Phenethyl salicylate

PBT assessment

PBT assessment: overall result

Reference

Name:

phenethyl salicylate

Type of composition:

boundary composition of the substance

State / form:

solid: particulate/powder

Reference substance:

phenethyl salicylate

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of 2-phenylethyl 2-hydroxybenzoate for effects in the environment:

 

The chemical 2-phenylethyl 2-hydroxybenzoate (CAS no. 87-22-9) is used to as a flavouring agent in foods. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for2-phenylethyl 2-hydroxybenzoate. 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 of test chemical was determined in accordance with the OECD Guideline 301 F (Ready Biodegradability: Manometric Respirometry Test) (Experimental study report, 2000). 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. 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. Test chemical undergoes 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 with test chemical plus reference substance show no toxic effect of test chemical to the micro-organisms at the test concentration (100 mg/l). Thus, test chemical is considered as readily biodegradable.

 

Thus, based on the available information, it indicates that chemical 2 -phenylethyl 2 -hydroxybenzoate was 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 be 73%). In soil,2-phenylethyl 2-hydroxybenzoatewas expected to have negligible to slow mobility based upon a Log KOC value of 3.5 to 3.7 (at pH 7.0). 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, 22.1% of the chemical will partition into water according to the Mackay fugacity model level III in EPI suite version 4.1. 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 5% i.e reported as 4.02% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded thatchemicalSodium naphthalene-1-sulphonateis 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:

 

The estimated BCF value from authoritative databases was evaluated to bein the range of 1.95 to 1560, respectively and the octanol water partition coefficient of the test chemical from various reliable sources was evaluated to be in the range 4.26 to 4.5, respectively, which is close to 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 availablevarious experimental studies ofshort term eco-toxicity for fishof the structurally similar read across substance and applying the weight of evidence approach, the LC50 value was evaluated to be in the range of > 12.5 mg/l to 43 mg/L, respectively. On the basis of available data of2-phenylethyl 2-hydroxybenzoate(CAS no. 87-22-9) of short term toxicity of aquatic invertebrates and algae study, the EC50 value was evaluated to be 4.91 mg/l and 12.36 mg/l, respectively. These value suggest that the substance is likely to be hazardous to aquatic organisms. Since the test chemical is readily biodegradable in water, chemical2-phenylethyl 2-hydroxybenzoateis considered as not hazardous to aquatic organisms at environmentally relevant concentrations and hence, considered to be ‘Not classified’ as per the CLP regulation.

 

There are no available long-term toxicity evaluations forchemical 2-phenylethyl 2-hydroxybenzoate. 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.