Linseed oil, ester with pentaerythritol

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:

weight of evidence

Study period:

From August 04, 1997 to August 08, 1997

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

GLP - The test solution is prepared without removing undissolved test substance. No analytical monitoring of the test substance is performed. No reference substance is tested.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

yes

Remarks:

Reference substance is not tested. Not all fishes surveyed were 2.0 ± 1.0 cm in length. Temperatures temporally exceed the recommended range of 21 - 25 °C by 2 °C.

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Deviations:

yes

Remarks:

Reference substance is not tested. Not all fishes surveyed were 2.0 ± 1.0 cm in length. Temperatures temporally exceed the recommended range of 21 - 25 °C by 2 °C.

GLP compliance:

yes

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION:
- Method: At 0 h 1.25 g of the test substance was weighted and dispersed in 5 litres of hot (~60 °C) carbon filtered tap water by high shear mixing at 15000 rpm for 15 min in a 5 litre conical flask to maximise the shearing effect of the blade. This gave a 250 mg/L stock. The stock was prepared daily then the test media prepared by appropriate dilution of the stock.
- Controls: yes, water control

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra fish
- Source: bred in-house
- Length at study initiation (mean): 3.7 cm (fish from control tank surveyed at the end of the test)
- Weight at study initiation (mean): 0.48 g (fish from control tank surveyed at the end of the test )
- Method of breeding: They were reared in carbon-filtered tap-water and maintained under the following conditions: pH 6.5 - 8.0, temperature 25 ± 2 °C, dissolved oxygen > 60% saturated (> 4.8 mg/L) and photoperiod 16 h light: 8 h dark. Variability of total hardness results from natural fluctuations in tap water supply (normal range 90 - 150 mg/L as CaCO3). Disturbance was kept to a minimum except from feeding and maintenance activities. The fish were fed on live and proprietary fish food (Artemia and Tetramin).
- Batch: 47Z

ACCLIMATION
- Acclimation period: 72 h
- Acclimation conditions: The test fish were isolated and all fish get no food 24 h prior to the start of the test.

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

118 - 123 mg/L as CaCO3

Test temperature:

23.5 - 27.0°C

pH:

7.3 - 8.0

Dissolved oxygen:

4.9 - 7.5 mg/L

Nominal and measured concentrations:

Nominal: 10, 18, 32, 56 and 100 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: tank
- Material: all-glass, size: 6 L, fill volume: 5 L
- Aeration: All vessels were aerated.
- Renewal rate of test solution: every 24 h
- No. of organisms per concentration: 7

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: carbon-filtered tap water
- Intervals of water quality measurement: The temperature, pH and dissolved oxygen concentrations were determined daily at all concentrations. The total hardness was determined daily in both old and new media from the control and top concentration only.

OTHER TEST CONDITIONS
- Photoperiod: 16 h light/ 8 h dark
- Light intensity: normal room lighting

EFFECT PARAMETERS MEASURED: Mortality was observed after 96 h (futher observations not stated) and abnormalities in swimming activity and loss of balance were observed daily.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: No visible abnormalities were observed and the fish behaviour was unaffected at any of the concentrations.
- Mortality of control: none

Sublethal observations / clinical signs:

No mortalities were observed at any of the test concentrations.

Validity criteria fulfilled:

yes

Conclusions:

Under the study conditions, the 96 h LC50 was determined to be >100 mg/L and the NOEC for was 100 mg/L (nominal).

Executive summary:

A study was conducted to determine the acute toxicity of pentaerythritol tetraisostearate to Danio rerio (zebra fish) under semi-static conditions according to OECD Guideline203, in compliance with GLP. The substance was tested at the nominal concentrations of 10, 18, 32, 56 and 100 mg/L. No analytical dose verification was conducted. The validity criteria for the study were met. No mortality was observed in the control or test substance group. Under the study conditions, the 96 h LC50 in zebra fish was determined to be >100 mg/L and the NOEC for was 100 mg/L (nominal) (van Egmond, 1997).

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

Not available

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Deviations:

no

Qualifier:

according to guideline

Guideline:

other: 5.1.1 "Acute toxicity for Fish" of the EEC-Directive 79/831

Deviations:

no

GLP compliance:

not specified

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Strain: Barachydanio rerio (Teleostei, Cyprinidae)
- Source: West Aquarium GmbH
- Age at study initiation (mean and range, SD): 2 months


ACCLIMATION
- Acclimation conditions: The fish were held together in a glass tank (200 L). Reconstituted water was used as holding water (according to OECD-guideline 203)
- Type and amount of food: Tetra Min(R) Hauptfutter (Art. no. 1004 DN, produced by Tetra-Werke). The amount was regulated according to the actual consumption observed
- Feeding frequency: Twice daily
- Health during acclimation (any mortality observed): All were in good health and condition, no mortality

Test type:

static

Water media type:

saltwater

Limit test:

yes

Total exposure duration:

96 h

Test temperature:

Between 21 and 25°C

pH:

6.0 to 8.5

Dissolved oxygen:

>60%

Nominal and measured concentrations:

100 and 1000 mg/L (nominal)

Details on test conditions:

TEST SYSTEM
- Test vessel:
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: length 300 mm, with 200 mm and height 220 mm
- Aeration: an aquarium aerators, brand Optima (Art. no. A 10007, produced by Weltweit GmbH & Co. KG, D- 2081) were used for continuous aeration
- Renewal rate of test solution (frequency/flow rate): no
- No. of organisms per vessel: 10

Reference substance (positive control):

not specified

Key result

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: None

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: None

Details on results:

- Mortality of control: no deaths
- Other adverse effects control: none
- Abnormal responses: no

Conclusions:

Under the study conditions, the 96 h LC0 and LC50 were > 1000 mg/L.

Executive summary:

A study was conducted to evaluate the acute toxicity of glycerides, C16-18 and C18-unsatd. (in the form of alkali-refined linseed oil) to Zebra fish (Danio rerio) according to OECD Guideline 203. Fish were exposed in separate test batches to different concentration (100 and 1000 mg/L) of the substance over a period of 96 h (each tank with 10 fish). Observations were made at 0, 24, 48, 72 and 96 h for the mortality rates, abnormal symptoms in the swimming behaviour, in visible physiological functions as well as in the outward appearance of the test fish. Fish were considered dead if touching of the caudal peduncle produced no reaction and if no breathing movements could be observed. Under the study conditions, the 96 h LC0 and LC50 in Zebra fish were > 1000 mg/L (nominal) (Dommröse, 1988).

 

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

Acute toxicity to fish was assessed based on toxicity studies for substances representative of the main constituents, which can be categorised as pentaerythritol esters (PE) and glycerol esters (GE). The results are presented below:

 

Pentaerythritol esters (PE)

A study was conducted to determine the acute toxicity of pentaerythritol tetraisostearate to Danio rerio (zebra fish) under semi-static conditions according to OECD Guideline203, in compliance with GLP. The substance was tested at the nominal concentrations of 10, 18, 32, 56 and 100 mg/L. No analytical dose verification was conducted. The validity criteria for the study were met. No mortality was observed in the control or test substance group. Under the study conditions, the 96 h LC50 in Zebra fish was determined to be >100 mg/L and the NOEC for was ≥100 mg/L (nominal) (van Egmond, 1997).

 

Glycerol esters (GE)

A study was conducted to evaluate the acute toxicity of glycerides, C16-18 and C18-unsatd. (in the form of alkali-refined linseed oil) to Zebra fish (Danio rerio) according to OECD Guideline 203. Fish were exposed in separate test batches to different concentration (100 and 1000 mg/L) of the substance over a period of 96 h (each tank with 10 fish). Observations were made at 0, 24, 48, 72 and 96 h for the mortality rates, abnormal symptoms in the swimming behaviour, in visible physiological functions as well as in the outward appearance of the test fish. Fish were considered dead if touching of the caudal peduncle produced no reaction and if no breathing movements could be observed. Under the study conditions, the 96 h LC0 and LC50 in Zebra fish were > 1000 mg/L (nominal) (Dommröse, 1988).