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Ecotoxicological information

Long-term toxicity to aquatic invertebrates

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Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
key study
Study period:
From Mar. 1, 2011 to May.25, 2011.
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
OECD guideline test with GLP compliance, but without GLP certificate. Furthermore prior to initiating the definitive test, a preliminary test was performed at concentrations of 0.125, 0.25, 0.5 and 1.0 mg/L without GLP compliance. Therefore this study should be used with restrictions.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
Deviations:
yes
Remarks:
The temperature of artificial climate chamber was measured but not the test medium. This deviation does not affect the validity of the study.
GLP compliance:
yes
Remarks:
This stud y has been inspected in accordance with the GLP Principles as published by OECD [ENV/MC/CHEM (98)17] in 1998.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Same with the substance notified in the section 1 of this dossier

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
At 0 hours and 14 days after exposure, 2 ×approximately 100 mL samples from each test solution were taken from additional beakers (in parallel to the other test solutions). In other words, 2 ×approximately 100 mL samples from each test solution was taken from the freshly prepared test solutions. At 48 hours and 16 days after exposure, 3 ×approximate 50 mL samples were taken from each concentration and analyzed. In addition, one sample was taken from the solvent control approximate 100 mL.

Test solutions

Vehicle:
yes
Details on test solutions:
Prior to initiating the definitive test, a preliminary test was performed at concentrations of 0.125, 0.25, 0.5 and 1.0 mg/L (Non-GLP state).
The solubility of BDP in the test solution was not more than 0.5 mg/L, and there was no significant difference between the number of offspring in each test concentration and solvent controls. Based on the results of the pre-test, test concentrations of 0.20 and 0.40 mg/L were selected.
Stock solution: 107.2 mg test substance (with purity of 98.38%) was fully dissolved and made up to 25 mL with dimethylformamide (DMF) to obtain the stock solution of 4218 mg/L. Then the stock solution was diluted to destinated concentrations of 0.20 and 0.40 mg/l.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Obey with the OECD guideline 211.

Study design

Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d
Post exposure observation period:
no data

Test conditions

Hardness:
in the range of 207-226 mg/L (CaCO3)
Test temperature:
19.1-20.1°C
pH:
7.6-8.5
Dissolved oxygen:
9.6-10.7 mg/L
Salinity:
no data
Nominal and measured concentrations:
Nominal concentrations: 0.2 and 0.4 mg/l; The measured concentrations of the fresh test solutions and old solution after 48 hours renewal were in the range of 95 %-110 % of nominal concentration 0.2 mg/L; the measured concentration were in the range of 83 %-103 % of nominal concentration of 0.4 mg/L in fresh test solution and old solution after 48 h renewal. Therefore, the toxic effect values were calculated based on the nominal concentration.
Details on test conditions:
Obey with the OECD guideline 211.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Effect concentrationsopen allclose all
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 0.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 0.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: Livability at birth
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
>= 0.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality
Remarks:
Mortality of parent animals
Details on results:
Compared with the blank control, there was no significant difference among the solvent control, test concentrations of 0.20 mg/l and 0.40 mg/L on the fecundity, mortality of the parent animals, livability of offspring at the birth. At the concentration of 0.4 mg/L, the length of parental animal was longer than that of blank control, had significant difference.
Results with reference substance (positive control):
Not required
Reported statistics and error estimates:
Results of the toxicity test were interpreted by standard statistical techniques using the function of data analysis in EXCEL Version 2003. The mean number of dead and living offspring per parent animals was calculated, respectively. The NOEC was estimate by One Way Analysis of Variance (One Way ANOVA).

Any other information on results incl. tables

In the pre-test, The test concentrations were selected for concentration analysis during pretest. For the nominal concentration of 1 mg/L, both the measured concentration at 0 h and 24 h were 42 % of the nominal concentration, which indicated that the test substance was not fully dissolved in the test medium. From the analytical result, the test substance was not fully dissolved in the test medium at the concentration of 1 mg/L. Therefore, the data at the concentration of 1 mg/L was not used for toxicity assessment. Based on the results of the pre-test, test concentrations of 0.20 and 0.40 mg/L were selected for definitive test. 

Applicant's summary and conclusion

Validity criteria fulfilled:
yes
Remarks:
OECD guideline test
Conclusions:
In the Daphnia magna reproduction test, on the basis of the nominal concentrations, the NOEC of BDP to Daphnia magna is ≥0.40 mg/L, and which was above the water solubility of BDP.
Executive summary:

Reproduction Test (21 days, Semi-Static System) of BDP to Daphnia magna Straus was conducted in accordance with OECD test guideline 211, under semi-static conditions with two test concentrations of 0.20 and 0.40 mg/L.Ten test daphnids were exposed to each test concentration and controls for a period of 21 days. For each concentration and the control, 10 replicates were performed. Each replicate contained only one daphnid. The daphnids were observed for reproduction and growth during the exposure. The measured concentration of test substance was in the range of 83 % to102 % of nominal values in the fresh (0 hour) and old test solution (48 hours). Th erefore, all effect values were given based on the nominal concentration. The calculations and values were based on 0.20 and 0.40 mg/L nominal concentrations. From the test, the results show that on the basis of the nominal concentrations, the NOEC of BDP to Daphnia magna is not less than0.40 mg/L, and which means the NOEC was not less the water solubility determined for BDP.