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PBT assessment

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PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Classification of Phenethyl salicylate for effects in the environment:

 

The chemical Phenethyl salicylate (CAS no. 87-22-9) is used as a flavour and fragrance agent. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Phenethyl salicylate. 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

The ready biodegradability ofPhenethyl salicylate(CAS no. 87 -22 -9) was determined by the OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test). Fresh activated sludge from a biological waste water treatment plant treating predominantly domestic sewage was used. The sludge is collected in the morning, washed three times in the mineral medium (by centrifuging at 1000 g for 10 minutes, discarding the supernant and resuspending in mineral medium) and kept aerobic until being used on the same day. Initial test substance concentration used in the study was 100 mg/l. Mineral medium was prepared by mixing 50 ml of solution A and 2000 ml deionised water, adding 5 ml of each of the solutions B, C and D and making up to 5 litres with deionised water. The pH is measured and if necessary adjusted to 7.4 +/- 0.2 with phosphoric acid or potassium hydroxide. The water used during this study is deionised water containing less than 10 mg/l dissolved organic carbon. Suspended solids concentration used in the study was 3.289 g/l. To obtain a concentration of inoculum of 30 mg/l (dry weight) in a 250 ml flask, 2.28 ml of sludge is needed (inoculum). Sodium benzoate (100 mg/l) (purity min. 99.0%) was used as a reference substance for the study. Degradation of sodium benzoate exceeded 40% after 7 days and 65% after 14 days, the activity of the inoculum was thus verified and the test is considered as valid.Phenethyl salicylateundergoes 93% biodegradation after 28 days in the test conditions. Biodegradation starts on day 3 and reached 80% at the end of the 10-day window (day 3 to 13). The curves obtained with the reference substance alone and withPhenethyl salicylateplus reference substance show no toxic effect ofPhenethyl salicylateto the micro-organisms at the test concentration (100 mg/l). Thus,Phenethyl salicylateshould be regarded as readily biodegradable according to this test.

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to 73.0%). In soil, Phenethyl salicylate was expected to have negligible to slow mobility based upon an experimental LogKOC in the range 0.5 – 3.8. Thehalf-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, 22.1% 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 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 5% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that Phenethyl salicylate is not persistent 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 determined to be in the range 1 - 1560. 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 estimations for invertebrates and algae for the substance indicates the LC50/EC50 value to be in the range 1.2 - 4.91 mg/L. These value suggest that the substance is likely to be hazardous to Aquatic organisms at environmentally relevant concentrations and can be considered as classified in Aquatic chronic category 2 as per the CLP regulation

 

There are no available long-term toxicity evaluations for Phenethyl salicylate. 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.