Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Here follows a compiled description of the PBT assessment:

1. Persistence assessment

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

                     Abiotic degradation

Fast Green FCF is not expected to undergo hydrolysis in the environment due to the lack of functional groups that hydrolyze under regular environmental conditions (Lyman WJ et al; Handbook of Chemical Property Estimation Methods. Washington, DC: Amer. Chem. Soc. pp. 7-4, 7-5, 8-12 (1990)).

                     Biotic degradation

 

The Biodegradation Probability program (BIOWIN) in EPI suite version 4.1 estimates the probability of rapid aerobic biodegradation of an organic chemical in the presence of a mixed population of environmental microorganism. The chemical was predicted as not readily biodegradable by the BIOWIN model. The criteria were: BIOWIN 2<2 and BIOWIN 3<2.2 or BIOWIN 6<0.5 and BIOWIN 3<2.2. The exact values are given in Table 1 as follows:

 

Table 1Summary of the result from BIOWIN prediction model (EPI suite version 4.1):

 

BIOWIN 2	BIOWIN 3	BIOWIN 6
0.0000	1.7326	0.0000

 

Environmental fate

If released to the environment, Fast Green FCF is expected to be found predominantly in sediment (60.5%). It is also expected to be found in water (0.7%) and soil (38.8%) (Based on assessment by Mackay Fugacity model level III in EPI suite version 4.1, 2016).

 

The predicted half-life in soil, water and sediment fulfils the vP criterion within Annex XIII of REACH (see Table 2).

Table 2Summary of estimated half-life and Mackay Fugacity model (level III) in freshwater, sediment and soil by EPI suite version 4.1, 2016:

Medium	Predicted half-life	Mackay fugacity model level III
fresh- or estuarine water	180days	0.7%
fresh- or estuarine sediment	1620.83days	60.5%
soil	360 days	38.8%

In soil, Fast Green FCF is expected to have no mobility based upon an KOC of 1x10⁺¹⁰(estimated by MCI method in EPI suite version 4.1, 2016). The chemical is therefore estimated to have very strong sorption to soil and sediment and negligible migration potential to the ground water.

 

Fast Green FCF is not expected to volatilize from dry soil surfaces based upon a vapour pressure of 1.7E-43 mm Hg. Fast Green FCF is not expected to volatilize from moist soil surfaces based upon an estimated Henry's Law constant of 1.49E-40 atm-cu m/mole. Volatilization from water surfaces is not expected to be an important fate process based on an estimated Henry's Law constant of 1.49E-40 atm-cu m/mole(Cited from: Chemical Aquatic Fate and Effects (CAFE) Database version 1.1 (computer software), developed by National Oceanographic and atmospheric administration, Seattle, US, Oct 2016).

 

2. Bioaccumulation assessment

 

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

 

I.                   The estimated bioconcentration factor (BCF) was 3.162 L/kg (EPI suite version 4.1., 2016).

 

II.                The octanol-water partition coefficient (log Pow) was estimated to -5.42 (SRC PhysProp Database, 2012) and -3.22 (EPI suite version 4.1., 2016).

 

Values under I. and II. are below the cut-off criterions in Annex XIII for potentially bioaccumulative. The criterions for potentially bioaccumlative in fish and the food chain were as follow: a log Kow above 4.5 and a BCF value above 2000 L/kg.

3. Toxicity assessment

 

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

 

Mammals

 

The substance unfulfilled the following classifications: H350, H372, H373, H340 and H360.

Freshwater organisms

Based on the EC50-values in Table 3 for the chemical, it is considered that Fast Green FCF is not hazardous to the aquatic organisms at environmentally relevant concentrations and can be classified as non-hazardous as per the CLP classification.

Table 3Illustration the available short-term (acute) toxicity assessments in aquatic organisms:

Test species	Endpoint	Exposure duration	Result	Reference
Oryzias latipes	LC0	48 hours	3000 mg/L	The Journal of Toxicological Science, Vol. 3 205-214, 1978
Daphnia magna	EC50	48 hours	104.04 mg/L	SSS QSAR Prediction, 2015
Chlorella vulgaris	EC30	72 hours	213 mg/L	UERL Study report, 2016
Scenedesmus subspicatus (new name: Desmodesmus subspicatus)	EC50	72 hours	105.15 mg/L	SSS QSAR Prediction, 2015

Overall conclusion about Persistence, Bioaccumulation and Toxicity (PBT).

 

Based on critical, independent and collective evaluation of information summarized herein, the tested compound only fulfils vP criterion within Annex XIII. Hence, the tested compound has not been classified as a PBT compound within Annex XIII.