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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:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from a secondary source.

Qualifier:

according to guideline

Guideline:

other: EG Guideline 92/69 C.1

Qualifier:

according to guideline

Guideline:

other: DIN 38412 Part 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 203 (Fish, Acute Toxicity Test)

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

- Concentrations: The nominal test material concentration was 1000 mg/l.
Measured concentrations: 880 mg/l at 0 hours; 922/947 mg/l at 24 hours; 885 mg/l at 72 hours; average value of 943 mg/l (water filtered initial solution).

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: The hard-to-dissolve tested substance was added to tap water to provide a concentration of 1g/l and stirred for 18 hours.
The solution was filtered and the TOC content determined. This solution serves as the primary dilution of the test substance. The test began immediately after preparation of the test solution. The nominal test material concentration was 1000 mg/l.

Test organisms (species):

Danio rerio (previous name: Brachydanio rerio)

Details on test organisms:

TEST ORGANISM
- Common name: zebra danio

Test type:

semi-static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

96 h

Hardness:

18 mg/L as CaCO3.

Test temperature:

20 to 21°C

pH:

The pH values ranged from 7.8 to 8.4 units in the controls and 8.2 to 9.3 units in the test chambers

Dissolved oxygen:

8.0 to 8.9 mg/L in the controls and 7.8 to 9.0 mg/L in the test chambers

Nominal and measured concentrations:

The nominal test material concentration was 1000 mg/l.
Measured concentrations: 880 mg/l at 0 hours; 922/947 mg/l at 24 hours; 885 mg/l at 72 hours; average value of 943 mg/l (water filtered initial solution).

Details on test conditions:

TEST MEDIUM / WATER PARAMETERS
- Total organic carbon: 6 mg/L.

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

LC0

Effect conc.:

>= 934 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Other details not known

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 934 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Other details not known

Details on results:

- Mortality of control: 0%

Validity criteria fulfilled:

not specified

Conclusions:

Based on effect of mortality of aquatic fishes, the 96 hrs LC0 value was determined to be >= 934mg/l. Based on LC0, LC50 value was considered as > 934 mg/l.

Executive summary:

An acute toxicity to fish study was carried out for time period of 96 hrs by following the OECD Guide-line 203 "Fish, Acute Toxicity Test",DIN 38412 Part 1, EG Guideline 92/69 C.1. Study was performed under semistatic condition. Brachydanio rerio was used as test organism. Test was carried out at temperature 20 to 21°C. The pH values ranged from 7.8 to 8.4 units in the controls and 8.2 to 9.3 units in the test chambers. The DO values ranged from 8.0 to 8.9 mg/L in the controls and 7.8 to 9.0 mg/L in the test chambers. water hardness and TOC was determined to be 18 mg/L as CaCO3 and 6 mg/L respectively.Verification was done analytically using TOC-500 Infrared Analyzer.  The tested substance was added to tap water to provide a concentration of 1g/l and stirred for 18 hours. The solution was filtered and the TOC content determined. The test began immediately after preparation of the test solution. The nominal test material concentration was 1000 mg/l. Measured concentrations were 880 mg/l at 0 hours; 922/947 mg/l at 24 hours; 885 mg/l at 72 hours average value of 943 mg/l (water filtered initial solution). 0% mortality in control was observed. Based on effect of mortality, LC0 value was determined to be >= 934mg/l. Based on LC0, LC50 value was considered as > 934 mg/l and hence, test chemical was considered as non-toxic to aquatic fishes and considered to be not-classified a sper CLP classification criteria.

Reference 2

Endpoint:

short-term toxicity to fish

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

secondary literature

Justification for type of information:

Data is from a secondary source.

Qualifier:

according to guideline

Guideline:

other: EPA-660/3-75-009 (USEPA 1975)

Principles of method if other than guideline:

Short term toxicity to fish study was carried out for time period of 96 hrs.

GLP compliance:

not specified

Analytical monitoring:

not specified

Details on sampling:

- Concentrations: 0, 10, 100, 180, 320, 560, 1000 mg/L
- Sampling method: Test substance was added directly to exposure vessels and 4.2 mL of methanol added to controls because methanol is released on hydrolysis of test substance. Manner of addition of test substance to dilution water not documented.
- Sample storage conditions before analysis: test substance not stable in aqueous solutions; measured hydrolysis half-life is 1.5 to 6.0 min at 25ºC over the pH range of 4 to 7

Vehicle:

yes

Remarks:

methanol

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: Test substance was added directly to exposure vessels and 4.2 mL of methanol added to controls because methanol is released on hydrolysis of test substance. Manner of addition of test substance to dilution water not documented.

Test organisms (species):

Lepomis macrochirus

Details on test organisms:

TEST ORGANISM
- Common name: bluegill
- Source: Lesser Ketones Manufacturing Association Leesburg, VA
- Age at study initiation (mean and range, SD): juvenile
- Length at study initiation (length definition, mean, range and SD): 3.4 cm (range 2.8-4.2 cm)


ACCLIMATION
- Acclimation period: 2 wk

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Hardness:

40 to 48 mg CaCO3/L

Test temperature:

22°C

pH:

pH 7.2 to 7.6
·pH: initiation (t = 0 h): mean 7.2 (range 7.2-7.3); 48 h observation: mean 8.5 (range 7.4-9.6)

Dissolved oxygen:

initiation (t = 0 h): mean 13.4 mg/L (range 13.0-13.5 mg/L); termination (t = 96 h): mean 8.4 mg/L (range 8.0-8.5 mg/L)

Nominal and measured concentrations:

0, 10, 100, 180, 320, 560, 1000 mg/L

Details on test conditions:

TEST SYSTEM
- Test vessel: polyethylene-lined vessels
- Aeration: Yes (vessels aerated prior to study initiation but not during study)
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 10
- Biomass loading rate: loading rate of 10 fish per exposure vessel

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: reconstituted soft-water prepared from glass-distilled water
- Alkalinity: 3 to 35 mg CaCO3/L

OTHER TEST CONDITIONS
- Adjustment of pH: yes
- Photoperiod: No


TEST CONCENTRATIONS
- Range finding study : yes
- Test concentrations: 0, 10, 100, 180, 320, 560, 1000 mg/L
- Results used to determine the conditions for the definitive study: Test solutions for range-finding study were prepared 30 minutes prior to addition of fish. Time of test solution preparation and time of fish addition were not recorded for the definitive study

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

200 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Other details not known

Duration:

96 h

Dose descriptor:

LOEC

Effect conc.:

180 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Other details not known

Duration:

96 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: Other details not known

Details on results:

- Mortality of control: No mortality observed in controls. The one mortality observed in the 100 mg/l exposure (NOEC) at 24 hour observation was not considered dose related (no additional mortality was observed and results were identical to the 180 mg/l exposure).

Reported statistics and error estimates:

Probit analysis (Finney, 1952

Validity criteria fulfilled:

not specified

Conclusions:

Based on mortality of aquatic fishes, the 96 hrs NOEC, LOEC, LC10 and LC50 values were determined to be 100, 180, 127 (65-161; 95% CI) and 200(157-258; 95% CI) mg/l respectively.

Executive summary:

An acute toxicity to fish study was carried out for time period of 96 hrs by following the method of EPA-660/3-75-009 (USEPA 1975). Study was performed under statc condition. Juvenile Lepomis macrochirus which was obtained from Lesser Ketones Manufacturing Association Leesburg, VA of length of of 3.4 cm (range 2.8-4.2 cm) was used as test organism which were acclimated to laboratory conditions a minimum of two weeks before testing of loading rate of 10 fish per exposure vessel total of 80 fish were used. Reconstituted soft-water prepared from glass-distilled water was used as dilution water. Test substance was added directly to exposure vessels and 4.2 mL of methanol added to controls because methanol is released on hydrolysis of test substance. Test solutions for range-finding study were prepared 30 minutes prior to addition of fish.Test was carried out at temperature 22°C of pH 7.2 to 7.6. pH at initiation (t = 0 h) mean 7.2 (range 7.2-7.3) 48 h observation mean 8.5 (range 7.4-9.6). Dissolved oxygen initiation (t = 0 h) mean 13.4 mg/L (range 13.0-13.5 mg/L) termination (t = 96 h) mean 8.4 mg/L (range 8.0-8.5 mg/L). Hardness and alkalinity was 40 to 48 mg CaCO3/L and 3 to 35 mg CaCO3/L respectively. Nominal test concentrations used were 0, 10, 100, 180, 320, 560, 1000 mg/L. Duplicate controls and single exposure concentrations were used.  Polyethylene-lined vessels containing 10 L of dilution water. vessels were aerated before study initiation but not during study.  Time of test solution preparation and time of fish addition were not recorded for the definitive study. Based on effect of mortality of test fishes NOEC, LOEC, LC10 and LC50 values were determined to be 100, 180 127 (65-161; 95% CI) and 200 (157-258; 95% CI) mg/l respectively. Thus, based on LC50 value test chemical was considered as non-toxic to test fishes and hence considered to be not-classified as per CLP classificaton criteria.

Reference 3

Endpoint:

short-term toxicity to fish

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

weight of evidence

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from computational model developed by USEPA

Qualifier:

according to guideline

Guideline:

other: Modeling database

Principles of method if other than guideline:

Estimation 96 hrs EC50 value of test chemical on aquatic fishes by EPI Suite ECOSAR version 1.11

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

other: Fish

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

96 h

Reference substance (positive control):

no

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Remarks on result:

other: LC50 value was determined to be > 100 mg/l (i.e 1790000 mg/l)

Validity criteria fulfilled:

not specified

Conclusions:

Based on effect of test chemical on the mortality of the test organism aquatic fishes the 96 hrs LC50 value was estimated to be >100 mg/l (i.e 1790000 mg/l)

Executive summary:

The toxicity of the test chemical to aquatic fishes was predicted using EPI Suite ECOSAR version 1.11. On the basis of effect of test chemical observed in a static system on the mortality of the test organism during the 96 hr exposure duration, the median lethal concentration (LC50) for the test chemical was estimated to be >100 mg/l (1790000 mg/l). Thus, based on the LC50 value, test chemical can be considered as non-toxic to aquatic fishes and hence, considered to be 'not classified' as per the CLP classification criteria

Description of key information

Based on effect of test chemical on the mortality of the test organism aquatic fishes the 96 hrs LC50 value was estimated to be >100 mg/l (i.e 1790000 mg/l)

Additional information

Predicted data of target chemical and supporting weight of evidence studies for it's  structurally similar read across chemicals has been reviewed to determine the effect of the test chemical on aquatic fishes. The studies are as mentioned below:

 

First study includes the toxicity of the test chemical to aquatic fishes was predicted using EPI Suite ECOSAR version 1.11. On the basis of effect of test chemical observed in a static syst tem on the mortality of the test organism during the 96 hr exposure duration, the median lethal concentration (LC50) for the test chemical was estimated to be >100 mg/l (1790000 mg/l). Thus, based on the LC50 value, test chemical can be considered as non-toxic to aquatic fishes and hence, considered to be 'not classified' as per the CLP classification criteria.

 

Second study includes an acute toxicity to fish study was carried out for time period of 96 hrs by following the method of EPA-660/3-75-009 (USEPA 1975). Study was performed under statc condition. Juvenile Lepomis macrochirus which was obtained from Lesser Ketones Manufacturing Association Leesburg, VA of length of of 3.4 cm (range 2.8-4.2 cm) was used as test organism which were acclimated to laboratory conditions a minimum of two weeks before testing of loading rate of 10 fish per exposure vessel total of 80 fish were used. Reconstituted soft-water prepared from glass-distilled water was used as dilution water. Test substance was added directly to exposure vessels and 4.2 mL of methanol added to controls because methanol is released on hydrolysis of test substance. Test solutions for range-finding study were prepared 30 minutes prior to addition of fish.Test was carried out at temperature 22°C of pH 7.2 to 7.6. pH at initiation (t = 0 h) mean 7.2 (range 7.2-7.3) 48 h observation mean 8.5 (range 7.4-9.6). Dissolved oxygen initiation (t = 0 h) mean 13.4 mg/L (range 13.0-13.5 mg/L) termination (t = 96 h) mean 8.4 mg/L (range 8.0-8.5 mg/L). Hardness and alkalinity was 40 to 48 mg CaCO3/L and 3 to 35 mg CaCO3/L respectively. Nominal test concentrations used were 0, 10, 100, 180, 320, 560, 1000 mg/L. Duplicate controls and single exposure concentrations were used.  Polyethylene-lined vessels containing 10 L of dilution water. vessels were aerated before study initiation but not during study.  Time of test solution preparation and time of fish addition were not recorded for the definitive study. Based on effect of mortality of test fishes NOEC, LOEC, LC10 and LC50 values were determined to be 100, 180 127 (65-161; 95% CI) and 200 (157-258; 95% CI) mg/l respectively. Thus, based on LC50 value test chemical was considered as non-toxic to test fishes and hence considered to be not-classified as per CLP classificaton criteria.

 

Third study includes an acute toxicity to fish study was carried out for time period of 96 hrs by following the OECD Guide-line 203 "Fish, Acute Toxicity Test",DIN 38412 Part 1, EG Guideline 92/69 C.1. Study was performed under semistatic condition. Brachydanio rerio was used as test organism. Test was carried out at temperature 20 to 21°C. The pH values ranged from 7.8 to 8.4 units in the controls and 8.2 to 9.3 units in the test chambers. The DO values ranged from 8.0 to 8.9 mg/L in the controls and 7.8 to 9.0 mg/L in the test chambers. water hardness and TOC was determined to be 18 mg/L as CaCO3 and 6 mg/L respectively.Verification was done analytically using TOC-500 Infrared Analyzer.  The tested substance was added to tap water to provide a concentration of 1g/l and stirred for 18 hours. The solution was filtered and the TOC content determined. The test began immediately after preparation of the test solution. The nominal test material concentration was 1000 mg/l. Measured concentrations were 880 mg/l at 0 hours; 922/947 mg/l at 24 hours; 885 mg/l at 72 hours average value of 943 mg/l (water filtered initial solution). 0% mortality in control was observed. Based on effect of mortality, LC0 value was determined to be >= 934mg/l. Based on LC0, LC50 value was considered as > 934 mg/l and hence, test chemical was considered as non-toxic to aquatic fishes and considered to be not-classified a sper CLP classification criteria.

 

Based on effect of test chemical on the mortality of the test organism aquatic fishes the 96 hrs LC50 value was estimated to be >100 mg/l (i.e 1790000 mg/l).

 

Based on above information test chemical was considered as non-toxic to test fishes and considered to be not-classified a sper CLP classification criteria.