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EC number: 209-683-1 | CAS number: 590-46-5
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 07/02/2018-20/02/2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 442B (Skin Sensitization: Local Lymph Node Assay: BrdU-ELISA)
- Version / remarks:
- 2010
- Qualifier:
- according to guideline
- Guideline:
- other: test method B.51 of the council regulation No.640/2012 of 06 July 2012
- GLP compliance:
- yes (incl. QA statement)
- Type of study:
- mouse local lymph node assay (LLNA): BrdU-ELISA
Test material
- Reference substance name:
- Betaine hydrochloride
- EC Number:
- 209-683-1
- EC Name:
- Betaine hydrochloride
- Cas Number:
- 590-46-5
- Molecular formula:
- C5H12NO2.Cl
- IUPAC Name:
- 2-(trimethylazaniumyl)acetate
- Reference substance name:
- Minor constituents present in very low concentration and not affecting the hazardous properties of the substance
- Molecular formula:
- Traces of metals such as V, Mo, Zr, Ba, Sn, Ti
- IUPAC Name:
- Minor constituents present in very low concentration and not affecting the hazardous properties of the substance
- Reference substance name:
- Water
- EC Number:
- 231-791-2
- EC Name:
- Water
- Cas Number:
- 7732-18-5
- Molecular formula:
- H2O
- IUPAC Name:
- Water
- Test material form:
- solid: particulate/powder
- Details on test material:
- lot number 20161110
Constituent 1
impurity 1
impurity 2
- Specific details on test material used for the study:
- batch number: 20161110
solid white powder
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA:J
- Sex:
- female
- Details on test animals and environmental conditions:
- Female CBA/J (CBA/JRj) strain mice (SPF caw) were supplied by Elevage Janvier Labs (F-53941 Le Genest Saint Isle). On receipt the animals were randomly allocated to cages. The animals were nulliparous and non-pregnant. After an acclimatisation period of at least five days under stabling and nutritional conditions identical to those of the test, the animals were selected at random and given a number unique within the study by indelible ink-marking on the tail and a number written on a cage card. At the start of the main study the animals were 8 weeks old.
The animals were weighed at the beginning and at the end of the study.
Study design: in vivo (LLNA)
- Vehicle:
- other: Pluronic L92 (1%) (CAS 9003-11-6)
- Concentration:
- 0 - 10 - 25 - 50 %
- No. of animals per dose:
- 4
- Details on study design:
- PRE-SCREEN TESTS:
As no information was available regarding irritant potential or systemic toxicity of the test item in the mouse, a preliminary screening test was performed using one mouse. The mouse was treated by daily application of 25 μL of the test item diluted at 50% in Pluronic® L92 at 1% (maximun concentration administrable) to the dorsal surface of each ear for three consecutive days (Days 1, 2, 3). The mouse was observed daily from Day 1. Any signs of toxicity or excessive local irritation noted during this period were recorded. Ear thickness was recorded on Day 1, Day 3 and on Day 6. The bodyweight of the mouse was recorded on Day 1 (prior to dosing) and Day 6.
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
Criteria used to consider a positive response:
Ear thickness measurements and recording of local reactions were performed in order to assess any possible irritant effect of the test item, as possible irritancy may be involved in false positive lymphoproliferative responses.
On day 1 and on day 3 (before application) as well as on day 6 (after sacrifice) of each experiment, the thickness of the right ear of each animal of the vehicle control and treated groups was measured by a micrometer.
Furthermore, on day 6, punch biopsies of 8 mm in diameter of the apical area of both ears were prepared and weighed in order to assess the irritation potential of the test item and the two lymph nodes per mouse were weighed.
Any irritation reaction (erythema and oedema) was recorded in parallel. Any other observation (dryness, presence of residual test item...) was noted.
The irritation level of the test item is determined according to the following table:
% increase in ear thickness between day 1 and day 3 and/or between day 1 and day 6 Interpretation
< 10 % Non irritant
10 – 25 % Slightly irritant*
> 25 % Irritant
The test item should also be considered as an irritant if the score of erythema is higher or equal to 3.
On day 6 (end of the test), the animals were euthanized with sodium pentobarbital (Dolethal®). The draining auricular lymph nodes from the four mice were excised.
A single cell suspension of the lymph node cells of 4 mice of each group was prepared by gentle mechanical tissue disaggregation through a 200-mesh cell strainers in 4 mL of PBS (Ca2+ / Mg2+ - free) containing 0.5% BSA into a well of a multi-well 6.
10 μL of this cell suspension was diluted in 10 mL of physiological saline solution (NaCl 0.9%). The lymphocyte cells were counted using a cell counter (Beckman Coulter Z2).
For the run, the lower size selected was 5 μm and the upper size selected was 15 μm (the average size of a lymphocyte is 8 μm).
TREATMENT PREPARATION AND ADMINISTRATION:
Groups of four mice were treated with the test item diluted at the concentrations of 50%, 25% and 10% in Pluronic® L92 at 1%. The mice were treated by daily application of 25 μL of the appropriate concentration of the test item to the dorsal surface of each ear for three consecutive days (Days 1, 2 and 3). The test item formulation was administered using an automatic micropipette and spread over the dorsal surface of the ear using the tip of the pipette.
A further group of four mice received the test vehicle alone in the same manner. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
- Positive control results:
- An EC1.6 value of 14.58% was observed for the test item α-Hexylcinnamaldehyde, resulting in a classification as a sensitiser in Category 1, Sub-category 1B, in accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures.
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- 0.74
- Test group / Remarks:
- 10%
- Key result
- Parameter:
- SI
- Value:
- 1.01
- Test group / Remarks:
- 25%
- Key result
- Parameter:
- SI
- Value:
- 1.01
- Test group / Remarks:
- 50%
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- In view of these results, under these experimental conditions, the test item betaine hydrochloride does not have to be classified as a sensitizer, in accordance with the criteria for classification, packaging and labelling of dangerous substances and mixtures of the Regulation No. 1272/2008.
No signal word or hazard statement is required.
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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