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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 (5or8)-aminonaphthalene-2-sulphonic acid for effects in the environment:

 

The aim of the PBT assessment of (5or8)-aminonaphthalene-2-sulphonic acid (CAS no. 51548-48-2) was to evaluate whether this chemical fulfils the PBT criterion within Annex XIII. The PBT assessment were based on toxicological information in conjunction with standardized environmental fate- and bioaccumulation models. Here follows a description of the PBT assessment.

 

 

Persistence assessment

The tested substance does not fulfil the P criterion within Annex XIII based on the assessment that here follows:

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to 84.9%). The Soil Adsorption Coefficient i.e Koc value of (5or8)-aminonaphthalene-2-sulphonic acid was estimated as Koc -173.6 L/kg (log Koc=2.239) by means of MCI method at 25 deg.C. This Koc value indicates that the substance (5or8)-aminonaphthalene-2-sulphonic acid has low sorption to soil and sediment and therefore have moderate migration potential to groundwater. In addition, the half-life in soil (75 days estimated by EPI suite) indicates that the chemical is not persistent in soil and hence, the exposure risk to soil dwelling animals is low.

 

If released in to the environment, 14.9 % of the chemical will partition into water according to the Mackay fugacity model level III in EPI suite version 4.1 (2016). However, the half-life (37.5 days estimated by EPI suite) indicates that the exposure risk to aquatic animals is moderate to low.

 

Moreover, its persistent characteristic is only observed in the sediment compartment but Fugacity modelling shows that sediment is not an important environmental fate (less than 1% when estimated by EPI Suite version 4.1). Hence it has been concluded that 5or8)-aminonaphthalene-2-sulphonic acid is not persistent in nature.  

 

 

Bioaccumulation assessment

The tested substance does not fulfil the B criterion within Annex XIII based on the assessment that here follows:

 

The octanol-water partition coefficient (Log Kow) is estimated as -0.906 at 25ºC (EPI suite version 4.1, 2016). If this chemical is released into the aquatic environment, there should be a low risk for the chemical to bioaccumulate in fish and food chains.

 

Toxicity assessment

The tested substance does not fulfil the T criterion within Annex XIII based on the assessment that here follows:

 

Mammals

The tested chemical is regarded to be not classified for carcinogenicity, mutagenicity and reprotoxicity, Further, there is no evidence of chronic toxicity, as identified by the classifications STOT (repeated exposure), category 1(oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume) or category 2 (oral, dermal, inhalation of gases/vapours, inhalation of dust/mist/fume).

 

Aquatic organisms

All available short-term eco-toxicity estimation for fish, invertebrates and algae for the substance indicates the LC50/EC50 value are above 100 mg/L indicating that the substance is classified as non-hazardous as per the CLP criteria.These values suggest classification for aquatic toxicity will not be applicable for all of the tropic levels.The chemical was therefore not considered as hazardous to aquatic environments as per the criteria set out in Annex XIII.

 

 

Conclusion

Based on critical, independent and collective evaluation of information summarized herein, the tested compound does not fulfil the P, B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.