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Diss Factsheets
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EC number: 222-775-6 | CAS number: 3609-96-9
- 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 4 March 1981 to 3 April 1981
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 1981
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- Study was conducted equivalent to the not longer valid Guideline OECD 401.
- Principles of method if other than guideline:
- Groups of 5 mice of each sex were given a single gavage dose with observation for mortality for 10 days. Clinical observations were made at 2 h and 24 h after treatment; body weights
were only recorded prior to dosing. The observation period was 10 days instead of 14 recommended by guideline. - GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- no
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
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: Füllinsdorf Albino (SPF)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hoffmann-La Roche & Co. Ltd, Company breeding farm: Tierfarm Füllinsdorf. (no further details)
- Age at study initiation: not stated
- Weight at study initiation: 20 g
- Fasting period before study: not stated
- Housing: 5/Macrolon type III cage
- Diet: standard diet ad libitum
- Water: drinking water ad libitum
- Acclimation period: not stated
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1
- Humidity (%): 50 +/- 10
- Air changes (per hr): 20-25
- Photoperiod (hrs dark / hrs light): 12 h/12 h
IN-LIFE DATES: (main study) From: 1981-03-24 To:1981-04-03
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- Concentration in vehicle: (main study) 150-600 mg/ml
MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw - Doses:
- 0, 3, 4.2, 6, 8.5, 13 g/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 10 days
- Frequency of observations and weighing: clinical observations at 2 h and 24 h following treatment; observation for mortality daily for 10 days; body weights recorded only prior to
treatment
- Necropsy of survivors performed: no
- Other examinations performed: none - Statistics:
- probit analysis
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 400 mg/kg bw
- Based on:
- test mat.
- 95% CL:
- >= 4 500 - <= 6 400
- Remarks on result:
- other: observation limited to 10 days
- Mortality:
- No deaths at 3 g/kg bw, death of all exposed within 24 h at 8.5 g/kg bw, and above. See table 1.
- Clinical signs:
- other: Clinical observations were limited to 2 h and 24 h after treatment; the descriptions given are very limited. See table 1.
- Gross pathology:
- Not examined.
- Other findings:
- None.
Any other information on results incl. tables
Table 1: Number of animals dead and with evident toxicity and time range within which mortality occurred
Dose | Mortality (dead/total) | Time of death (within) | Overt toxicity | |
(g/kg bw) | Combined (5 male, 5 female)* | 2 h | 24 h | |
0 (control) | 0/10 | - | none | none |
3.0 | 0/10 | - | none | none |
4.2 | 2/10 | 24 h | none | none |
6.0 | 7/10 | 24 h | slight relaxation | none |
8.5 | 10/10 | 24 h | death | - |
12.0 | 10/10 | 24 h | death | - |
* Separate data for each sex not given
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A study conducted according to a protocol that was similar to OECD 401, but limited in some respects and without GLP status, identified an acute oral LD50 value of 5.4 g/kg bw for male and female mice.
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