Phenethyl phenylacetate

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of Phenethyl phenylacetate for effects in the environment:

 

The chemical Phenethyl phenylacetate (CAS no. 102-20-5) is used in perfumes and cosmetics. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Phenethyl phenylacetate. 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 Manometric respirometry test following the OECD guideline 301F to determine the ready biodegradability of the test chemical (Experimental study report, 2015). The study was performed at a temperature of 20± 1°C. Mixture of domestic waste water, surface soil and soil samples was used as a test inoculum for the study. OECD mineral medium was used for the study. 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 100 mg/L, while that of inoculum was 10 ml/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 % degradation of procedure control (reference substance) was also calculated using BOD & ThOD and was determined to be 227.4%. The DO depletion (mg O2/l) in control on 28th day is 19.1 mg O2/l which fullfills the control validity criteria (i.e., The DO depletion of the inoculum blank is normally 20-30 mg O2/l and should not be greater than 60 mg/l in 28 days). Degradation of Sodium acetate exceeds 168.29% after 7 days and 212.76 % after 14 days. The activity of the inoculum is thus verified and the test is considered as valid.The BOD28 value of test chemical was observed to be 0.814 mgO2/mg. ThOD was calculated as 2.53 mgO2/mg. Accordingly, the % degradation of the test item after 28 days of incubation at 20 ± 1°C according to manometric respirometry test was determined to be 32.17%.Based on the results, the test item, under the test conditions, was considered to be inherently biodegradable at 20 ± 1°C over a period of 28 days. 

 

On the basis of above results for test chemical Phenethyl phenylacetate, it can be concluded that the test chemical was considered to be inherently biodegradable in nature 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 estimated BCF value from authoritative database was evaluated to be ranges from 309.6 to 746.06, respectively and the octanol water partition coefficient of the test chemical was determined to 3.827 at 25°C as per the OECD TG 117, 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 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 and algae for the substance Phenethyl phenylacetate (CAS no. 102-20-5) indicates the LC50/EC50 value to be in the range 7.4 to 15.55 mg/L, respectively and on the basis of the of the available short-term eco-toxicity data for aq. invertebrates of the structurally and functionally similar read across chemical and applying the weight of evidence approach, for the substance Phenethyl phenylacetate (CAS no. 102-20-5) indicates the LC50/EC50 value to be in the range 16.6 to 60.7 mg/L, respectively.

 

Further, on the basis of the of the available long-term eco-toxicity data for fish and aq. invertebrates of the structurally and functionally similar read across chemical and applying the weight of evidence approach, for the substance Phenethyl phenylacetate (CAS no. 102-20-5) indicates 28/30 d NOEC value as >0.154 to <0.92 mg/l (for fish) and >0.17 to <0.519 mg/l (for aq. invertebrates), respectively. These value suggest that the substance is likely to be hazardous to aquatic organisms at environmentally relevant concentrations and hence, considered to be classified in ‘aquatic chronic category 2’ as per the CLP regulation.

 

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.