Diethyl sulphate

Developmental toxicity / teratogenicity

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 for cross-reference:

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

Test material information

Constituent 1

Reference substance name:

Diethyl sulphate

EC Number:

200-589-6

EC Name:

Diethyl sulphate

Cas Number:

64-67-5

Molecular formula:

C4H10O4S

IUPAC Name:

diethyl sulfate

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.