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Short-term toxicity to fish

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Reference
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
January 04 – 08, 2013
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
GLP - Guideline study, tested with the source substance Isononyl neopentanoate. According to the ECHA guidance document “Practical guide 6: How to report read-across and categories (March 2010)”, the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
Due to the difficult dissolving properties of Isononyl Pivalate, the appropriate method of dosing the test item was by preparation of a Water Accommodated Fraction (WAF).
One WAF with a nominal loading of 100 mg/L was prepared according to the OECD guidance No. 23 and stirred slowly using a star shape magnetic stirring bar for about 24 h at room temperature (about 20 °C).
The test item was weighed and immediately transferred to dilution water of appropriate volume. The solution was prepared in a glass bottle which was equipped with a drain port.
The contents of the vessels were stirred at 100 rpm (digital display) for 24 h at room temperature (21 ± 1°C). After stirring, the contents of the vessels were left to settle for a further 24 h. The saturated aqueous phase was then drained via the drain port. The first 100 mL were discarded. The mid part of the water body was used for filling the test vessels.
The test medium was used immediately and not kept longer than 1 - 2 hours. The remaining eluate was discarded.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebrafish
- Strain: Danio rerio (Teleostei, Cyprinidae)
- Source: test facility bred
- Weght: mean 0.12 g
- Length at study initiation (length definition, mean, range and SD): mean 2.3 cm
- Feeding during test: no feeding of the fish occurred during the test as well as 24 h before test start.
Test type:
semi-static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
1.0 mmol/L
Test temperature:
Mean 22.9 °C
pH:
8.4
Dissolved oxygen:
95 mg/L
Nominal and measured concentrations:
A limit test with one nominal loading of 100 mg test item/L
Details on test conditions:
TEST SYSTEM
- Test vessel: the test vessels were full glass aquaria of 12 L for keeping up to 10 litres of test solution
- Type: the test vessels were slightly aerated via a glass capillary
- Renewal rate of test solution: once after 48 h
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: purified drinking water
- Total organic carbon: 0.65 mg/L
- Metals: copper < 6.75 µg/L, iron < 7.35 µg/L, manganese < 2.99 µg/L, zinc < 1.57 µg/L.
- Chlorine: <0.02 mg/L
- Alkalinity: 1.6 mmol/L
- Ca/Mg ratio: 0.7/0.3
- Conductivity: 216.8 µS/cm
- Culture medium different from test medium: no
- Intervals of water quality measurement: monthly

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 12/12 hours


EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortality and clinical signs (sub-lethal and abnormal behavior) were recorded at 3 h, 24 h, 48 h, 72 h and 96 h after fish exposure.

TEST CONCENTRATIONS
- Justification for using less concentrations than requested by guideline: limit test
- Range finding study: yes.
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: range finding test at nominal loadings: 100 mg/L, 10 mg/L and 1.0 mg/L. No mortality, clinical signs or any distress were observed throughout the range finding test.
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: no abnormalities
- Observations on body length and weight: at the beginning of the study
- Other biological observations: no clinical signs or sublethal effects (e.g. loss of equilibrium, change in swimming behaviour, etc.)
- Mortality of control: no mortality in control
- Other adverse effects control: no adverse effects
- Abnormal responses: no
- Effect concentrations exceeding solubility of substance in test medium: the evaluation of the effects was based on nominal loading concentration for the test solution preparation.
Sublethal observations / clinical signs:

Neither clinical signs nor mortality could be observed throughout the study (Table 1), (Table 2).

Table 1: Clinical signs during the test period of 96 h (number of fish per treatment n=7)

Concentration

Isononyl Pivalate

[mg/L]

Test duration

3 h

24 h

48 h aged

48 h fresh

72 h

96 h

Control

nd.

nd.

nd.

nd.

nd.

nd.

100

nd.

nd.

nd.

nd.

nd.

nd.

nd.: no symptoms detected

Table 2: Cumulative mortality during the test period of 96 h (number of fish per treatment n=7)

Concentration Isononyl Pivalate

[mg/L]

Test duration

3 h

24 h

48 h aged

48 h fresh

72 h

96 h

Control

0

0

0

0

0

0

100

0

0

0

0

0

0

Validity criteria fulfilled:
yes
Conclusions:
Based on the results of this study, the LL50 of Isononyl pivalate was determined to be > 100 mg test item/L. The NOEL based on the visual observation is reported as >= 100 mg/L.
Executive summary:

In the 96 h acute toxicity test, conducted according to the OECD guideline 203, zebrafish (Danio rerio) were exposed to a Water Accommodated Fraction (WAF) of the test item Isononyl Pivalate at nominal loading concentration of 100 mg/L under semi-static conditions. Seven fish were used for treatment and in the control. Neither clinical signs nor mortality were observed throughout the study.

Based on the results of this study, the LL50 of Isononyl Pivalate was determined to be > 100 mg test item/L. The NOEC based on the visual observation is reported as >= 100 mg/L (NOEL >= 100 mg/L). This toxicity study is classified as acceptable and satisfies the guideline requirement for “Fish, Acute Toxicity Test”

Description of key information

No effects up to the water solubility limit (< 0.05 mg/L; OECD 203)

Key value for chemical safety assessment

Additional information

Since no studies investigating the short-term toxicity of isodecyl pivalate (CAS 60209-82-7) to fish are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 read across to the structurally related source substance isononyl pivalate was conducted. The source substance is characterized by the same fatty acid component (pivalic acid) and a shorter fatty alcohol chain length (C9 iso (source substance) compared to C10 iso (target substance)). This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and within the analogue justification in IUCLID Section 13. In this case of read-across, the best suited (highest degree of structural similarity, nearest physico-chemical properties) source substance was used for the assessment.

The study available for the read-across substance isononyl pivalate was performed according to OECD 203 under GLP-conditions (IME Fraunhofer, 2013). Danio rerio was exposed to a nominal loading rate of 100 mg/L (limit test). The test solutions were prepared as Water Accommodated Fractions (WAFs) to exclude physical effects due to the poor solubility of the substance in water. No analytical measurements were performed to verify the nominal loading rates. After an exposure of 96 h, no mortality was observed and a LL50 > 100 mg/L was determined.

Based on the available result from one structurally related source substance (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which is characterized by a comparable structure, it can be concluded thatisodecyl pivalatewill not exhibit acute toxicity to fish up to the limit of water solubility (< 0.05 mg/L).