Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study planned
Study period:
Nov. 1 2011 to Feb 1 2012

Data source

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 211 (Daphnia magna Reproduction Test)
GLP compliance:
yes

Test material

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

Sampling and analysis

Analytical monitoring:
yes

Test solutions

Vehicle:
yes
Details on test solutions:
Firstly, 1 g BDP is weighed by electric balance and then dissolved with dimethylformamide in 50 ml flask to get 20 g/l liquor. After that, 400,160,64 and 25.6 µL liquor is transferred into the 1 L flasks,repectively,and dissolved with M4 medium to get the 8,3.2,1.28 and 0.512mg/l test solution.
25.6,10.24 and 4.096 ml solution taking from the 8 mg/l test solution is transferred into the 1L flasks,repectively,and dissolved with M4 medium to get the 0.205,0.082 and 0.033 test solution.

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:
yes
Total exposure duration:
21 d

Test conditions

Hardness:
The fully defined medium M4 media(see SOP EX015) is used in the laboratory.
Test temperature:
20±1°C
pH:
7.8±0.2
Dissolved oxygen:
The dissolved oxygen concentration should be above 3 mg/l. In order to meet criteria, the test vessels should be aerated for 6 hours before the culture.
Salinity:
The fully defined medium M4 media (see SOP EX015) is used in the laboratory.
Nominal and measured concentrations:
Nominal concertrations 5mg/l.
Details on test conditions:
Obey with the OECD guideline 211.
Reference substance (positive control):
yes
Remarks:
Potassium dichromate

Results and discussion

Applicant's summary and conclusion

Executive summary:

According to Directive 67/548/EECandCommission Regulation (EC) No: 790/2009, classification for BDPasR53and asaquatic chronic category 4, respectively,isnot assuredbased on the available data on aquatic environment, because of the absence of chronic toxicity evidences. If the chronic toxicity NOECs > water solubility or > 1 mg/Lthe classification of BDP as R53 oraquatic chronic category 4will be revised and abolished. Therefore, the long-term toxicity study on Daphnia needs to be proposed.