Registration Dossier

Ecotoxicological information

Endpoint summary

Administrative data

Description of key information

Additional information

Aquatic Toxicity :

Short-term toxicity to Fish :

The lethal concentration (LC50) value of phthalylsulfathiazole in fish (Pimephales promelas) in a 96 hr study on mortality effect was estimated to be 26.87273mg/L. The supporting studies also predicted an LC50 value above 20 mg/L

 

Sr. No

Endpoint name

Value

Units

Species

1

LC50 26.87273 mg/l Pimephales promelas
 2  LC50  26.03736  mg/l  Oncorhynchus mykiss
 3  LC50  21.81385  mg/l  Lepomis macrochirus

 

But the BCF value of phthalylsulfathiazole reported was not >= 500 as well as the substance was found to be rapidly degradable.Thus considering only the value from CLP Criteria for aquatic classification of the substance , it is concluded that phthalylsulfathiazole could not exhibit short term toxicity to fish (Pimephales promelas)

Long-term toxicity to Fish :

According to column I of annex IX, Long-term toxicity testing on fish was considered for waiver as short term toxicity data has already been provided as part of Annex VIII requirements.

Short -term toxicity to Aquatic invertebrate :

The effective concentration (EC50) value of phthalylsulfathiazole in aquatic invertebrate (Daphnia Magna) in a 48 hr study based on intoxication effect was estimated to be 334.7654 mg/L. Thus considering the value from CLP Criteria for aquatic classification of the substance , it is concluded that phthalylsulfathiazole could not exhibit short term toxicity to aquatic invertebrate (Daphnia Magna)

But the supporting study shows value 19.05196mg/l , since the BCF value of the substance phthalylsulfathiazole was not >=500 and it is readily biodegradable, therefore it is concluded that phthalylsulfathiazole could not exhibit short term toxicity to aquatic invertebrate (Daphnia Magna)

Sr. No

Endpoint name

Value

Units

Species

1

EC50 334.7654 mg/l Daphnia Magna
 2  LC50  19.05196  mg/l  Daphnia Magna

 

Based on the above the endpoint values and considering the CLP Criteria for aquatic classification it can be concluded that the substance phthalylsulfathiazole could not exhibit short term toxicity to aquatic invertebrate (Daphnia Magna)

Long- term toxicity to Aquatic invertebrate :

The no observed effect concentration (NOEC) value of the compound phthalylsulfathiazole for a 504 hour study on Aquatic invertebrate (Daphnia Magna) based on the effect on reproduction was estimated to be 0.2292814 mg/L

Toxicity to aquatic algae and cynobacteria :

The no observed effect concentration (NOEC) value of phthalylsulfathiazole in green algae (Pseudokirchnerella subcapitata) in a 72 hr study on growth effect was estimated to be 2.589638 mg/L. But the BCF value of phthalylsulfathiazole reported was not >= 500 as well as the substance was found to be rapidly degradable.Thus considering the CLP Criteria for aquatic classification of the substance , it is concluded that phthalylsulfathiazole could not exhibit short term toxicity to green algae (Pseudokirchnerella subcapitata)

But the supporting studies shows value EC50 = 14.59537mg/l and EC50 = 19.3344mg/l ,since the BCF value of the substance phthalylsulfathiazole was not >=500 and it is readily biodegradable, therefore it is concluded that phthalylsulfathiazole could not exhibit short term toxicity to green algae (Pseudokirchnerella subcapitata)

Sr no

Endpoint Value Unit Species
 1  NOEC  2.589638  mg/l Pseudokirchnerella subcapitata
2  EC50  19.3344  mg/l Pseudokirchnerella subcapitata
 3  EC50  14.59537  mg/l  Pseudokirchnerella subcapitata

 

Based on the above the endpoint values and considering the CLP Criteria for aquatic classification it can be concluded that the substance phthalylsulfathiazole could not exhibit short term toxicity to aquatic algae (Pseudokirchnerella subcapitata)

Toxicity to microorganism :

The inhibition growth concentration (IGC50) value of phthalylsulfathiazole in microorganism (Tetrahymena pyriformis) for 48 hr study on the basis of effect on growth was estimated to be 25.10465 mg/L.

The supporting study shows Minimum Inhibitory Concentration of substance phthalylsulfathiazole on microorganism at dose concentration of <=250ug/ml

Sr no

Endpoint Value Unit Species
 1  IGC50  25.10465  mg/l Tetrahymena pyriformis
2 MIC  <=250  ug/ml Escherichia coli ATCC 25922, LM1-Escherichia coli, LM2-Escherichia coli, Pseudomonasaeruginosa ATCC 27853 LM-Staphylococcus aureus, Staphylococcus aureus methicillin-sensitive ATCC 29213 and Staphylococcus aureus methicillin-resistant ATCC 43300