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:
5 March 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2016
Report date:
2016

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
ISO 6341 (Water quality - Determination of the Inhibition of the Mobility of Daphnia magna Straus (Cladocera, Crustacea))
Deviations:
no
GLP compliance:
no
Remarks:
Tetsing was not conducted to GLP, the study was conducted in accordance with ISO test methods and the solutions were analysed after exposure. For this reason we believe the results obtained within this literature report are adequate for assessment.

Test material

Constituent 1
Chemical structure
Reference substance name:
Reaction mass of 4,4'-methylenediphenol and 2,2'-methylenediphenol and o-[(4-hydroxyphenyl)methyl]phenol
EC Number:
908-912-9
Cas Number:
1333-16-0
Molecular formula:
C39H36O6
IUPAC Name:
Reaction mass of 4,4'-methylenediphenol and 2,2'-methylenediphenol and o-[(4-hydroxyphenyl)methyl]phenol
Test material form:
solid

Sampling and analysis

Analytical monitoring:
yes
Remarks:
HPLC

Test solutions

Vehicle:
yes
Remarks:
Ultrapure water
Details on test solutions:
Stock solutions were prepared by dissolving BPF (20 and 30 mg/L) in ultrapure water by mixing the solutions on a magnetic stirrer for at least 24 h. Chemicals were purchased from SigmaeAldrich (99% purity or higher). All chemicals used for toxicity testing were of analytical grade.

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
Water fleas D. magna Straus 1820 (Clone A) were obtained from the ECT Oekotoxikologie, Florsheim, Germany. Water fleas were kept in 3-L aquariums covered with glass plates (20 daphnids in 2.5 L of Elendt M4 medium) at 21 ± 1 °C in a 16 h light/8 h dark photoperiod. Water fleas were fed daily as follows: four times with green algae D. subspicatus (0.13 mg of C/daphnid), twice per week with Tetramin
(20 mg blended in deionized water/aquarium) and once a week with dry yeast (5 mg blended in deionized water/aquarium)

Study design

Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
48 h

Test conditions

Test temperature:
The test was carried out in a temperature controlled room at 21 ± 1 °C.
Nominal and measured concentrations:
4.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.8, 9.0, 10.0, 15.0, 20.0, 30.0 mg/L
Details on test conditions:
In the D. magna acute immobilisation toxicity test, water fleas (neonates, less than 24 h old) were exposed in two replicates per control (dilution water) and treated concentration of BPF (4.0, 5.5, 6.0, 6.5, 7.0, 7.5, 8.0, 8.8, 9.0, 10.0, 15.0, 20.0, 30.0 mg/L), in a temperature-controlled room at 21 ± 1 °C. Ten water fleas were placed into each test vessel containing 30 mL of test solution. After 24 and 48 h of exposure percentages of immobile daphnids for each replicate of tested concentration of BPF were calculated. Immobilisation of water fleas was determined by slightly moving the test vessel and those water
fleas, which were not able to swim within 15 s after agitation, were considered as immobile (ISO 6341, 2012).
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
24 h
Dose descriptor:
other: EC20
Effect conc.:
6.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
other: EC20
Effect conc.:
5.2 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
EC50
Effect conc.:
13.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
EC50
Effect conc.:
8.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
24 h
Dose descriptor:
other: EC80
Effect conc.:
26.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mobility
Duration:
48 h
Dose descriptor:
other: EC80
Effect conc.:
14.7 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality

Applicant's summary and conclusion

Validity criteria fulfilled:
not applicable
Conclusions:
At the 24 hour time point the test substance had an EC50 of 13.1 mg/L with 95% confidence limits of 10.0 - 17.2 mg/L.
At the 48 hours time point the test substance had an EC50 of 8.7 mg/L with 95% confidence limits of 6.6 - 11.5 mg/L.
Executive summary:

A study was performed to assess the acute toxicity of the test item to Daphnia magna. The method followed was compatiable with ISO 6341, 2012.

The 48 -hour EC50 for the test item to Daphnia magna was determined to to 8.7 mg/L with 95% confidence limits of 6.6 - 11.5 mg/L.