 101/R1)F1

Administration / exposure

Route of administration:
intraperitoneal
Vehicle:
DMSO
Analytical verification of doses or concentrations:
not specified
Details on mating procedure:
Mating for 30 min only, beginning at the time when the newly ovulated eggs were in the ampulla of the oviduct, thus synchronizing the time of fertilization.
Duration of treatment / exposure:
1 injection
Frequency of treatment:
not relevant (1 injection)
Duration of test:
up to the 17th day of gestation
Doses / concentrations
Remarks:
Doses / Concentrations:
150 mg/kg
Basis:
no data
No. of animals per sex per dose:
between 17 and 54 females were mated. Between 17 and 43 were pregnant.
Control animals:
yes, concurrent vehicle

Results and discussion

Results: maternal animals

Effect levels (maternal animals)

Dose descriptor:
dose level:
Effect level:
150 mg/kg bw (total dose)
Based on:
no data
Basis for effect level:
other: developmental toxicity

Results (fetuses)

Details on embryotoxic / teratogenic effects:
Embryotoxic / teratogenic effects:yes

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Any other information on results incl. tables

Treatment

Resorption bodies (%)

Mid- and late-gestation deaths (%)

Live fetuses examined

Live fetuses with defect (%)

Control

5

1.5

3436

1.3

DES

24

37

157

24

fetal anomalies (% of the number of fetuses examined)

Hydropia: 6.4

Abdominal wall: 3.2

Limb and/or tail: 12.7

Eyes: 2.5

Exencephaly: 1.9

Applicant's summary and conclusion

Conclusions:
DES was toxic for the zygote and induced fetal malformations.
Executive summary:

The developmental and teratogenic effects of DES were studied in mouse after ip injection of 150 mg/kg. Dams were exposed early after mating (between 1 and 9 hours). The effects were oberved at the 17th gestation day.

DES induced stillbirths and anomalies of the fetuses.