Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Reference
Name:
9,10-Anthracenedione, 1,4-diamino-, N,N'-bis(4-C7-17-branched alkylphenyl) derivs.
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
Composition 1
PBT status:
the substance is not PBT / vPvB
Justification:

Classification of9,10-Anthracenedione, 1,4-diamino-, N,N'-bis(4-C7-17-branched alkylphenyl) derivs.for effects in the environment:

 

The chemical9,10-Anthracenedione, 1,4-diamino-, N,N'-bis(4-C7-17-branched alkylphenyl) derivs.(CAS no. 97862-23-2) is used as a dye for colouration.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for9,10-Anthracenedione, 1,4-diamino-, N,N'-bis(4-C7-17-branched alkylphenyl) derivs. 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 theEstimation Programs Interface Suite (2018) was run to predict the biodegradation potential of the test compound 9,10 -Anthracenedione, 1,4 -diamino-, N,N'-bis(4 -C7 -17 -branched alkylphenyl) derivs. (CAS no. 97862 -23 -2) 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 9,10 -Anthracene dione, 1,4 -diamino-, N,N'-bis(4 -C7 -17 -branched alkylphenyl) derivs.  is 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 thatchemical9,10-Anthracenedione, 1,4-diamino-, N,N'-bis(4-C7-17-branched alkylphenyl) derivs.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 94%). In soil,9,10-Anthracenedione, 1,4-diamino-, N,N'-bis(4-C7-17-branched alkylphenyl) derivs.was expected to have negligible mobility based upon a Log Koc value of 8.81, 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% of the chemical will partition into water according to the Mackay fugacity model level III in EPI suite version 4.1 (2018).However, the half-life(180 days estimated by EPI suite) indicates that the chemical is persistent inwater and the exposure risk to aquatic animals is moderate to high. 

 

Moreover, its persistent characteristic is also observed in the sediment compartment but Fugacity modelling shows that sediment is not an important environmental fate (less than 1% i.e. reported as 0.000982% when estimated by EPI Suite version 4.1).

 

Although the half-life values in soil indicate the chemical to be Very persistent (vP), since only predicted data is available for the substance, it has been concluded that9,10-Anthracenedione, 1,4-diamino-, N,N'-bis(4-C7-17-branched alkylphenyl) derivs.is likely to be persistent (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 database was determined to be 3.162 L/Kg, respectively. 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

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 is highly insoluble in water (solubility: < 0.01 mg/L at 25° 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 criterion but does not fulfil the B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.