N-[4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]phenyl]acetamide

Short-term toxicity to fish

Link to relevant study record(s)

Reference

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:

other: Data is from computational model developed by USEPA

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:

ECOSAR estimates log Kow values using the US EPA's KOWWIN Program for aquatic toxicity.Toxicity of a chemical was measured on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program based upon the octanol /water partition coefficient (Kow). Data from ECOSAR class,neutral organics was used.

The estimation methods in EPI Suite™ have been developed by government, academic, and private sector researchers over many years and represent some of the best techniques currently available. The intended application domain of EPI Suite is organic chemicals, and inorganic as well as organometallic chemicals generally can be considered outside the domain.

GLP compliance:

no

Analytical monitoring:

no

Vehicle:

no

Test organisms (species):

other: Fish

Test type:

static

Water media type:

freshwater

Total exposure duration:

96 h

Reference substance (positive control):

not specified

Duration:

96 h

Dose descriptor:

LC50

Effect conc.:

0.945 mg/L

Nominal / measured:

estimated

Conc. based on:

test mat.

Basis for effect:

mortality (fish)

Validity criteria fulfilled:

not specified

Conclusions:

Based on the QSAR prediction done using the EPI Suite ECOSAR version 1.10, the 96 hours LC50 was estimated to be 0.945 mg/l on fish for test substance with mortality effects.

Executive summary:

Based on the QSAR prediction done using the EPI Suite ECOSAR version 1.10, the 96 hours LC50 was estimated to be 0.945 mg/l on fish for substance test substance with mortality effects.

Description of key information

An acute toxicity test was conducted for 96 hrs for assessing the effect of test chemical on Zebra fish (Danio rerio). The test was performed in accordance to OECD guideline No. 203 “Fish Acute Toxicity Test”. Zebra fish (Danio rerio) of average length of 1.87 cm was used as a test organism. Test fishes were kept in the test water under natural conditions along with proper feed and aeration for seven days. Test chemical solution was prepared by dissolving 5000 mg of test chemical in 5000 ml of RO water to get the final concentration of 1000 mg/L. which was then analytically determined. The final solubility value obtained after analytical detection was 0.16 mg/L. The remaining test solutions were prepared by dilution from the above stock solution. Limit test was performed at a test chemical concentration of 0.16 mg/l. The analytical determinations were performed by UV-VIS spectrophotometer for selected test concentration at 0 hour and 96 hours. The concentration of the test chemical being tested and was not within the range of ± 20 %. Therefore, the analysis of the results was based on measured concentration. Test fishes were exposed to test chemical in a 7 lit bowl aquaria containing 4 liters of potable water. The test vessels were placed at a temperature of 21-25°C, pH 7.6, dissolved oxygen 8.3 mg/l and under a photoperiod of 16:8 hr light: dark conditions, respectively. The pH and oxygen values were measured at the beginning of the test and every 24 hours thereafter. The lethal concentration was calculated using the concentration/ percentage response curve. After the 96 hours of exposure, there was no mortality in the control group, and the dissolved oxygen concentration was 93% of the air saturation value, thus meeting the validity criteria. The median lethal concentrations [LC50 (96 h)] for test chemical on Danio rerio (Zebra Fish) was determined to be > 0.16 mg/L.

Key value for chemical safety assessment

Fresh water fish

Fresh water fish

Effect concentration:

0.16 mg/L

Additional information

Experimental studyand predicted data of the target chemical and various supporting weight of evidence studies for its read across substance was reviewed for the short term toxicity to fish end point which is summarized as below:

 

In an experimental study from study report (2020), an acute toxicity test was conducted for 96 hrs for assessing the effect of test chemical on Zebra fish (Danio rerio). The test was performed in accordance to OECD guideline No. 203 “Fish Acute Toxicity Test”. Zebra fish (Danio rerio) of average length of 1.87 cm was used as a test organism. Test fishes were kept in the test water under natural conditions along with proper feed and aeration for seven days. Test chemical solution was prepared by dissolving 5000 mg of test chemical in 5000 ml of RO water to get the final concentration of 1000 mg/L. which was then analytically determined. The final solubility value obtained after analytical detection was 0.16 mg/L. The remaining test solutions were prepared by dilution from the above stock solution. Limit test was performed at a test chemical concentration of 0.16 mg/l. The analytical determinations were performed by UV-VIS spectrophotometer for selected test concentration at 0 hour and 96 hours. The concentration of the test chemical being tested and was not within the range of ± 20 %. Therefore, the analysis of the results was based on measured concentration. Test fishes were exposed to test chemical in a 7 lit bowl aquaria containing 4 liters of potable water. The test vessels were placed at a temperature of 21-25°C, pH 7.6, dissolved oxygen 8.3 mg/l and under a photoperiod of 16:8 hr light: dark conditions, respectively. The pH and oxygen values were measured at the beginning of the test and every 24 hours thereafter. The lethal concentration was calculated using the concentration/ percentage response curve. After the 96 hours of exposure, there was no mortality in the control group, and the dissolved oxygen concentration was 93% of the air saturation value, thus meeting the validity criteria. The median lethal concentrations [LC50 (96 h)] for test chemical on Danio rerio (Zebra Fish) was determined to be > 0.16 mg/L. 

 

In a prediction done using the EPI Suite ECOSAR version 1.10 (2017), the 96 hours LC50 was estimated to be 0.945 mg/l on fish for substance test substance with mortality effects.

 

Another Prediction done using Danish QSAR database (2018) in which the average value of both models i.e Leadscope and SciMatics SciQSAR model were presented in Battery model. On the basis of this, 96 hours LC50 was estimated to be 0.44 mg/l on Pimephales promelas for test substance with mortality effects.

 

In a supporting weight of evidence study from peer reviewed journal (Kuo-HsiungL et al, 2002), short term toxicity test was performed to evaluate the effect of test material to fish Cyprinus carpio. The test animals were fed with yeast in a 224 (diameter), 46 (height)-cm circular plastic pool. Before the experiment, the test organisms were acclimatized in aquaria for 2 weeks under conditions similar to those under which the tests were performed. Four carps of 2 to 6 cm in size, were introduced to each 10-L beaker containing 5 L of different concentrations of test chemical i.e, 10, 50, 100, 200, and 500 mg/l. After 48 h of exposure period, median lethal concentration (LC50) values were calculated by using trimmed Spearman Karber method. The median lethal concentration (LC50) of test material on Cyprinus carpio after 48 h was observed to be 0.022 mg/l.

 

For the test chemical, another short term toxicity test was performed to evaluate the effect of test material to fish Cyprinus carpio (Kuo-HsiungL et al, 2002). The test procedure and conditions were similar as mentioned above. The median lethal concentration (LC50) of test material on Cyprinus carpio after 48 h was observed to be 0.045 mg/l.

 

Thus, based on the LC50 value, test chemical can be considered as toxic to aq. algae and thus can be considered to be classified in ‘Aquatic acute/chronic 1 category’ as per CLP classification criteria.