Registration Dossier

Administrative data

Endpoint:
toxicity to other aquatic vertebrates
Type of information:
experimental study
Adequacy of study:
other information
Reliability:
3 (not reliable)
Rationale for reliability incl. deficiencies:
significant methodological deficiencies
Remarks:
The puritiy of the test substance is not provided in the publication. Additionally, the test concentrations used were by far higher than the threshold concentration at 100 mg/L for the acute aquatic test design.

Data source

Reference
Reference Type:
publication
Title:
Actions of antifertility chemicals on Xenopus laevis spermatozoa in vitro
Author:
Jones P and Jackson H
Year:
1973
Bibliographic source:
J. Reprod. Fert. (1974) 38, 347-357

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
A sperm suspension (0.3 mL) was thoroughly mixed with a solution (1.2 mL) of the test substance over a range of concentrations; a control was also included.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid

Sampling and analysis

Analytical monitoring:
no

Test solutions

Vehicle:
no

Test organisms

Test organisms (species):
Xenopus laevis
Details on test organisms:
HOUSING
- Vessels: Polypropylene boxes measuring 17.5 x 11 x 5 inches filles with 1.25 to 1.5 gallons of tap water
- Number of animals per vessel: 3 - 4
- Temperature: 22 - 24 °C
- Feeding: Twice a week with chopped liver

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
120 min

Test conditions

Test temperature:
22 °C
Nominal and measured concentrations:
Nominal: 125, 250, 500, 1000 and 2000 mg/L

Results and discussion

Any other information on results incl. tables

Very high concentrations of ethyleneurea on Xenopus spermatozoa produced abnormal embryos. Over the concentration range of 2000 to 125 mg/L, cleavage rates were high at all levels after 30 and 60 minutes of exposure. The majority of eggs developed abnormally at the highest concentration (2000 mg/L). At lower dose levels, the toxic effect rapidly disappeared and after exposure for 60 and 120 min normal development was clearly dose-dependent. No effects were observed at a concentration of 125 mg/L.

Applicant's summary and conclusion