Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate

PBT assessment

PBT assessment: overall result

Reference

Name:

Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate

Type of composition:

legal entity composition of the substance

State / form:

solid: bulk

Reference substance:

Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of Disodium 6 -hydroxy-5 -[(2 -methoxy-4 -sulphonato-m-tolyl)azo]naphthalene-2 -sulphonate for effects in the environment:

 

The chemical Disodium 6-hydroxy-5 -[(2 -methoxy-4 -sulphonato-m-tolyl)azo]naphthalene-2 -sulphonate (CAS no. 25956 -17 -6) is used as a color additive in various food products such as beverages, candy cereals, confections, desserts and ice cream etc.. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Disodium 6 -hydroxy-5 -[(2 -methoxy-4 -sulphonato-m-tolyl)azo]naphthalene-2 -sulphonate. The PBT criterion was herein assessed based on experimental data in conjunction with standardized environmental fate models. Here follows a description of the PBT assessment.

 

Persistence assessment

The tested substance fulfil the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

In a prediction done by using the Estimation Programs Interface Suite (EPI suite, 2018), the biodegradation potential of the test compound Disodium 6 -hydroxy-5 -[(2 -methoxy-4 -sulphonato-m-tolyl)azo]naphthalene-2 -sulphonate (CAS no. 25956 -17 -6) in the presence of mixed populations of environmental microorganisms was estimated. The biodegradability of the substance was calculated using seven different models such as Linear Model, Non-Linear Model, Ultimate Biodegradation Timeframe, Primary Biodegradation Timeframe, MITI Linear Model, MITI Non-Linear Model and Anaerobic Model (called as Biowin 1-7, respectively) of the BIOWIN v4.10 software. The results indicate that chemical Disodium 6 -hydroxy-5 -[(2 -methoxy-4 -sulphonato-m-tolyl)azo]naphthalene-2 -sulphonate is expected to be not readily biodegradable.

 

Experimental results from the read across substances also indicate that they are not readily biodegradable.

 

Thus, based on the available information, it indicates that chemical Disodium 6 -hydroxy-5 -[(2 -methoxy-4 -sulphonato-m-tolyl)azo]naphthalene-2 -sulphonate can be expected to be not readily biodegradable in water and thus likely to be persistent (P) in nature.

 

Bioaccumulation assessment

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

 

Theoctanol water partition coefficient of the test chemical was evaluated to be ranges from -1.28 to -0.55, respectively, which is less than the threshold of 4.5.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 of the available short-term eco-toxicity data for fish, invertebrates and algae for the substance Disodium 6 -hydroxy-5 -[(2 -methoxy-4 -sulphonato-m-tolyl)azo]naphthalene-2 -sulphonate indicates the LC50/EC50 value was determined to be ranges from >100 to 149.94 mg/l. These value suggest that the substance is not likely to be hazardous to Aquatic organisms at environmentally relevant concentrations and can be considered to be ‘not classified’ as per the CLP regulation.

 

There are no available long-term toxicity evaluations for chemical Disodium 6 -hydroxy-5 -[(2 -methoxy-4 -sulphonato-m-tolyl)azo]naphthalene-2 -sulphonate. By speculation, long-term NOEC for aquatic organisms were not expected for the substance at concentration below 0.01 mg/L based on the data mentioned above.

 

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 fulfils the P criterion but does not fulfil the B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.