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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)
Endpoint summary
Administrative data
Description of key information
A reliable study for skin irritation on citric acid conducted largely in accordance with OECD 404 and in compliance with GLP, found the citric acid to be mildly irritating to the skin of rabbits. Current EC criteria would find the material to be non-irritant.
A generally reliable study for eye irritation on citric acid, apparently conducted according to OECD 405 and GLP, reported that a 30% aqueous solution of the test substance caused well defined to moderate
conjunctival irritation that had not fully resolved after 14 days. A 10% solution was associated with weak to moderate conjunctival effects, resolved after 7 days. Given the 30% solution
effects would have been allowed to dissipate for 21 days, it is likely the test substance would not be considered irritating to the eyes according to EU criteria (please see attached expert
letter as reference).
Key value for chemical safety assessment
Skin irritation / corrosion
Link to relevant study records
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- from 22 to 24 Feb 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped: abraded and non-abraded
- Vehicle:
- water
- Controls:
- not required
- Duration of treatment / exposure:
- 4 h
- Observation period:
- observed at 0, 20 and 44 h following 4-h exposure
- Number of animals:
- 3
- Details on study design:
- Tested as 30% aqueous solution on intact and abraded skin under an occlusive covering. Examined at 0, 20 and 44 h following 4 -h exposure;. Current guidelines recommend
examination at 1, 24, 48 and 72 h, or until resolution of effects. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- (of all 3 animals)
- Time point:
- other: 0, 20, 44 h following 4-h exposure
- Score:
- 0.8
- Max. score:
- 8
- Reversibility:
- other: not fully reversible within: 44 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- (of all 3 animals)
- Time point:
- other: 0, 20, 44 h following 4-h exposure
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- no indication of irritation
- Other effects:
- -
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A study conducted largely in accordance with OECD 404, but without GLP and using an occlusive dressing, found citric acid to be non-irritant to the intact skin of rabbits. The PII score of 0.8/8, reflecting effects in abraded skin, was said to indicate a material that would be classified as non-irritant. Current EC criteria would concur with this finding.
- Endpoint:
- skin irritation: in vivo
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from 22 to 24 Feb 1984
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Justification for type of information:
- Potassium citrate salts are known to show a very high solubility in water and dissociate rapidly.
Potassium in known to be non-toxic. The toxicity is determined by the citrate moiety of the substance.
Because of that a read-across to citric acid is suitable for the determination of the toxicity. - Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- no
- Species:
- rabbit
- Strain:
- New Zealand White
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped: abraded and non-abraded
- Vehicle:
- water
- Controls:
- not required
- Duration of treatment / exposure:
- 4 h
- Observation period:
- observed at 0, 20 and 44 h following 4-h exposure
- Number of animals:
- 3
- Details on study design:
- Tested as 30% aqueous solution on intact and abraded skin under an occlusive covering. Examined at 0, 20 and 44 h following 4 -h exposure;. Current guidelines recommend
examination at 1, 24, 48 and 72 h, or until resolution of effects. - Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- mean
- Remarks:
- (of all 3 animals)
- Time point:
- other: 0, 20, 44 h following 4-h exposure
- Score:
- 0.8
- Max. score:
- 8
- Reversibility:
- other: not fully reversible within: 44 h
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- overall irritation score
- Basis:
- mean
- Remarks:
- (of all 3 animals)
- Time point:
- other: 0, 20, 44 h following 4-h exposure
- Score:
- 0
- Max. score:
- 8
- Remarks on result:
- no indication of irritation
- Other effects:
- -
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- A study conducted largely in accordance with OECD 404, but without GLP and using an occlusive dressing, found citric acid to be non-irritant to the intact skin of rabbits. The PII score of 0.8/8, reflecting effects in abraded skin, was said to indicate a material that would be classified as non-irritant. Current EC criteria would concur with this finding.
Referenceopen allclose all
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test.
Score at time point / Reversibility | Erythema/eschar | Edema |
Intact skin | Max. score: 4 | Max. score: 4 |
0 h | 0/0/0 | 0/0/0 |
20 h | 0/0/0 | 0/0/0 |
44 h | 0/0/0 | 0/0/0 |
Average 0 h, 20 h, 44 h | 0 | |
Abraded skin | ||
0 h | 1/1/2 | 1/1/1 |
20 h | 1/1/1 | 0/0/1 |
44 h | 1/1/1 | 0/0/1 |
Average 0 h, 20 h, 44 h | 1.7 | |
Intact and abraded skin: average 0, 20, 44 h | 0.8 |
Table 1: Irritant/corrosive response data for each animal at each observation time up to removal of each animal from the test.
Score at time point / Reversibility | Erythema/eschar | Edema |
Intact skin | Max. score: 4 | Max. score: 4 |
0 h | 0/0/0 | 0/0/0 |
20 h | 0/0/0 | 0/0/0 |
44 h | 0/0/0 | 0/0/0 |
Average 0 h, 20 h, 44 h | 0 | |
Abraded skin | ||
0 h | 1/1/2 | 1/1/1 |
20 h | 1/1/1 | 0/0/1 |
44 h | 1/1/1 | 0/0/1 |
Average 0 h, 20 h, 44 h | 1.7 | |
Intact and abraded skin: average 0, 20, 44 h | 0.8 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not irritating)
Additional information
Justification for classification or non-classification
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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