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Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Reference 1

Endpoint:

short-term toxicity to aquatic invertebrates

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:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

not specified

Analytical monitoring:

yes

Details on sampling:

- Concentrations: Nominal concentrations in mg/L:
7.5, 15, 30, 60, 120 and a control

Measured concentrations in mg/L:
5.7, 15, 21, 45 and 100

Vehicle:

not specified

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Controls: dilution water control

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Age at study initiation (mean and range, SD): : < 24 hours
- Source: Springborn Smithers culture facility.
- Feeding during test : yes
- Food type: Daphnids were fed a unicellular green algae (Ankistrodesmus falcatus, 4 x 107 cells/mL) at a rate of 0.5 to 1.5 mL per vessel daily
- Amount: 0.5 mL of a combination of yeast, cereal leaves and flaked fish food (YCT) daily.
- Frequency: Daily

Test type:

flow-through

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

CaCO3 of 44 mg/L

Test temperature:

20 ± 1 ºC.

pH:

6.8 to 7.3

Dissolved oxygen:

DO concentration range of 9.8 to 9.9 mg/L at test initiation and ranged from 9.4 to 9.5 at test termination

Conductivity:

of 210 to 240 µmhos/cm.

Nominal and measured concentrations:

Nominal concentrations in mg/L:
7.5, 15, 30, 60, 120 and a control

Measured concentrations in mg/L:
5.7, 15, 21, 45 and 100

Details on test conditions:

TEST SYSTEM
- Test vessel: 1600-mL square glass battery jars) had two 2-cm holes drilled in the sides, 15 cm from the bottom,
- Type (delete if not applicable): closed (covered with Nitex 40 mesh screen for drainage)
- Volume of solution: 1400 mL
- Aeration: No
- No. of organisms per vessel: 10
- No. of vessels per concentration (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Laboratory well water
- Total organic carbon: 0.58 and 0.48 mg/L
- Alkalinity: 21 mg/L


OTHER TEST CONDITIONS
- Adjustment of pH: Yes
- Photoperiod: 16 hours of light and 8 hours of darkness.
- Light intensity: fluorescent bulbs

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Other details not known

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Other details not known

Details on results:

- Other biological observations: Number immobilized as compared to the number exposed: Number immobilized: 3, Number exposed: 120 (includes control)
- Mortality of control: mortalities (5% and 10%) observed in the control

Validity criteria fulfilled:

not specified

Conclusions:

Based on effect on mobility of test daphnids, the 48 hrs NOEC and EC50 value was determined to be 100 and >100 mg/l respectively.

Executive summary:

An acute short term toicity to aquatic invertebrates study was carried out for time period of 48 hrs, by following the OECD Guide-line 202. Study was performed under flow through condition. Daphnia magna of age >24hrs which was obtained from Springborn Smithers culture facility and was used as test organism. Daphnids were fed a unicellular green algae (Ankistrodesmus falcatus, 4 x 107 cells/mL) at a rate of 0.5 to 1.5 mL per vessel daily depending on the age of the adult organisms in the culture vessel and 0.5 mL of a combination of yeast, cereal leaves and flaked fish food (YCT) daily. Study was carried out temperature of 20 ± 1 ºC by following 16-hour light, 8-hour dark photoperiod. Dilution water was used from Laboratory well water. The dilution water had a total hardness and alkalinity as CaCO3 of 44 mg/L and 21 mg/L, respectively, a pH range of 6.8 to 7.3. The pH measured in the dilution water control vessel replicates was 7.0 at test initiation and 7.1 at test termination. And a specific conductivity range of 210 to 240 µmhos/cm.  The TOC concentration of the dilution water was 0.58 and 0.48 mg/L. The test area was illuminated with fluorescent bulbs. Light intensity was measured once during the test. The dilution water control vessels had a measured DO concentration range of 9.8 to 9.9 mg/L at test initiation and ranged from 9.4 to 9.5 at test termination. Nominal concentrations used were 7.5, 15, 30, 60, 120 and a control whereas, Measured concentrations used were 5.7, 15, 21, 45 and 100 respectively. Verification was done analytically using GC/FID. 1600-mL square glass battery jars used as test vessel had two 2-cm holes drilled in the sides, 15 cm from the bottom which were covered with Nitex 40 mesh screen for drainage.  The total test solution volume was maintained at 1400 mL.  Two replicate test vessels were established for each treatment level and a dilution water control (two replicates, ten daphnids per replicate vessel). 5% immobilization was observed among daphnids exposed to the control and 10% immobilization was observed among daphnids exposed to the 5.7 mg/l in treatment level. Based on effect of test daphnids, NOEC and EC50 value was determined to be 100 and >100 mg/l respectively. Thus, based on EC50 value test chemical was considered as non-toxic to aquatic invertebrates and hence, considered to be not-classified as per CLP classification criteria.

Reference 2

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

weight of evidence

Reliability:

4 (not assignable)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Data is from a secondary source.

Qualifier:

according to guideline

Guideline:

other: EG Guideline 92/69/EWG

Qualifier:

according to guideline

Guideline:

other: DIN 38412 Part 1;

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

GLP compliance:

not specified

Analytical monitoring:

not specified

Details on sampling:

- Concentrations: Nominal concentrations in mg/L: 0, 8.7, 16.4, 28.4, 54.7, 94.0, 174.9, 306.0, 546.5, and 983.7 mg/L.

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances)
- Method: test 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.

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: Water flea
- Age at study initiation (mean and range, SD): <24 hours
- Feeding during test : No

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Hardness:

Water hardness was reported as 2.5mmol/L

Test temperature:

20°C

pH:

The control pH was 7.5 units and the test vessel pH ranged from 7.5 to 8.7 units.

Dissolved oxygen:

The control DO was 8.4 mg/L and the test vessel DO ranged from 7.8 to 8.7 mg/L.

Nominal and measured concentrations:

Nominal concentrations in mg/L: 0, 8.7, 16.4, 28.4, 54.7, 94.0, 174.9, 306.0, 546.5, and 983.7 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessel: glass cylinders
- Volume of solution: 10 ml
- Aeration: No
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Total organic carbon: <1 mg/L.
- Alkalinity: 0.8 m mol/L.

OTHER TEST CONDITIONS
- Adjustment of pH: Yes
- Photoperiod: Dark

Reference substance (positive control):

not specified

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

592 mg/L

95% CI:

> 349 - < 1 003

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Duration:

48 h

Dose descriptor:

NOEC

Effect conc.:

94 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: Other details not known

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

331 mg/L

95% CI:

> 249 - < 441

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Validity criteria fulfilled:

not specified

Conclusions:

Based on effect of mobiity of test daphnids, the 48 hrs NOEC, EC50 values were determined to be 94 and 331 mg/l respectively.

Executive summary:

Short term toxicity to aquatic invertebrates study was carried out for time period of 48 hrs by foloowing the OECD Guide-line 202, DIN 38412 Part 1; EG Guideline 92/69/EWG. Study was performed under static condition. Age <24 hours Daphnia Magna was used as test organism which were not fed during the test. Test was carried out at 20°C vessels were kept in the dark and not aerated during the test. The control pH was 7.5 units and the test vessel pH ranged from 7.5 to 8.7 units. The control DO was 8.4 mg/L and the test vessel DO ranged from 7.8 to 8.7 mg/L. Water hardness, alkalinity and TOC were 2.5mmol/L ,0.8 mmol/L and <1 mg/L respectively. Test was carried out at nominl concentrations of 0, 8.7, 16.4, 28.4, 54.7, 94.0, 174.9, 306.0, 546.5, and 983.7 mg/L. Test 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. Glass cylinder was used as test vessel graduated to 10 ml. Each concentration had 4 replicate vessels and each vessel contained 5 test organisms. Based on effect of mobiity of test daphnids NOEC, EC50 values were determined to be 94 and 331(95% confidence limits: 249-441 mg/L) mg/l respectively. Thus, based on EC50 value test chemical was considered as non-toxic to test daphids and hence considered to be not classified as per CLP classification criteria.

Reference 3

Endpoint:

short-term toxicity to aquatic invertebrates

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 48 hrs LC50 value of test chemical on aquatic invertebrates by EPI Suite ECOSAR version 1.11

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

Daphnia magna

Test type:

static

Water media type:

freshwater

Limit test:

no

Total exposure duration:

48 h

Reference substance (positive control):

no

Duration:

48 h

Dose descriptor:

LC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: LC50 value was determined to be > 100 mg/l (i.e 680000 mg/l)

Validity criteria fulfilled:

not specified

Conclusions:

Based on effect of test chemical on the mobilty of the test organism aquatic invertebrates, the 48 hrs LC50 value was estimated to be > 100 mg/l (i.e 680000 mg/l).

Executive summary:

The toxicity of the test chemical to aquatic invertebrates was predicted using EPI Suite ECOSAR version 1.11. On the basis of effect of test chemical observed in a static system on the mobilityof the test organism during the 48 hr exposure duration, the median lethal concentration (LC50) for the test chemical was estimated to be >100 mg/l (680000 mg/l). Thus, based on the LC50 value, test chemical can be considered as non-toxic to test daphnids 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 mobilty of the test organism aquatic invertebrates, the 48 hrs LC50 value was estimated to be > 100 mg/l (i.e 680000 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 invertebrates. The studies are as mentioned below:

 

First study includes the toxicity of the test chemical to aquatic invertebrates was predicted using EPI Suite ECOSAR version 1.11. On the basis of effect of test chemical observed in a static system on the mobilityof the test organism during the 48 hr exposure duration, the median lethal concentration (LC50) for the test chemical was estimated to be >100 mg/l (680000 mg/l). Thus, based on the LC50 value, test chemical can be considered as non-toxic to test daphnids and hence, considered to be 'not classified' as per the CLP classification criteria.

 

Second study includes short term toxicity to aquatic invertebrates study was carried out for time period of 48 hrs by foloowing the OECD Guide-line 202, DIN 38412 Part 1; EG Guideline 92/69/EWG. Study was performed under static condition. Age <24 hours Daphnia Magna was used as test organism which were not fed during the test. Test was carried out at 20°C vessels were kept in the dark and not aerated during the test. The control pH was 7.5 units and the test vessel pH ranged from 7.5 to 8.7 units. The control DO was 8.4 mg/L and the test vessel DO ranged from 7.8 to 8.7 mg/L. Water hardness, alkalinity and TOC were 2.5mmol/L ,0.8 mmol/L and <1 mg/L respectively. Test was carried out at nominl concentrations of 0, 8.7, 16.4, 28.4, 54.7, 94.0, 174.9, 306.0, 546.5, and 983.7 mg/L. Test 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. Glass cylinder was used as test vessel graduated to 10 ml. Each concentration had 4 replicate vessels and each vessel contained 5 test organisms. Based on effect of mobiity of test daphnids NOEC, EC50 values were determined to be 94 and 331(95% confidence limits: 249-441 mg/L) mg/l respectively. Thus, based on EC50 value test chemical was considered as non-toxic to test daphids and hence considered to be not classified as per CLP classification criteria.

 

Third study includes an acute short term toicity to aquatic invertebrates study was carried out for time period of 48 hrs, by following the OECD Guide-line 202. Study was performed under flow through condition. Daphnia magna of age >24hrs which was obtained from Springborn Smithers culture facility and was used as test organism. Daphnids were fed a unicellular green algae (Ankistrodesmus falcatus, 4 x 107 cells/mL) at a rate of 0.5 to 1.5 mL per vessel daily depending on the age of the adult organisms in the culture vessel and 0.5 mL of a combination of yeast, cereal leaves and flaked fish food (YCT) daily. Study was carried out temperature of 20 ± 1 ºC by following 16-hour light, 8-hour dark photoperiod. Dilution water was used from Laboratory well water. The dilution water had a total hardness and alkalinity as CaCO3 of 44 mg/L and 21 mg/L, respectively, a pH range of 6.8 to 7.3. The pH measured in the dilution water control vessel replicates was 7.0 at test initiation and 7.1 at test termination. And a specific conductivity range of 210 to 240 µmhos/cm.  The TOC concentration of the dilution water was 0.58 and 0.48 mg/L. The test area was illuminated with fluorescent bulbs. Light intensity was measured once during the test. The dilution water control vessels had a measured DO concentration range of 9.8 to 9.9 mg/L at test initiation and ranged from 9.4 to 9.5 at test termination. Nominal concentrations used were 7.5, 15, 30, 60, 120 and a control whereas, Measured concentrations used were 5.7, 15, 21, 45 and 100 respectively. Verification was done analytically using GC/FID. 1600-mL square glass battery jars used as test vessel had two 2-cm holes drilled in the sides, 15 cm from the bottom which were covered with Nitex 40 mesh screen for drainage.  The total test solution volume was maintained at 1400 mL.  Two replicate test vessels were established for each treatment level and a dilution water control (two replicates, ten daphnids per replicate vessel). 5% immobilization was observed among daphnids exposed to the control and 10% immobilization was observed among daphnids exposed to the 5.7 mg/l in treatment level. Based on effect of test daphnids, NOEC and EC50 value was determined to be 100 and >100 mg/l respectively. Thus, based on EC50 value test chemical was considered as non-toxic to aquatic invertebrates and hence, considered to be not-classified as per CLP classification criteria.

 

Based on effect of test chemical on the mobilty of the test organism aquatic invertebrates, the 48 hrs LC50 value was estimated to be > 100 mg/l (i.e 680000 mg/l).

 

Based on above information test chemical was considered as non-toxic to aquatic invertebrates and hence, considered to be not-classified as per CLP classification criteria.