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EC number: 201-069-1 | CAS number: 77-92-9
- 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
An acute oral LD50 value of 5400 mg/kg bw in mouse is reported in a reliability 2 study which is broadly equivalent to the OECD test guideline 401 (Roche 1981).
An acute dermal LD50 value of >2000mg/kg bw in rat was determined in a reliable study conducted according to OECD 402 and in compliance with GLP (Safepharm, 2006; rel 1).
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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
- Remarks:
- Equivalent to guideline study with acceptable restrictions.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- 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
- 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 - Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- 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
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 400 mg/kg bw
- 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.
- Interpretation of results:
- GHS criteria not met
- Remarks:
- Criteria used for interpretation of results: EU
- 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.
Reference
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 |
|
Combined (5 male, 5 female)* |
2 h |
24 h |
||
Control |
0/10 |
- |
none |
none |
3 |
0/10 |
- |
none |
none |
4.2 |
2/10 |
24 h |
none |
none |
6 |
7/10 |
24 h |
slight relaxation |
none |
8.5 |
10/10 |
24 h |
death |
- |
12 |
10/10 |
24 h |
death |
- |
* Separate data for each sex not given
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 5 400 mg/kg bw
Acute toxicity: via inhalation route
Endpoint conclusion
- Endpoint conclusion:
- no study available
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 21/10/2004-23/01/2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- The study was conducted according to the appropriate OECD guideline and in complikance with GLP.
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River (UK) Ltd, Margate, Kent, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: minimum 200g
- Housing: solid-floor polypropylene cages furnished with woodflakes. Individually housed during the exposure nperiod and in groups of five, by sex, for the remainder of the study.
- Diet: Certified rat and mouse diet (code 5LF2), ad libitum
- Water: mains drinking water, ad libitum
- Acclimation period: minimum 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25
- Humidity (%): 30-70
- Air changes (per hr): minimum 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: To: - Type of coverage:
- semiocclusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- TEST SITE
- Area of exposure: the back
- % coverage: 10%
- Type of wrap if used: surgical gauze, semi-occluded with a piece of self-adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing (if done): the bandage was removed after the exposure period, and the treated skin and surrounding hair wiped with cotton wool moistened with distilled water to remove any residual test material.
- Time after start of exposure: 24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg
- For solids, paste formed: no. The appropriate amount of test material, moistened with distilled water, was applied as evenly as possible - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg
- No. of animals per sex per dose:
- 5M,5F
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed for deaths and overt signs of toxicity 1/2, 1, 2 and 4 hours after dosing. Individual bopdy weights were recorded prior to application of the test material on day 0 and on days 7 and 14.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: The gross necropsy consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. - Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- There were no deaths.
- Clinical signs:
- other: There were no signs of systemic toxicity.
- Gross pathology:
- No abnormalities were noted at necropsy.
- Other findings:
- None reported.
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value of >2000mg/kg bw was determined in a reliable study conducted according to an appropriate test protocol.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
- Dose descriptor:
- LD50
- Value:
- 2 000 mg/kg bw
Additional information
Citric acid has low toxicity via the oral route as reflected by the LD50 of 5400 mg/kg bw in mouse reported in the key study (Roche, 1981; Rel 2).
A second, reliability 2 study further supports this finding with LD50 values of 5790 mg/kg bw and 11700 mg/kg bw in mouse and rat respectively (Yokotani 1971). The study by Roche in mouse was chosen as the key study because it is the most recent, with observation period closer to that of guideline (10 days) than in the study by Yokotani (7 days) in rat. This choice has no implication on classification, although the LD50 in rat in the supporting study appears to be significantly higher relative to the result in mouse in the key study. No reliable data are available for the inhalation route, although two reports on the tussigenic potential of citric acid are included (Zelenak 1982, Forsberg and Karlsson, 1986; rel 4).
Citric acid has low acute toxicity via the dermal route, with and LD50 of >2000 mg/kg bw in rat (Safepharm, 2006; Rel 1).
Justification for classification or non-classification
Based on the available information on the acute oral and dermal toxicity of citric acid, no classification is required according to Regulation (EC) No. 1272/2008.
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