Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine

PBT assessment

PBT assessment: overall result

Reference

Name:

bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine

Type of composition:

boundary composition of the substance

State / form:

solid: bulk

Reference substance:

bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of 4-(1,1,3,3-tetramethylbutyl)-N-[4-(1,1,3,3-tetramethylbutyl)phenyl]anilinefor effects in the environment:

 

The chemical 4-(1,1,3,3-tetramethylbutyl)-N-[4-(1,1,3,3-tetramethylbutyl)phenyl]aniline (CAS no. 15721-78-5) is used as an antioxidant.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 4-(1,1,3,3-tetramethylbutyl)-N-[4-(1,1,3,3-tetramethylbutyl)phenyl]aniline. 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 fulfils the P criterion within Annex XIII based on the assessment that here follows:

 

Biotic degradation

In a prediction done by using the Estimation Programs Interface Suite (2018) was run to predict the biodegradation potential of the test chemical 4 -(1,1,3,3 -tetramethylbutyl)-N-[4 -(1,1,3,3 -tetramethylbutyl)phenyl]aniline(CAS no. 15721 -78 -5)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 chemical 4 -(1,1,3,3 -tetramethylbutyl)-N-[4 -(1,1,3,3 -tetramethylbutyl)phenyl]anilineis expected to be not readily biodegradable.

 

Experimental results from the read across substances also indicate that they are not readily biodegradable.

 

Thus, based on the available information, it indicates that chemical 4-(1,1,3,3-tetramethylbutyl)-N-[4-(1,1,3,3-tetramethylbutyl)phenyl]aniline can be expected to be not readily biodegradable in water and thus likely to be persistent (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 93.1%). In soil, 4 -(1,1,3,3 -tetramethylbutyl)-N-[4 -(1,1,3,3 -tetramethylbutyl)phenyl]anilinewas expected to have negligible mobility based upon a Log KOC value ranging from 4.55 to 6.7, respectively. The half-life in soil (360 days estimated by EPI suite) indicates that the chemical is very persistent in soil and the exposure risk to soil dwelling animals is moderate to high.

 

If released in to the environment, 6.32% 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 (180 days estimated by EPI suite) indicates that the substance is persistent in water andthe exposure risk to aquatic animals is moderate to high.

 

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 0.581% when estimated by EPI Suite version 4.1).

 

Although the half-life value indicates that the chemical to be Very Persistent (vP), since only predicted data is available for the substance, it has been concluded that 4 -(1,1,3,3 -tetramethylbutyl)-N-[4 -(1,1,3,3 -tetramethylbutyl)phenyl]aniline is considered to be persistent (P) in nature.

 

 

Bioaccumulation assessment

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

 

The estimated BCF value from modelling databases was evaluated to beranges from 6140 to 1000000, respectively and the octanol water partition coefficient of the test chemical was estimated to be 10.82,which is greater than the threshold of 4.5. If this chemical is released into the aquatic environment, there should be a high risk for the chemical to bioaccumulate in fish and food chains.

 

Although the BCF value indicate the chemical to be Very Bioaccumulative (vB), since only predicted data is available for the substance, it has been concluded that 4 -(1,1,3,3 -tetramethylbutyl)-N-[4 -(1,1,3,3 -tetramethylbutyl)phenyl]aniline is considered to be bioaccumulative (B) infish 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

As per Column 2 (Annex VIII) of the REACH regulation,testing for this end point is considered scientifically unjustified since there are mitigating factors indicating that aquatic toxicity is unlikely to occur as the substance 4-(1,1,3,3-tetramethylbutyl)-N-[4-(1,1,3,3-tetramethylbutyl)phenyl]aniline is highly insoluble in water (solubility: < 0.052 mg/L at 38° C). 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 P and B criterion but does not fulfil the T criterion and has therefore not been classified as a PBT compound within Annex XIII.