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PBT assessment

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PBT assessment: overall result

Reference
Name:
β-bromostyrene
Type of composition:
legal entity composition of the substance
State / form:
solid: bulk
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of Beta-bromostyrene for effects in the environment:

 

The chemical Beta-bromostyrene (CAS no. 103-64-0) is used as a food additive and as a fragrance in soaps, detergents, creams, lotions and perfumes etc. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Beta-bromostyrene. 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

Although 2 studies (which is not performed as per the OECD test guideline and duration of the study is very less) from authoritative database and peer reviewed journal indicate that the chemicalBeta-bromostyreneis not readily biodegradable, but on the basis of detailed experimental study results from study report (K1 study) and as per the OECD test guideline for the test chemical Beta-bromostyrene (CAS no. 103-64-0), it indicates that chemical Beta-bromostyrene can be 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 78.6%). In soil,Benzyl isovaleratewas expected to have slow mobility based upon a Log KOC value of 3.263 ± 0.001 at 25°C. 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, 18.7% 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 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 1% i.e reported as 0.552% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that chemical Beta-bromostyrene is not persistent (not P) 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 ranges from 3 to 235, respectively and theoctanol water partition coefficient of the test chemical ranges from 3.15 to 3.391, respectively which is less than 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 available short-term eco-toxicity data for fish, aq. invertebrates and algae for the substanceBeta-bromostyreneindicates the LC50/EC50 value to be in the range 4.41 – 50.4 mg/L. These value suggest that the substance is likely to be hazardous to aquatic organisms. Since the chemical Beta-bromostyrene is readily biodegradable in water, test chemical can be considered as not hazardous to aquatic organismsat environmentally relevant concentrations and can be considered to be ‘not classified’ as per the CLP regulation.

 

There are no available long-term toxicity evaluations for Beta-bromostyrene. 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.