Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Short-term toxicity to fish

Based on the EPI Suite ECOSAR version 1.10 prediction model, the 96 hours LC50 was estimated to be 11064.50 mg/l on Fish for substance 2,4-Thiazolidinedione (CAS no.2295-31-0) on the basis of mortality effects.

Short-term toxicity to aquatic invertebrates

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the six closest read across substances, the short term toxicity on aquatic invertebrates was predicted for 1,3-thiazolidine-2,4-dione i.e 2,4-Thiazolidinedione (Cas no. 2295-31-0). Effect concentration i.e EC50 value was estimated to be 173.69 mg/l for Daphnia magna for 48 hrs duration. Based on the effect value, 1,3-thiazolidine-2,4-dione i.e 2,4-Thiazolidinedione (Cas no. 2295-31-0) was likely to be non toxic to aquatic invertebrates, hence it can be considered to be not classified as per the CLP classification criteria for aquatic environment.

Toxicity to aquatic algae and cyanobacteria

Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, the short term toxicity on aquatic algae and cyanobacteria was predicted for target substance 1,3-thiazolidine-2,4-dione i.e 2,4-Thiazolidinedione (CAS no. 2295-31-0). EC50 value was estimated to be 110.96 mg/l for Pseudokirchneriella subcapitata for 72 h duration. Based on this value it can be concluded that the substance 1,3-thiazolidine-2,4-dione i.e 2,4-Thiazolidinedione (CAS no. 2295-31-0) is considered to be non toxic to aquatic environment and can be considered to be not classified as per the CLP classification criteria.

Toxicity to microorganisms

From Reaxy database the antibacterial activity (MIC) of test chemical 1,3-thiazolidine-2,4-dione i.e 2,4-Thiazolidinedione (Cas no.2295-31-0) was observed at dose concentration 300 μg/disc and value of zone of inhibition is < 7 mm.

Additional information

Short-term toxicity to fish

Using the EPI Suite ECOSAR version 1.11, the short term toxicity on fish was predicted for test substance 2,4-Thiazolidinedione (CAS no.2295-31-0) on the basis of effects observed in a static freshwater system. The lethal concentration LC50 value for the substance was estimated to be 11064.50 mg/l for fish for 96 hr exposure duration. Based on this lethal value it can be concluded that the substance 2,4-Thiazolidinedione (CAS no.2295-31-0)can be considered to be non toxic to aquatic environment and thus it become not classified as per the CLP classification criteria.

Short-term toxicity to aquatic invertebrates

Four studies including predicted data from validated tools and experimental data from peer reviewed journal also from authorative database for short term aquatic invertebrate’s endpoint of test chemical 1,3-thiazolidine-2,4-dione i.e 2,4-Thiazolidinedione (Cas no. 2295-31-0) with relevant read across which is structurally similar to target were summarised as follows:

 

First data from prediction using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the six closest read across substances, which indicate the short term toxicity on aquatic invertebrates was predicted for 1,3-thiazolidine-2,4-dione i.e 2,4-Thiazolidinedione (Cas no. 2295-31-0). Effect concentration i.e EC50 value was estimated to be 173.69 mg/l for Daphnia magna for 48 hrs duration.

Similarly prediction by EPI suite, ECOSAR version 1.1, on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program suggest the LC 50 value for short term toxicity to aquatic invertebrates was predicted. On the basis of EPI suite, ECOSAR version 1.1, the LC 50 value for short term toxicity to aquatic invertebrates was predicted to be 5083.027 mg/l for 1,3-thiazolidine-2,4-dione i.e 2,4-Thiazolidinedione in 48 hrs.

Above both predicted results of target assist by experimental result of read across chemical 2methyl 6,8-dideoxy-6-[(1-methyl-4-propyl-L-prolyl)amino]-1-thio-D-erythro-alpha-D-galacto-octopyranoside i.e Lincomycin (Cas no. 154-21-2) which suggest From peer reviewed journal- Ecotoxicology (2010) 19:662–669 an acute toxicity test was mentioned which indicate the acute lethal toxicity of Lincomycin (Cas no. 154-21-2) on freshwater invertebrate Daphnia magna for exposure period 48 hrs. Culture and maintenance of D. magna was performed at 20 ± 1 deg.C in 7-liter glass jars containing moderately hard water. White fluorescent light (12.1 lmol/m2/s) was provided to Daphnia during the culture and maintenance with 16:8 h light: dark photoperiod. Daphnia were fed with YCT (1:1:1 mixture of Yeast: Ceropyl: Tetramin) and algae (Selenastrum capricornutum). Three pH conditions of 7.4, 8.3 and 9.2 were chosen for experiment. And Data analysis has done by modified US EPA Probit analysis, the Spearman–Karber method, or the trimmed Spearman–Karber method. Thus based on the pH effect the Effective concentration to 50% (EC50) on test organism Daphnia magna was observed to be >500 mg/l.

One another read across 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-ethylsulfonyl-2-pyridylsulfonyl)urea (Cas no. 122931-48-0) from authorative database i.e ECOTOX database indicate Short term toxicity to aquatic invertebrates was performed in Daphnia magna (Water Flea) for 48 hrs with <24 hrs age. Test in fresh water media with static condition. During the experiment, the EC 50 value for 1-(4,6-dimethoxypyrimidin-2-yl)-3-(3-ethylsulfonyl-2-pyridylsulfonyl)urea i.e Rimsulfuron (Cas no.122931-48-0) was determined to be 360 mg/l on the basis of intoxication.

Thus based on the all available effect concentrations which is in the range of 173.69 mg/l to 5083.027 mg/l of target and read across chemicals come to the conclusion that test substance 1,3-thiazolidine-2,4-dione i.e 2,4-Thiazolidinedione (Cas no. 2295-31-0) was likely to be non toxic to aquatic invertebrates as it not exceed the classification criteria, hence it can be considered to be not classified as per the CLP regulation.

Toxicity to aquatic algae and cyanobacteria

Two studies including predicted data from validated tools for short term toxicity to aquatic algae endpoint of test chemical 1, 3-thiazolidine-2, 4-dione i.e 2, 4-Thiazolidinedione (Cas no. 2295-31-0) were summarised as follows:

 

First data from prediction using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the six closest read across substances, which indicate the short term toxicity on aquatic algae and cyanobacteria was predicted for target substance 1, 3-thiazolidine-2, 4-dione i.e 2, 4-Thiazolidinedione (Cas no. 2295-31-0). EC50 value was estimated to be 110.96 mg/l for Pseudokirchneriella subcapitata for 72 h duration. Based on this value it can be concluded that the substance 1, 3-thiazolidine-2, 4-dione i.e 2, 4-Thiazolidinedione (Cas no. 2295-31-0) is considered to be non toxic to aquatic environment and can be considered to be not classified as per the CLP classification criteria.

 

Similarly prediction by EPI suite, ECOSAR version 1.1, on the basis of similarity of structure to chemicals for which the aquatic toxicity has been previously measured by structure-activity relationships (SARs) program suggest on the basis of effects observed in a static freshwater system, the effect concentration EC50 value for the substance is estimated to be 1576.864 mg/l for green algae for 96 h duration. Based on this value, it can be concluded that the test chemical 1, 3-thiazolidine-2, 4-dione i.e 2, 4-Thiazolidinedione (Cas no. 2295-31-0) can be considered as non-toxic to green algae at environmentally relevant concentrations and can be considered not-classified as per the CLP classification criteria.

Thus based on the both predicted effect concentrations which is in the range 110.96 mg/l to 1576.864 mg/l of target come to the conclusion that test substance 1, 3-thiazolidine-2, 4-dione i.e 2, 4-Thiazolidinedione (Cas no. 2295-31-0) was likely to be non toxic to aquatic algae as it not exceed the classification criteria of aquatic toxicity as per the CLP.

Toxicity to microorganisms

Antibacterial activity observed of test substance 1,3-thiazolidine-2,4-dione (Cas no.2295 -31 -0) in bacterial species Pseudomonas aeruginosa UFPEDA 39 strain,Escherichia coli UFPEDA 224 strain,Serratia marcescens UFPEDA 398 strain,Staphylococcus aureus UFPEDA 01 strain,Mycobacterium smegmatis UFPEDA 71 strain,Enterococcus faecalis UFPEDA 138 strain,Micrococcus luteus UFPEDA 06 strain,Bacillus subtilis UFPEDA 16 strain and fungal species Candida albicans UFPEDA 1007 strain at dose concentration 300 μg/disc.

Based on the experimental observation of antibacterial activity (MIC) the value of zone of inhibition is < 7 mm.