Registration Dossier

Ecotoxicological information

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
short-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1990-05-16 to 1990-08-17
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Study performed under the appropriate guideline during that time. The EC-50 results reported are referring to a testing time of 24 hours, whereas the new guideline requests to report data after 48 hours of exposure of daphnia to the test item. ECHA's endpoint specific guidance, chapter R.7B 8p49) says "...Invertebrates: ...standard testing data might be substituted by... a 24 hour EC50 value from short-term toxicity testing on Daphnia sp. according to OECD 202, but this should only be used in conjunction with other data (e.g. on time-dependence of toxicity) as part of a Weight of Evidence approach." Considering the overall quality of the study and consistency of the data obtained, and since the results from the test item at 24 hours can be compared with 24-hours toxicity data from the positive control substance, the study is considered as a Klimisch-2 study with acceptable restrictions, which eventually can qualify the study as a key study.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)
Version / remarks:
adopted April 4, 1984
Deviations:
yes
Remarks:
During that time OECD 202 requested to report EC50 after 24 hours, instead of EC50 48 hours as requested in the new version of OECD 202.
Qualifier:
according to
Guideline:
EU Method C.2 (Acute Toxicity for Daphnia)
Version / remarks:
adopted September 19, 1984
Deviations:
yes
Remarks:
EC50 after 24 hours is being reported
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
according to guideline

Test solutions

Vehicle:
yes

Test organisms

Test organisms (species):
Daphnia magna

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
24 h
Remarks on exposure duration:
appropriate testing time for the OCED 202 version at that time
Post exposure observation period:
not applicable

Test conditions

Hardness:
11.8 °DH
Test temperature:
18 - 22 °C
pH:
DSW: pH 8.2 1/- 0.2 after aeration
test batches: pH 8.2 - 8.9
Dissolved oxygen:
9.1 - 11.5 mg/l
Salinity:
Not being reported as such, however the detailed mineral composition of the used so-called "Dutch standard water" (DSW) is given in the original study report.
Nominal and measured concentrations:
Measured concentration varied between 93 and 106 % of the nominal concentrations of the test item (see study on acute fish toxicity conducted in parallel by Boger 1990).
Details on test conditions:
TEST SYSTEM
- Test vessel: 250 ml , all-glass
- Type (delete if not applicable): open
- Material, size, headspace, fill volume: all-glass, 250 ml, 150 ml, 100 ml
- Aeration: none
- Type of flow-through (e.g. peristaltic or proportional diluter): no flow-thru design applied
- Renewal rate of test solution (frequency/flow rate): not applicable
- No. of organisms per vessel: 10 per 100 ml medium
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2
- No. of vessels per vehicle control (replicates): not applicable
- Biomass loading rate: not reported

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
289 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks:
including mortality
Remarks on result:
other: 95% CL: 215 - 530 mg/l
Duration:
24 h
Dose descriptor:
NOEC
Effect conc.:
18 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Remarks:
including mortality
Reported statistics and error estimates:
The EC5O-value at 24 of exposure was calculated from the probits of the percentages of affected daphnia and the logarithms of the corresponding nominal concentrations using the maximum likelihood estimation method (Finney, D.J., 1971: Probit analysis, Cambridge University Press, Cambridge, U.K., 3rd edition).

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Conclusions:
The 24h-EC50 of the substance was 289 mg/l with 95% confidence interval ranging from 215 to 530 mg/l. The No Observed Effect Concentration for the registered substance with respect to mobility of Daphnia magna was found to be 18 mg/l after 24 hours of exposure.