Phenethyl butyrate

PBT assessment

PBT assessment: overall result

Reference

Name:

phenethyl butyrate

Type of composition:

boundary composition of the substance

State / form:

liquid

Reference substance:

phenethyl butyrate

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of Phenethyl butyrate for effects in the environment:

 

The chemical Phenethyl butyrate (CAS no. 103-52-6) is used as a flavouring agent in foods and as a fragrances in cosmetics, shampoos, other toiletries etc. It is also used in non-cosmetic products such as household cleaners and detergents. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Phenethyl butyrate. 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

In a prediction using the Estimation Programs Interface Suite (2018), the biodegradation potential of the test chemical 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 test chemical is expected to be readily biodegradable.

 

Experimental results from the read across substances also indicate that they are readily biodegradable.

 

Thus, based on the available information, it indicates that chemical Phenethyl butyrate can be considered to be readily biodegradable in water and thus likely to be not persistent (not P) in nature.

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to 73%). In soil,Phenethyl butyrate was expected to have slow mobility based upon a Log KOC value of 2.99 at 25°C. The half-life in soil (30 days estimated by EPI suite) indicates that the chemical is not persistent in soil and the exposure risk to soil dwelling animals is moderate to low.

 

If released in to the environment, 24.3% of the chemical will partition into water according to the Mackay fugacity model level III in EPI suite version 4.1 (2017). However, the half-life (15 days estimated by EPI suite) indicates that the chemical is not persistent in water and the exposure risk to aquatic animals is moderate to low.

 

Moreover, its persistent characteristic is only observed in the sediment compartment but Fugacity modelling shows that sediment is not an important environmental fate (less than 1% i.e reported as 0.654% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that chemical Phenethyl butyrate is 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 102.8 L/Kg and theoctanol water partition coefficient of the test chemical was determined to be ranges from 2.489 to 3.55, 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, aq. invertebrates and algae for the substance Phenethyl butyrate indicates the LC50/EC50 value to be in the range 3.31 – 47.4 mg/L. These value suggest that the substance is likely to be hazardous to aquatic organisms. Since the chemical Phenethyl butyrate is readily biodegradable in water, test chemical can be considered as not hazardous to aquatic organismsat 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 Phenethyl butyrate. 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.