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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate
Type of composition:
boundary composition of the substance
State / form:
solid: bulk
Reference substance:
disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoatefor effects in the environment:

 

The chemical Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate (CAS no. 17372-87-1) is used as an analytical reagent in fluorimetry. It is used as a biological stain and as a dye in inks, cosmetics (lipstick) and textiles, etc. Also used as an intermediate in the production of red inks and toners. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate.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

Although two studies, one study results from peer reviewed journal indicate the chemical Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate to be not readily biodegradable which was not performed as per the standard guideline and in other study, duration of the study was very less (i.e, 1 day), so considering the another experimental study result of the test chemicalDisodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoatefrom study report (K1) performed as per the standard OECD Guideline 301 D (Ready Biodegradability: Closed Bottle Test), it indicates that chemical Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate can be considered to be readily biodegradable in water and thus likely to be not persistent (not P) 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 of the test chemical was evaluated to be ranges from -1.68 to -1.33, 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 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate indicates the LC50/EC50 value to be in the range 51.3 to 2700 mg/L, respectively. These value suggest that the substance is likely to be hazardous to aquatic organisms at environmentally relevant concentrations. Since the test chemical is readily biodegradable in nature, chemical Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate 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 Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate. 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 does not fulfil the P, B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.