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Short-term toxicity to fish

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to fish

Type of information:

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

Adequacy of study:

key study

Study period:

From 08 August 1988 to 12 August 1988

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Remarks:

no analytical monitoring

Justification for type of information:

Refer to the Quaternary ammonium salts (QAS) category or section 13 of IUCLID for details on the category justification. The study with the read across substance is considered sufficient to fulfil the information requirements as further explained in the provided endpoint summary.

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

yes (incl. QA statement)

Analytical monitoring:

no

Details on sampling:

A clear stock solution of 15 mg/mL was prepared by diluting 0.15 g of the test substance with distilled water in a 10 mL flask. The appropriate volume of stock solution was then added to 15 L of dilution water in each test aquaria and mixed by stirring.

Vehicle:

yes

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION
- Chemical name of vehicle: Water
- Concentration of vehicle in test medium (stock solution): Stock suspension of 15 mg/L was prepared by diluting 0.15 g of the test substance with distilled water in a 10 mL flask.

Test organisms (species):

Oncorhynchus mykiss (previous name: Salmo gairdneri)

Details on test organisms:

TEST ORGANISM
- Species: Salmo gairdneri (new name: Oncorhynchus mykiss)
- Source: Commercial supplier in California
- Length at study initiation (length definition, mean, range and SD): Mean = 33 mm; range = 27-40 mm
- Weight at study initiation (mean and range, SD): Mean = 0.31 g; range = 0.12- 0.58 g
- Feeding during test: No

ACCLIMATION
- Acclimation period: 14 d
- Acclimation conditions (same as test or not): Yes
- Type and amount of food: Dry commercial pelleted food, ad libitum
- Feeding frequency: Daily, except during the 48 h prior to testing
- Health during acclimation (any mortality observed): Yes (i.e., 1.1%)

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

34 mg/L as CaCO3

Test temperature:

12-13 ⁰C

pH:

7.5

Dissolved oxygen:

67-72%

Nominal and measured concentrations:

Nominal: 0, 390, 670, 1,090, 1,820 and 3,030 µg/L (i.e., 0, 130, 223, 363, 607 and 1010 µg a.i./L)

Details on test conditions:

TEST SYSTEM
- Test vessel: 18.9 L glass aquaria which contained 15 L of the test solution
- Aeration: No
- No. of organisms per vessel: Ten
- No. of vessels per concentration (replicates): No data
- No. of vessels per control (replicates): No data
- Biomass loading rate: 0.21 g/L

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Deionized, reconstituted well water
- Alkalinity: 28 mg/L
- Conductivity: 150 µmhos/cm
- Culture medium different from test medium: No
- Intervals of water quality measurement: 24, 48, 72 and 96 h

OTHER TEST CONDITIONS
- Adjustment of pH: Not required
- Photoperiod: 16 h light and 8 h darkness
- Light intensity: 60 footcandles

EFFECT PARAMETERS MEASURED (with observation intervals if applicable): Mortalities were recorded at 0, 6, 24, 48, 72 and 96 h
TEST CONCENTRATIONS
- Spacing factor for test concentrations: <2
- Range finding study: Yes
- Test concentrations: 150 to 9,090 µg/L
- Results used to determine the conditions for the definitive study: After 96 h, 100% mortality at ≤1,520 µg/L.

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

2.35 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: i.e., equivalent to 783 µg a.i./L

Key result

Duration:

96 h

Dose descriptor:

LC100

Effect conc.:

3.03 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: i.e., equivalent to 1010 µg a.i./L

Key result

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

1.82 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

other: mortality, physical or behavioral abnormalities

Remarks on result:

other: i.e., equivalent to 607 µg a.i./L

Details on results:

Some of the surviving fish exhibited darkened pigmentation, erratic swimming behavior or complete loss of equilibrium.

Reported statistics and error estimates:

Probit analysis

Sublethal observations / clinical signs:

Deviation: The dissolved oxygen concentration were 75-77% of saturation (against 90% as per the protocol), however this deviation did not affect the results of the test.

Validity criteria fulfilled:

yes

Remarks:

As per OECD guideline 203

Conclusions:

Bsaed on the results of the read across study the 96 h LC50 and NOEC of the test substance can also be considered to be 783 and 607 µg a.i./L), respectively.

Executive summary:

A study was conducted to determine the acute toxicity study of the read across substance, Coco TMAC (active ingredient 33%), to the Rainbow trout (Oncorhynchus mykiss) according to a method similar to OECD Guideline 203, in compliance with GLP. Rainbow trouts (10 per concentration) were exposed to the test substance at concentrations of 0, 390, 670, 1,090, 1,820 and 3,030 µg/L (i.e., equivalent to 0, 130, 223, 363, 607 and 1010 µg a.i./L) for 96 h under static conditions and mortalities were determined. The 96 h LC50 by non-linear interpolation was estimated to be 2,350 µg/L, with a 95% confidence interval calculated by binomial probability of 1,820 - 3,030 µg/L. No analytical determination of the test substance was performed. Under the study conditions, the 96 h LC50 and NOEC were 2,350 and 1,820 µg a.i. /L (nominal; i.e., equivalent to 783 and 607 µg a.i./L), respectively (Surprenant, 1988). Bsaed on the results of the read across study the 96 h LC50 and NOEC of the test substance can also be considered to be 783 and 607 µg a.i./L), respectively.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

supporting study

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

other: Only a summary of study data available

Principles of method if other than guideline:

Zebra fish were exposed to the test substance for 96 h in a static test system

GLP compliance:

no

Specific details on test material used for the study:

- Präpagen 2916 (Hoe 2916)
- Clear liquid

Analytical monitoring:

no

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Test temperature:

23°C

Nominal and measured concentrations:

Nominal: 0, 1, 10, 100 and 500 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: 10L vessels
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 1

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

Reference substance (positive control):

no

Key result

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 500 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: i.e., equivalent to 200 mg a.i./L

Details on results:

Lightened color seen at 10 mg/L and above.
No observations at 1 mg/L

Validity criteria fulfilled:

not applicable

Conclusions:

Under the study conditions, the 96 h LC50 for zebra fish was >500 mg/L (nominal) (i.e., equivalent to >200 mg a.i./L)

Executive summary:

A study was conducted to determine the toxicity of the test substance, C12-14 TMAC (active ingredient 40%), to zebra fish (Danio rerio) after 96 h of exposure in a static test system. Groups of 10 fish were exposed to concentrations of 0, 1, 10, 100 and 500 mg/L. Cinical signs and mortality were recorded. No analytical dose verification was conducted. There was no mortality throughout the study. Lightened color was seen at 10 mg/L and above. No observations were made at 1 mg/L. Under the study conditions, the 96 h LC50 for zebra fish was >500 mg/L (nominal) (i.e., equivalent to >200 mg a.i./L) (Weigand and Markert, 1982).

Description of key information

Based on the available information, the LC50 value of 0.783 mg a.i./L from the better quality study with the read across substance has been considered further for hazard assessment of C12-14 TMAC.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.783 mg/L

Additional information

Study 1: A study was conducted to determine the toxicity of the test substance, C12-14 TMAC (active ingredient 40%), to zebra fish (Danio rerio) after 96 h of exposure in a static test system. Groups of 10 fish were exposed to concentrations of 0, 1, 10, 100 and 500 mg/L. Cinical signs and mortality were recorded. No analytical dose verification was conducted. There was no mortality throughout the study. Lightened color was seen at 10 mg/L and above. No observations were made at 1 mg/L. Under the study conditions, the 96 h LC50 for zebra fish was >500 mg/L (nominal) (i.e., equivalent to >200 mg a.i./L) (Weigand and Markert, 1982).

Study 2: A study was conducted to determine the acute toxicity study of the read across substance, Coco TMAC (active ingredient 33%), to the Rainbow trout (Oncorhynchus mykiss) according to a method similar to OECD Guideline 203, in compliance with GLP. Rainbow trouts (10 per concentration) were exposed to the test substance at concentrations of 0, 390, 670, 1,090, 1,820 and 3,030 µg/L (i.e.,equivalent to 0, 130, 223, 363, 607 and 1010 µg a.i./L)for 96 hunder static conditionsand mortalities were determined. The 96 h LC50 by non-linear interpolation was estimated to be 2,350 µg/L, with a 95% confidence interval calculated by binomial probability of 1,820 - 3,030 µg/L. No analytical determination of the test substance was performed. Under the study conditions, the 96 h LC50 and NOEC were 2,350 and 1,820 µg a.i. /L (nominal; i.e., equivalent to 783 and 607µg a.i./L), respectively (Surprenant, 1988). Bsaed on the results of the read across study the 96 h LC50 and NOEC of the test substance can also be considered to be 783 and 607 µg a.i./L), respectively.

Based on the available information, the LC50 value from the better quality study with the read across substance, Coco TMAC has been considered further for hazard assessment of C12-14 TMAC.