1-phenylethanol

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of 1-phenylethanol for effects in the environment:

 

The chemical 1-phenylethanol (CAS no. 103-52-6) are for example used as a flavour and fragrance agent and also as an intermediate. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 1-phenylethanol. 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 an experimental key study from authoritative databases (HSDB and PubChem, 2017), biodegradation experiment was conducted for 20 days for evaluating the percentage biodegradability of test substance 1-phenylethan-1-ol (CAS no. 98-85-1). The study was performed under aerobic conditions. Activated sludge was used as a test inoculums for the study. Initial test substance conc. used in the study was 100 mg/l. The percentage degradation of test substance 1-phenylethan-1-ol was determined to be approx. 100% in 14 or 20 days, depending on the inoculum size (heavy or light, respectively). Acetophenone was obtained as the major metabolite. Thus, based on percentage degradation, 1-phenylethan-1-ol is considered to be readily biodegradable in nature.

 

In addition to the above, multiple supporting studies (including one OECD 301D study) indicate that the substance is readily biodegradable.

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to 68.1%). In soil, 1-phenylethanol was expected to have low mobility based upon a KOC of 112.72 (Log Koc: 2.05). 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.

 

If released in to the environment, 30.4 % of the chemical will partition into water according to the Mackay fugacity model level III in EPI suite version 4.1 (2016). 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 1% when estimated by EPI Suite version 4.1). Hence it has been concluded that 1-phenylethanol 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:

 

The BCF value of the substance is estimated as 9 and the experimental log octanol-water partition coefficient (log Kow) was determined to be 1.636. 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 estimation for fish, invertebrates and algae for the substance indicates the LC50/EC50 value to be >100 mg/L. These value suggest that the substance can be considered to be non-hazardous as per the CLP regulation.

Long-term toxicity evaluations for 1-phenylethanol are available. NOEC values for substance in a 28 day on fish is estimated as 26.48 mg/L. and it is 13.28 mg/L in a 21 day exposure on Daphnia.

Based on the above information, adverse effects at environmentally relevant concentrations in freshwater species were not expected for 1-phenylethanol in all 3 trophic levels.

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.