Ichthyolic acid, sodium salt

Short-term toxicity to fish

Administrative data

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

key study

Study period:

start of study: 28 June 1993
termination of study: 2 July 1993

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1993

Report date:

2004

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

Version / remarks:

OECD Method No. 203 dated April 4th, 1984

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Ichthyolic acid, sodium salt

EC Number:

215-671-7

EC Name:

Ichthyolic acid, sodium salt

Cas Number:

1340-06-3

IUPAC Name:

Identification of the UVCB substance by "Chemcial Abstracts Index Name", among others: Ichthyolic Acid, Sodium Salt. No IUPAC name known.

Test material form:

liquid

Specific details on test material used for the study:

Test substance originated from a regular production batch R 92/0541. The description "sulfonated shale oil, pale" for the test substance (as mentioned in the study title) is a common general expression/identifier for ICHTHYOL PALE.

Sampling and analysis

Analytical monitoring:

not required

Remarks:

No analysis of samples was conducted as ICHTHYOL PALE (sulfonated shale oil, pale) is known to be stable as an aqueous solution.

Details on sampling:

Samples were taken both at the start and the end of the study (after 4 days exposure period) from the tanks of all the concentrations and the control and were stored at LPT (testing facility) at -20°C or colder. However, no analysis of the samples was conducted as ICHTHYOL PALE (sulfonated shale oil, pale) is known to be stable as an aqueous solution.

Test solutions

Vehicle:

no

Details on test solutions:

The test substance was used as supplied. The following concentrations of ICHTHYOL PALE were employed in the exposure medium: 2.37 mg, 4.21 mg, 7.48 mg, 13.30 mg and 23.70 mg per litre. The concentration interval factor was 1.78. The concentrations chosen were based on a preliminary test.

Test organisms

Test organisms (species):

Leuciscus idus

Details on test organisms:

Gold orfe/Leuciscus idus (fry of about 6.0 +- 2.0 cm were selected)
breeder: Fischzucht EGGERS, Martensweg 18, D-24594 Hohenwestedt, Germany

Study design

Test type:

semi-static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test conditions

Hardness:

Concentration of minerals:
CCaCl2: 2 mmol/l
MgSO4: 0.50 mmol/l
NaHCO3: 0.77 mmol/l
KCl: 0.077 mmol/l
The sum of calcium and magnesium ions was 2.5 mmol/l, the proportion of Ca:Mg ions was 4:1 and of Na:K ions 10:1.
The acid capacity was about 0.8 mmol/l.
The total hardness was equivalent to 250 mg CaCO3/l.
The total alkalinity was about 0.8 mmol/l.

Test temperature:

21.1°C - 21.4°C (measured daily)

pH:

7.50 - 8.04 (measured daily)

Dissolved oxygen:

O2-concentration: 80.7% - 99.4% of the air saturation value.

Salinity:

not applicable

Conductivity:

not measured

Nominal and measured concentrations:

The substance is readily soluble and stable in water. Nominal concentrations, therefore, can be assumed to be in line with actual concentrations.

Details on test conditions:

TEST SYSTEM
- Test vessel: glass tank
- Material, size, headspace, fill volume: 10 l (l x w x h = 290 mm x 190 mm x 195 mm)
- Aeration: by Pasteur pipettes (Kroll, 22525 Hamburg) at a rate of 2 to 3 air bubbles per second
- Renewal rate of test solution (frequency/flow rate): water changed after 48 hours
- 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: reconstituted water
- Total organic carbon: n.d.
- Particulate matter: n.d.
- Metals: n.d.
- Pesticides: not applicable
- Chlorine: not indicated
- Alkalinity: ca. 0.8 mmol/l
- Ca/Mg ratio: 4:1
- Culture medium different from test medium: not applicable
- Intervals of water quality measurement: not indicated

OTHER TEST CONDITIONS
- Adjustment of pH: daily measurement of pH
- Photoperiod: 16 h photoperiod daily
- Light intensity: not indicated

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Assessment of the behaviour, appearance and mortality of the fish was carried out at the beginning of the study, after 5, 15 and 30 minutes and 1, 3, 6, 24, 48, 72 and 96 hours after start of the exposure.

TEST CONCENTRATIONS
- Spacing factor for test concentrations: 1.78
- Justification for using less concentrations than requested by guideline: not applicable
- Range finding study: preliminary test with 0 to 376 mg/l exposure medium
- Test concentrations: 2.37/4.21/7.48/13.30/23.70 mg/l exposure medium

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Key result

Duration:

96 h

Dose descriptor:

LC50

Remarks:

The nominal LC50 (50% mortality of the fish after 96 hours) was calculated by linear regression analysis.

Effect conc.:

7.58 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat. (total fraction)

Basis for effect:

mortality (fish)

Details on results:

No toxic effects by Ichthyol Pale were observed at a concentration of 2.37 mg/l exposure medium (NOEC). First intolerance reactions were observed at a concentration of 4.21 mg/l exposure medium; two animals remained predominantly at the water surface with a marked oblique position and markedly increased gill breathing in a third animal out of 10 animals 24 hours after start of exposur, after 72 hours 2 animals and after 96 hours 1 animal were predominantly at the water surface. At this concentration 1 out of 10 animals died after 96 hours exposure.
The lowest lethal concentration for fish was 4.21 mg Ichthyol Pale/l exposure medium. The LC50 (96 h) was calculated as 7.58 mg Ichthyol Pale/l exposure medium.
Tested animals showed no change in the length and body weight at termination of the study compared to the 10 untreated animals.

Results with reference substance (positive control):

not applicable

Reported statistics and error estimates:

The nominal LC50 (50% mortality of the fish after 96 hours) was calculated by linear regression analysis. The 95%confidence limits were determined according to FINNEY.

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The acute toxicity of Ichthyolic Acid, Sodium Salt in fish (Leuciscus idus) was tested by means of trademark substance ICHTHYOL PALE in a semistatic test system according to OECD Method No. 203 (dated April 4th, 1984) in a test period of 96 hours.The threshold level of observed as well as lethal effects was determined to be 4.21 mg test substance/l exposure medium. The NOEC was determined to be at a concentration of 2.37 mg/l exposure medium. The LC50 was calculated by linear regression to be 7.58 mg/l exposure medium.