Fatty acids, tall-oil, compds. with oleylamine

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)

Version / remarks:

1992

Deviations:

no

Qualifier:

according to guideline

Guideline:

EU Method C.1 (Acute Toxicity for Fish)

Version / remarks:

2008

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

yes

Details on sampling:

Four samples were taken from the freshly prepared control and test media at 0 and 72 hours, respectively. Four samples were taken from the expired control and test media at 24 and 96 hours.
Samples were stored frozen until analysis.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: water accommodated fraction (WAF)
The test material was dispersed in dilution water in a glass aspirator at a nominal concentration of 100 mg/L. The contents were stirred for approximately 24 hours in the dark and then left to stand for approximately 24 hours in the dark. An aliquot was then removed from the mid-vessel region to provide the Water Accommodated Fraction (WAF).

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Common name: rainbow trout
- Source:commercial fish farm in the UK
- Length at study initiation: 5.47 cm (mean total length)
- Weight at study initiation: 1.53 g (mean wet weight)
- Feeding during test: none

ACCLIMATION
- Acclimation period: 14 days
- Acclimation conditions (same as test or not): same
- Type and amount of food: commercial fish food (TROUW (UK) Ltd. Nutra Fry 02); amount equivalent to 1% of the total wet-weight of fish in the holding tank; no food was given during the 24-hour period immediately before exposure.
- Health during acclimation: no madication, no mortality

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

169 mg/L as CaCO3

Test temperature:

14 -15 °C

pH:

7.8-8.5

Dissolved oxygen:

100-108% air saturation value

Nominal and measured concentrations:

nominal loading rate: 100 mg test material/L as WAF
mean measured TOC levels (after background correction):
in fresh media: 6.0-9.4 mg C/L (control mean: 0.9 mg C/L)
in expired media (24 h): 8.3-11.7 mg C/L (control mean: 1.0-1.6 mg C/L)
overall geometric mean value: 8.3 mg C/L

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria, containing 20 litres of medium to a depth of 18.5 cm.
- Type: open
- Aeration: yes
- 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
- Biomass loading rate: 0.765 g body weight/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: laboratory tap water, dechlorinated and softened by passage through a water purification system consisting of activated carbon filter, water softener and reverse osmosis treatment.
Total organic carbon: 0.9 mg C/L
- Culture medium different from test medium: no

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light : 8 hours dark with periods of subdued lighting at the beginning and end of each light phase

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality and sub-lethal effects; recorded at approx. 2, 4, 24, 48, 72 and 96 hours

TEST CONCENTRATIONS
- Spacing factor for test concentrations: not applicable (limit test)
- Range finding study
- Test concentrations: nominal loading rates 1, 10 and 100 mg/L
- Results used to determine the conditions for the definitive study: no mortality or sub-lethal effects were noted after 96 hours

Reference substance (positive control):

not required

Key result

Duration:

96 h

Dose descriptor:

LL50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: results are expressed in terms of loading rates

Duration:

96 h

Dose descriptor:

NOELR

Effect conc.:

>= 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks:

and sub-lethal effects

Remarks on result:

other: results are expressed in terms of loading rates

Details on results:

- Other biological observations: At the nominal loading rate of 100 mg/L a single mortality was recorded at 72 hours and sub-lethal effects were observed from 24 hours onwards, comprising darkening pigmentation and/or darkened eye-orbit area. These effects were attributed to the presence of a fish exhibiting aggressive behaviour, which following its isolation within the test vessel at 72 hours, the majority of fish appeared to recover (see Table 1). The absence of any mortality or sub lethal effects in the range finding test supports the conclusion that none of the effects seen in the test vessel during the definitive test were treatment-related.
- Mortality of control: zero
- Other adverse effects control: none

The test medium was colourless.

Reported statistics and error estimates:

The “no observed effect loading rate” (NOELR) was derived by direct inspection of the data for lethal and sub-lethal effects. An incidence rate of more than 10% was considered to be significant.

Sublethal observations / clinical signs:

Table 1 Mortality and sub-lethal effects

Loading rate (mg/L WAF)		Abnormality	Initial population = 10 fish / concentration
			2h	4h	24h	48 h	72 h	96 h
Control		NAD	10/10	10/10	10/10	10/10	10/10	10/10
100***		NAD	10/10	10/10	6/10	5/10	4/9	7/9
		DE	-	-	4/10*	2/10*	3/9*	-
		DKE	-	-	-	3/10*	1/9*	2/9*
		A	-	-	-	-	1/9**	-
NAD	no abnormalities detected
DE	darkened eye-orbital area
DKE	dark body and eye orbital area
A	aggressive behaviour; actively swimming and pursuing other fish in the vessel
*	Effects were attributed to the presence of a fish exhibiting aggressive behaviour, which following its isolation at 72 hours, the majority of the fish appeared to recover.
**	Isolation of aggressive fish
***	A single mortality was recorded at 72 hours. This death was attributed to the presence of a fish exhibiting aggressive behavior.

 

Validity criteria fulfilled:

yes

Remarks:

mortality of control animals <10%; concentration of dissolved oxygen in all test vessels >60% saturation

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Remarks:

study conducted for 48 h instead of 96 h

Qualifier:

according to guideline

Guideline:

other: DIN guideline 38412, part 15

Deviations:

no

GLP compliance:

yes

Remarks:

Quality Assurance Programme/GLP standards not specified

Analytical monitoring:

yes

Details on sampling:

Initial exposure levels were measured in the control and in the test solution.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: water accommodated fraction (WAF)
A saturated solution (initial weight: 150 mg/l) was prepared in reconstituted water and was stirred overnight. After a filtration step over a folded paper filter (595 1/2; diameter 320 mm, Schleier & Schuell, D-37582 Dassel) the filtrate was used without further treatment.

Test organisms (species):

Leuciscus idus

Details on test organisms:

TEST ORGANISM
- Common name: Golden Orfe
- Source: fish farm Eggers, Hohenwestedt, Germany
- Length at study initiation: 5-8 cm
- Corpulence factor: 0.8-1.1 g/cm3
- Feeding: Tetra Menü Spezialfutter
- Feeding during test: fish were not fed during the test

ACCLIMATION
- Acclimation period: at least 7 days
- Acclimation conditions: 20 - 21 °C
- Diluent water: tap water of Karlsruhe with the following quality:
acid capacity KS(4.3): 4.75 - 4.77 mmol/L
water hardness: 2.83 - 3.14 mmol/L
calcium Ca2+: 2.41 - 2.60 mmol/L
magnesium Mg2+: 0.42 - 0.54 mmol/L
sodium Na+: 0.28 - 0.33 mmol/L
potassium K+: 0.05 - 0.06 mmol/L
pH-value: 7.39 - 7.49
aeration: at least 80% of the air saturation value
- Type of food: Tetra Menü Spezialfutter
- Health during acclimation: fish were in good health

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Hardness:

2.7 mmol CaCO3/L

Test temperature:

20-21 °C

pH:

7.73 (control)
7.69 (saturated test solution)

Dissolved oxygen:

At least 80% of the air saturation value

Nominal and measured concentrations:

nominal loading rate: 150 mg/L
TOC-values at test start:
test solution (WAF): 1.41 mg/L
control: 1.20 mg/L

Details on test conditions:

TEST SYSTEM
- Volume: 10 L
- Aeration: permanent during the test duration
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- Biomass loading rate: 1 – 5.6 g/L (corpulence factor K = 0.8-1.1 g/cm³, length = 5-8 cm)

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted water
- Total organic carbon: 1.2 mg/L
- Acid capacity, KS(4.3): 0.7-0.9 mmol/L
- Inorganic salts: CaCl2: 2.2 mmol/L, MgSO4: 0.5 mmol/L, NaHCO3: 0.64 mmol/L
- Ca/mg ratio: 4:1
- Culture medium different from test medium: yes

OTHER TEST CONDITIONS
- Adjustment of pH: no
- Photoperiod: 16 h light: 8 h dark

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): mortality recorded after 48 h

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LL50

Effect conc.:

> 150 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: results are expressed in terms of loading rates

Duration:

48 h

Dose descriptor:

LL100

Effect conc.:

> 150 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: results are expressed in terms of loading rates

Duration:

48 h

Dose descriptor:

NOELR

Effect conc.:

>= 150 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: results are expressed in terms of loading rates

Details on results:

In a saturated solution of the test material in dilution water no mortality of fish after 48 hours was observed. Sub-lethal effects were not reported.

Validity criteria fulfilled:

yes

Description of key information

96-h LC50 (based on loading rates) >100 mg/L for Oncorhynchus mykiss (OECD TG 203, EU C.1)
48-h LC50 (based on loading rates)  >150 mg/L for Leuciscus idus (DIN guideline 38412, part 15)

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

The results indicate that the test material is not toxic to rainbow trout up to the limits of its water solubility and a NOEC and thus a PNEC cannot be determined.