Registration Dossier

Administrative data

Hazard for aquatic organisms

Freshwater

Hazard assessment conclusion:
PNEC aqua (freshwater)
PNEC value:
0.191 mg/L
Assessment factor:
100
Extrapolation method:
assessment factor
PNEC freshwater (intermittent releases):
0.191 mg/L

Marine water

Hazard assessment conclusion:
PNEC aqua (marine water)
PNEC value:
0.019 mg/L
Assessment factor:
1 000
Extrapolation method:
assessment factor

STP

Hazard assessment conclusion:
PNEC STP
PNEC value:
2.51 mg/L
Assessment factor:
10
Extrapolation method:
assessment factor

Sediment (freshwater)

Hazard assessment conclusion:
PNEC sediment (freshwater)
PNEC value:
241.497 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Sediment (marine water)

Hazard assessment conclusion:
PNEC sediment (marine water)
PNEC value:
241.497 mg/kg sediment dw
Extrapolation method:
equilibrium partitioning method

Hazard for air

Air

Hazard assessment conclusion:
no hazard identified

Hazard for terrestrial organisms

Soil

Hazard assessment conclusion:
PNEC soil
PNEC value:
111.906 mg/kg soil dw
Extrapolation method:
equilibrium partitioning method

Hazard for predators

Secondary poisoning

Hazard assessment conclusion:
no potential for bioaccumulation

Additional information

Classification is triggered based on available data, according to REGULATION (EC) No 1272/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006.

Conclusion on classification

Classification of phthalylsulfathiazole for effects in the environment

Several major guideline – estimation values (Klimisch 2) are available for phthalylsulfathiazole, indicates slight toxic effect for all the 3 key trophic levels (fish, invertebrate and algae). Among the values lower values which lead to the classification of the substance the value which have been considered for further calculation (invertebrate) is LC50 = 19.051 mg/L.

 

In determining the classification appropriate to phthalylsulfathiazole, it is necessary to consider all available evidence concerning its persistence, potential to accumulate and predicted or observed environmental fate and behaviour that may present a long-term and/or delayed danger to the structure and/or functioning of aquatic ecosystems. These points are considered below.

 

Persistence

Reliable studies are available to demonstrate that phthalylsulfathiazole is non persistent in nature and so is considered to have rapid biodegradation in the environment. In other words phthalylsulfathiazole degradation may therefore be expected to be fast. Thus it can be inferred that phthalylsulfathiazole is non persistent in character. 

 

Phthalylsulfathiazole is non persistent and so do not satisfy the criteria for classification as persistent (P). 

 

Potential to accumulate

Predicted and measured log Kow values for phthalylsulfathiazole is less than 4 (Log Kow = -2). The potential for phthalylsulfathiazole to bioaccumulate in the tissues of organisms that inhabit aquatic or terrestrial matrices is negligible as the BCF factor for the substance is less than 1000.  

 

 The calculated BCF of phthalylsulfathiazole is 5.25 dimensionless and below the threshold of 2000. 

 

Phthalylsulfathiazole does not satisfy the criterion for classification as bioaccumulative (B).

 

The toxicity values of fish, invertebrates and algae are LC50 = 26.87273 mg/L, EC50 = 19.051 mg/L are EC50 = 19.3344 mg/L, respectively. The toxicity values of all the trophic levels fall in the criteria for classification (CLP regulation) and so will qualify for classification as per the aquatic CLP criteria for classification in category 3. 

So, phthalylsulfathiazole will satisfy for the environmental effects criterion for classification as toxic (T).

 

Thus it can be inferred that phthalylsulfathiazole is not P & B (including vPvB) substance, but will qualify as T.