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 245.685mg/L. The supporting studies also predicted an LC50 value above 100 mg/L

Sr. No

Endpoint name

Value

Units

Species

1

LC50 245.685 mg/l Pimephales promelas
 2  LC50  152.0679  mg/l  Oncorhynchus mykiss
 3  LC50  147.8293  mg/l  Lepomis macrochirus

Therefore it can be concluded that the substance is not classified as per CLP criteria.

Short -term toxicity to Aquatic invertebrate :

The LC50 value of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid in aquatic invertebrate (Daphnia Magna) in a 48 hr study on mortality was estimated to be 718.3787 mg/L. No of studies reviewed for Short term toxicity to aquatic invertebrate and the results have been summarised below:

Sr. No

Endpoint name

Value

Units

Species

1

LC50 718.3787 mg/l Daphnia Magna
2 EC50  120.2614  mg/l Daphnia Magna
3  LC50  107.762  mg/l  Daphnia Magna
4  LC 50  284.638  mg/l  Daphnia Magna

 

Based on the above endpoint values of QSAR and supporting studies(ECOSAR) and considering the CLP Criteria for aquatic classification it can be concluded that the substance3-acetamido-5-amino-4-hydroxybenzene sulphonic acid does not exhibit short term toxicity to aquatic invertebrate (Daphnia Magna).Therefore it can be concluded that the substance is not classified.

Toxicity to aquatic algae and cynobacteria :

The effective concentration (EC50) value of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid in aquatic algae (Pseudokirchneriella subcapitata) in a 72 hr study based upon effect on growth was estimated to be 199.5558 mg/L. The summary of the results are presented below

 

Sr. No

Endpoint name

Value

Units

Species

1

EC 50 199.5558 mg/l Pseudokirchneriella subcapitata
 2  EC 50  179.126  mg/l  Green algae
 3  EC 50  380.534  mg/l  Green algae

 

Based on the above endpoint value of QSAR and supporting studies(ECOSAR) and considering the CLP Criteria for aquatic classification it can be concluded that the substance3-acetamido-5-amino-4-hydroxybenzene sulphonic acid do not exhibit short term toxicity to aquatic algae (Pseudokirchneriella subcapitata) .Therefore it can be concluded that the substance is not classified as per the CLP criteria.

Toxicity to microorganism :

Toxicity value(IG50 -46 h) of 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid to Tetrahymena pyriformis on the basis of growth inhibition is estimated as 309.9978 mg/L indicating that the substance do not have toxic effect on micro-organism.