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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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

Classification of 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acidfor effects in the environment:

 

The chemical 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid(CAS no. 18472-87-2) isused as a adhesives and sealants, air care products, finger paints, fertilisers, fuels, inks and toners, laboratory chemicals, lubricants and greases, paper chemicals and dyes, perfumes and fragrances, pharmaceuticals, polishes and waxes, semiconductors, textile treatment products and dyes, washing & cleaning products and cosmetics and personal care products. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid(CAS no. 18472-87-2). 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 does not fulfil the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

28-days Closed Bottle test following the OECD guideline 301D to determine the ready biodegradability of the test item 3,4,5,6 -tetrachloro-2 -(1,4,5,8 -tetrabromo-6 -hydroxy-3 -oxoxanthen-9 -yl)benzoic acid (CAS No.18472 -87 -2). The test system included control, test item and reference item. The concentration of test and reference item (Sodium Benzoate) chosen for the study was 32mg/l and 32mg/l, while that of inoculum was 32ml/l. ThOD (Theoretical oxygen demand) of test and reference item was determined by calculation. % Degradation was calculated using the values of BOD and ThOD for test item and reference item. The BOD28value of3,4,5,6 -tetrachloro-2 -(1,4,5,8 -tetrabromo-6 -hydroxy-3 -oxoxanthen-9 -yl)benzoic acid (CAS No.18472 -87 -2) was observed to be 0.5mgO2/mg. ThOD was calculated as 0.675mgO2/mg. Accordingly, the % degradation of the test item after 28 days of incubation at 20 ± 1°C according to Closed Bottle test was found to be 74.07%. Based on the results, the test item, under the test conditions, was found to be readily biodegradable at 20 ± 1°C over a period of 28 days.

 

Bioaccumulation assessment

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

 

The estimated BCF value from authoritative databases was determined to be 802.7 and octanol water partition coefficient of the test chemical is 0.165 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. 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 fulfils 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 indicates the LC50/EC50 value to be in the range 97.7 to > 200 mg/L, respectively. Since the chemical is readily biodegradable, substance is likely to be not hazardous to Aquatic organisms at environmentally relevant concentrations and can be considered to be `Not classified` as per the CLP regulation.

 

On the basis of the available long-term toxicity evaluations for chemical 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid, the LOEC value was determined to be 1 mg/l. By speculation, long-term NOEC for aquatic organisms were expected for the substance at concentration below 0.01 mg/L based on the data mentioned above

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