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Long-term toxicity to fish

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Reference
Endpoint:
adult fish: sub(lethal) effects
Type of information:
experimental study
Adequacy of study:
key study
Study period:
30 Dec 1994 - 27 Jan 1995
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study
Justification for type of information:
refer to category justification provided in IUCLID section 13
Qualifier:
according to
Guideline:
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
Deviations:
yes
Remarks:
The total wet weight of the fish for each concentration was determinded. The individual length or wet weight was not determined / The total length was determined instead the standard length.
Qualifier:
according to
Guideline:
other: EEC Ring test of a method of determining the effects of chemicals on the growth rate of fish (1989)
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Sampling method: approx. 1 L of water was taken from the controls and treatments in glass bottles. 57 mL 27% formol was added.
- Sample storage conditions before analysis: stored in glass bottles in the refrigerator
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Seven stock solutions were prepared in Milli-Q-water (210, 387, 682, 1160, 2220, 3790, 6610 mg/250 mL). Stock solutions were stored in a refrigerator and renewed on day 2, 5, 11, 16, 18 and 21. Before use they were stirred and warmed up to dissolve the test substance.
- Controls: DSWL prepared from ground water was for the controls
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebrafish
- Source: M.B. Ruysbroek B.V. (Noordvliet 159, Maassluis)
- Length at study initiation (length definition, mean, range and SD): 2.55 +/- 0.23 cm
- Weight at study initiation (mean and range, SD): 0.12 +/- 0.03 g
- Feeding during test
- Food type: artemias
- Frequency: daily
Test type:
flow-through
Water media type:
freshwater
Limit test:
no
Total exposure duration:
28 d
Hardness:
not stated
Test temperature:
24.1 - 25.5 °C
pH:
7.8 - 8.2
Dissolved oxygen:
7.2 mg/L
Nominal and measured concentrations:
Nominal concentrations: control, 0.18, 0.32, 0.56, 1.0, 1.8, 3.2, 5.6 mg/L
Measured concentrations:
- control (< 0.1 mg/L), 0.18 (0.2 mg/L), 0.32 (0.5 mg/L), 0.56 (0.7 mg/L), 1.0 (1.3 mg/L), 1.8 (2.2 mg/L), 3.2 (3.9 mg/L), 5.6 (3.1 mg/L) on 1995-01-02
- control (< 0.1 mg/L), 0.18 (0.3 mg/L), 0.32 (0.4 mg/L), 0.56 (0.7 mg/L), 1.0 (1.4 mg/L), 1.8 (2.5 mg/L), 3.2 (4.2 mg/L) on 1995-01-09
- control (0.1 mg/L), 0.18 (0.1 mg/L), 0.32 (0.1 mg/L), 0.56 (0.2 mg/L), 1.0 (0.5 mg/L), 1.8 (0.7 mg/L), 3.2 (1.7 mg/L) on 1995-01-16
- control (0.1 mg/L), 0.18 (0.2 mg/L), 0.32 (0.3 mg/L), 0.56 (0.5 mg/L), 1.0 (0.9 mg/L), 1.8 (1.9 mg/L), 3.2 (2.8 mg/L) on 1995-01-23
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass chambers in the flow-through system
- Fill volume: 2.64 L
- Aeration: slightly aerated
- Type of flow-through: Flow-through system according to Van Leeuwen et. al. (1988)
- Renewal rate of test solution (frequency/flow rate): every 60 min
- No. of organisms per vessel: 16
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: synthetic medium from ground water
- Total organic carbon: 2.1, 2.0, 1.9 mg/L (medium was prepared three times on amounts of 10000 L each)
- Intervals of water quality measurement: weekly and at the beginning and at the end of the test


OTHER TEST CONDITIONS
- Photoperiod: 16 h light and 8 h dark


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 2
Reference substance (positive control):
no
Duration:
28 d
Dose descriptor:
LC50
Effect conc.:
3.2 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Remarks on result:
other: 3.2 - 4.6 mg/L
Duration:
28 d
Dose descriptor:
other: LC100
Effect conc.:
5.6 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
1.8 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
mortality
Duration:
28 d
Dose descriptor:
NOEC
Effect conc.:
3.2 mg/L
Nominal / measured:
nominal
Conc. based on:
act. ingr.
Basis for effect:
other: growth
Details on results:
- Concentrations that produce lethal or other effects: The concentrations 3.2 and 5.6 mg a.i./L produced lethal effects. From day 7 the test species exposed to 1.8 and 3.2 mg a.i./L appeared to take up less food. But the length and weight did not deviate from the control.
- Cumulative mortality at each concentration and for each recommended observation time if possible (based on an analytical purity of the test substance of 100%): no mortality up to 1.8 mg a.i./L, one fish died on day 7 at 3.2 mg a.i./L, 100% mortality on day 3 at 5.6 mg a.i./L
- Mortality in the controls: 0%
- Behavioural observation of the fish (based on an analytical purity of the test substance of 100%): From day 7 the test species exposed to 1.8 and 3.2 mg a.i./L appeared to take up less food. But the length and weight did not deviate from the control.
Reported statistics and error estimates:
The log-logistic concentration response model of Van der Hoeven (1991) was used for the calculation of the LC50. The maximum likelihood of 1.6 mg/L was close to the confidence interval of 3.2 - 4.6 mg a.i./L.

The mortality was 100% after 2 days at the highest test concentrations of 5.6 mg a.i./L. At a concentration of 3.2 mg a.i./L a 50% mortality was observed after 28 days (LC50). The NOEC was in between 1 mg a.i./L (endpoint: condition) and 3.2 mg a.i./L (endpoint: growth).

Description of key information

NOEC (28 d) = 1.8 mg a.i./L, based on mortality of Danio rerio (OECD 204); read across (CAS 110615-47-9)

Key value for chemical safety assessment

Additional information

No data are available on the long-term toxicity of D-Glucopyranose, oligomeric, undecyl glycoside (CAS 98283-67-1) to fish. In accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read across was conducted to the structurally related category member substance D-Glucopyranose, oligomeric, C10-16-alkyl glycosides (CAS 110615-47-9). The read across approach is justified in the overall summary (IUCLID Chapter 6.1) and in detail in the category justification document attached in IUCLID Section 13.

 

In the study by TNO Institute of Environmental Sciences (1995), which was chosen as key study, the long-term toxicity to the zebrafish Brachydanio rerio was investigated in a prolonged fish toxicity test according to the OECD guideline 204 and GLP for 28 days (instead of 14 d). Therefore, the test can be considered as a long-term test. Additionally, parameters like behavior and growth were studied (according to “Guidance Document on Aquatic Ecotoxicology” published by the European Commission, 2002). The test resulted in a NOEC (28 d) of 1.8 mg a.i./L for the endpoint mortality and a NOEC (28 d) of 3.2 mg a.i./L based on growth.