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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 Hydratropaldehyde for effects in the environment

In determining the classification appropriate to Hydratropaldehyde, 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

Available data indicates that Hydratropaldehyde is not persistent in the aquatic and soil environment. Moreover, its persistent characteristics is only observed in the sediment compartment. In addition, the substance is predicted to be readily biodegradable. Hence it has been concluded that Hydratropaldehyde is not persistent in nature.  

 

Thus, Hydratropaldehyde is classified as a not persistent chemical. 

 

Potential to accumulate

The estimated log Kow values for Hydratropaldehyde is less than 4 (Log Kow = 1.96). The potential for Hydratropaldehyde to bioaccumulate in the tissues of organisms that inhabit aquatic or terrestrial matrices is negligible as the reported BCF value for the substance is less than 2000.  

 

The estimated BCF of Hydratropaldehyde is highest 18.03 dimensionless and below the threshold of 2000. 

 

Thus, Hydratropaldehyde does not satisfy the criterion for classification as bioaccumulative (B).

Toxicity

The lowest toxicity values of fish, invertebrates and algae are reported as LC50 = 8.052 mg/L, EC50 = 1.4 mg/L (24 hrs) and EC50 = 20.04 mg/L, respectively. These values suggest classification for aquatic toxicity in the Aquatic Chronic 2 category. But the BCF value of Hydratropaldehyde reported was not >= 500 as well as the substance was found to be rapidly degradable.(Does not fullfill CLP criteria for toxic classification).Thus considering the CLP Criteria for aquatic classification of the substance , it is concluded that Hydratropaldehyde is non hazardous to the aquatic environment.

In addition to aquatic toxicity, the substance, Hydratropaldehyde, 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, Hydratropaldehyde does not meet the criterion for classification as toxic (T).

 

Thus, in accordance with the requirements of Annex XIII; it can be inferred that Hydratropaldehyde is a not a PBT (including vPvB) substance.