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Registration Dossier
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Diss Factsheets
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EC number: 947-855-4 | CAS number: -
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: The study was conducted according to a protocol that is similar to an appropriate OECD test guideline, with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 975
- Report date:
- 1975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- Deviations:
- yes
- Remarks:
- Limited details on test animals and environmental conditions, only 50 cells per animal were scored for aberrations.
- GLP compliance:
- no
- Type of assay:
- other: in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
Test material
- Reference substance name:
- Citric acid
- EC Number:
- 201-069-1
- EC Name:
- Citric acid
- Cas Number:
- 77-92-9
- Molecular formula:
- C6H8O7
- IUPAC Name:
- citric acid
- Test material form:
- solid: granular
- Details on test material:
- Compound FDA 71-54, Citric acid
U.S.P. Control Number 121M231 IV, as supplied by the Food and Drug Administration
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Flow Laboratories random-bred, closed colony
- Age at study initiation: 10 to 12 weeks
- Weight at study initiation: 280 to 350 g
- Assigned to test groups randomly: yes
- Fasting period before study: no data
- Housing: Rats were housed one to five to a cage
- Diet: Free access to commercial 4% fat diet
- Water: Free access to water
- Acclimation period: 4 - 11 days
ENVIRONMENTAL CONDITIONS
No data
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle used: physiol. saline
- Justification for choice of vehicle: no data - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: The substance was suspended in 0.85% saline.
- Duration of treatment / exposure:
- 6, 24 and 48 hours
- Frequency of treatment:
- Single dose
Doses / concentrationsopen allclose all
- Dose / conc.:
- 1.2 mg/kg bw/day
- Remarks:
- test 1
- Dose / conc.:
- 12 mg/kg bw/day
- Remarks:
- test 1
- Dose / conc.:
- 120 mg/kg bw/day
- Remarks:
- test 1
- Dose / conc.:
- 300 mg/kg bw/day
- Remarks:
- test 2
- Dose / conc.:
- 500 mg/kg bw/day
- Remarks:
- test 2
- Dose / conc.:
- 3 000 mg/kg bw/day
- Remarks:
- test 2
- Dose / conc.:
- 3 500 mg/kg bw/day
- Remarks:
- test 2
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Triethylene Melamine, 0.3 mg/kg bw.
Examinations
- Tissues and cell types examined:
- Fifty metaphase spreads in bone marrow cells were scored per animal.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: Based on toxicity test data.
DETAILS OF SLIDE PREPARATION: Four hours after the last substance administration, and two hours prior to killing, each animal was given 4 mg/kg bw colcemid intraperitoneally in order to arrest the bone marrow cells in c-mitosis. Animals were killed by using CO2, and the adhering muscle and epiphysis of one femur were removed. The cells were suspended in HBSS, centrifuged and resuspended in a hypotonic KCl solution. After incubation at 37°C, the cells were centrifuged and fixated in methanol/acetid acid and after overnight incubation resuspended and 2-3 drops of the suspension were allowed to drop onto a clean, dry slide and allowed to dry at room temperature overnight. The slides were stained using a 5% Giemsa solution, mounted and covered with a coverglass.
METHOD OF ANALYSIS: The specimens were scanned with 10x and 24x objectives and suitable metaphase spreads were examined using oil immersion flatfield apochromatic objectives. The chromosome of each cell were counted and only diploid cells were analyzed. Fifty metaphase spreads were scored per animal.
OTHER: Mitotic indices were obtained by counting at least 500 cells and the ratio of the number of cells in mitosis/the number of cells observed was expressed as the mitotic index.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
Dose range test 1: 100, 250, 500, 1000, 2000, 3000 mg/kg. One animal died at 500 mg/kg bw, 2 animals died at 1000 mg/kg bw and 3 animals died at 2000 and 3000 mg/kg bw. The LD50 was determined as 1700 mg/kg bw.
Dose range test 2: 5000 mg/kg, no deaths occurred. The LD50 was determined as >5000 mg/kg bw.
RESULTS OF DEFINITIVE STUDY
The substance produced no detectable significant aberration of the bone marrow metaphase chromosomes of rats.
Applicant's summary and conclusion
- Conclusions:
- An in vivo bone marrow chromosome aberration study with Citric acid was performed equivalent to OECD 475 guideline, in male rats. It is concluded that the substance is not mutagenic in the in vivo bone marrow chromosome aberration assay.
- Executive summary:
An in vivo bone marrow chromosome aberration test was performed with Citric acid equivalent to OECD 475 guideline without GLP.
Groups of 5 male rats were orally administered to the test substance up to and including 3500 mg/kg bw for 6, 24 and 48 hours in two independently performed experiments. Reliable vehicle controls and positive controls were included. No treatment-related increase in the number of cells with aberrations were observed. It is concluded that the substance is not mutagenic in the in vivo bone marrow chromosome aberration assay.
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