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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

Classification of disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate for effects in the environment

In determining the classification appropriate to disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate, 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. The PBT assessment were based on toxicological information in conjunction with standardized environmental fate- and bioaccumulation models. These points are considered below. 

 

Persistence assessment

Available data indicates that disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate is not persistent in the aquatic and soil environment. Moreover, its persistent characteristic is only observed in the sediment compartment and Fugacity modelling shows that sediment is an important environmental fate (51.8% when estimated by EPI Suite version 4.1). Hence it has been concluded that disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate is persistent in nature.  

Thus, disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate is classified as a persistent chemical (P) but not very persistent (not vP) since only estimated half-life values for the same are available. 

Bioaccumulation assessment

The estimated highest reported BCF value of 75 L/kg wet wt. is lower than the threshold of 2000. The mean log Kow was also below the threshold value of 4.5 (Log Kow = -1). Thus it is concluded that disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate is not expected to bioaccumulate in the food chain

Thus, disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate does not satisfies the criterion for classification as bioaccumulative (B/ vB)

Toxicity assessment

The toxicity values of fish, invertebrates and algae are LC50 = 3000 and 1372-5000 mg/L, EC50 = 337; 377 and 165 mg/L and LC 50 = 209.24 and 108 mg/L, respectively. Also, the LC0 values of fish is > 0.01 mg/L (3000 mg/L). These values suggest classification for aquatic toxicity will not be applicable for all of the tropic levels and the substance can be considered as not toxic for marine/ freshwater organisms as per the criteria set out in Annex XIII.

In addition to aquatic toxicity, the substance, disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate, is not classified as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to CLP (Regulation (EC) No 1272/2008) and there is no evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure) according to Regulation (EC) No 1272/2008.

Thus, disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate does not meet the Annex XIII criterion for classification as toxic (T).

 

Thus, in accordance with the requirements of Annex XIII; it can be inferred that disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate is a not a PBT (including vPvB) substance