Registration Dossier

Administrative data

Endpoint:
toxicity to other aquatic vertebrates
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
Oct 28, 1994 - Dec 19, 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non-GLP study following ASTM (1988) protocol
Justification for type of information:
Read across is based on the category approach. Please refer to attached category document.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report Date:
1995

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: ASTM (American Society for Testing and Materials). 1988. Guide for Conducting Static Acute Toxicity Tests with Fishes, Macroinvertebrates, and Amphibians. Annual Book of ASTM Standards. Volume 1..04.E 729 -88el.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: clear liquid
Details on test material:
Diethylene glycol was purchased from Sigma Chemical Company (St. Louis, MO). The test substance was contained in opaque polypropylene containers (4 L size) or in amber glass bottles (1 L size). Prior to use in toxicity tests, the test substance was stored in darkness at room temperature. The test substance was analytical grade and was tested 100% active ingredient.
Specific details on test material used for the study:
Details on properties of test surrogate or analogue material (migrated information):
Not applicable.

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
Chemical analyses were conducted at MDS Environmental Services (Environmental Laboratory, Mississauga, Ontario) with samples collected during the toxicity testing phase (at the beginning and end of each exposure period for each concentration, or when there was complete mortality of test organisms). Submission of samples for chemical analysis were selected based on test organism response (to bracket the concentration with no mortality, partial mortality, and/or complete mortality). Samples from control solutions were submitted for chemical analysis from the end of the test and for "background check" only. Chemical analyses were conducted for each replicate for each concentration bracketing the LC50 concentration. Glycol analyses were conducted using GC/FID direct aqueous injection.

Test solutions

Vehicle:
no
Details on test solutions:
Dilution water quality was continuously monitored and documented. Laboratory dilution water was analyzed for metals, organic and inorganic chemicals according to various daily, weekly, monthly, quarterly and annual schedules, as appropriate for each parameter.
All aqueous testing is conducted using the well-established practice of negative (clean) controls consisting of organisms handled and treated in an identical manner to sample exposed organisms but exposed only to dilution water (i.e., no test substance).

Test organisms

Test organisms (species):
Xenopus laevis
Details on test organisms:
Adult Zenopus laevis (African clawed frog) were obtained from Carolina Biological Supply. The adults were injected with chlorionic gonadotropin hormone, and were mated to produce fertilized eggs in-house. Juvenile frogs were raised from eggs until the appropriate stage was reached.

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h
Post exposure observation period:
No additional information.

Test conditions

Hardness:
130-140 mg/l
Test temperature:
20-21 degrees Celsius
pH:
7.74-8.2
Dissolved oxygen:
7.6-8.6
Salinity:
Alkalinity as CaCO3: > 20 mg/l
Nominal and measured concentrations:
0, 6250, 12500, 25000, 50000, 100000 (nominal)
The concentrations of DEG in exposure vessels were measured at the end of tests and were within 14% of initial concentrations.
Details on test conditions:
5 organisms/test vessel
Duplicate test vessels
Test vessels were plastic, 200 ml
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
20 358 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 17285-23978
Duration:
48 h
Dose descriptor:
LC50
Effect conc.:
20 496 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks on result:
other: 15679-26484
Details on results:
In replicate A, the 48 hr LC50 was 20,358 mg/l with a 95% confidence interval of 17,285-23,978 mg/l.
In replicate B, the 48 hr LC50 was 20,496 mg/l with a 95% confidence interval of 15,679-26,484 mg/l.
Results with reference substance (positive control):
No data
Reported statistics and error estimates:
LC50 was calculated by the Spearman-Karber Method for the first replicate, and Probit Method for the 2nd replicate.

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
In replicate A, the 48 hr LC50 was 20,358 mg/l with a 95% confidence interval of 17,285-23,978 mg/l.
In replicate B, the 48 hr LC50 was 20,496 mg/l with a 95% confidence interval of 15,679-26,484 mg/l.
Executive summary:

In replicate A, the 48 hr LC50 was 20,358 mg/l with a 95% confidence interval of 17,285-23,978 mg/l.

In replicate B, the 48 hr LC50 was 20,496 mg/l with a 95% confidence interval of 15,679-26,484 mg/l.