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Diss Factsheets
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EC number: 204-625-1 | CAS number: 123-41-1
- 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
No study on skin and eye irritation available; however, the pH value of pH = 14.9 (45 % aqueous solution, Struyvelt E, 2012) and various dilutions of this solution have a pH value of pH = 13.1 – 14.2 (10 - 90 % (w/w) of 45 % solution in water, Intertek, 2013))
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is a strong acid (pH ≤ 2.0) or base (pH ≥ 11.5) and the available information indicates that it should be classified as skin corrosion (Category 1, 1A, 1B or 1C)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vitro / ex vivo
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- the study does not need to be conducted because the substance is classified as skin corrosion, leading to classification as serious eye damage (Category 1)
- the study does not need to be conducted because the substance is a strong acid (pH <= 2.0) or base (pH => 11.5) and the available information indicates that it should be classified as serious eye damage (Category 1)
Reference
Endpoint conclusion
- Endpoint conclusion:
- no study available
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no study available
Additional information
According to REACH Annex VII Column 1 the assessment of the endpoint “skin irritation” shall comprise the following consecutive steps:
(1) an assessment of the available human and animal data,
(2) an assessment of the acid or alkaline reserve,
(3) in vitro study for skin corrosion,
(4) in vitro study for skin irritation
According to column 2, steps 3 and 4 do not need to be conducted if i.a. the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes. These criteria are met because the product (45 % Choline Base solution) has a pH = 14.9 (Struyvelt E, 2012) and various dilutions of this solution have a pH value of pH = 13.1 – 14.2 (10 - 90 % (w/w) of 45 % solution in water, Intertek, 2013) and hence, the test for skin irritation / corrosion of choline hydroxide does not need to be conducted.
Also, according to REACH Annex VII Column 1 the assessment of the endpoint “eye irritation” shall comprise the following consecutive steps:
(1) an assessment of the available human and animal data,
(2) an assessment of the acid or alkaline reserve,
(3) in vitro study for eye irritation.
According to column 2, step 3 does not need to be conducted if i.a. the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes. These criteria are met, as stated above, and hence, the test does not need to be conducted.
So, in summary, choline hydroxide needs to be classified as skin and eye corrosive, the tonnage-driven data requirements under REACH are fully met, no datagaps were identified and no further testing needs to be performed.
Justification for selection of skin irritation / corrosion endpoint:
According to REACH Annex VII Column 1 the assessment of this endpoint shall comprise the following consecutive steps:
(1) an assessment of the available human and animal data,
(2) an assessment of the acid or alkaline reserve,
(3) in vitro study for skin corrosion,
(4) in vitro study for skin irritation
According to column 2, steps 3 and 4 do not need to be conducted if i.a. the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes. These criteria are met because the product (45 % Choline Base solution) has a pH = 14.9 (Struyvelt E, 2012) and various dilutions of this solution have a pH value of pH = 13.1 – 14.2 (10 - 90 % (w/w) of 45 % solution in water, Intertek, 2013) and hence, the test does not need to be conducted.
Justification for selection of eye irritation endpoint:
According to REACH Annex VII Column 1 the assessment of this endpoint shall comprise the following consecutive steps:
(1) an assessment of the available human and animal data,
(2) an assessment of the acid or alkaline reserve,
(3) in vitro study for eye irritation.
According to column 2, step 3 does not need to be conducted if i.a. the available information indicates that the criteria are met for classification as corrosive to the skin or irritating to eyes. These criteria are met because the product (45 % Choline Base solution) has a pH = 14.9 (Struyvelt E, 2012) and various dilutions of this solution have a pH value of pH = 13.1 – 14.2 (10 - 90 % (w/w) of 45 % solution in water, Intertek, 2013) and hence, the test does not need to be conducted.
Effects on skin irritation/corrosion: corrosive
Effects on eye irritation: corrosive
Justification for classification or non-classification
Due to the high pH-value of the test item (pH = 14.9 (45 % solution, Struyvelt E, 2012), pH = 13.1 – 14.2 (10 - 90 % (w/w) of 45 % solution in water, Intertek, 2013) and pKb value (pKb = 5.06 for 0.0064-0.0403 M solutions (Seidel A (ed.) 2004. Kirk-Othmer Encyclopedia of Chemical Technology, Fifth edition, Wiley-Interscience, John Wiley & Sons, Inc., Publication)), choline hydroxide needs to be classified as corrosive to the skin and eye, according to Regulation 1272/2008/EC.
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.
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