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PBT assessment

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PBT assessment: overall result

Reference
Name:
sulisobenzone
Type of composition:
boundary composition of the substance
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Classification ofSulisobenzone for effects in the environment:

 

The chemical Sulisobenzone (CAS no. 4065-45-6) is used as an ultraviolet absorber for leather and textiles, and ultraviolet screen for humans. Also used in cosmetics and shampoos etc. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Sulisobenzone. 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

On the basis of various experimental results from study reports and peer reviewed journal of biodegradation studies for the test chemicalSulisobenzone (CAS no. 4065-45-6), it indicates thatchemical Sulisobenzonewas 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 80.4%). In soil, Sulisobenzonewas expected to have rapid to moderate mobility based upon a Log KOC value ranging from 0.992 to 1.826, respectively. The half-life in soil (75 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, 19.5% 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 (37.5 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 0.0997% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded thatchemicalSulisobenzone 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:

 

The estimated BCF value from authoritative and modelling databases was evaluated to be ranges from 3 to 4.29, respectivelyand the octanol water partition coefficient of the test chemical was determined to be 0.515 at 25°C, 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, invertebrates and algae for the substance Sulisobenzone indicates the LC50/EC50 value was determined to be ranges from 25 to < 464 mg/l. These value suggest that the substance is likely to be hazardous to aquatic organisms at environmentally relevant concentrations. Since, the test chemical is readily biodegradable in water, chemical can be considered as non-toxic to aquatic organisms and thus considered to be ‘not classified’ as per the CLP regulation.

 

On the basis ofthe experimental study oflong term eco-toxicity data for fish and aq. invertebrates, the NOEC value was determined to be ranges from 0.128 to 5 mg/l, respectively. Thus, long-term NOEC for aquatic organisms were not expected for the substance at concentration below 0.01 mg/l.

 

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.