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Diss Factsheets

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:
key study
Study period:
1994-10-25 to 1995-03-24
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-study. Guideline from 1986.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1995
Report date:
1995

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
EU Method C.20 (Daphnia magna Reproduction Test)
Deviations:
no
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
EC Number:
228-985-4
EC Name:
Methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate
Cas Number:
6386-38-5
Molecular formula:
C18H28O3
IUPAC Name:
methyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate

Sampling and analysis

Analytical monitoring:
yes
Details on sampling:
- Concentrations:
Day 0: from all test solutions including the controls
Day 2: from the 'old' solutions at 0.16, 0.56 and 2.2 mg/L
Days 6 and 14: from 0.56, 1.0 and 2.2 mg/L
Day 21: from all test solutions including the controls
- Volume: 10 mL
- Sample storage conditions before analysis: under deep frozen conditions

Test solutions

Vehicle:
yes
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: First, stock solutions were prepared in methanol (Merck, extra pure) at a concentration of 25 g/L on a weekly basis. These stocks were used to prepare fresh stock solutions in methanol (Merck, extra pure) at the start of the test and at each renewal. These stocks contained test substance concentration of a factor of 10E04 greater than the final test concentrations in M4 medium to provide a methanol concentration of 0.1 mL/L in all test solutions. All test solutions were clear. There was no indication of precipitation of the test materia
1. Test medium without test substance or any other additives (0 mg/L),
2. Test medium without test substance but with the additive used in the treatment of the stock solutions, i.e. methanol (0.1 mL/L).

Test organisms

Test organisms (species):
Daphnia magna
Details on test organisms:
TEST ORGANISM
- Common name: Daphnia magna (Crustacea, Cladocera) (Straus, 1820)
- Age of parental stock (mean and range, SD): < 24 hours
- Feeding during test: yes
- Food type: a suspension of fresh water algae
- Amount: The ration was 1.10E06 cells/ml/day
- Frequency: daily



Study design

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

Test conditions

Test temperature:
19.5 - 21.5 °C
pH:
7.6 - 8.7
Dissolved oxygen:
7.0 - 9.8 mg/L
Nominal and measured concentrations:
nominal: 0.16, 0.30, 0,56, 1,0 and 2.2 mg/L
measured: 0.123, 0.173, 0.367, 0.572, 1.143 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 100 ml (8 x 04 cm), all-glass covered with a perspex plate.
- No. of organisms per vessel: 1 neonate
- No. of vessels per concentration (replicates): 10 vessels per concentration

TEST MEDIUM / WATER PARAMETERS
- M 4 in accordance to the guideline

OTHER TEST CONDITIONS
- Photoperiod: 16 hours photoperiod daily
- Light intensity: 600 lux

VEHICLE CONTROL PERFORMED: yes

Reference substance (positive control):
no

Results and discussion

Effect concentrationsopen allclose all
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
1.8 g/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
immobilisation
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
0.97 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
immobilisation
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
1.1 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: 0.9 - 1.2
Duration:
21 d
Dose descriptor:
EC50
Effect conc.:
0.59 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: 0.54 - 0.65
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
0.56 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
other: overall
Duration:
21 d
Dose descriptor:
LOEC
Effect conc.:
0.367 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
other: overall
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.3 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: Based on Dunns Multiple Comparison-Kruskal-Wallis test (P=0.05)
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.173 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: Based on Dunns Multiple Comparison-Kruskal-Wallis test (P=0.05)
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
0.18 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: 0.00 - 0.33 mg/L
Duration:
21 d
Dose descriptor:
EC10
Effect conc.:
0.14 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: 0.08 - 0.21 mg/L
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.16 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: Based on Williams' Test (P=0.05)
Duration:
21 d
Dose descriptor:
NOEC
Effect conc.:
0.123 mg/L
Nominal / measured:
meas. (geom. mean)
Conc. based on:
test mat.
Basis for effect:
reproduction
Remarks on result:
other: Based on Williams' Test (P=0.05)
Details on results:
- Mortality of parent animals:
During the main part of the test period, the EC50 for mobility remained > the highest test concentration which corresponded with the maximum solubility of test item. On day 20 a total of 6 out of the 10 parental Daphnia had died. At lower concentrations, mortality of parental Daphnia remained at or below 20 % during the total test period of 21 days, with exception of those exposed to 0.56 mg/l. Here one Daphnia was lost at the renewal on day 12. Therefore, the final mortality rate was 22 %, I.e. 2 out of 9 parental Daphnia.
Reported statistics and error estimates:
The reproduction values of the two control groups (blank and solvent) were compared with the use of the t-test. When no statistical difference was found between these two control groups, their values were combined and the reproduction values of the treated groups were statistically compared with those of the combined control groups. For each concentration the results of reproduction were tested for normality and for homogeneity of variance. Furthermore, these data were statistically tested using a mean comparison test (Williams' Test) and a multiple comparison test (Dunns Multiple Comparison - Kruskal-Wallis test). The overall threshold level of effect and the overall NOEC were determined on basis of these statistics. The EC50 (immobilisation) and the EC50 (reproduction) were calculated. Additionally an EC25 and EC10 were calculated for reproduction.
The mortality of the parental daphnids in the controls did not exceed 20%. The average cumulative number of young per female in the controls after 21 days was > 60 (blank: 161 + 20, solvent: 164 + 42).

Applicant's summary and conclusion