Glycerides, C18-36

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

Study period:

18 Jul- 22 Jul 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions (no analytics performed)

Qualifier:

according to guideline

Guideline:

ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test substance was directly weighed into the test vessels, filled up to final volume of 5 L with standard dilution water and afterwards stirred 10 seconds by Ultraturrax
- Controls: yes

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Feeding during test: none
- Pre-treatment: none

ACCLIMATION
- Health during acclimation: Mortality prior to test < 0.1%

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

About 250 mg CaCO3/L

Test temperature:

22.5 - 23.5°C

pH:

7.5 - 8.0

Dissolved oxygen:

60-98% air saturation values

Nominal and measured concentrations:

Nominal concentrations: 1000, 3000 and 10000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 10L fish basins, containing 5L test water
- Renewal rate of test solution: daily
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1


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


OTHER TEST CONDITIONS
- Photoperiod: 16 hours illumination per day


EFFECT PARAMETERS MEASURED: Mortality, recorded at 0, 6, 24, 48, 72 and 96 hours


TEST CONCENTRATIONS
- Spacing factor for test concentrations: 3

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)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: The fish did not show any abnormal behaviour.
- Mortality of control: no

Sublethal observations / clinical signs:

No effect up to the limit of the water solubility of the test substance was observed.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

08 - 12 Jan 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study with acceptable restrictions: No analytics of the test substance was performed.

Qualifier:

according to guideline

Guideline:

ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: The test substance was directly added to the test vessels. The vessels were filled up to final volumes of 5L with standard solution water and then were stirred 3 minutes by ultraturrax.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Feeding during test: none

ACCLIMATION
- Health during acclimation (any mortality observed): Mortality prior to test was < 0.1%.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

250 mg/L as CaCO3

Test temperature:

22.0 - 23.5%

pH:

7.6 - 7.8

Dissolved oxygen:

45 - 97% saturation

Nominal and measured concentrations:

Nominal: 100, 300, 1000, 3000 and 10000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: fish basins
- Size, fill volume: 10 L, 5 L
- Renewal rate of test solution: daily
- No. of organisms per vessel: 10
- No. of vessels per concentration: 1
- No. of vessels per control: 1

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

OTHER TEST CONDITIONS
- Photoperiod: 16h light per day

EFFECT PARAMETERS MEASURED: Mortality was recorded after 0, 6, 24, 48, 72 and 96h test duration.

Reference substance (positive control):

no

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)

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)

Details on results:

- Behavioural abnormalities: No abnormal behaviour was observed.
- Mortality of control: No mortality was observed in the control and in any treatment.

Sublethal observations / clinical signs:

- 0% mortality reported in both treatment and control vessels

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Study period:

18 Jul- 22 Jul 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions (no analytics performed)

Qualifier:

according to guideline

Guideline:

ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)

GLP compliance:

no

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)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Reference 4

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Study period:

08 - 12 Jan 1990

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP Guideline study with acceptable restrictions: No analytics of the test substance was performed.

Qualifier:

according to guideline

Guideline:

ISO 7346-1 (Determination of the Acute Lethal Toxicity of Substances to a Freshwater Fish [Brachydanio rerio Hamilton-Buchanan (Teleostei, Cyprinidae)] - Part 2: Semi-static method)

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

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)

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)

Reference 5

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

20 Oct- 22 Oct 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: DIN 38412/15 German standard method for the examination of water, waste water and sludge; bioassays (group L); determination of the effect of substances in water on fish- fish test (L 15)

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: A specific amount of test substance was added directly to the test vessels (filled up to final volumes of 10 L) and the solution stirred for 5 minutes by ultraturrax

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name: Golden orfe
- Length at study initiation: approx. 6 cm
- Feeding during test: no

Test type:

static

Water media type:

freshwater

Total exposure duration:

48 h

Hardness:

Approximately 16° dH (about 93 mg Ca/L and 12 mg Mg/L)

Test temperature:

20.0-20.5 °C

pH:

7.7-7.8

Dissolved oxygen:

62-92% air saturation

Nominal and measured concentrations:

Nominal: 100, 300, 1000, 3000 and 10,000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: basins containing 10 L test water
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Copper- and chlorine-free drinking water

OTHER TEST CONDITIONS
- Photoperiod: 16 hours light per day

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality at 0, 6, 24 and 48 hours

Duration:

48 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:

No mortalities or any sign of abnormal behaviour were reported at any of the concentrations tested

Sublethal observations / clinical signs:

Table 1. Mortality %

Concentration (mg/L)	Incubation time (h)
	0	6	24	48
100	0	0	0	0
300	0	0	0	0
1000	0	0	0	0
3000	0	0	0	0
10000	0	0	0	0

 

Reference 6

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

supporting study

Study period:

20 Oct- 22 Oct 1986

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: DIN 38412/15 German standard method for the examination of water, waste water and sludge; bioassays (group L); determination of the effect of substances in water on fish- fish test (L 15)

GLP compliance:

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Description of key information

No effects up to the limit of water solubility; read-across.

Additional information

Since no studies investigating the short-term toxicity of Dub TGI 24 to fish are available, in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5 a read-across to the structurally related source substances, Glycerides, C16-18 and C18-unsatd. (CAS No. 67701-30-8), Docosanoic acid, ester with 1,2,3-propanetriol (CAS No. 77538-19-3) and Glycerides,C14-18 and C16-18 unsaturated, mono-, di- and tri- (CAS No. 91052-28-7) was conducted. The source substances are representative to evaluate the short-term toxicity of the target substance to fish. The target substance is characterized as a mono, di and triesters with glycerol and 2-decyltetradecanoic acid. The source substances are structurally very similar to the target substance.   Glycerides, C16-18 and C18-unsatd. (CAS No. 67701-30-8) is an UVCB substance consisting of C16 – C18 (even) and C18 unsaturated fatty acids with glycerol mainly as triglycerides. Docosanoic acid, ester with 1,2,3-propanetriol (CAS No. 77538-19-3) could be a mono, di and triester mainly with C22 fatty acid and glycerol. Glycerides,C14-18 and C16-18 unsaturated, mono-, di- and tri- (CAS No. 91052-28-7) is characterized as mono, di and triester of glycerol with fatty acids of C14-18 and C16-18 unsaturated.

This read-across is justified in detail in the overall summary (IUCLID Section 6.1) and 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) read-across substance was used for the assessment.

The first study investigated the short-term effects of the source substance Glycerides, C16-18 and C18-unsatd. (CAS 67701-30-8) to freshwater fish. The non-GLP study was performed according to ISO guideline 7346-1 using a semi-static test design. Danio rerio was exposed 96 hours to nominal test substance concentrations of 1000, 3000 and 10000 mg/L. No mortality was observed at any of the tested concentrations and therefore the LC50 (96 h) was determined to be > 10,000 mg/L (nominal).

The second study evaluating the acute toxicity of docosanoic acid, ester with 1,2,3-propanetriol (CAS 77538-19-3) to fish was conducted according to the ISO Guideline 7346-1, under GLP conditions. Danio rerio was exposed to the test substance for 96 hours within a semi-static water regime, at nominal concentrations ranging from 100 to 10000 mg/L. After the exposure period, no mortality was observed in treatment or control groups and therefore, the LC50 (96 h) was determined to be > 10,000 mg/L (nominal).

The third study investigated the short-term toxicity of the source substance Glycerides, C14-18 and C16-18 unsaturated, mono-, di- and tri- (CAS 91052-28-7) to freshwater fish. This test was performed according to the German national Guideline DIN 38412/15 (Examination of water, waste water and sludge; bioassays (L); determination of the effect of substances in water on fish- Fish test (L15)). In this static test, Leuciscus idus were exposed to the test substance for 48 hours. After this period, no mortality or any other effects were reported at any of the concentrations tested (LC50 (48 h) > 10000 mg/L nominal). According to the Guidance on information requirements and chemical safety assessment, chapter R.7b, results obtained at shorter test durations that the standard 96 hours (OECD 203) should be treated with caution and always in combination with other data (read-across, non-testing, etc.). As this study supported the results from both other read across substances, that no short-term effects to fish are expected up to the limit of water solubility, this study is used as supporting study.

Based on the available results from structurally related source substances (in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) which are characterized by a similar ecotoxicological profile and comparable structure, it can be concluded that Dub TGI 24 will not exhibit short-term effects to fish up to the limit of water solubility.