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PBT assessment

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PBT assessment: overall result

Type of composition:
boundary composition of the substance
State / form:
solid: bulk
Reference substance:
PBT status:
the substance is not PBT / vPvB

Classification of12H-phthaloperin-12-onefor effects in the environment:


The chemical 12H-phthaloperin-12 -one (CAS no. 6925-69-5) is used as a dye. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 12H-phthaloperin-12-one. 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

42-days Closed Bottle test following the OECD guideline 301 D was performed to determine the ready biodegradability of the test chemical. The study was performed at a temperature of 20°C. The test system included control, test item and reference item. Polyseed were used for this study. 1 polyseed capsule were added in 500 ml D.I water and then stirred for 1 hour for proper mixing and functioning of inoculum. This gave the bacterial count as 10E7 to 10E8 CFU/ml. At the regular interval microbial plating was also performed on agar to confirm the vitality and CFU count of microorganism. The concentration of test and reference item (Sodium Benzoate) chosen for both the study was 4 mg/L, while that of inoculum was 32 ml/l. OECD mineral medium was used for the study. 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 % degradation of procedure control (reference item) was also calculated using BOD & ThOD and was determined to be 70.48%. Degradation of Sodium Benzoate exceeds 45.18 % on 7 days & 70.48 % on 14th day. The activity of the inoculum was thus verified and the test can be considered as valid. The BOD42 value of test chemical was observed to be 0.5 mgO2/mg. ThOD was calculated as 2.19 mgO2/mg. Accordingly, the % degradation of the test item after 42 days of incubation at 20 ± 1°C according to Closed Bottle test was determined to be 22.83%. Based on the results, the test item, under the test conditions, was considered to be primary inherently biodegradable in nature.


Thus, based on the above available information, it has been concluded 12H-phthaloperin-12-one is 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:


Theestimated BCF value from authoritative database was evaluated to be upto 381.57 dimensionless, respectively and theoctanol water partition coefficient of the test chemical was determined to be 3.966 ± 0.000 at 25°C as per OECD TG 117, 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:



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 invertebrates and algae as per OECD TG for the substance12H-phthaloperin-12-one,the LC50/EC50 value was determined to be 3.19 mg/l and > 2 mg/l, respectivelyand on the basis of the various experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach,the LC50/EC50 value for fishof the test chemicalcan be determined to be in the range 2.09 – 2.8 mg/L, respectively. These value suggest that the substance is likely to be hazardous to aquatic organisms at environmentally relevant concentrations. However the obtained median lethal/effective concentration is very much higher than the solubility of the test chemical. Thus considering water solubility and toxicity values test chemical can be categorised into not classified category.


On the basis ofthelong term eco-toxicity data for fish and aq. invertebrates, the NOEC value was determined to be 2.024 mg/l and 1.534 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.



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.