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EC number: 244-599-9 | CAS number: 21829-50-5
- 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
Endpoint summary
Administrative data
Description of key information
The substance is not irritating to skin and eyes.
Key value for chemical safety assessment
Skin irritation / corrosion
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Skin irritation
The skin irritation potential of tris[(2 -hydroxyethyl)ammonium] citrate was studied in vitro in the GLP-compliant OECD Guideline 439, using Epiderm reconstructed skin membranes (TNO Triskelion B.V., 2011a). The EpiDerm™ skin membranes were topically exposed the test substance for 1 h. After culturing for 42 h the viability of the epidermal cells was assessed using the MTT test. The general principle for the detection of viability via the MTT test is the conversion of the yellow tetrazolium salt (MTT) to the purple coloured product formazan by mitochondrial enzymes. The formation of formazan was measured using a spectrophotometer. The results were interpreted according to the following scheme: if the mean tissue viability expressed as % of negative control was ≥ 50%, the substance was considered not irritating to skin (UN GHS No Category); if the mean tissue viability was < 50%, the substance was considered to be irritating; UN GHS Category 2. Phosphate-buffered saline (PBS) and 5% sodium dodecyl sulphate (SDS) were used as a positive and a negative controls, respectively. Three replicates were used for each substance.
The mean tissue viability was 96 ± 3% for tris[(2 -hydroxyethyl)ammonium] citrate, 100 ± 1% for PBS and 5 ± 1% for 5% SDS. Based on the results of the study, the substance is not irritating to skin.
Eye irritation
Eye irritating potency of tris[(2 -hydroxyethyl)amminoum] citrate was studied in vivo in the GLP-compliant OECD Guideline 405 study with three female New Zealand White rabbits (TNO Triskelion B.V., 2011b). The study was conducted after the non-GLP evaluation of the eye irritation in vitro using the Isolated Chicken Eye Test (OECD 438) did not reveal signs of severe irritancy. 0.1 mL of the test substance was instilled into the conjunctival cul-de-sac of the right eye of each rabbit; the untreated eyes served as negative controls. The effects were scored at 1, 24, 48, 72 hours and 7 days post-instillation. The substance caused slight redness (mean score at 24 + 48 + 72 hours 0.72 out of max. 3) and slight swelling of the conjunctivae (mean score 1 at 1 hours post-observation out of max. 4; mean score 0 at 24 + 48 + 72 hours) and moderate ocular discharge (mean score 2 out of max. 3 at 1 hour post-instillation; mean score 0 at 24 + 48 + 72 hours). At 72 hours after treatment, the eye effects had cleared completely. Based on the results of the study, the substance is not irritating to eyes.
Justification for classification or non-classification
Based on the negative results of the GLP-compliant guideline in vitro skin irritation study with the EpiDerm skin membranes and in vivo study with rabbits, classification of the substance for skin and eye irritation is not warranted in accordance with EU Directive 67/548 and EU Classification, Labeling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
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