Nicotine dihydrogen ditartrate

Short-term toxicity to aquatic invertebrates

Link to relevant study record(s)

Reference

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

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

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 for the target chemical is summarized based on the structurally similar read across chemicals

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Reason / purpose for cross-reference:

read-across source

Qualifier:

according to guideline

Guideline:

other: as mentiooned below

Principles of method if other than guideline:

WoE report is based on two short term toxicity study of aquatic invertebrate for the test chemical :
2)The objective of the present study was to develop the method for determination of toxicity of test material on the growth of aquatic invertebrate daphnia magna by satisfying the guideline.

3)Toxicity to aquatic invertebrate test was carried out according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) to study the effects of test chemical.

4) The 48-h static acute tests with D. pulex were conducted.

GLP compliance:

not specified

Analytical monitoring:

yes

Vehicle:

not specified

Details on test solutions:

3.Each test consisted of a water or solvent control (0.5 ml solvent/L) and five concentrations of toxicant dissolved in water or solvent (0.5 ml/L solvent).

Test organisms (species):

Daphnia magna

Details on test organisms:

2)TEST ORGANISM
- Common name: Water flea
- Age at study initiation (mean and range, SD): 0-24 hrs old
- Source: Test organisms obtain from the stock-culture units of the Environmental Research Laboratory-Duluth
- Feeding during test: Not fed 24 hrs before and during the test


3) TEST ORGANISM
- Common name: Water Flea
- Source: Department of Biology, University of Turku, Finland.
- AGE: <24 h
- Age of parental stock (mean and range, SD):
- Feeding during test: every second or third day depending on the density of the culture.
- Food type: Scenedesmus algae
- no feeding during the test

2. TEST ORGANISM
- Common name: water flea
- Strain: Daphnia pulex
- Age at study initiation: less than 24 hours
- Feeding: no feeding during test
- Food type: The food for the daphnids during these tests consisted of a 1 : 1:1 : 1 :4 mixture of four single-species green algae cultures with cerophyl medium (0.3 ng/ml)

Test type:

static

Water media type:

freshwater

Total exposure duration:

24 h

Hardness:

2) 44.7 (40.8 to 47.6 mg/L CaCO3)

Test temperature:

2) 17.2° C (16.5 to 18.4 ° C)
3) 20 ° C
4) 17 C

pH:

2) 7.39 (6.84 to 7.80)

Details on test conditions:

2)Details on test conditions
TEST SYSTEM
- Test vessel: Glass beaker
- Material, size, headspace, fill volume: For daphnia exposure chamber was 250 ml beakers with two 1.9 cm holes located 1 cm from the bottom and on opposite sides of each beaker.
- Renewal rate of test solution (frequency/flow rate): Flow-through
- No. of organisms per vessel: 20
- No. of vessels per concentration (replicates): 2
- No. of vessels per control (replicates): 2

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: Water obtain from Lake superior. 2 L proportional diluter with a dilution factor of 0.5 was used.
- Alkalinity: 43.0 mg/L CaCO3 (40.4 to 49.5 mg/L CaCO3)

OTHER TEST CONDITIONS
- Adjustment of pH: Yes
- Photoperiod: 12 hrs photoperiod was used
- Light intensity: 17 lumens at the surface of water.

EFFECT PARAMETERS MEASURED (with observation intervals if applicable) : Immobility, all other parameters including pH, temperature were measured


- Results used to determine the conditions for the definitive study: Immobility of daphnia magna


3) TEST SYSTEM
- Test vessel: polypropylene vessels
- Type (delete if not applicable): closed
- Material, size, headspace, fill volume: 100-ml
- aeration : no aeration
- No. of organisms per vessel: Twenty neonates (<24 h)
- No. of vessels per concentration (replicates): five concentrations


OTHER TEST CONDITIONS
- Light intensity: 12: 12-h light: dark cycle

2. - Material, size, headspace, fill volume: 150 ml
- No. of organisms per vessel: 10 neonates

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

3.25 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: 95 % CI was 2.72-3.88 mg/l

Duration:

24 h

Dose descriptor:

EC50

Effect conc.:

1.39 mg/L

Nominal / measured:

meas. (not specified)

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: toxic

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

4.64 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Remarks on result:

other: toxic

Details on results:

3. Immobilization was determined visually after 24 h.
4. immobilization was maeasured during the test.

Reported statistics and error estimates:

3. The EC5O values were calculated using regression analysis after linearization of the dose-response curves by logarithmic transformation of the concentrations .

Conclusions:

The test chemical is likely to be toxic to aquatic invertebrate atleast in the dose range of 1.39-4.64 mg/l.

Executive summary:

Following studies of structurally and functionallysimilar read across includes data to conclude the toxicity extent of test material towards aquatic invertebrate is summarized as follows:

For data available for structurally similar read across the objective of the present study was to develop the method for determination of toxicity of test material on the growth of aquatic invertebrate daphnia magna by satisfying the guideline. According to the OECD guideline 202 daphnia magna maintain in the appropriate system and follows all the criteria which meet the guideline.Chemical analyzed with a Hewlett-Packard 5840A gas chromatograph equipped with model 7671 A auto injector and also with FID.

0-24 hrs old daphnia magna obtain from the stock-culture units of the Environmental Research Laboratory-Duluth. Organismsnot fed 24 hrs before and during the test.Test conducted in 250 ml beakers with two 1.9 cm holes located 1 cm from the bottom and on opposite sides of each beaker. 20 daphnia per concentration were exposed for 48 hrs and the immobility were observed. Adult daphnids were separated into 2liter battery jars. After 24 hrs, 0-24 hrs old daphnia were carefully collected using fire polished glass tubes and squeeze bulbs, counted into 250 ml exposure beakers which were randomly hung in the 10 × 30 cm compartments of the 12 exposure tanks. After 48 hrs immobility and dead organisms were measured by dissecting microscope.

 

Based on the immobility of daphnia magna by the chemical exposure for 48 hrs, the EC50 was determine to be 3.25 mg/l with the 95 % CI of 2.72-3.88 mg/l. Based on the EC50 chemical was consider as toxic and classified as chronic 2 as per CLP criteria.

Experimental study for structurally similar read across suggests that the Toxicity to aquatic invertebrate test was carried out according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) to study the effects of test chemical. Effective concentration EC50 to 50% of Daphnia pulex 1.39 mg/L. It can be concluded from the value that the test chemical is toxic to the aquatic invertebrate and can be considered as “aquatic chronic 2” as per the classification criteria for aquatic environment.

Further it is supported by another structurally similar read across 2 also suggests that the The 48-h static acute tests with D. pulex were conducted. Effective concentration EC50 to 50% of daphnia pulex when exposed to tst chemical for 48 hrs is 4.64 mg/L. It can be concluded from the intoxication value that the test chemical is toxic to the quatic environment and can be considered as “Aquatic chronic 2” as per the classification criteria for aquatic environment.

Thus based on the effect concentrations which is in the range 1.39 mg/L to 4.64 mg/l gives the conclusion that test chemical  is likely to be toxic to aquatic environment at environmentally relevant concentrations and applying weight of evidence approach it can be considered to be “aquatic chronic 2” as per the CLP classification criteria.

Description of key information

Short-term toxicity to aquatic invertebrates:

Following studies of structurally andfunctionallysimilar read across includes data to conclude the toxicity extent of test material towards aquatic invertebrate is summarized as follows:

For data available for structurally similar read acrossthe objective of the present study was to develop the method for determination of toxicity of test material on the growth of aquatic invertebrate daphnia magna by satisfying the guideline. According to the OECD guideline 202 daphnia magna maintain in the appropriate system and follows all the criteria which meet the guideline.Chemical analyzed with a Hewlett-Packard 5840A gas chromatograph equipped with model 7671 A auto injector and also with FID. 0-24 hrs old daphnia magna obtain from the stock-culture units of the Environmental Research Laboratory-Duluth. Organismsnot fed 24 hrs before and during the test.Test conducted in 250 ml beakers with two 1.9 cm holes located 1 cm from the bottom and on opposite sides of each beaker. 20 daphnia per concentration were exposed for 48 hrs and the immobility were observed. Adult daphnids were separated into 2liter battery jars. After 24 hrs, 0-24 hrs old daphnia were carefully collected using fire polished glass tubes and squeeze bulbs, counted into 250 ml exposure beakers which were randomly hung in the 10 × 30 cm compartments of the 12 exposure tanks. After 48 hrs immobility and dead organisms were measured by dissecting microscope.

 

Based on the immobility of daphnia magna by the chemical exposure for 48 hrs, the EC50 was determine to be 3.25 mg/l with the 95 % CI of 2.72-3.88 mg/l. Based on the EC50 chemical was consider as toxic and classified as chronic 2 as per CLP criteria.

Experimental study for structurally similar read across suggests that the Toxicity to aquatic invertebrate test was carried out according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) to study the effects of test chemical. Effective concentration EC50 to 50% of Daphnia pulex 1.39 mg/L. It can be concluded from the value that the test chemical is toxic to the aquatic invertebrate and can be considered as “aquatic chronic 2” as per the classification criteria for aquatic environment.

Further it is supported by another structurally similar read across 2 also suggests that the The 48-h static acute tests with D. pulex were conducted. Effective concentration EC50 to 50% of daphnia pulex when exposed to tst chemical for 48 hrs is 4.64 mg/L. It can be concluded from the intoxication value that the test chemical is toxic to the quatic environment and can be considered as “Aquatic chronic 2” as per the classification criteria for aquatic environment.

Thus based on the effect concentrations which is in the range 1.39 mg/L to 4.64mg/lgives the conclusion that test chemical is likely to be toxic to aquatic environment at environmentally relevant concentrations and applying weight of evidence approach it can be considered to be “aquatic chronic 2” as per the CLP classification criteria.

Key value for chemical safety assessment

Fresh water invertebrates

Fresh water invertebrates

Effect concentration:

4.64 mg/L

Additional information

Short-term toxicity to aquatic invertebrates:

Following studies of structurally andfunctionallysimilar read across includes data to conclude the toxicity extent of test material towards aquatic invertebrate is summarized as follows:

For data available for structurally similar read acrossthe objective of the present study was to develop the method for determination of toxicity of test material on the growth of aquatic invertebrate daphnia magna by satisfying the guideline. According to the OECD guideline 202 daphnia magna maintain in the appropriate system and follows all the criteria which meet the guideline.Chemical analyzed with a Hewlett-Packard 5840A gas chromatograph equipped with model 7671 A auto injector and also with FID.

0-24 hrs old daphnia magna obtain from the stock-culture units of the Environmental Research Laboratory-Duluth. Organismsnot fed 24 hrs before and during the test.Test conducted in 250 ml beakers with two 1.9 cm holes located 1 cm from the bottom and on opposite sides of each beaker. 20 daphnia per concentration were exposed for 48 hrs and the immobility were observed. Adult daphnids were separated into 2liter battery jars. After 24 hrs, 0-24 hrs old daphnia were carefully collected using fire polished glass tubes and squeeze bulbs, counted into 250 ml exposure beakers which were randomly hung in the 10 × 30 cm compartments of the 12 exposure tanks. After 48 hrs immobility and dead organisms were measured by dissecting microscope.

 

Based on the immobility of daphnia magna by the chemical exposure for 48 hrs, the EC50 was determine to be 3.25 mg/l with the 95 % CI of 2.72-3.88 mg/l. Based on the EC50 chemical was consider as toxic and classified as chronic 2 as per CLP criteria.

Experimental study for structurally similar read across suggests that the Toxicity to aquatic invertebrate test was carried out according to the OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test) to study the effects of test chemical. Effective concentration EC50 to 50% of Daphnia pulex 1.39 mg/L. It can be concluded from the value that the test chemical is toxic to the aquatic invertebrate and can be considered as “aquatic chronic 2” as per the classification criteria for aquatic environment.

Further it is supported by another structurally similar read across 2 also suggests that the The 48-h static acute tests with D. pulex were conducted. Effective concentration EC50 to 50% of daphnia pulex when exposed to tst chemical for 48 hrs is 4.64 mg/L. It can be concluded from the intoxication value that the test chemical is toxic to the quatic environment and can be considered as “Aquatic chronic 2” as per the classification criteria for aquatic environment.

Thus based on the effect concentrations which is in the range 1.39 mg/L to 4.64mg/lgives the conclusion that test chemical is likely to be toxic to aquatic environment at environmentally relevant concentrations and applying weight of evidence approach it can be considered to be “aquatic chronic 2” as per the CLP classification criteria.