Glycerol monomyristate

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:

25 Oct - 29 Oct 2012

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)

Qualifier:

according to guideline

Guideline:

other: OECD Series on Testing and Assessment No. 126 "Threshold approach for acute fish toxicity" (May 31st, 2010)

Qualifier:

according to guideline

Guideline:

other: OECD Guidance Document No. 23 on Aquatic Toxicity of Difficult Substances and Mixtures, OECD 2000

GLP compliance:

yes (incl. QA statement)

Remarks:

LUBW Landesanstalt für Umwelt, Messungen und Naturschutz Baden-Württemberg, Karlsruhe, Germany

Analytical monitoring:

yes

Details on sampling:

- Sampling method: At the start and at the end of the experimental phase samples (4 mL) were taken and filtered with a 0.45 µm cellulose acetate (CA) membrane filter (Whatman FP 30/0.45 µm). First the filter was washed with 100 mL bi-distilled water and with ca. 10 mL sample.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Due to the sparingly soluble properties of the test item, the study was performed with WAFs ("water accommodated fraction") prepared with sysnthetic fish water according to OECD 203. The solid test item was weighted on a piece of polyethylene foil (rinsed with ethanol and H2O bidest. before). The solid fat was melted in the drying oven at about 50 °C. In addition the synthetic fish medium was heated to about 40 °C on a hot plate. The the melted test item was transferred together with the polyethylene foil into a defined volume of the heated synthetic fish medium into a 1000 mL beaker. Two beakers were prepared like this and stirred for a period of 48 hours at 19.4 - 22.2 °C in diffuse light. For stirring an overhead high-grade stainless steel radial impeller was used (about 500 rpm). The impeller was placed about 4 cm above the bottom of the beakers. The depth of the vortex was about 10% of the total height of the liquid. After stirring was stopped, undissolved material was allowed to sediment or float for a period of about 70 minutes. After this sedimentation period the WAF was clear. Very small crumbs of the test item were observed on the surface and at the bottom of the beakers. The test solutions were withdrawn from the middle of the suspension in the beakers using a glass tube and transferred into the test vessels (aquarium). It was not possible to avoid that small crumbs of the test item were transferred into the test vessels. The filtration of the WAF to obtain the water soluble fraction (WSF) was not taken into consideration to avoid unwanted impacts of the filtration process and to have a worst case scenario.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: Aquarium Dietzenbach Fischzucht, Dietzenbach, Germany; held in the Hydrotox laboratory since October 9th, 2012.
- Length at study initiation: 2.5 - 3 cm
- Housing: After arrival in the lab, the fish were held at 21 - 25 °C in synthetic fish water according to OECD 203 with a light/dark cycle of 14:10 hours. The aquarium was cleaned at least once in two weeks and the water was changed at least once a week. Five days a week the fish were fed twice with commercially available fish feed (TetraMin from TetraWerke, Melle, Germany). The water temperature and the appearance of the fish were checked on a daily basis.
- Feeding during test: none

ACCLIMATION
- Acclimation period: 8 days before test start
- Acclimation conditions (same as test or not): same

Eight days before the test started the fish were held in synthetic fish water under test conditions with 1 litre water per fish. The water was renewed twice during this period. The temperature was in a range of 22.6 to 23.1 °C. The target range of 21 to 25 °C ± 1 °C kept. The fish were kept at a light/dark cycle of 14:10 and were fed twice every working day. 24 hours before the start of the test, a last feeding was carried out. During this pre-test keeping period the fish behaved normally. One fish died.

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

22.8 - 23.1 °C

pH:

7.7 - 7.8

Dissolved oxygen:

5.5 - 8.2 mg O2/L

Nominal and measured concentrations:

Nominal: control, 20 mg/L (WAF, nominal loading rate)
The analysis of dissolved organic carbon (DOC) in the tests solutions resulted in DOC concentrations between 1.8 mg/L at the start and 1.9 mg/L at the end of the test. The latter value corresponds to a measured test concentration of 2.7 mg/L test material.

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Material, size, headspace, fill volume: 8 L aquarium
- 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:
Stock Solutions (synthetic fish water):
DF1: CaCI2 x 2 H2O: 294 g/L (2.0 mol/L)
DF2: MgSO4 x 7 H2O: 123.3 g/L (0.5 mol/L)
DF3: KCI: 2.3 g/L (0.03 mol/L)
DF4: NaHCO3: 25.9 g/L (0.3 mol/L)

The synthetic fish water is prepared as described in the following: To 10 mL each of solutions DF 1 and 2 and 25.5 mL each of solutions DF3 and DF4 deionised water was added up to 10 litres (concentration in the test: DF1: 2.0 mmol/L, DF2: 0.5 mmol/L, DF3: 0.07 mmol/L and DF4: 0.76 mmol/L).

- Intervals of water quality measurement: The pH of the test and the control aquarium was measured and recorded at the beginning and at the end of the test. The oxygen concentration (mg/L), the min-max temperatures and the behaviour of the fish were recorded on a daily basis.

OTHER TEST CONDITIONS
- Photoperiod: light/dark cycle of 14:10

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality daily

TEST CONCENTRATIONS
- Results used to determine the conditions for the definitive study: A limit test with a nominal loading rate of 20 mg/L was performed. This concentration was chosen according to the OECD Series on Testing and Assessment No. 126 "Threshold approach for acute fish toxicity". It was the lowest EL50 determined in the Algal Growth Inhibition Test (EL50 = 13.0 mg/L) and the Daphnia, Acute Toxicity Test (EL50 = 36.5 mg/L).

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 20 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

WAF

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

>= 20 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Remarks:

WAF

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 2.7 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Remarks:

WAF

Basis for effect:

mortality (fish)

Remarks on result:

other: Measured final concentration

Details on results:

- No fish died or showed any abnormal behaviour during the 96 hours exposure period.

- The analysis of dissolved organic carbon (DOC) in the tests solutions resulted in DOC concentrations between 1.8 mg/L at the start and 1.9 mg/L at the end of the test. The latter value corresponds to a measured test concentration of 2.7 mg/L test material.

Sublethal observations / clinical signs:

Accompanying analysis:

The results from the DOC analytics indicate that the test item is only sparringly soluble in the test solution. In the test solution with a nominal loading rate of 20 mg/L only 1.9 mg/L DOC was analysed maximum. The TOC of the test item was determined with 69.1%. Therefore 13.8 mg/L DOC was expected in the solution. Only 13.8% of the amount expected was detected. The test item is only sparringly soluble in the test medium. The DOC concentration analysed corresponds to 2.7 mg/L test item.

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:

guideline study with acceptable restrictions

Remarks:

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°C

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)

Remarks:

Summary of available data used for the endpoint assessment of the target substance.

Adequacy of study:

key study

Justification for type of information:

Please refer to the analogue justification attached to chapter 13.

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 20 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: source, RA-A, CAS 91052-49-2, Cremer, 2012

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)

Remarks on result:

other: source, RA-A, CAS 77538-19-3, BASF, 2001

Description of key information

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

Additional information

Data on the acute toxicity of Glycerol monomyristate (CAS 27214-38-6) to fish are not available. The assessment was therefore based on studies conducted with the source substances Glycerides, C12-18 mono- and di- (CAS 91052-49-2) and Docosanoic acid, ester with 1,2,3-propanetriol (CAS 77538-19-3) as part of a read across approach, which is in accordance with Regulation (EC) No. 1907/2006, Annex XI, 1.5.Please refer to the analogue justification for more details on the read-across approach.

The acute toxicity of the source substance Glycerides, C12-18 mono- and di- (CAS 91052-49-2) to fish was investigated in a limit test according to OECD 203, under GLP conditions. Fish of the species Danio rerio were exposed for 96 hours to a Water Accomodated Fraction (WAF) with a nominal loading rate of 20 mg/L. The WAFwas prepared by adding the test material into water, stirring for a period of 48 hours, followed by a sedimentation period of about 70 minutes. After the sedimentation period, the WAF was clear. Very small crumbs of test item were however, observed on the surface and at the bottom of the beakers. The test solution was prepared without a further filtration step. Analytical measurements of the test concentration were performed via TOC and DOC analysis at the start and at the end of the test. The initial concentration was determined to be 1.8 mg/L, whereas 1.9 mg/L were reported at the end of the test. The latter value corresponds to a measured test concentration of 2.7 mg/L test material. After an exposure period of 96 hours, no mortality was reported in control or treatment group and therefore, the LL50 (96 h) was determined to be > 20 mg/L (nominal, loading rate) and > 2.7 mg/L (measured final test material concentration).

The acute toxicity of the source substance Docosanoic acid, ester with 1,2,3-propanetriol (CAS 77538-19-3) to fish was tested according to the ISO Guideline 7346-1, under GLP conditions. Fish of the species Danio rerio were exposed to nominal test substance concentrations of 100, 300, 1000, 3000 and 10000 mg/L for 96 hours. A semi-static test with a daily renewal of the test solutions was set up. At the end of the exposure period, no mortality was observed in treatment or control groups and the LC50 (96 h) was determined to be > 10000 mg/L (nominal).

Based on the available data on the source substances acute toxic effects of the target substance Glycerol monomyristate (CAS 27214-38-6) are not expected up to the limit of water solubility.