Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 203-490-6 | CAS number: 107-43-7
- 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
Betaine has not been found to be an irritant or corrosive in any in vitro or in vivo tests performed. Betaine has also been tested in well prepared and conducted studies, resembling OECD TG 404 performed on humans for skin irritation. Eye irritation testing was performed by executing OECD TG405 study in accordance with GLP. In vitro testing of skin absorption resulted in extremely low permeation, 0.1%.
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from NOV 19 2006 to FEB 4 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well designed and executed study for percutaneous absorption (permeation potential) of betaine in vitro using Franz chambers with freshly isolated human epidermis (abdominal skin). This study was selected as the key study because the information provided for the hazard endpoint is sufficient for the purpose of classification and labelling and/or risk assessment.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 428
- Deviations:
- yes
- Remarks:
- only one dose (5%) was used as duplicate, intead of series but two different vehicles were used.
- Principles of method if other than guideline:
- Franz chambers: donor and receiver chamber filled with PBS. Atop betaine (5% in saline or emulsion, pH7.4. Completely solubilized) was applied, samples were withdrawn from receiver chamber at appropriate intervals and analysed.
- GLP compliance:
- no
- Species:
- other: Human freshly isolated abdominal epidermis
- Strain:
- not specified
- Type of coverage:
- other: In vitro: Franz chambers (donor/receiver)
- Preparation of test site:
- other: In vitro: freshly isolated human epidermis clamped between cell halves
- Vehicle:
- physiological saline
- Remarks:
- or emulsion
- Controls:
- not required
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 1,2,4,6,8,11 and 24 hours
- Number of animals:
- in vitro
- Irritation / corrosion parameter:
- other: percutaneous permeation/absorption (in vitro diffusion study using Franz chambers) at 1, 2, 4, 6, 8, 11 and 24 hours
- Value:
- ca. 0
- Remarks on result:
- other:
- Remarks:
- extremely low permeation, 0,1% of the initial dose regardless of formulation
- Other effects / acceptance of results:
- Percutaneous permeation of betaine was extremely low. Less than 0.1 % of the initial dose applied atop the skin permeated through the skin regardless of the formulation.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was tested for percutaneous absorption using Franz chambers with a protocol similar to OECD guideline 428. The test was designed and performed adequately. The result show that the test substance has an extremely low percutaneous permeation capability.
- Executive summary:
The test substance was tested for percutaneous absorption using Franz chambers with a protocol similar to OECD guideline 428. The results showed that betaine has an extremely low percutaneous permeation capability (0.1% of the initial dose regardless of formulation). Therefore, the test substance considered not irritating under the conditions of this test.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Eye irritation
Link to relevant study records
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 15 OCT 1991 to 25 OCT 1991
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
- Species:
- rabbit
- Strain:
- other: Albino
- Vehicle:
- water
- Remarks:
- 10% w/v solution
- Controls:
- other: The untreated eye served as control.
- Amount / concentration applied:
- 0.1 mL of 10% solution
- Duration of treatment / exposure:
- single dose
- Observation period (in vivo):
- 1, 24, 48, and 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- Animals were examined under a standard light source designed to comply with the requirements of BS 950 Part 1 (Artificial Daylight for the Assessment of Colour). The eyes were assessed for damage or irritation to the cornea, iris and conjunctiva using the untreated eye as a control.
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Irritant / corrosive response data:
- No signs of irritation or corneal or iridial lesions were observed in any of the animals throughout the 72-hour observation period.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The application of betaine (natural extract AP, 10% w/v in distilled water) did not result in any ocular irritation, and it can be considered non-irritant at the concentration used in this study.
- Executive summary:
Betaine was tested in an in vivo eye irritation study according to OECD guideline 405. The application of betaine (natural extract AP, 10% w/v in distilled water) did not result in any ocular irritation, and it can be considered non-irritant at the concentration used in this study.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Respiratory irritation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Betaine has been widely used in cosmetics because of its anti-irritant properties and its favourable effects on skin health as an anti-irritant. Multiple studies have been conducted on humans to study the effects. Respiratory sensitisation has not been tested since the physical state along with particle size, hygroscopic properties and vapour pressure provide information that betaine cannot cause concern for respiratory irritation.
Justification for classification or non-classification
Skin irritation: Not classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, as irritant / corrosive: based on testing on skin sensitisation and irritation on animals and humans.
Eye irritation: Not classified according to EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008, based on eye irritation testing on animals.
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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