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Diss Factsheets
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EC number: 208-901-2 | CAS number: 546-46-3
- 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
![](https://www.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / bone marrow chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study was conducted according to a protocol that is similar to an appropriate OECD test guideline, with acceptable restrictions. The restrictions were that only 50 cells per animal were scored for aberrations. It was not compliant with GLP. Read across to the registered substance is considered scientifically justified.
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:
- only 50 cells analysed per animal
- GLP compliance:
- no
- Type of assay:
- chromosome aberration assay
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
- Details on test material:
- - Name of test material (as cited in study report): Compound FDA 71-54, citric acid, granular
- Substance type: monoconstituent substance
- Physical state: solid
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: 10-12 weeks
- Weight at study initiation: 325-375 g
- Assigned to test groups randomly: yes
- Fasting period before study:
- Housing: 1-5 per cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 4-11 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no information
- Humidity (%): no information
- Air changes (per hr): no information
- Photoperiod (hrs dark / hrs light): no information
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- - Vehicle(s)/solvent(s) used: physiol. saline
- Justification for choice of solvent/vehicle: none given
- Concentration of test material in vehicle: no information
- Amount of vehicle (if gavage or dermal): no information - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: no information
- Duration of treatment / exposure:
- 1 and 5 days
- Frequency of treatment:
- single dose and daily for 5 days
- Post exposure period:
- Subacute study (five doses): 4 hours after final compound administration, 4 mg/kg Colcemid was given intraperitoneally. Animals were sacrificed 2 hours later.
Acute study (single dose): Animals were sacrificed 6, 24 and 48 hours after administration
Doses / concentrations
- Remarks:
- Doses / Concentrations:
test 1: 1.2, 12.0, 120 mg/kg bw; test 2; 300, 500, 3000, 3500 mg/kg bw
Basis:
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- - triethylenemelamine
- Justification for choice of positive control(s): none given in report
- Route of administration: ip injection
- Doses / concentrations: 0.3 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: based on toxicity test data
DETAILS OF SLIDE PREPARATION: duplicate slides were prepared with fixed bone marrow cells, and stained with Giesma
METHOD OF ANALYSIS: The slides were examined using optical microscopes and the chromosomes were counted. Diploid cells were analysed for chromatid and chromosome gaps and breaks; reunions, > 10 aberrations, polyploidy, pulverisation and any other aberrations.
50 cells were scored per animal. Mitotic indices were determined from 500 cells per animal.
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- not examined
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 100, 250, 500, 1000, 2000, 3000 mg/kg
- Solubility: not reported
- Clinical signs of toxicity in test animals: none reported
- Evidence of cytotoxicity in tissue analyzed: not reported
- Rationale for exposure: based on LD 50
RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): none
- Appropriateness of dose levels and route: appropriate dose and route
- Statistical evaluation: no statistically significant effects
Any other information on results incl. tables
Table 2 Test 1 Acute study
Compound |
Dose (mg/kg bw) |
Time |
Mitotic index |
% cells with aberrations |
Negative control |
saline |
6 |
6 |
0 |
24 |
12 |
0 |
||
48 |
12 |
0 |
||
Low level |
1.20 |
6 |
5 |
0.4 |
24 |
9 |
0 |
||
78 |
7 |
0 |
||
Intermediate level |
12.0 |
6 |
6 |
0.4 |
24 |
10 |
0 |
||
48 |
6 |
0 |
||
LD5 |
120 |
6 |
4 |
0 |
24 |
8 |
0.9 |
||
48 |
7 |
0 |
||
Positive control |
0.3 |
48 |
5 |
30 |
Table 3 Test 1 Subacute study
Compound |
Dose (mg/kg bw) |
Mitotic index |
% cells with aberrations |
Negative control |
saline |
5 |
0 |
Low level |
1.20 |
4 |
0 |
Intermediate level |
12.0 |
5 |
0 |
LD5 |
120 |
4 |
0 |
Table 4 Test 2 Acute study
Compound |
Dose (mg/kg bw) |
Time |
Mitotic index |
% cells with aberrations |
Negative control |
saline |
6 |
3.67 |
0 |
24 |
2.86 |
3 |
||
48 |
5.16 |
5 |
||
Intermediate level |
500 |
6 |
3.45 |
0 |
24 |
3.20 |
1 |
||
48 |
3.90 |
1 |
||
High level |
3500 |
6 |
4.47 |
29 |
24 |
3.47 |
0 |
||
48 |
5.73 |
0 |
||
Positive control |
0.3 |
48 |
1.06 |
101 |
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Citric acid has been tested according to a protocol that is similar to OECD 475. No treatment-related increase in the number of cells with aberrations was observed. Vehicle and positive controls gave expected results. It is concluded that the test substance is negative for the induction of chromosome aberrations in vivo under the conditions of the test.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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