1,4-bis(p-tolylamino)anthraquinone

PBT assessment

PBT assessment: overall result

Reference

Name:

1,4-bis(p-tolylamino)anthraquinone

Type of composition:

boundary composition of the substance

State / form:

solid: bulk

Reference substance:

1,4-bis(p-tolylamino)anthraquinone

PBT status:

the substance is not PBT / vPvB

Justification:

Classification of 1,4-bis(p-tolylamino)anthraquinonefor effects in the environment:

 

The chemical 1,4-bis(p-tolylamino)anthraquinone (CAS no. 128-80-3) is used as a colorant for cosmetic and dyeing agents. It is used in externally applied drugs and cosmetics. Also used in plastic resin, polystyrene, ABS resin, acrylic, polyester resin, polycarbonate, contact lenses and haptics of intraocular lenses etc. It is used for staining variety of resin and fibres.The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for 1,4-bis(p-tolylamino)anthraquinone. 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

In an experimental key study from study report (1992), biodegradation experiment was conducted for 28 days for evaluating the percentage biodegradability of test chemical. The study was performed in accordance with OECD Guideline 301 C (Ready Biodegradability: Modified MITI Test (I))under aerobic conditions at a temperature of 24°C. Activated sludge, domestic (adaptation not specified) obtained from a domestic waste water sewage plant was used as a test inoculum for the study. Initial test substance conc. used in the study was 30 mg/l. Flasks were used as a test vessel for the study. An amount of sludge from a domestic waste water sewage plant corresponding to 7.5 mg dry material for positive control ANILINE and 25 mg dry material for the test article were added to 250 ml of the final test medium. The test flasks was incubated on a SAPROMAT D12 (Voith GmbH) supplied with an evaluation program. The biodegradation of the test article was followed by exposing it to microorganisms from the secondary effluent of a domestic waste water sewage plant and determined by means of the biochemical oxygen demand (BOD) for 28 days. At the end of the incubation period, samples of atleast 10 ml from all flasks were centrifuged and thereafter directly analysed. TOC analyses were performed with the various filtrates, using a Shimadzu TOC Analyser (Shimadzu TOC 500). Aniline (positive control) was used as a reference substance for the study. Untreated inoculum was used as an inoculum blank. It degraded by 67.8% and 71.5% after 7 and 14 days respectively. A slight degradation was observed in the flask without inoculum, allowing the assumption that the test article was not only degraded by microorganisms. The percentage degradation of test chemical was determined to be 29.9% by BOD parameter in 28 days. Thus, based on percentage degradation, test chemical is considered to be inherently biodegradable in nature.

 

In a supporting study,28-days Closed Bottle test following the OECD guideline 301 D to determine the ready biodegradability of the test chemical (Experimental study report, 2018. The study was performed at a temperature of 20°C. The test system included control, test item and reference item. Polyseed were used as a test inoculum for the study. The concentration of test and reference item (Sodium Benzoate) chosen for both the study was 4 mg/L, while that of inoculum was 32 ml/l. OECD mineral medium was used for the study. ThOD (Theoretical oxygen demand) of test and reference item was determined by calculation. % degradation was calculated using the values of BOD and ThOD for test item and reference item. The % degradation of procedure control (reference item) was also calculated using BOD & ThOD and was determined to be 73.49%. Degradation of Sodium Benzoate exceeds 39.15% on 7 days & 70.48% on 14th day. The activity of the inoculum was thus verified and the test can be considered as valid. The BOD28 value of test chemical was observed to be 1 mgO2/mg. ThOD was calculated as 2.37 mgO2/mg. Accordingly, the % degradation of the test item after 28 days of incubation at 20 ± 1°C according to Closed Bottle test was determined to be 42.19%. Based on the results, the test item, under the test conditions, was considered to be inherently biodegradable in nature.

Thus, based on the above available information, it has been concluded that chemical 1,4-bis(p-tolylamino)anthraquinone is considered to be inherently biodegradable and thus likely to be not persistent (Not P) in nature.

 

Bioaccumulation assessment

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

 

Theoctanol water partition coefficient of the test chemical from study reports was determined to be ranges from 6.4 to 8.2, respectively. Since the logKow value 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.

 

Thus, based on the available information, chemical 1,4-bis(p-tolylamino)anthraquinone is considered likely to be bioaccumulative (B) in nature.

 

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 1,4-bis(p-tolylamino)anthraquinone indicates the LC50/EC50 value to be in the range 100 – 158.9 mg/L, respectively. These value suggest that the substance is not likely to be hazardous to Aquatic organisms at 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 1,4-bis(p-tolylamino)anthraquinone. 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 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.