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Short-term toxicity to fish

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Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Study period:
11 April 1988 to 15 April 1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Qualifier:
according to guideline
Guideline:
OECD Guideline 203 (Fish, Acute Toxicity Test)
Deviations:
not specified
GLP compliance:
yes
Analytical monitoring:
no
Vehicle:
no
Details on test solutions:
Stock solutions of the test material were prepared by mechanical dissolving (Ultra-Turrax) the appropriate amount of the test substance in the required volume of deionised water. This stock solution was transferred into the test medium of one glass tank. Loading of the test medium with the test sample was done 2 h before the start of the test. Until the transfer of fish into the test solution, the contents of each glass tank were mixed thoroughly using a mechanical stirrer in order to facilitate the dispersing of the test sample.
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra-fish
- Strain: Brachydanio rerio (Teleostei, Cyprinidae)
- Source: West Aquarium GmbH + Co. KG, D- 3422 Bad Lauterberg
- Age at study initiation (mean and range, SD): Two months (approx.)
- Length at study initiation (length definition, mean, range and SD): 2.0 ± 1.0 cm


ACCLIMATION
- Acclimation period: 13 d
- Acclimation conditions: The fish was transferred to a tank with a total water volume of about 200 L for adaptation to the environmental conditions during the test. During the adaptation period, the holding of the test fish was performed using a semi-static system in which the reconstituted water was recirculated and filtered continuously.
- Type and amount of food: Tetra Min Hauptfutter (Art.-No. 1004 DN, produced by Tetra-Werke, Dr. rer.nat. Ulrich Baensch GmbH, D- 4520 Melle 1)
- Feeding frequency: Twice daily
- Health during acclimation (any mortality observed): Good health, no mortality observed

Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
20.8-21.8
pH:
7.5-7.6
Dissolved oxygen:
>86% (at 96 h)
Nominal and measured concentrations:
100 and 1000 mg/L (nominal)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: The glass tanks for the different test batches had the following dimensions: length 300 mm, width 200 mm and height 220 mm.
- Aeration: For the continuous aeration of the test medium in the different glass tanks special aquarium aerators, brand Optima (Art.-No. A 10007, produced by Weltweit GmbH & Co. KG, D- 2081 Holm near Hamburg) were used. Air was bubbled into the test medium through Pasteur pipettes directly connected with the aerator by flexible PVC tubes. The air-stream was regulated with tube-clamps providing for each tank a uniform air-stream of 1 to 3 bubbles per second.
- No. of organisms per vessel: 10


TEST MEDIUM / WATER PARAMETERS
- Source/preparation of reconstituted water: It was prepared according to the Annex of OECD-Guideline 203 in the following way (referred to a total volume of 10.0 L):
117.6 g Calcium chloride dihydrate CaCl2.2H2O (Art.No. 2382, produced by E. Merck AG, D- 6100 Darmstadt) were dissolved in deionised water; this solution was made up with deionised water to a total volume of 1.0 L.
49·3 g Magnesium sulfate heptahydrate MgSO 4.7H2O (Art.-No. 5886 produced by E. Merck AG, D-6100 Darmstadt) were dissolved in deionised water; this solution was made up with deionisd water to a total volume of 1.0 L.
25.9 g Sodium hydrogencarbonate O 3 (Art.-No. 6329, produced by E. Merck AG, D-6100 Darmstadt) were dissolved in deionised water; this solution was made up with deionised water to a total volume of 1.0 L.
2.3 g Potassium chloride KCl (Art.-Noo 4936, produced by E. Merck AG, D-6100 Darmstadt) were dissolved in deionised water; this solution was made up with deionised water to a total volume of 1.0 L.
For the preparation of the reconstituted water, 25 mL each of the four afore-mentioned solutions were mixed; this mixture was then made up with deionised water to a total volume of 10.0 L. Thus reconstituted water prepared in the described way, met the following requirements:
The sum of the calcium and magnesium ions was 2.5 mmol/L. The molar ratio of calcium to magnesium ions was 4:1. The molar ratio of sodium to potassium ions was 10:1. The total alkalinity or acid capacity was 0.8 mmol/L.
- Conductivity: < 0.1 µS/cm


OTHER TEST CONDITIONS
- Adjustment of pH: Yes, determination of pH was carried out with the measuring device pH 91/Set (Art.-No. 9.774091, produced by WTW, D-8120 Weilheim)


EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Mortality rates, abnormal symptoms in the swimming behaviour, in visible physiological functions as well as in the outward appearance of the test fish were observed at 0, 24, 48, 72 and 96 h.


Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Validity criteria fulfilled:
not specified
Conclusions:
Under the test conditions, the 96 h LC0 of the constituent for Brachydanio rerio was found to be 1,000 mg/L.
Executive summary:

A study was conducted to determine the lethal effects of the constituent glycerides C16 -18 and C18 -unsatd. (castor oil) to the Zebra-fish (Brachydanio rerio) using a static system according to the OECD Guideline 203. Fish were exposed in separate test batches to different concentration (100 and 1000 mg/L) of the constituent in the test medium over a test period of 96 h (each tank with 10 fish). Observations were made at 0, 24, 48, 72 and 96 h for the mortality rates, abnormal symptoms in the swimming behaviour, in visible physiological functions as well as in the outward appearance of the test fish. Fish were considered dead if touching of the caudal peduncle produced no reaction and if no breathing movements could be observed. Under the test conditions, the 96 h LC0 of the constituent for Brachydanio rerio was found to be 1,000 mg/L (Dommrose, 1988).

Endpoint:
short-term toxicity to fish
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
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:
not specified
Analytical monitoring:
no
Vehicle:
no
Test organisms (species):
Danio rerio (previous name: Brachydanio rerio)
Details on test organisms:
TEST ORGANISM
- Common name: Zebra fish
- Strain: Barachydanio rerio (Teleostei, Cyprinidae)
- Source: West Aquarium GmbH
- Age at study initiation (mean and range, SD): 2 months


ACCLIMATION
- Acclimation conditions: The fish were held together in a glass tank (200 L). Reconstituted water was used as holding water.
- Type and amount of food: Tetra Min(R) Hauptfutter (Art. no. 1004 DN, produced by Tetra-Werke). The amount was regulated according to the actual consumption observed
- Feeding frequency: Twice daily
- Health during acclimation (any mortality observed): All were in good health and condition, no mortality
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
Between 21 and 25°C
pH:
6.0 to 8.5
Dissolved oxygen:
>60%
Nominal and measured concentrations:
100 and 1,000 mg/L (nominal)
Details on test conditions:
TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: length 300 mm, with 200 mm and height 220 mm
- Aeration: aquarium aerators, brand Optima (Art. no. A 10007, produced by Weltweit GmbH & Co. KG, D- 2081) were used for continuous aeration
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 10

Reference substance (positive control):
not specified
Key result
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
1 000 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Basis for effect:
mortality (fish)
Details on results:
- Mortality of control: no deaths
- Other adverse effects control: none
- Abnormal responses: no
Validity criteria fulfilled:
not specified
Conclusions:
Under the test conditions, the 96 h LC0 of the constituent for Brachydanio rerio was found to be 1,000 mg/L.
Executive summary:

A study was conducted to evaluate the lethal effects of the constituent glycerides C16 -18 and C18 -unsatd. (linseed oil) to Zebra fish (Brachydanio rerio) according to OECD guideline 203. The fish were exposed in separate test batches to different concentrations (100 and 1,000 mg/L) of the constituent in the test medium over a test period of 96 h (each tank with 10 fish). The observations were made at 0, 24, 48, 72 and 96 h for mortality, abnormal symptoms in the swimming behaviour, in visible physiological functions as well as in the general appearance of the test fish. The exposed fish were considered dead if the caudal peduncle produced no reaction upon touch and if no breathing movements could be observed. Under the test conditions, the nominal 96 h LC0 of the constituent for Brachydanio rerio oil was found to be 1,000 mg/L (Dommrose, 1988b).

Endpoint:
short-term toxicity to fish
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
24 March 2010 to 30 March 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Justification for type of information:
Refer to the section 13 for details on the read across justification. The acute fish study with the read across substance is used as a supporting 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
Qualifier:
according to guideline
Guideline:
other: OECD Series on testing and assessment No. 23: Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Concentrations: 0 and 100 mg/L, nominal
- Sampling method: Duplicate samples from the freshly prepared test media and the control were taken at the start of the test.
For the determination of the stability of the test substance under the test conditions, respectively the maintenance of the test substance concentrations during the test period, samples were taken in duplicate out of the test media and the control at 96 h.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
1,002.9 mg of the test substance were added directly to 10,029 mL test water and carefully stirred for about 24 h at room temperature in the dark to dissolve as much as possible. After cessation of mixing and a following period of settling to allow phase separation, the aqueous phase, i.e. the water accommodated fraction, was drawn off carefully and used as the test medium.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: rainbow trout
- Source: Forellenzuchtbetrieb Frauenhofer Institut Molekularbiologie und Angewandte Oekologie, Aud dem Aberg 1, 57392 Schmallenberg, Germany
- Age at study initiation (mean and range, SD): Juveniles
- Length at study initiation (length definition, mean, range and SD): 4.41 +/- 0.2 cm
- Weight at study initiation (mean and range, SD): 0.74 +/- 0.09 g
- Feeding during test: no

ACCLIMATION
- Acclimation period: at least 12 d
- Acclimation conditions (same as test or not): yes
- Feeding frequency: 3 times per week or daily until 24 h before test start
- Health during acclimation (any mortality observed): no mortality
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Test temperature:
15°C
pH:
7.7 - 7.9
Dissolved oxygen:
93 - 102%
Nominal and measured concentrations:
- Nominal: 0 and 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: 12 L glass aquaria
- Type (delete if not applicable): open
- Aeration: slight
- Renewal rate of test solution (frequency/flow rate):
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
> 100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
(water accommodated fraction)
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
100 mg/L
Nominal / measured:
nominal
Conc. based on:
test mat.
Remarks:
(water accommodated fraction)
Basis for effect:
mortality (fish)
Sublethal observations / clinical signs:

The concentration of test substance recorded by total organic carbon analysis was below the limit of quantification in the control and test vessels. The LOQ was equivalent to 5 mg/L. Test concentrations were therefore based on nominal values.

Validity criteria fulfilled:
yes
Conclusions:
Based on the results of the read across study, 96 h LC50 and NOEC for the test substance, Soaps, stocks, vegetable oil, acidulated, are considered to be >100 and 100 mg/L WAF (nominal), respectively.
Executive summary:

A study was conducted to determine the acute toxicity of, read across substance, 'oils, vegetable, deodorizer distillates' to rainbow trout in a static 96 h test (OECD Guideline 201 and EU method C.1). Rainbow trout were exposed to water accommodated fraction of the nominal read across substance concentrations of 0 and 100 mg/L for 96 h. Mortality and signs of toxicity were followed throughout the study. Analytical verification of the test concentrations were conducted at the concentrations of the read across substance in the test medium. The samples collected at start and after 96 h were analysed via the TOC-method. Under the test conditions, the 96 h LC50 of the read across substance was >100 mg/L (nominal). The 96 h NOEC was 100 mg/L WAF (nominal) (Kley and Deierling, 2010a). Based on the results of the read across study, 96 h LC50 and NOEC for the test substance, Soaps, stocks, vegetable oil, acidulated, are considered to be >100 and 100 mg/L WAF (nominal), respectively.

Endpoint:
short-term toxicity to fish
Type of information:
read-across based on grouping of substances (category approach)
Adequacy of study:
supporting study
Study period:
24 March 2010 to 17 April 2010
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions
Remarks:
KL2 due to RA
Justification for type of information:
Refer to the section 13 for details on the read across justification. The acute fish study with the read across substance is used as a supporting 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
Qualifier:
according to guideline
Guideline:
other: OECD Series on testing and assessment No. 23: Guidance Document on Aquatic Toxicity Testing of Difficult Substances and Mixtures, 2000
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Analytical monitoring:
yes
Details on sampling:
- Appropriate amounts of the stock solution were diluted with pure water to get TC standard solutions in the range from 1 to 50 mg Carbon/L and IC standard solutions in the range of 1 to 25 mg Carbon/L.

Analysis of the Test Substance Concentrations:
- Sampling: Duplicate samples from the freshly prepared test medium of the only test concentrations and the control were taken at the start of the test. For the determination of the stability of the test material under the test conditions, respectively the maintenance of the test substance concentrations during the test period, samples were taken in duplicate out of all test media and the control at the end of the test (96 h).
- Analysis: The concentrations of the test substance were analysed in the duplicate test media samples from the only test concentration and both sampling times (0 and 96 h). From the control samples only one of the duplicate samples was analysed from each of both sampling times.
Vehicle:
no
Details on test solutions:
PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
1,000 mg of the test substance were added directly to 10,000 mL test water and carefully stirred for about 24 h at room temperature in the dark to dissolve as much as possible. After cessation of mixing and a following period of settling to allow phase separation, the aqueous phase, i.e. the water accommodated fraction, was drawn off carefully and used as the test medium.
Test organisms (species):
Oncorhynchus mykiss (previous name: Salmo gairdneri)
Details on test organisms:
TEST ORGANISM
- Common name: Rainbow Trout
- Source: Forellenzuchtbetrieb Fraunhofer Institut Molekularbiologie und Angewandte Oekologie, Auf dem Aberg 1, 57392 Schmallenberg, Germany.
- Age at study initiation (mean and range, SD): Juveniles
- Length at study initiation (length definition, mean, range and SD): 4.83 ± 0.36 cm
- Weight at study initiation (mean and range, SD): 0.90 ± 0.25 g
- Feeding during test: No


ACCLIMATION
- Acclimation period: 12 d
- Acclimation conditions (same as test or not): Same
- Feeding frequency: Three times/wk or daily until 24 h before the test was started
- Health during acclimation (any mortality observed): No
Test type:
static
Water media type:
freshwater
Limit test:
yes
Total exposure duration:
96 h
Hardness:
2.5 mmol/L (= 250 mg/L) as CaCO3
Test temperature:
14 - 15°C
pH:
7.9- to 8.1
Dissolved oxygen:
91- 100% of the air saturation value
Nominal and measured concentrations:
Nominal: 0 and 100 mg/L
Details on test conditions:
TEST SYSTEM
- Test vessel: Glass aquaria
- Type (delete if not applicable): Closed
- Material, size, headspace, fill volume: 12 L glass aquaria with 8 L test medium
- Aeration: Yes (slightly aerated during the test)
- Renewal rate of test solution (frequency/flow rate):
- 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: Reconstituted water
- Alkalinity: 0.8 mmol/L
- Ca/mg ratio: 4:1 (based on molarity)
- Conductivity: < 10 µScm-1
- Culture medium different from test medium: No


OTHER TEST CONDITIONS
- Adjustment of pH: Yes
- Photoperiod: 16 h light : 8 h dark; 30 min dawn/dusk period
- Light intensity: 590 - 1160 lux

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : The test fish were observed after approximately 2, 24, 48, 72 and 96 h test duration for sublethal effects and mortality.

TEST CONCENTRATIONS
- Range finding study
- Test concentrations: 100 mg/L
- Results used to determine the conditions for the definitive study: Yes
Reference substance (positive control):
no
Key result
Duration:
96 h
Dose descriptor:
NOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: water accommodated fraction
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LOEC
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: water accommodated fraction
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC0
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: water accommodated fraction
Basis for effect:
mortality (fish)
Key result
Duration:
96 h
Dose descriptor:
LC50
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: water accommodated fraction
Basis for effect:
mortality (fish)
Duration:
96 h
Dose descriptor:
LC100
Effect conc.:
>= 100 mg/L
Nominal / measured:
nominal
Conc. based on:
other: water accommodated fraction
Basis for effect:
other: mortality and sublethal effects
Details on results:
- Behavioural abnormalities: No
- Mortality of control: No
- Other adverse effects control: No sublethal effects during the exposure time
- Abnormal responses: No
- Effect concentrations exceeding solubility of substance in test medium: There were no remarkable observations
Sublethal observations / clinical signs:

Determination of the Test Item

Based on the results of TOC measurements the concentration of the test substance was determined using a calibration curve.

Calibration Range

1 to 50 mg Carbon/L in pure water in the case of TC-calibration and

1 to 25 mg Carbon/L in pure water in the case of IC-calibration

Linearity of Response

Correlation of peak area of different standard solutions with their corresponding concentrations, using a linear regression

Regression Coefficient

At least 0.9987 in the case of TC

at least 0.9955 in the case of IC



Typical Calibration Curve

y =4.1577 * x - 1.0347in the case of TC

y =3.5631 * x – 1.1193in the case of IC

Limit of Detection

LODTC: 2.252 mg Carbon/L;

 LODIC: 1.911 mg Carbon/L

Limit of Quantification

5 mg Carbon/L

119 % (n = 4, RSD 9 %)

Mean Recovery in the Fortified Samples

111 % (n = 4, RSD 2 %)

 Mean recovery in the test samples

 Since the test substance is not well water soluble, all results were below LOQ

Validity criteria fulfilled:
yes
Conclusions:
Based on the results of the read across study, 96 h LC50 and NOEC for the test substance, Soaps, stocks, vegetable oil, acidulated, are considered to be >100 and 100 mg/L WAF (nominal), respectively.
Executive summary:

A study was conducted to evaluate the acute toxicity of the read-across substance 'soybean oil, deodorizer distillate' to freshwater rainbow trout (Oncorhynchus mykiss) in a static test (OECD Guideline 203 and EU method C.1). Rainbow trout were exposed to nominal water accommodated fractions of 0 and 100 mg/L for 96 h. Mortality and signs of toxicity were followed throughout the study. Analytical verification of the test concentrations were conducted at the concentrations of the read-across substance in the test medium. The samples collected at start and after 96 h were analysed via the TOC-method. Under the test conditions, the 96 h LC50 of the read-across substance was determined to be >100 mg/L (nominal). The 96 h NOEC was 100 mg/L (nominal) (Kley and Deierling, 2010b). Based on the results of the read across study, 96 h LC50 and NOEC for the test substance, Soaps, stocks, vegetable oil, acidulated, are considered to be >100 and 100 mg/L WAF (nominal), respectively.

Description of key information

Based on the studies with major constituents as well as by read-across to the similar deodorizer distillates, the 96 h LC50 >100 mg/L and NOEC of ≥ 100 mg/L and ≥ 100 mg/L (nominal) has been considered further for the hazard assessment of 'soaps, stocks, vegetable oil, acidulated'.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish
Effect concentration:
100 mg/L

Additional information

There is no information on the aquatic toxicity of ‘soaps, stocks, vegetable oil, acidulated’. However, considering that its composition is comparable to that of various types of deodorizer distillates produced from vegetable oils, its acute aquatic toxicity potential to fish has been evaluated on the basis of available studies with major constituents as well as by read-across to the similar deodorizer distillates.

A study was conducted to determine the acute toxicity of, read across substance, 'oils, vegetable, deodorizer distillates' to rainbow trout in a static 96 h test (OECD Guideline 201 and EU method C.1). Rainbow trout were exposed to water accommodated fraction of the nominal read across substance concentrations of 0 and 100 mg/L for 96 h. Mortality and signs of toxicity were followed throughout the study. Analytical verification of the test concentrations were conducted at the concentrations of the read across substance in the test medium. The samples collected at start and after 96 h were analysed via the TOC-method. Under the test conditions, the 96 h LC50 of the read across substance was >100 mg/L (nominal). The 96 h NOEC was 100 mg/L WAF (nominal) (Kley and Deierling, 2010a). Based on the results of the read across study, 96 h LC50 and NOEC for the test substance, Soaps, stocks, vegetable oil, acidulated, are considered to be >100 and 100 mg/L WAF (nominal), respectively.

A study was conducted to evaluate the acute toxicity of the read-across substance 'soybean oil, deodorizer distillate' to freshwater rainbow trout (Oncorhynchus mykiss) in a static test (OECD Guideline 203 and EU method C.1). Rainbow trout were exposed to nominal water accommodated fractions of 0 and 100 mg/L for 96 h. Mortality and signs of toxicity were followed throughout the study. Analytical verification of the test concentrations were conducted at the concentrations of the read-across substance in the test medium. The samples collected at start and after 96 h were analysed via the TOC-method. Under the test conditions, the 96 h LC50 of the read-across substance was determined to be >100 mg/L (nominal). The 96 h NOEC was 100 mg/L (nominal) (Kley and Deierling, 2010b). Based on the results of the read across study, 96 h LC50 and NOEC for the test substance, Soaps, stocks, vegetable oil, acidulated, are considered to be >100 and 100 mg/L WAF (nominal), respectively.

Further, studies conducted with glyceride representative substances i.e., for ‘glycerides, C16 and C18-unsatd. and C18-unsatd. hydroxy’ (in the form of castor oil) and ‘glycerides, C16-18 and C18-unsatd.’ (in the form of linseed oil) indicate no toxicity to zebra fish (Brachydanio rerio) at up to 1,000 mg/L in OECD 203 static tests (Dommröse, 1988 a and b).,

Overall based on the above studies, ‘soaps, stocks, vegetable oil, acidulated' is considered to have low acute toxicity potential in fish and a 96 h LC50 value >100 mg/L has been considered further for hazard assessment.