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Classification & Labelling & PBT assessment

PBT assessment

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PBT assessment: overall result

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

Classification of 3'-hydroxyacetophenone for effects in the environment:

 

The chemical3'-hydroxyacetophenone(CAS no. 121-71-1) is used as an intermediate in dyestuff applications and chemical synthesis as well as a laboratory chemical. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 3'-hydroxyacetophenone. 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 fate

Estimation Programs Interface Suite (EPI suite, 2016) was run to predict the biodegradation potential of the test compound 3'-Hydroxyacetophenone (CAS no. 121 -71 -1) in the presence of mixed populations of environmental microorganisms. 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 3'-Hydroxyacetophenone is expected to be readily biodegradable.

 

The information from various structurally similar read across substances also indicate that they are readily biodegradable 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 79%). In soil, 3'-hydroxyacetophenone was expected to have moderate mobility based upon a Log Koc of 1.82. 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 low.

 

If released in to the environment, 20.8 % 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, 3'-hydroxyacetophenone 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 3'-hydroxyacetophenone is estimated as 0.9978 L/kg (EPI Suite, 2016) and the partition coefficient of the substance is determined to be in range Log Kow 1.19-1.39. 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 and algae for the substance as well as its read-across substances indicates the LC50/EC50 value are above 100 mg/L indicating that the substance is classified as non-hazardous as per the CLP criteria.

The available short-term eco-toxicity estimation for invertebrates indicates the EC50 to be in the range 15 – 76.8 mg/L. these value suggest classification in Aquatic chronic 3 category but since the substance is readily biodegradable in nature, hence it was considered to be not classified as per the CLP regulation.

There are no available long-term toxicity evaluations for 3'-hydroxyacetophenone. NOEC values for the read-across substances in a 48-72 hour study on invertebrates and algae are reported as 17.1 to 51 mg/L

These values suggest classification for aquatic toxicity will not be applicable for all of the tropic 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.