Registration Dossier

Ecotoxicological information

Long-term toxicity to aquatic invertebrates

Administrative data

Endpoint:
long-term toxicity to aquatic invertebrates
Type of information:
experimental study
Adequacy of study:
supporting study
Study period:
5 March 2016
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

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

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: ISO 10706, 2000
Deviations:
no
GLP compliance:
no

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:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
21 d

Test conditions

Test temperature:
The test was carried out in a temperature controlled room at 21 ± 1 °C.
Nominal and measured concentrations:
0.84, 1.7, 3.4, 6.7,13.4 mg/L
Details on test conditions:
D. magna reproduction tests were run in a semi-static exposure system (ISO 10706, 2000). Individual daphnid was exposed in a 100 mL beaker containing 50 mL of tested concentration of BPF (0.84, 1.7, 3.4, 6.7,13.4 mg/L) and dilution water (control), which were replaced three times a week (on Monday, Wednesday and Friday) with newly prepared test samples. For each tested concentration, ten replicates were used, and the experiments were repeated at least three times for each tested chemical. Water fleas were fed daily with a diet of algae D. subspicatus (0.15 mg C/female). On Mondays, Wednesdays and Fridays survival of adults were checked and neonates were counted. At the same time the pH value, temperature and concentration of dissolved oxygen were measured. To verify the stability of tested chemicals, initial concentrations of freshly prepared samples of BPF, in which water fleas were exposed for 2 or 3 days, were analyzed by chemical analysis as described in details on analytical method section. Our results showed that the measured concentrations of BPF at the start of the experiment were within 90% of the nominal concentrations and did not drop by more than 20% after 2 or 3 days of
exposure to water fleas. The endpoints of 21 d chronic toxicity testswere survival of females, reproduction, i.e., cumulative number of living offspring per surviving female, the average brood size per
female, the number of broods per female, days to first brood and body length. The average brood size was calculated by dividing the number of neonates per female with the number of broods per
female. Body length of daphnid was measured from the top of the head to the base of the tail spine using a stereoscopic microscope (Nikon SMZ 1000 with a DS-Fi1 digital camera) and a NIS-Elements
Documentation 2.2 imaging software.
Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
6.7 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
13.4 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
mortality
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.84 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
1.68 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
1.68 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
3.36 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
growth

Any other information on results incl. tables

21 d NOEC/NOLC, LOEC/LOLC values obtained for BPF to water fleas.

BPF (mg/L)
NOEC/LOLC LOEC/LOLC
Reproduction
Number of neonates/female 0.84 1.68
Brood Size 0.84 1.68
Days to first brood 0.84 1.68
Number of broods/females 0.84 1.68
Body Length 1.68 3.36
Mortality 6.7 13.4

Applicant's summary and conclusion

Validity criteria fulfilled:
not applicable
Conclusions:
The 21 d NOEC was determined at 0.84 mg/L of BPF for all investigated reproduction endpoints. At the highest tested concentration (13.4 mg/L of BPF), all of the exposed water fleas died in few days, but up to 6.7 mg/L of BPF no mortality was observed. From this the following NOEC/LOEC values were determined 0.85 mg/L and 1.68 mg/L (reproduction), 1.68 mg/L and 3.36 mg/L (growth), and 6.70 and 13.4 mg/L (Mortality).
Executive summary:

A study was performed to assess the chronic toxicity of the test item to Daphnia magna. The method followed was compatiable with ISO 10706, 2000.

The 21 d NOEC was determined at 0.84 mg/L of BPF for all investigated reproduction endpoints. At the highest tested concentration (13.4 mg/L of BPF), all of the exposed water fleas died in few days, but up to 6.7 mg/L of BPF no mortality was observed. From this the following NOEC/LOEC values were determined 0.85 mg/L and 1.68 mg/L (reproduction), 1.68 mg/L and 3.36 mg/L (growth), 6.70 and 13.4 mg/L (Mortality).