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Diss Factsheets
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EC number: 206-169-9 | CAS number: 305-84-0
- 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
Acute Toxicity: other routes
Administrative data
- Endpoint:
- acute toxicity: other routes
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 2013
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Safety and Efficacy Evaluation of Carnosine, An Endogenous Neuroprotective Agent for Ischemic Stroke
- Author:
- Ok-Nam Bae et al.
- Year:
- 2 013
- Bibliographic source:
- Stroke. 44(1): 205–212. doi:10.1161/STROKEAHA.112.673954.
Materials and methods
- GLP compliance:
- no
Test material
- Reference substance name:
- Carnosine
- EC Number:
- 206-169-9
- EC Name:
- Carnosine
- Cas Number:
- 305-84-0
- Molecular formula:
- C9H14N4O3
- IUPAC Name:
- (2S)-2-(3-aminopropanoylamino)-3-(1H-imidazol-4-yl) propanoic acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan
- Age at study initiation: adult
- Weight at study initiation: 250 - 300 g
Administration / exposure
- Route of administration:
- intravenous
- Vehicle:
- other: saline
- Details on exposure:
- For toxicity assessment, saline or the test substance were administered over 5 min into an indwelling intravenous catheter in the left femoral vein.
- Doses:
- 100, 500, 1000, or 2000 mg/kg bw
- No. of animals per sex per dose:
- 12
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: daily assessments for systemic signs of toxicity was performed
- Necropsy of survivors performed: yes
- Other examinations performed: body weight, food consumption, activity, and mortality were evaluated, to examine organ-specific toxicity, histopathological evaluations were performed on bone marrow, cerebellum, cerebrum, brain stem, hippocampus, heart, lung, liver, and kidney in randomly selected animals. - Statistics:
- Means and standard errors of means (SEM) were calculated for all treatment groups. The data were subjected to student t-test or one-way ANOVA followed by Duncan’s test to determine the significant differences between treatment groups. Statistical analysis was performed using SPSS software (Chicago, IL). In all cases, a p value of <0.05 was considered significant.
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: absence of adverse toxic effects
- Mortality:
- No rat died.
- Clinical signs:
- No clinical signs of toxicity observed.
- Body weight:
- No significant differences were found between control (saline-treated) and carnosine-treated groups both in body weight change and the amount of food consumption.
- Gross pathology:
- Administration of the test substance did not induce signs of toxicity in any of the examined organs.
Applicant's summary and conclusion
- Conclusions:
- Under the conditions of the conducted study in rats, the test substance did not induce death or other signs of toxicity at a doses of 100 - 2000 mg/kg bw (administered intravenously).
The available data on acute toxicity of the test substance do not meet criteria for classification according to Regulation (EC) 1272/2008. - Executive summary:
Acute toxicity of the test substance administered intravenously was investigated in male, adult Sprague-Dawley rats. Although the test substance was not administered via the oral route, the data can be used in a weight of evidence approach for acute oral toxicity of the test substance. Since the availability of the test substance via the intravenous route is assumed to be at a maximum of 100%, the data are considered adequate to cover and evaluate the acute oral toxicity of the test substance.
In the study, groups of 12 rats per sex per dose were administered the test substance at doses of 100, 500, 1000, or 2000 mg/kg bw. The rats were observed for a period of 14 days. Daily assessments of systemic signs of toxicity were performed and included measurements of body weight, food consumption, activity, analysis of organ-specific toxicity, histopathological evaluations at the end of the study period (bone marrow, cerebellum, cerebrum, brain stem, hippocampus, heart, lung, liver, and kidney in randomly selected animals) and mortality. No deaths were observed. Furthermore, no clinical signs of toxicity were observed and there was no difference found between control (saline-treated) and test item-treated groups both in body weight change and the amount of food consumption. Administration of the test substance did not induce signs of toxicity in any of the examined organs. Hence, a LD50 greater than 2000 mg/kg bw was determined in this study. The available data on acute toxicity of the test substance do not meet the criteria for classification according to Regulation (EC) 1272/2008.
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