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PBT assessment

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PBT assessment: overall result

Reference
Name:
7-(diethylamino)-4-methyl-2-benzopyrone
Type of composition:
boundary composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of 7-(diethylamino)-4-methyl-2-benzopyrone for effects in the environment:

 

The chemical 7-(diethylamino)-4-methyl-2-benzopyrone (CAS no. 91-44-1) is used as an optical brightener. It is used in coatings (paper, labels and book covers), to dye textile fibers, plastics, inks etc.. Also used to make pigments for paints and lacquers. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 7-(diethylamino)-4-methyl-2-benzopyrone. 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 to determine the ready biodegradability of the test item. The study was performed at a temperature of 20°C. The test system included control, test item and reference item. Polyseed were used as inoculum at concentration 10E7 to 10E8 CFU/ml. The concentration of test and reference item (Sodium Benzoate) chosen for both the study was 4 mg/L, while that of inoculum was 32ml/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 72.28 %. Degradation of Sodium Benzoate exceeds 45.18 % on 7 days & 59.03% on 14th day. The activity of the inoculum was thus verified and the test can be considered as valid. The BOD42 value of 7-(diethylamino)-4-methyl-2-benzopyrone(CAS No.91-44-1) was observed to be 1.07 mgO2/mg. ThOD was determined by calculation as 2.28 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 46.92 %. Based on the results, the test item under the test conditions was considered to be ultimate inherently biodegradable in nature.

 

Thus, based on the available information, it indicates that chemical 7-(diethylamino)-4-methyl-2-benzopyrone is considered to be inherently biodegradable in water and thus likely to be not 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 and modelling databases was evaluated to be ranges from 1.53 to 244, respectivelyand the octanol water partition coefficient of the test chemical was evaluated to be ranges from 2.52 to 3.22,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 substance 7-(diethylamino)-4-methyl-2-benzopyrone (CAS no. 91 -44 -1) indicates the LC50/EC50 value was determined to be ranges from 10.56 to 17.5 mg/l. These value suggest that the substance is likely to be hazardous to Aquatic organisms at environmentally relevant concentrations and thus considered to be classified in ‘aquatic chronic category 3’ as per the CLP regulation.

 

There are no available long-term toxicity evaluations for chemical 7-(diethylamino)-4-methyl-2-benzopyrone. 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.