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

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

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
- Strain: not applicable
- Source: Aquafarm Ryba, Zeven, Germany
- Age at study initiation (mean and range, SD): not mentioned
- Length at study initiation: approx. 2.4 cm
- Weight at study initiation: not mentioned
- Method of breeding: not mentioned
- 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

Post exposure observation period:

none

Hardness:

not mentioned

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

Salinity:

not mentioned

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 statisitcs 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).

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Read-across to K1 study therefore K2 is the maximum Kliomisch score that can be assigned

Justification for type of information:

Please see the read-across report attached in section 13 of this dossier.

Reason / purpose for cross-reference:

read-across source

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
- Strain: not applicable
- Source: Aquafarm Ryba, Zeven, Germany
- Age at study initiation (mean and range, SD): not mentioned
- Length at study initiation: approx. 2.4 cm
- Weight at study initiation: not mentioned
- Method of breeding: not mentioned
- 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

Post exposure observation period:

none

Hardness:

not mentioned

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

Salinity:

not mentioned

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 statisitcs 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

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. There were no reported mortalities at 0 and 100 mg/l test concentrations.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Marine water fish

Marine water fish

Effect concentration:

100 mg/L

Additional information

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 LL₅₀ based 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).