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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Classification of aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex for effects in the environment

Several major guideline – estimation values (Klimisch 2) are available for aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex, indicates no toxic effect on fish and any other tropic levels.  Thus, the value which have been considered for further calculation (fish) is LC50 = 240.5083 mg/L.

 

In determining the classification appropriate to aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex , it is necessary to consider all available evidence concerning its persistence, potential to accumulate and predicted or observed environmental fate and behavior 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 aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex is persistent in nature and so is considered to have negligible biodegradation in the environment. In other words aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex degradation may therefore be expected to be slow. Thus it can be inferred that aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex is persistent in character. 

 

Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex is persistent and so satisfies the criteria for classification as persistent (P). 

 

Potential to accumulate

Measured log Kow values for aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex is less than 4 (log Kow = 1.1486). The potential for aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex 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 aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex is 3.162 dimensionless and below the threshold of 2000. 

 

Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex does not satisfy the criterion for classification as bioaccumulative (B).

 

The toxicity values of fish, invertebrates and algae are LC50 = 240.5083mg/L, LC50= 145.8254mg/L and NOEC = 5.644174mg/L, respectively. The end point result values indicate that the substance will not have any toxic effect as the values are beyond the classifying range. So, the substance will not qualify for classification as per the CLP regulation. 

So, aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex does not satisfy the environmental effects criterion for classification as toxic (T).

 

Thus it can be inferred that aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex neither is B & T substance, but will qualify as P. So, as per the Annex XIII of the REACH Regulation the substance in general will be considered as not PBT.