Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 219-091-5 | CAS number: 2353-45-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
Here follows a compiled description of the PBT assessment:
- 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).
- 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.
- 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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.