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EC number: 203-536-5 | CAS number: 107-95-9
- 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
Endpoint summary
Administrative data
Description of key information
- Acute toxicity:
-oral: LD50 >5000 mg/kg bw (limit test, Guidelines for Toxicity Studies of Drugs (Japan) , GLP conditions, fixed dose procedure);
-inhalation: waiver;
-dermal: waiver.
Key value for chemical safety assessment
Additional information
Only 1 acute toxicity
(oral) test is available on beta-alanine. The single oral dose toxicity
test of beta-alanine was conducted according to the Guidelines for
Toxicity Studies of Drugs (Japan) under GLP conditions (fixed dose
procedure). 6 Sprague-Dawley rats were dosed by gavage to 0 and 5000
mg/kg bw beta-alanine dissolved in water. The animals were subsequently
observed for a period of 14-day. In the preliminary test, no mortality
occurred at 5000 mg/kg, which is the maximum dose level that could be
administered. Therefore, 5000 mg/kg was determined as the dosage level.
No male or female rats in any groups died throughout the observation
period. No male or female rats with abnormal findings were observed in
the control group throughout the observation period.
In the 5000 mg/kg group, decrease in voluntary movement was observed in
4 male and 6 female rats for the first 0 to 30 minutes after dosing, and
the incidences of the finding in male and female rats of the 5000 mg/kg
group were significantly higher than those in the control group. In the
5000 mg/kg group, diarrhoea was observed in male rat for the first 0 to
30 minutes after dosing, 2 male rats at 3 hours and 3 male and 3 female
rats at 6 hours after dosing. It is concluded that LD50of
beta-alanine in both male and female rats by a single oral
administration is higher then 5000 mg/kg.
No acute toxicity test conducted via inhalation or dermal route is available. However acute toxicity tests via inhalation and dermal route do not need to be conducted. In fact, according to Regulation No 1907/2006 (REACH) Annex VIII, Section 8.5.2, Column 2, testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Beta-alanine vapour pressure is very low (0.00000674 Pa at 25 °C). Exposure to vapour can thus be precluded. Moreover, as the beta-alanine Mean Mass Areodynamic Diameter (MMAD) is > 100 µm, an inhalative exposure will be only likely, if beta-alanine would be used in a spray application. As a spray use of beta-alanine was excluded by the dossier submitter, exposure by inhalation can be precluded. Furthermore, the results of acute oral toxicity conducted with the substance showed no acute systemic toxicity after oral administration (LD50> 5000 mg/kg bw). Therefore, based on the low vapour pressure, exposure considerations, and on the available data on the toxicity of the substance additional testing on the acute inhalation toxicity is not considered necessary, will not be proposed and should be avoided in terms of animal welfare. Furthermore, according to Regulation No 1907/2006 (REACH) Annex VIII, Section 8.5, Column 2, information about at least one further route shall be provided. If there is only one route of exposure, information needs to be provided only for that route. Danish (Q)SAR Database predicts a low dermal absorption (0.001 mg/cm²/event) for beta-alanine. DERMWIN Skin Permeability Model predicts a very low dermal absorption for beta-alanine (0.00029 mg/cm²/h). Moreover, the results of acute oral toxicity as well as skin and eye irritation studies conducted with the substance showed no acute systemic toxicity after oral administration (LD50> 5000 mg/kg bw) and no skin and/or eye irritation potential. Therefore, based on the available data on the toxicological properties of the substance, systemic toxic effects after acute dermal exposure are unlikely to occur. Testing on the acute dermal toxicity of the substance is not considered necessary and should be avoided in terms of animal welfare.
Justification for classification or non-classification
Overall, beta-alanine is not to be classified according to DSD or CLP classification criteria.
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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