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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Justification for type of information:
Refer to analogue justification provided in IUCLID section 13.
Reason / purpose for cross-reference:
read-across source
Reason / purpose for cross-reference:
read-across source
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: Water Accommodated Fraction (WAF)
Basis for effect:
mortality (fish)
Remarks on result:
other:
Remarks:
Source: Key, source, RA-A, CAS 93803-87-3, Croda, 1998, C. carpio, 96 h, RL1
Conclusions:
The retained effect concentration for the short-term toxicity to fish is an LL50 (96 h) of > 100.0 mg/L (nominal, OECD 203, read-across).
Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
07 Mar - 11 Mar 1994
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: GLP-Guideline study with acceptable restrictions (Insoluble test substance was visible during the test).
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
yes
Remarks:
Fish were fed during the main-test
GLP compliance:
yes
Analytical monitoring:
yes
Details on sampling:
- Concentrations: Samples were taken from 1000 and 10000 mg/L test system after 0 h and 24 h.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test substance was directly weighed into the test vessels and treated with ultraturrax for 10 sec.
- Eluate: no
- Differential loading: yes
- Controls: yes, water control
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: zebra fish
- Source: Obtained from Fa. Westaquarium, Germany (delivered on 15 Dec 1993)
- Feeding during test
- Food type: Altromin N 1324 spezial 161293 1500 (preliminary study); Altromin N 1324 spezial 140694 0825 (main study)
Test type:
semi-static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Test temperature:
21.5 - 23.1 °C
pH:
8.1 - 8.6
Dissolved oxygen:
67 - 89%
Nominal and measured concentrations:
Nominal: control - 1000 - 3000 - 10000 mg/L
Measured (DOC analysis):
1000 mg/L (=39.2 mg DOC/L): 2.1 mg DOC/L (0 h); 2.0 mg DOC/L (24 h); 1.0 mg DOC/L (0 h); 1.5 mg DOC/L (24 h)
10000 mg/L (=392 mg DOC/L): 2.8 mg DOC/L (0 h); 2.0 mg DOC/L (24 h); 1.2 mg DOC/L (0 h); 1.5 mg DOC/L (24 h)
Details on test conditions:
TEST SYSTEM
- Fill volume: 5 L
- Renewal rate of test solution (frequency): every 24 h
- No. of organisms per vessel: 10

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: drinking water

OTHER TEST CONDITIONS
- Adjustment of pH: no

EFFECT PARAMETERS MEASURED: mortality was checked after 0, 4-6, 24, 48, 72 and 96 h of exposure
Reference substance (positive control):
no
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 10 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Behavioural abnormalities: no behavioural effects were observed
- Mortality of control: 0%
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: The test substance was not completely soluble in water and floated on top of the surface of the test solutions.
Sublethal observations / clinical signs:

Table 1: Percental mortality of fish during the study

Concentration [mg/L]

% mortality after x hours

0 h

4-6 h

24 h

48 h

72 h

96 h

0

0

0

0

0

0

0

1000

0

0

0

0

0

0

3000

0

0

0

0

0

0

10000

0

0

0

0

0

0

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 Apr - 24 Apr 1998
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP Guideline study
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
no
Qualifier:
according to guideline
Guideline:
EU Method C.1 (Acute Toxicity for Fish)
Deviations:
no
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Two stock solutions were prepared in water at nominal 1 and 100 mg/L. applying magnetic stirring for ca. 23 h to achieve maximum soluble fraction of the test substance in the test medium. Subsequently, these stock solutions were transferred to a separating funnel and left tot stabilize for ca. 4 h. The water phase in the middle of the separating funnel was used for testing. Both solutions were clear and colourless.
- Eluate: no
- Differential loading: yes
- Controls: yes, water control
Test organisms (species):
Cyprinus carpio
Details on test organisms:
TEST ORGANISM
- Common name: carp
- Source: Obtained from Bio International, Roermond, The Netherlands (F1 from a single parent-pair nred om UV-treated water)
- Length at study initiation: 2.09 +/- 0.10 cm
- Weight at study initiation: 0.22 +/- 0.04 g
- Feeding during test: none

ACCLIMATION
- Acclimation period: At least 12 days after delivery.
- Acclimation conditions (same as test or not): same as test
- Type and amount of food: Commercial fish feed "Trouvit"
- Feeding frequency: daily
- Health during acclimation (any mortality observed): Mortality seven days prior to the start of the test was less than 5%.
Test type:
static
Water media type:
freshwater
Limit test:
no
Total exposure duration:
96 h
Hardness:
250 mg CaCO3/L
Test temperature:
20.1 - 20.6 °C
pH:
7.8 - 8.1
Dissolved oxygen:
6.9 - 9.3 mg O2/L
Nominal and measured concentrations:
Nominal: 0, 10 and 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: all-glass vessels
- Material, size, headspace, fill volume: all glass, 4 L, headspace: 1.5 L, fill volume: 2.5 L
- Aeration: no
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 0.77 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: ISO-medium, formulated using Milli-RO water (tap water purified by reverse osmosis) with the following composition: Ca2+ 80 mg/L, Mg2+ 12 mg/L, Na+ 15 mg/L, K+ 3 mg/L, Cl- 145 mg/L, SO4 2- 49 mg/L, HCO3 47 mg/L
- Culture medium different from test medium: no
- Intervals of water quality measurement: Oxygen, pH, nitrate and nitrite and ammonia concentration were measured once a week.

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

EFFECT PARAMETERS MEASURED: Mortality was observed after 2, 24, 48, 72 and 96 h.
Reference substance (positive control):
yes
Remarks:
pentachlorophenol
Duration:
96 h
Dose descriptor:
LL50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: Water Accommodated Fraction (WAF)
Basis for effect:
mortality (fish)
Details on results:
- Mortality of control: no
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: A thin test substance film was observed on the surface after 24 h for the 10 mg/L test concentration after 24 h. A test substance film was observed on the surface for the 100 mg/L test concentration after 24 h.
Results with reference substance (positive control):
- Results with reference substance valid? yes
- Mortality: yes
- LC50: Between 0.10 - 0.15 mg/L

Description of key information

No effects up to the limit of water solubility (< 2.5 µg/L, 20 °C; OECD 203, C. carpio); read-across

Key value for chemical safety assessment

Additional information

There is no study available, in which the short-term toxicity of the target substance fatty acids, C14-22, C16-24-alkyl esters (CAS 92797-30-3) to fish was assessed. Therefore, read-across to the structurally related source substances 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) and fatty acids, C16-18, C12-18-alkyl esters (CAS 95912-87-1) was conducted in accordance with Regulation (EC) No. 1907/2006 Annex XI, 1.5. The source substances are characterized by fatty acid esters of similar chain lengths and are therefore considered suitable representatives for the assessment of the short-term toxicity of the target substance to fish. A detailed justification of the analogue approach is provided in IUCLID section 13.

The available study with the source substance 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) was conducted according to OECD guideline 203 and GLP (Croda, 1998).

In a static test, the model organismCyprinus carpio(carp) was exposed to Water Accommodated Fractions (WAFs) with nominal loading levels of 10 and 100 mg/L for 96 h. The actual test item concentrations in the test vessels could not be analytically determined due to the very low water solubility. After 96 h, no mortality was observed and an LL50 (96 h) of > 100 mg/L (nominal) was derived. Hence, 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) does not cause toxic effects to fish up to the limit of water solubility (< 0.05 mg/L).

The available study with the source substance fatty acids, C16-18, C12-18-alkyl esters (CAS 95912-87-1) was conducted according to EU Method C.1 and GLP (BASF, 1994). In a static test, the zebrafishDanio reriowas exposed to the three nominal concentrations of 1000, 3000 and 10000 mg/L test item for 96 h. The test item was directly applied to the test vessels without filtration. Despite the undissolved test material floating on the surface of the test media, no effects of the dissolved or undissolved test item were observed and an LC50 (96 h) of > 1000 mg/L (nominal) was derived. Thus, fatty acids, C16-18, C12-18-alkyl esters (CAS 95912-87-1) did not cause any toxic effects to fish up to the limit of water solubility (< 0.05 mg/L).

Based on the structural and chemical similarity of the target and source substance, the target substance is expected to exhibit a similar ecotoxicological profile as the source substances. Therefore, it can be concluded that the target substance fatty acids, C14-22, C16-24-alkyl esters (CAS 92797-30-3) does not cause short-term effects to fish up to the limit of water solubility (< 2.5 µg/L).