Fatty acids, palm-oil, hydrogenated

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

Mar. 2010 to Oct. 2010

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to standard guidelines in compliance with GLP. TOC analyses conducted as dose verification.

Justification for data waiving:

other:

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

no

Test guideline 3

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)

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Details on test material:

- Name of test material (as cited in study report): Oils, vegetable, deodorizer distillates
- Substance type: Glycerides, fatty acids and unsaponifiable matter of vegetable origin
- Physical state: Liquid/pasty, brown
- Lot/batch No.: 12011
- Expiration date of the lot/batch: 14 July 2010
- Storage condition of test material: in original cntainer at room temperature (15 - 25°C) in the dark

Sampling and analysis

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 item under the test conditions, respectively the maintenance of the test item concentrations during the test period, samples were taken in duplicate out of the test media and the control at 96 hours.

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
1,002.9 mg of the test item were added directly to 10,029 mL test water and carefully stirred for about 24 hours 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

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Strain:
- 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 days
- Acclimation conditions (same as test or not): yes
- Feeding frequency: 3 times per week or daily until 24 hours before test start
- Health during acclimation (any mortality observed): no mortality

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test conditions

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

Results and discussion

Effect concentrations

Effect concentrations 1

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(water accomodated fraction)

Basis for effect:

mortality (fish)

Effect concentrations 2

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

(water accomodated fraction)

Basis for effect:

mortality (fish)

Any other information on results incl. tables

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.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

Under the test conditions, the 96 h LC50 of the test substance was > 100 mg/L (nominal). The 96 h NOEC was 100 mg/L (nominal).

Executive summary:

A study was conducted to determine the acute toxicity of '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 test 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 test material 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 test substance was > 100 mg/L (nominal). The 96 h NOEC was 100 mg/L (nominal).