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PBT assessment

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PBT assessment: overall result

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

Classification of 1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline for effects in the environment:

 

The chemical 1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline (CAS no. 8003-22-3) is used as an inert ingredient in non-food pesticide products. Also used in spirit lacquers, polystyrenes, polyamides, polycarbonates, acrylic resins, colored smokes, externally applied drugs and cosmetics, and occasionally in hydrocarbon solvents. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline. 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

28-days Manometric respirometry test following the OECD guideline 301F to determine the ready biodegradability of the test item1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline(CAS No. 8003-22-3). The test system included control, test item and reference item. The concentration of test and reference item (Sodium Benzoate) chosen for both the study was 100mg/L, while that of inoculum was 10ml/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 of1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline(CAS No. 8003-22-3) was observed to be 0.0363 mgO2/mg. ThOD was calculated as 2.225mgO2/mg. Accordingly, the % degradation of the test item after 28 days of incubation at 20 ± 1°C according to manometric respirometry test was found to be 1.63%. Based on the results, the test item, under the test conditions, was found to be non-biodegradable at 20 ± 1°C over a period of 28 days. 

 

In a prediction using the Estimation Programs Interface Suite, the biodegradation potential of the test compound chemical,3-Isobenzofurandione, reaction products with methylquinoline and quinoline(CAS No. 8003-22-3) 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,n3-Isobenzofurandione, reaction products with methylquinoline and quinoline(CAS No. 8003-22-3) is expected to be not readily biodegradable

                                                                 

Hence, it has been concluded thatchemical 3-Isobenzofurandione, reaction products with methylquinoline and quinoloneis 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:

 

The estimated BCF value from authoritative databases was determined to be61.25 L/Kg and the octanol water partition coefficient of the test chemical was determined to be ranges from 3.55 to 4.1, 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 substance1,3-Isobenzofurandione, reaction products with methylquinoline and quinolineindicates the LC50/EC50 value to be > 5.438 mg/L, respectively.

 

There are no available long-term toxicity evaluations for the test chemical1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline. 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.