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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
Endpoint summary
Administrative data
Description of key information
Based on the available data the test item is not sensitising.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Remarks:
- existing human data and experience
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Human Repeat Insult Patch Test (HRIPT)
- GLP compliance:
- no
- Type of study:
- patch test
- Justification for non-LLNA method:
- Human data are available from a human patch test. Thus no LLNA test is necessary.
- Species:
- other: human
- Route:
- epicutaneous, semiocclusive
- Vehicle:
- other: cuticle cream
- Concentration / amount:
- 4%
- Day(s)/duration:
- 21 d
- Adequacy of induction:
- not specified
- Details on study design:
- HRIPT; semi-occlusive patches applied 3x/wk for 3 wks; a challenge patch was applied after 2 wks.
- Key result
- Reading:
- 1st reading
- Group:
- test chemical
- Dose level:
- 4%
- No. with + reactions:
- 0
- Total no. in group:
- 56
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on several studies on citric salts and organic citrate derivatives the CIR Expert Panel concludes the following:
Alkyl derivatives of citric acid might have sensitising properties as the study results are ambigous.
Metal citrates do only have to be considered to be sensitising if caused my the metal moiety of the substance. As alkali metal ions are nonb as non sensitising, those metal salt containing only sodium, potassium and hydrogen can be stated as not sensitising. - Executive summary:
The assessment report states regarding citric salts and compounds:
In sensitization testing, a cuticle cream containing 4% citric acid was not an irritant or a sensitizer in humans.
2.5% aq. citric acid produced positive results in skin prick test in 3 of 91 urticaria or anigoedema patients.
Triethyl citrate, applied undiluted during epidermal induction, was a strong sensitizer in a guinea-pig maximization test, but 20% in pet. was not a primary irritant or sensitizer in human studies.
Trioctyldodecyl citrate was a mild sensitizer in a local lymph node assay when applied neat, but the same concentration was not an irritant or sensitizer in human studies.
Tributyl citrate (concentration not stated) was not a sensitizer in animal studies.
In human studies, 25% tristearyl citrate and 100% triisostearyl citrate were not irritants or sensitizers in repeated insult patch tests.
- Endpoint:
- skin sensitisation: in vitro
- Data waiving:
- study scientifically not necessary / other information available
- Justification for data waiving:
- an in vitro skin sensitisation study does not need to be conducted because adequate data from an in vivo skin sensitisation study are available
Referenceopen allclose all
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
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.
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