Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Suspensions of the 300 mg test substance were prepared in 3 l drinking water. shaking machine 130 rpm at room temperature for 24 h.
After 24 h the shaking was stopped and the solutions were filtered through paper filters directly into the test vessles used for the test, pH of the test solutions was not justified. The nominal concentration used for the test was 100 mg/l.
- Controls: yes, negative control

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebrafish
- Source: Aquafarm Ryba, Zeven, Germany
- Length at study initiation: approx. 2.4 cm
- Feeding during test: none

ACCLIMATION
- Acclimation period: not mentioned

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

22 - 23.4 °C

pH:

control: 7.62 - 8.31
test substance: 7.74 - 8.24

Dissolved oxygen:

control: 8.0 - 8.3 mg O2/L
test substance: 7.9 - 8.3 mg O2/L

Nominal and measured concentrations:

control / 100 mg/L (nominal)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 5 L capacity glass tanks
- Aeration: not mentioned
- Renewal rate of test solution (frequency/flow rate): daily
- No. of organisms per vessel: 7
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: not mentioned

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted
- Total organic carbon: not mentioned
- Particulate matter: not mentioned
- Alkalinity: not mentioned
- Ca/mg ratio: not mentioned
- Conductivity: not mentioned
- Culture medium different from test medium: no
- Intervals of water quality measurement: not mentioned

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: day/night-cycle 16 h/8h
- Light intensity: not mentioned

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): 24, 48, 72 and 96 h the test solutions were examined for dead animals. The pH was not adjusted furthermore during the test.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable
- Justification for using less concentrations than requested by guideline: limit test
- Range finding study: not performed

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)

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: not observed
- Observations on body length and weight: no changes in length and body weights compared to the negative controls
- Other biological observations: none
- Mortality of control: 0%
- Other adverse effects control: none
- Abnormal responses: none
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: none
- Effect concentrations exceeding solubility of substance in test medium: test conducted at test concentration above solubility of test substance

Results with reference substance (positive control):

no reference substance tested

Reported statistics and error estimates:

no statistics performed

Sublethal observations / clinical signs:

Table: Mortality (cumulative data)

concentration (nominal)[mg/L]	Number of fish	Mortality in %
		24 h	48 h	72 h	96 h
0 (control)	7	0	0	0	0
100	7	0	0	0	0

Validity criteria fulfilled:

yes

Conclusions:

Under the present test conditions no toxic effects caused by the test item were observed at a nominal concentration of 100 mg/L exposure medium in a limit test. None of the animals died.

Executive summary:

In a 96-h acute toxicity study according to OECD 203 and GLP, zebrafish (Danio rerio) were exposed to the test substance (CAS 91744-38-6, Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts) at concentrations of 0 and 100 mg/L nominal (limit test) under semi-static conditions. The 96-h LL₅₀based on mortality was > 100 mg/L.  No sublethal effects were observed. Based on the results of this study, the test substance would be classified as non-toxic to Danio rerio.

Although the test substance has a low water solubility and the actual test concentration was not verified, the study is classified as acceptable. In WAF procedure, suspensions of the 300 mg test substance were prepared in 3L drinking water and shaken at room temperature for 24 h. After 24 h the shaking was stopped and the solutions were filtered through paper filters directly into the test vessels used for the test. Therefore it can be concluded that the test substance is not toxic at a loading of 100 mg/L (NOELR = 100 mg/L).

Description of key information

No effects up to the water solubility limit (OECD 203); read-across

Additional information

Since no studies investigating the short-term toxicity of Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates (CAS 91052-16-3) to fish are available for this endpoint, in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read across to the structurally related source substance Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts (CAS 91744-38-6) was conducted. The target substance Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates (CAS 91052-16-3) and the source substance Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts (CAS 91744-38-6) are considered to be structurally very similar. The difference between both substances is that the source substance is the potassium salt of the target substance. Since both substances share common similar functional groups and neither the target nor the source substance consist of any structural alerts leading to a different toxicity profile this read-across is suitable. This read-across is further justified 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 Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts (CAS 91744-38-6) was performed according to OECD 203 under GLP-conditions (Lebertz, 2001). 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 that Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates will not exhibit acute toxicity to fish up to the limit of water solubility.