1,4-bis[(4-butylphenyl)amino]-5,8-dihydroxyanthraquinone

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of 1,4-bis[(4-butylphenyl)amino]-5,8-dihydroxyanthraquinone for effects in the environment:

The chemical1,4-bis[(4-butylphenyl)amino]-5,8-dihydroxyanthraquinone(CAS no. 28198-05-2) is used as a dyestuff agent. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for1,4-bis[(4-butylphenyl)amino]-5,8-dihydroxyanthraquinone. 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 fullfil the P criterion within Annex XIII based on the assessment that here follows:

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is soil (i.e.estimated to 79.7%).Thehalf-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, 16.4% 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 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% when estimated by EPI Suite version 4.1).

 

Hence it has been concluded that1,4-bis[(4-butylphenyl)amino]-5,8-dihydroxyanthraquinoneis not persistent in nature.

 

 

Bioaccumulation: aquatic/sediment

The tested substance fulfils the B criterion within Annex XIII based on the assessment that here follows:

 

Theestimated BCF value from authoritative databases was determined to be in the range 940 - > 1000000 and theoctanol water partition coefficient of the test chemical is 12.23 which is more than the threshold of 4.5. If this chemical is released into the aquatic environment, there should be a moderate to high risk for the chemical to bioaccumulate in fish and food chains.

 

Although the BCF values indicate the chemical to be Very bioaccumulative (vB), since only predicted data is available for the substance, it has been concluded that1,4-bis[(4-butylphenyl)amino]-5,8-dihydroxyanthraquinoneis bioaccumulative (B) in nature.

 

Toxicity

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

As per Column 2 (Annex VIII) of the REACH regulation, a study does not need to be conducted if there are mitigating factors indicating that aquatic toxicity is unlikely to occur for instance if the substance is highly insoluble in water. The test substance was determined to be highly insoluble in water (solubility =0.00000000458 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 fulfils the B criterion but does not fulfil the P and T criterion and has therefore not been classified as a PBT compound within Annex XIII.