Nicotine dihydrogen ditartrate

Endpoint summary

Description of key information

Short-term toxicity to fish:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the short term toxicity of fish of the test chemical.The studies are as mentioned below:

Study was conducted to investigate the effect of test chemical on the mortality rate of fishes Oncorhynchus mykiss (Rainbow Trout) and Lepomis macrochirus (Bluegill) by providing the exposure period of 96hrs. According to the OECD guideline 202 test organisms were maintain in the appropriate system and follows all the criteria which meet the guideline.Chemical analyzed with a Hewlett-Packard 5840 A gas chromatograph equipped with model 7671 A auto injector and also with FID.Both fishes obtain from the stock-culture units of the Environmental Research Laboratory-Duluth. Organisms not fed 24 hrs before and during the test.Test conducted in glass aquaria tank 60×30×30 cm deep. Tank divided into six compartments and one wide compartment with stainless steel screen divider. One standpipe were also present at the top.Test performed in duplicates with control which simultaneously run with the test chemical. Effect calculated by Trimmed Spearman- Karber method were used.As the test conducted on the two species of fish different effect concentrations were obtain at which 50 % mortality were observed. Based on the mortality of Oncorhynchus mykiss (Rainbow Trout) by the exposure of Nicotine sulfate for 96 hrs, the LC50 was determine to be 7.31 mg/l. And based on the mortality of Lepomis macrochirus (Bluegill), the LC50 was determine to be 4.31 mg/l.Based on the LC50 chemical was consider as toxic and classified as chronic 2 as per the CLP classification criteria.

The above information was further supported by data for structurally similar read across, short term 96 h test was conducted to evaluate effect of test material on Oncorhynchus mykiss (Rainbow trout, age 13 -21 days fry) . The median lethal effect concentrtaion LC50 was observed to be 4 mg/l . Based on the effect concentration it can be concluded that test material is toxic to fish an d can be classified as aquatic chronic 2.

The test chemical  is  likely to be toxic to fish  in the dose range of 4 - 7.31 mg/l.Based on the LC50 chemical was consider as toxic and classified as chronic 2 as per the CLP classification criteria.

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.

Toxicity to aquatic algae and cyanobacteria:

Thus based on the effect concentrations which is in the range 69 to 90mg/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 3” as per the CLP classification criteria.

Toxicity to microorganisms:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxicity of microorganism of the test chemical .The studies are as mentioned below:

Aim of this study was to determine the toxicity of test chemical on the growth of microorganisms. Test conducted on two different organisms Ruminococcus albus and Butyrivibrio fibrisolvens. As the two different species Ruminococcus albus and Butyrivibrio fibrisolvens exposed with the test chemical nicotine sulphate, effect on the growth of organisms vary. The IGC for Ruminococcus albus was determine to be 10 mg/l and on the other species it was observed that the growth inhibited at 100 mg/l.

Above study was further supported by data for another structurally similar read across substance ,microtox test was performed on Photobacterium phosphoreum for 5 min . The EC50 value was observed to be 37 mg/l. Test substance has inhibitory effects on microorganism. The test chemical ist likely to be toxic to microorganism  atleast in the dose range of 37 - 100 mg/l

Additional information

Short-term toxicity to fish:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the short term toxicity of fish of the test chemical.The studies are as mentioned below:

Study was conducted to investigate the effect of test chemical on the mortality rate of fishes Oncorhynchus mykiss (Rainbow Trout) and Lepomis macrochirus (Bluegill) by providing the exposure period of 96hrs. According to the OECD guideline 202 test organisms were maintain in the appropriate system and follows all the criteria which meet the guideline.Chemical analyzed with a Hewlett-Packard 5840 A gas chromatograph equipped with model 7671 A auto injector and also with FID.Both fishes obtain from the stock-culture units of the Environmental Research Laboratory-Duluth. Organisms not fed 24 hrs before and during the test.Test conducted in glass aquaria tank 60×30×30 cm deep. Tank divided into six compartments and one wide compartment with stainless steel screen divider. One standpipe were also present at the top.Test performed in duplicates with control which simultaneously run with the test chemical. Effect calculated by Trimmed Spearman- Karber method were used.As the test conducted on the two species of fish different effect concentrations were obtain at which 50 % mortality were observed. Based on the mortality of Oncorhynchus mykiss (Rainbow Trout) by the exposure of Nicotine sulfate for 96 hrs, the LC50 was determine to be 7.31 mg/l. And based on the mortality of Lepomis macrochirus (Bluegill), the LC50 was determine to be 4.31 mg/l.Based on the LC50 chemical was consider as toxic and classified as chronic 2 as per the CLP classification criteria.

The above information was further supported by data for structurally similar read across, short term 96 h test was conducted to evaluate effect of test material on Oncorhynchus mykiss (Rainbow trout, age 13 -21 days fry) . The median lethal effect concentrtaion LC50 was observed to be 4 mg/l . Based on the effect concentration it can be concluded that test material is toxic to fish an d can be classified as aquatic chronic 2.

The test chemical  is  likely to be toxic to fish  in the dose range of 4 - 7.31 mg/l.Based on the LC50 chemical was consider as toxic and classified as chronic 2 as per the CLP classification criteria.

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.

Toxicity to aquatic algae and cyanobacteria:

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

Objective of this first study was to determine the effect of test chemical on the growth rate of Scenedesmus subspicatus. Test conducetd under the static system for 72 hours. Based on the growth rate inhibition of algae, EC50 was determine at 90 mg/l whereas EC0 at 25 mg/l. Thus on the basis of EC50 value, chemical consider to be toxic and can be consider to be classiifed in aquatic chronic category 3.

Further it is supported by another structurally similar read across 2 also suggests that the toxicity to aquatic algae test was carried out to study the effects of test chemical on aquatic algae. Effective concentration EC50 to 50% Pseudokirchnerella subcapitata when exposed to test chemical is 69 mg/L. It can be concluded from the value that the test chemical is toxic to the aquatic algae and can be considered as “Aquatic chronic 3” as per the classification criteria for aquatic environment.

Thus based on the effect concentrations which is in the range 69 to 90mg/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 3” as per the CLP classification criteria.

Toxicity to microorganisms:

Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxicity of microorganism of the test chemical .The studies are as mentioned below:

Aim of this study was to determine the toxicity of test chemical on the growth of microorganisms. Test conducted on two different organisms Ruminococcus albus and Butyrivibrio fibrisolvens. As the two different species Ruminococcus albus and Butyrivibrio fibrisolvens exposed with the test chemical nicotine sulphate, effect on the growth of organisms vary. The IGC for Ruminococcus albus was determine to be 10 mg/l and on the other species it was observed that the growth inhibited at 100 mg/l.

Above study was further supported by data for another structurally similar read across substance ,microtox test was performed on Photobacterium phosphoreum for 5 min . The EC50 value was observed to be 37 mg/l. Test substance has inhibitory effects on microorganism. The test chemical ist likely to be toxic to microorganism  atleast in the dose range of 37 - 100 mg/l.

As the chemical shows toxicity on fish and invertebrates, thus consider to be toxic and classified in aquatic chronic 2 category as per the CLP classiication criteria.