Registration Dossier

Diss Factsheets

Ecotoxicological information

Long-term toxicity to fish

Currently viewing:

Administrative data

Link to relevant study record(s)

Reference
Endpoint:
long-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 215 (Fish, Juvenile Growth Test)
GLP compliance:
yes
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 24B187
- Expiration date of the lot/batch: 23 march 2016
- Purity test date: 100%

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: cool place
- Stability under test conditions:stable in container after opening/ in water/in soil/in light
Analytical monitoring:
yes
Remarks:
DOC analysis
Details on sampling:
The new solutions of 0.56, 1.4, 3.5, 8.9, 22 and 56 mg/L at 0, 6, 13, 20 and 27 days and the old solutions at 1, 7, 14, 21 and 28 days were sampled for DOC analysis.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: 1.7, 4.2, 10.5, 20.7, 66 and 168 mg of the test substance for each test group were weighed into beakers and dissolved with test water to obtain the test substance suspensions. The suspensions were transferred into 5L jars and tghe beakers were washed with test water respectively. The test water was added up to 3000 mL to obtain the loading concentrations. The suspensions were stirred with magnetic stirrers for about 24h and filtered through 0.22 µm filter membranes.
Test organisms (species):
other: Gobiocypris rarus
Details on test organisms:
TEST ORGANISM
- Common name: rare minnow
- Source: Southwest University
- Weight at study initiation (mean and range, SD): 50 - 100 mg

FEEDING DURING TEST
- Food type: Artemia (eggs obtained from Shandong besen Feed Co Ltd)
- Amount: 4% body weight per day in two 2% body weight portions per day
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Hardness:
150 mg/L as CaCO3
Test temperature:
21.3 - 23.8 °C
pH:
7.60 - 8.25
Dissolved oxygen:
61 - 100% saturation
Nominal and measured concentrations:
Nominal: 0.56, 1.4, 3.5, 8.9, 22 and 56 mg/L loading rate WAFs
Details on test conditions:
TEST SYSTEM
- Test vessel: 5 L glass jars containing 2 L test solution
- Renewal rate of test solution (frequency/flow rate): every 24h
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: dechlorinated tap water
- Total organic carbon: 1.9 mg/L
- Culture medium different from test medium: no
- Intervals of water quality measurement: The pH and dissolved oxygen of all test groups were measured at 0, 6, 13, 20, 27d (new solutions) and 1, 7, 14, 21 and 28d (old solutions). The temperature was continuously measured in an additional container with test water.

OTHER TEST CONDITIONS
- Photoperiod: 14h light/10h dark
- Light intensity: artificial light of white fluorescent lamp

EFFECT PARAMETERS MEASURED: the fish were examined daily during the test period and any abnormalities and mortalities were recorded.
Reference substance (positive control):
no
Key result
Duration:
28 d
Dose descriptor:
NOELR
Effect conc.:
1.4 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
growth rate
Duration:
28 d
Dose descriptor:
LOELR
Effect conc.:
3.5 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
growth rate
Duration:
28 d
Dose descriptor:
EL50
Effect conc.:
3.46 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
growth rate
Duration:
28 d
Dose descriptor:
EL10
Effect conc.:
0.55 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
growth rate
Remarks on result:
other: 0.227 - 1.96 mg/L CL
Duration:
28 d
Dose descriptor:
other: LL100
Effect conc.:
22 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat. (dissolved fraction)
Basis for effect:
mortality
Details on results:
- Fish weights (individual and mean values) on day 0, 14 (if measured) and 28: see Table 1 (attached)
- Tank-average or pseudo-specific growth rates for periods 0-28d: see Table 2 (attached)
- Type of and number with morphological abnormalities: none
- Type of and number with behavioural abnormalities: The mortality rates in the treatments of 22 and 56 mg/L were 100%. The abnormal behavior in the 56 mg/L treatment were found at 19 - 24d and at 22 - 25d for the 22 mg/L treatment. The abnormal behavior was overturning and losing of balance. There were no abnormal behavior and mortality in any other treatment.

DOC concentration of the test solutions:

The new solutions of 0.56, 1.4, 3.5, 8.9, 22 and 56 mg/L at 0, 6, 13, 20 and 27 days and the old solutions at 1, 7, 14, 21 and 28 days were detected. The actual DOC concentrations of the new test substance solution at the starting of the test and after renewal (after subtraction of the background value) were 4.61 - 18 mg/L. The old test substance solutions before renewal and at the end of the test were 4.78 - 17.7 mg/L (equivalent to 87.8 - 104% of the measured concentrations of the new solutions). The average DOC concentrations of the 0.56, 1.4, 3.5, 8.9, 22 and 56 mg/L treatments (after subtraction of the background value) were 7.81, 8.63, 8.44, 9.97, 13.2 and 16.5 mg/L, respectively. The fact that the actual DOC concentrations remained in the range of 80 - 120% of the measured concentration of the new solutions over the 24h exposure intervals indicate that the test concentrations were stable.

Validity criteria fulfilled:
yes

Description of key information

NOELr (28d) = 1.4 mg/L (nominal, loading rate) for Gobiocypris rarus (OECD 215)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
1.4 mg/L

Additional information

One study investigating the long-term toxicity of Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide (CAS 1000817-22-0) to freshwater fish is available. The study was performed according to OECD guideline 215 under GLP conditions using Gobiocypris rarus as test organism (Liu 2016). Loading rate WAFs between 0.56 and 56 mg/L were tested under semi-static conditions. DOC analysis indicated stable test solutions. The 28d-NOELr value was determined to be 1.4 mg/L based on nominal loading concentrations.