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Short-term toxicity to Fish:

Various predicted data for chemical PyrazoloneTalong with its read across substance were reviewed to summarize the following information: 

48 hrs aquatic toxicity study (SSS QSAR prediction model, 2016) was conducted to assess toxic effects of the test compound PyrazoloneT(CAS no 118-47-8) and the results were predicted. The study was based on the effects of the test compound on the Zebra fish in a static fresh water system. The predicted data suggests the effective concentration (EC50) for the test compound PyrazoloneTwas estimated to be 572.70123291mg/L on the basis of mortality. 

 

48 hrs aquatic toxicity study (EPI suite, 2016) was conducted to assess toxic effects of the test compoundPyrazoloneT(CAS no118-47-8) and the results were predicted. The study was based on the effects of the test compound on fish in a static fresh water system. The predicted data suggests the lethal concentration (LC50) for the test compoundPyrazoloneTwas estimated to be 6.46 x 105mg/l. 

 

Short term toxicity study (Yaushide TONOGAL, Masahiro IWAIDA, Masatomo TATI, Youki OSE and Takahiko SATO,1978) toOryzias latipeswas carried out for 48 hrs and survival rate (in %) was determined. Himedaka (Oryzias latipes) of same age (2 cm long and 0.2 in weights) was used for the study. The test fishes were acclimatized for 10 days in tap water. In 1 litre solution of pH 7.0 containing 3,000 mg/l of test substance Tartrazine, ten fishes were kept in the tank without direct sunlight for 48 hrs and survival rate was determined. Water temperature was 20C and aeration was provided with bubbler. Median Tolerance Limit (TLm) was also determined after 24 and 48 hrs. The TLm value was not reported. As no mortality of test animal was observed after 48 hrs, the LC0 value was found to be 3,000 mg/l. Thus, the survival rate of fish after 48 hrs was found to be 100%.

Short term toxicity study (Data bank of Environmental Properties of Chemicals (EnviChem))toOryzias latipeswas carried out for 48 hrs. The 48 hrs LC50 value to test organismOryzias latipeswas found to be greater than 1000 mg/l.

 

On the basis of results of various predictions and read across, the chemicalPyrazoloneT can be considered as not likely to be toxic to fishes at environmentally relevant concentrations and can be classified as non- hazardous as per the criteria of CLP regulation

Toxicity to aquatic invertebrates

Various predicted data for chemical PyrazoloneT along with its read across substance were reviewed to summarize the following information:

 

48 hrs aquatic toxicity study (SSS QSAR prediction model, 2016) was conducted to assess toxic effects of the test compound PyrazoloneT(CAS no 118-47-8) and the results were predicted. The study was based on the effects of the test compound on the Daphnia magna in a static fresh water system. The predicted data suggests the effective concentration (EC50) for the test compound PyrazoloneTwas estimated to be131.89mg/L on the basis of mortality. 

 

48 hrs aquatic toxicity study (EPI suite, 2016) was conducted to assess toxic effects of the test compound PyrazoloneT(CAS no 118-47-8) and the results were predicted. The study was based on the effects of the test compound on Daphnia magna in a static fresh water system. The predicted data suggests the effective concentration (EC50) for the test compound PyrazoloneTwas estimated to be 258000 mg/L. 

 

Estimated 48 hrs EC50 value of test substance Pyrazolone T on Daphnia magna was determined by three different models i.e, Battery, Leadscope and SciQSAR used within Danish QSAR database.

Based on mortality of test organism Daphnia magna, the estimated 48 hrs EC50 value by three different model i.e, Battery, Leadscope and SciQSAR used within Danish QSAR database was found to be 299.506mg/l.

 

Short term toxicity study to cladoceranCeriodaphnia dubiawas carried out for 48 hrs. Stock solutions of test substance Tartrazine was made by dissolving the appropriate amount in 1 or 2 L of the Sydney mains water and then gently stirred for 12 h in the dark at 23±1°C using Teflon magnetic stirrers. Stirring was conducted so that no bubbles were formed when the test substance was dissolved, as the formation of bubbles leads to depletion of surfactants in the solution. Light was excluded during the stirring to minimize photodegradation of the chemicals. Stock solutions were diluted to the appropriate concentrations immediately prior to the commencement of a test. Test chemical was stored in the dark at 22±2°C.

 All neonates used in the toxicity tests were less than 24 h old.C. cf.dubiawere cultured and tested at 23±1°C in dechlorinated Sydney mains water which was filtered (1µm), aged (1 month), and adjusted to 500µS/cm with seawater. Cultures ofC. cf.dubiawere maintained in 2-L glass beakers and transferred to fresh water three times weekly. Food was provided after water renewal at a concentration of 25,000 cells/ml of each of the unicellular algaePseudokirchneriellia subcapitataPrintz (formerly namedSelenastrum capricornutum) andAnkistrodesmussp.

 Five cladocera were randomly allocated to each test beaker and each treatment in a test was triplicated. Beakers were then randomly positioned in constant temperature cabinets and maintained at 23±1°C with a 16 : 8-h light to dark regime and light intensity below 1000 lx at the surface of the solutions. Animals were not fed during the tests.The test was terminated after 48 hrs andthe number of immobile cladocera counted.Immobilization was defined as the absence of visible movement by the cladocera within 15 s of gentle agitation of the test solution.

 The 48-h EC50 (immobilization) values and 95% confidence intervals were based on nominal concentrations and were determined by the trimmed Spearman-Karber method.Based on immobilization of the test organism, the EC50 value was found to be 5706.55mg/l.

Short term toxicity study to Artemia Salina was carried out for 24-48 hrs. The test chemical conc. used for the study was 5343.68 mg/l and 534.368 mg/l, respectively. A. salina eggs (encysted dried gastrulae) were commercially obtained, and were stored at -20°C, Eggs used in experiments were washed and stored at room temperature in a desiccator over anhydrous granular CaCl,. Larvae were obtained by incubating eggs in petri dishes containing muslin-filtered sea water at 30°C for 24 hours. The larvae were separated from shells, dead larvae and unhatched eggs by their phototactic movements toward a light source.

Food dyes of various concentrations were placed in a petri dish, and sea water containing 20 to 30 larva ewas added. After this was incubated at 30°C for 24 hours and 48 hours, larvae surviving were measured by direct count. The same method was tested from 5 to 6 times for each concentration, and the death rate was calculated.

The study was performed under static conditions for 24 – 48 hrs at 30°C. Death was assumed to have occurred when there was no movement. The death rate was defined as the average of the percentage of deaths observed for 24 hours and 48 hours.

Based on death rate or mortality of test organism, the LC83.8 value was found to be 5343.68 mg/l.

 

On the basis of results of various predictions and read across, the chemicalPyrazoloneT can be considered as not likely to be toxic to aquatic invertebrates at environmentally relevant concentrations and can be classified as non- hazardous as per the criteria of CLP regulation.

Toxicity to aquatic algae and cyanobacteria

Various predicted data for the target chemical Pyrazolone T (CAS No. 118-47-8) were reviewed to summarize the following information:

Based on the QSAR prediction done using the EPI Suite ECOSAR version 1.10 (EPI suite, 2016), the 96 hours EC50 was estimated to be 44420.914 mg/l on green algae for substance Pyrazolone T with growth inhibition effects. Thus based on this value, it can be concluded that the substance can be considered as non-toxic to aquatic organisms and thus can be classified as not hazardous as per the CLP criteria.

72 hrs aquatic toxicity study was predicted (SSS QSAR Prediction model, 2016) to assess toxic effects of the test compound Pyrazolone T (CAS No. 118-47-8) and the results were predicted. The study was based on the effects of the test compound on Desmodesmus subspicatus in a static fresh water system. The predicted data suggests the effective concentration (EC50) for the test compound Pyrazolone T (CAS No. 118-47-8) was estimated to be49.874 mg/l on the basis of growth rate. Thus based on this value, it can be concluded that the substance can be classified as aquatic chronic category 3. Since the partition coefficient of the test chemical is not≥ 4 (i.e, log Kow = -1.0), test chemical Pyrazolone T can be considered asnon-toxic to aquatic organisms and thus cannot be classified as hazardous as per the CLP criteria.

Estimated 72 hrs EC50 value of test substance Pyrazolone T on Pseudokirchneriella subcapitata was determined (Danish QSAR database, 2016) by three different models i.e, Battery, Leadscope and SciQSAR used within Danish QSAR database. Based on inhibition in growth rate of test organism Pseudokirchneriella subcapitata, the estimated 72 hrs EC50 value was found to be319.2977mg/l. Thus based on this value, it can be concluded that the substance can be considered as non-toxic to aquatic organisms and thus cannot be classified as hazardous as per the CLP criteria.

Based on the overall reported results of various predicted data for target substance, it can be concluded that the substance can be classified as not hazardous as per the CLP criteria.