Oils, lard, sulfated, ammonium salts

Short-term toxicity to fish

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Study period:

2013

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: GLP compliant study conducted according to internationally recognised test methods. For read across justification see Section 13.

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes

Analytical monitoring:

yes

Details on sampling:

- Concentrations: 0 and 100 mg/L nominal.
- Sampling method: Samples taken from centre of test vessel using a glass pipette. Samples taken approximately 30 minutes before start of exposure and following 96 hours exposure
- Sample storage conditions before analysis: in glass ampoules

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: As recommended by ECETOC 1996 and OECD 2000. A Water Accommodated Fraction (WAF) of the substance was prepared by mixing the test substance with water for a prolonged period sufficient to ensure equilibration between the test item and the water phase. An appropriate amount of the test substance item was weighed out and into the test vessel with an appropriate amount of dilution water. The test medium was mixed with an ultraturrax (1 minutes at 17000 rpm) prior to stirring the dispersion at 750 rpm for at least 24 hours at room temperature.
- Controls: No
- Chemical name of vehicle (organic solvent, emulsifier or dispersant): None used
- Concentration of vehicle in test medium (final test solution(s) including control(s)): Not applicable
- Evidence of undissolved material (e.g. precipitate, surface film, etc): None - all appeared as clear solutions on visual inspection

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: Zebra fish
- Source: Umweltbundesamt, Schichauweg 58, D-12307 Berlin
- Age at study initiation (mean and range, SD): approximately 21 months
- Length at study initiation (length definition, mean, range and SD): 35 mm (31 - 39 mm)
- Weight at study initiation (mean and range, SD):mean(n=10) : 0.31 g (0.22 - 0.49 g)
- Feeding during test: No

ACCLIMATION
- Acclimation period: 14 days
- Health during acclimation (any mortality observed): No mortalities during last 7 days of acclimatisation

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Post exposure observation period:

No

Hardness:

100 mg/L, as CaCO3

Test temperature:

22 °C

pH:

8.0 - 8.2

Dissolved oxygen:

8.4 - 8.8 mg/L

Salinity:

N/A fresh water

Nominal and measured concentrations:

nominal concentrations: 0 100 mg/L
measured concentrations at 0 hours:
measured concentrations at 96 hours:

Details on test conditions:

TEST SYSTEM
- Test vessel: glass aquaria
- Material, size, headspace, fill volume: 11.5 x 13 x 20 cm, 3 L capacity; 2 L fill volume, depth of water 16.5 cm
- Aeration: No details
- Type of flow-through (e.g. peristaltic or proportional diluter): Not applicable
- Renewal rate of test solution (frequency/flow rate): Not applicable
- No. of organisms per vessel: 7 fish of one group
- No. of vessels per concentration (replicates): 1
- No. of vessels per control (replicates): 1
- No. of vessels per vehicle control (replicates): Not applicable
- Biomass loading rate: < 1 g fish / L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Tap water filtered on activated charcoal and aerated for at least 24 hours to remove chlorine.
- Intervals of water quality measurement: Daily

OTHER TEST CONDITIONS
- Adjustment of pH: No
- Photoperiod: 16 hours light / 8 hours dark
- Light intensity: room light, 36 - 191 Lux at water surface

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : mortality/clinical signs assessed 1 and 6 hours after start of exposure and daily thereafter

TEST CONCENTRATIONS
- Spacing factor for test concentrations: Not applicable
- Justification for using less concentrations than requested by guideline: N/A
- Range finding study: Yes - Indicated LC50 > 100 mg/L

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

behaviour

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Details on results:

- Behavioural abnormalities:
- Mortality:
- Other adverse effects control: None
- Abnormal responses: None other than noted above
- Any observations (e.g. precipitation) that might cause a difference between measured and nominal values: None
- Effect concentrations exceeding solubility of substance in test medium: No

Reported statistics and error estimates:

Not applicable

Sublethal observations / clinical signs:

                   

 

Validity criteria fulfilled:

yes

Conclusions:

Under the conditions in which this study was performed the LC50 (96h) for fish was > 100 mg/L (nominal) and the NOEC was 100 mg/L (nominal).

Executive summary:

Acute toxicity to fish has been investigated in a 96 hour test according to OECD test methods. The LC50 (96h) was determined to be > 100 mg/L (nominal concentration) and the NOEC was 100 mg/L (nominal concentration).

Description of key information

Short-term toxicity to fish: LC50 > 100 mg/L; NOEC 100 mg/L

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

100 mg/L

Additional information

Acute toxicity to fish has been investigated in a 96 hour test on an analogue of the substance according to OECD test methods. The LC50 (96h) was determined to be > 100 mg/L (nominal concentration) and the NOEC was 100 mg/L (nominal concentration).

(Q)SAR estimation on analogues of the substance indicates a LC50 > 100 mg/L, in agreement with the experimentally determined value.