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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

Reference
Name:
benzyl isobutyrate
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
benzyl isobutyrate
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of Benzyl isobutyrate (CAS no. 103-28-6) for effects in the environment:

The test chemical Benzyl isobutyrate (CAS no. 103-28-6) is used in ir care products, perfumes and fragrances, pharmaceuticals, polishes and waxes, washing & cleaning products and cosmetics and personal care products. The test chemical herein critically and independently evaluated for the PBT.

The aim was to assess whether the PBT criterion within Annex XIII was fulfilled forBenzyl isobutyrate. The PBT criterion was herein assessed based on experimental data in conjunction with standardized environmental fate models.

 

1. Persistence assessment

 

The tested substance doesn’t meet the P criterion within Annex XIII based on the assessment that here follows:

 

1.1.Overall degradability

 

All the biodegradable studies available for the target chemical Benzyl isobutyrate (CAS no. 103-28-6), conducted using the OECD 301 F guidelines states that the test chemical can undergo degradation up to 100% in the exposure period of 28 days, By which it is categorised into readily biodegradable chemical.

In conclusion, the chemical was estimated to be non-persistent in water, because of it biodegradable nature

1.2 Environmental fate and exposure risk

The test chemical 103-28-6 if released intentionally or un intentionally into the environmental media. It is predicted that the test chemical would mostly accumulate in the soil up to 72.3 % followed by water (25%) and sediment (0.361%).

 

Table 2:Summary of estimated half-life and Mackay Fugacity model (level III) in freshwater, sediment and soil by EPI suite version 4.1:

 

Medium

Predicted half-life

Mackay fugacity model level III

fresh- or estuarine water

15 days

25%

fresh- or estuarine sediment

135 days

0.361%

soil

30 days

72.3%

 

The test chemical, Benzyl isobutyrate was estimated to be readily biodegradable in nature, and it could be very persistence in soil. As the values obtained are predicted, thus it cannot be considered as persistent chemical.

 

2. Bioaccumulation assessment

 

The tested substance doesn’t meet the B criterion within Annex XIII based on the assessment that here follows:

I.             Section 4.7, of Partition coefficient was studied based on the OECD 117 guidelines. The Reverse Phase High Performance Liquid Chromatographic method has been applied to determine the log Kow. The Log Kow value of the test chemical Benzyl isobutyrate was obtained to be 2.99, at 25°C. On the basis of this value, test chemical Benzyl isobutyrate can be considered to have hydrophilic nature.

J.            Section 4.7, of Partition coefficient was studied based on the OECD 117 guidelines. The Reverse Phase High Performance Liquid Chromatographic method has been applied to determine the log Kow. The Log Kow value of the test chemical Benzyl isobutyrate was obtained to be 2.99, at 25°C. On the basis of this value, test chemical Benzyl isobutyrate can be considered to have hydrophilic nature.

K.            

By relying on the data, CAS 103-28-6 chemical cannot be classified into Bio accumulative category.

 

3.    Toxicity assessment

 

The tested substance doesn’t meet the T criterion within Annex XIII based on the assessment that here follows:

 

3.1. Mammals

 

The substance didn’t fulfil the criteria for the mammalian toxicity, neither CMR nor STOT RE as per ANNEX XIII of PBT classification.

 

3.2. Freshwater organisms

The effects of test chemical was studied on the aquatic ecosystem, by using the fish, daphnia and algae as the experimental model. The studies on the various aquatic species revealed that the toxic values of the test chemical was ranging from 5.92 to 146 mg/L. Though the test chemical has comparatively lower toxic values, due to its readily biodegradable in nature, the test chemical can be considered slightly hazardous in nature. By considering all the data available related to the ecotoxicity endpoints, it is expected that the test chemical is will not have NOEC value below 0.01mg/L.

It can be concluded that the test chemical cannot be toxic to the aquatic ecosystem. Thus, it can be classified as non-toxic chemical as per Annex XIII for PBT classification. 

 

Overall conclusion about Persistence, Bioaccumulation and Toxicity (PBT).

Based on critical, independent and collective evaluation of information summarized herein, the tested compound didn’t meet P,B and T criterion within Annex XIII. Hence, the tested compound has not been classified as a PBT compound within Annex XIII.