Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Classification of Tetraoctylammonium bromide for effects in the environment:

 

The chemical Tetraoctylammonium bromide (CAS no. 14866-33-2) is used as a disinfectant or preservative as well as a surface treatment agent in hospitals and industry. The aim was to assess whether the PBT criterion within Annex XIII was fulfilled for Tetraoctylammonium bromide. 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

Biodegrdability of test chemical Tetraoctylammonium Bromide (CAS no. 14866-33-2) is predicted using OECD QSAR tool box v.3.4 using log Kow as primary descriptor. The test chemical tetraoctylammonium Bromide undergoes 0.060 % percent biodegrdadation by taking BOD as parameter and by taking microorganisms as inoculum in 28 days. So it is concluded that the test chemical Tetraoctylammonium Bromide is not readily biodegradable.

 

Another prediction done by using Estimation Programs Interface Suite (EPI suite, 2017) to estimate the biodegradation potential of the test compound Tetraoctylammonium Bromide (CAS no.14866-33-2) 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 Biowin 1-7, respectively) of the BIOWIN v4.10 software. The results indicate that chemical Tetraoctylammonium Bromide is expected to be not readily biodegradable.

 

Experimental results from the similar substances (CAS: 1116-76-3 and 7173-51-5) also indicate that they are not readily biodegradable.

 

Environmental fate

According to the fugacity model levels III, the most likely environmental fate for this test chemical is sediment (i.e.estimated to 62.3%). In sediment and soil, Tetraoctylammonium bromide was expected to have negligible mobility based upon a LogKOC in the range 4.45 – 8.37. Thehalf-life in sediment (135 days estimated by EPI suite) indicates that the chemical is persistent in the medium.

 

If released in to the environment, 32.7% and 4.84% of the chemical will partition into soil and water respectively, according to the Mackay fugacity model level III in EPI suite version 4.1 (2017). The half-life (15 days in water and 30 days in sediment as estimated by EPI suite) chemical is not persistent in both the compartments.

 

Hence, it has been concluded that Tetraoctylammonium bromide is persistent in nature.

 

 

Bioaccumulation assessment

The tested substance does not fulfil the B criterion within Annex XIII based on the assessment that here follows:

 

Theestimated BCF value from authoritative database was determined to be in the range 56.3 - 1461 and theoctanol water partition coefficient of the test chemical is 4.47 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 estimations for fish, invertebrates and algae for the substance indicates the LC50/EC50 value to be >100 mg/L. These value suggest that the substance is likely to be non-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 Tetraoctylammonium bromide. 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 P criterion but does not fulfil the B and T criterion and has therefore not been classified as a PBT compound within Annex XIII.