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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 Calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate for effects in the environment:

 

The chemicalCalcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate(CAS no. 5281-04-9) is usedas a hair dyeing agent in cosmetics.  It is used to dye paint, ink, color paint and watercoloretc.Also used for coloring rubber, plastic cords, and household chemical products. It is mainly used in PVC, RUB, PE and powder coating.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled forCalcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate. 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 fulfils the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

Biodegradation study was conducted for 28 days for evaluating the percentage biodegradability of test substance calcium 3 -hydroxy-4 -[(4 -methyl-2 -sulfonatophenyl)diazenyl]-2 -naphthoate (CAS no. 5281 -04 -9). The study was performed according to OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I) under aerobic conditions. Activated sludge (non-adapted) was used as a test inoculums for the study. Concentration of inoculum i.e, sludge used was 30 mg/l and initial test substance conc. used in the study was 100 mg/l, respectively. The percentage degradation of test substance calcium 3 -hydroxy-4 -[(4 -methyl-2 -sulfonatophenyl)diazenyl]-2 -naphthoate was determined to be 10 and 0% by BOD and HPLC parameter in 28 days. Thus, based on percentage degradation, calcium 3 -hydroxy-4 -[(4 -methyl-2 -sulfonatophenyl)diazenyl]-2 -naphthoate is considered to be not readily biodegradable in nature.

 

Estimation Programs Interface Suite was run to predict the biodegradation potential of the test compound Calcium 3 -hydroxy-4 -[(4 -methyl-2 -sulfonatophenyl)diazenyl]-2 -naphthoate (CAS no. 5281 -04 -9) in the presence of mixed populations of environmental microorganisms. 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 Calcium 3 -hydroxy-4 -[(4 -methyl-2 -sulfonatophenyl) diazenyl]-2 -naphthoate is expected to be not readily biodegradable.

 

Experimental results from the read across substances (CAS no: 3567-66-6 and 4430-18-6) also indicate that they are not readily biodegradable.

 

Hence it has been concluded thatchemicalCalcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoateis likely to be 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 BCF value from authoritative database was determined to be ranges from 0.7 to 8.51, respectively and theoctanol water partition coefficient of the test chemical was determined to be range from 2.4 to 3.44, 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 fulfilthe Tcriterion 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 indicates the LC50/EC50 value to be in the range 33 to 280 mg/L, respectively. These value suggest that the substance is likely to be hazardous to Aquatic organisms at environmentally relevant concentrations and can be considered to be classified in ‘Aquatic Chronic Category 3’ as per the CLP regulation.

 

There are available long-term toxicity evaluations for invertebrates for the test chemical Calcium 3-hydroxy-4-[(4-methyl-2-sulfonatophenyl)diazenyl]-2-naphthoate. The long term EC50 & LC50 value was determined to be 9.1 and 9.7 mg/l, respectively

 

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.