Fatty acids, C16-18

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:

26 Sep - 28 Sep 1983

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: National guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: DIN 38412/15

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Preparation of a stock suspension, while the suspension was stirred, aliquots were taken and transferred into the test vessels with drinking water, test solution was then stirred for 15 min with ultra sound

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name: Golden orfe
- Length at study initiation: about 6 cm
- Feeding during test: none

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

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

Test temperature:

no data

pH:

no data

Dissolved oxygen:

no data

Salinity:

n.a.

Nominal and measured concentrations:

nominal: 0.1, 0.5, 2.8, 16, 90, 90, 250 and 1000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: fish basin with 10 L test water
- No. of organisms per vessel: 10
- No. of vessels per control: no control

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: copper- and chloride-free drinking water

OTHER TEST CONDITIONS
- Photoperiod: 16 h

EFFECT PARAMETERS MEASURED: mortality after 0, 6, 24 and 48 h

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC0

Effect conc.:

1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

48 h

Dose descriptor:

LC100

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: none

Sublethal observations / clinical signs:

No mortality occured at any test concentration.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

02 Nov - 06 Nov 1981

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: National guideline study with acceptable restrictions

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:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: preparation of suspension with a not documented concentration of the product under use of ultrasound, aliquots were pipetted into test vessels and filled up with standard dilution water
- Controls: none

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

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

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

about 250 mg CaC03/L

Test temperature:

23.5 °C

pH:

7.2 - 8.1 instead of the recommended 7.6 - 8.0, this is not supposed to have any negative effect on the fish

Dissolved oxygen:

7.4 - 8.6 mg O2/L

Nominal and measured concentrations:

nominal: 0.1, 0.5, 2.8, 16, 90, 250 and 1000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 10 L fish basin containing 5 L test water
- Renewal rate of test solution: daily
- No. of organisms per vessel: 10

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

OTHER TEST CONDITIONS
- Photoperiod: 16 h

EFFECT PARAMETERS MEASURED: mortality after 0, 6, 24, 48 and 96 h

Reference substance (positive control):

no

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)

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)

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

> 1 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities: none

Sublethal observations / clinical signs:

No mortality occured at any test concentration.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

migrated information: read-across based on grouping of substances (category approach)

Adequacy of study:

weight of evidence

Study period:

12 Jan - 14 Jan 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: National guideline study with acceptable restrictions

Qualifier:

according to guideline

Guideline:

other: DIN 38412/15

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Method: Test substance was directly weighted into the test vessels and filled up to final volmues of 10 L with drinking water and stirred with ultraturrax for 5 minutes
- Controls: no

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name: Golden orfe
- Length at study initiation: about 6 cm
- Feeding during test: none

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

16 dH (~93 mg Ca and 12 mg Mg/L)

Test temperature:

no data

pH:

7.6 - 8.4

Dissolved oxygen:

76 - 94 %

Nominal and measured concentrations:

nominal: 1000, 3000, 10000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: fish basin containing 10 L test water
- No. of organisms per vessel: 10
- No. of vessels per concentration:1

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: copper and chlorine free drinking water
- Ca/mg ratio: 93 mg Ca/ 12 mg Mg

OTHER TEST CONDITIONS
- Photoperiod: 16 h light

EFFECT PARAMETERS MEASURED: mortality after 0, 6, 24 and 48 h

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC0

Effect conc.:

10 000 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

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)

Duration:

48 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: none

Sublethal observations / clinical signs:

No mortality was recorded at any test concentrations.

Description of key information

No effects on fish up to the limit of water solubility

Additional information

Studies are available for the pure homologue members of the fatty acid category. In addition some studies are summarized for certain fatty acid mixtures. Generally it could be stated that toxicity of fatty acids to aquatic organisms increases with increasing chain length up to the water solubility limit at a chain length of C12. For longer chains, no effects at saturation are observed.

For the fatty acids, C16 -18 (CAS 67701 -03 -5), which contains as main constituents C16 with a content of 15 -80% and C18 with a content of 25 - 80%, read-across is performed to studies available for the pure homologues palmitic acid (C16 - CAS 57 -10 -3) and stearic acid (C18 - CAS 57 -11 -4). For evaluation of the mixture, only studies available for the pure homologues which were determined as key studies or used of a weight of evidence approach were chosen for a read-across. All linked studies conducted with the pure homologues were used in a weight of evidence approach to cover the endpoint "short-term toxicity to fish" for the considered fatty acid mixture.

 

Fatty acid homologue	LC50(as reported in the study)	Water solubility*	Test design and species	Reference
C16 - CAS 57-10-3 palmitic acid	> 1000 mg/L (nominal)	< 0.05 at 20 °C	96 h, semi-static,Danio rerio	Richterich and Mühlberg, 2001a
C18 - CAS 57-11-4 stearic acid	> 10000 mg/L (nominal)	insoluble	48 h, static,Leuciscus idus	Richterich and Mühlberg, 2001b
C16 - C18 - CAS 67701-03-5	> 1000 mg/L (nominal)	< 0.05 at 20 °C	48 h, static,Leuciscus idus	Richterich and Mühlberg, 2001c

* see category justification

The homologue C16 (palmitic acid: CAS 5 7 -10 -3) was tested on zebrafish (Danio rerio) according to ISO 7346 -1 in a semi-static test (Richterich and Mühlberg, 2001a). In the study nominal concentrations of 0.1, 0.5, 2.8, 16, 90, 250 and 1000 mg/L were tested. No mortality was observed at any test concentration and thus up to the limit of water solubility which is below 0.05 mg/L. In the study the LC50 was reported to be above 1000 mg/L.

The homologue C18 (stearic acid: CAS 57 -11 -4) was tested on golden orfe (Leuciscus idus) (Richterich and Mühlberg, 2001b). In the static test, which was conducted according to DIN 38412/15, the fish were exposed to different concentrations of the test substance (1000, 3000, 10000 mg/L nominal). In the study no effects on fish were reported, resulting in a LC50 > 10000 mg/L.

The C16 -18 fatty acid mixture (CAS 67701 -03 -5) was tested on golden orfe (Leuciscus idus) over a period of 48 h (Richterich and Mühlberg, 2001c). The static test was conducted according to DIN 38412/15. In that test the LC50 was reported to be > 1000 mg/L, which is above the given water solubility of the mixture.

Concluding from the results reported for the pure homologues C16 and C18 no toxicity within the range of water solubility is expected for the considered fatty acid mixture.