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Registration Dossier
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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: - | CAS number: -
- 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
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
- Justification for type of information:
- Judged to be scientifically reliable and appropriate for risk assessment by the Expert Panel of dermatologists and scientists at the Cosmetics Ingredient Review, Washington, DC., U.S.A.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 16 CFR 1500.3
- Version / remarks:
- compliant with U.S. CPSC
- Principles of method if other than guideline:
- This summary data provided in a peer-reviewed publication reflects the opinion of the CIR Expert Panel that the test data are valid and informative. The study was commissioned by the Cosmetics, Toiletries and Fragrance Association (CTFA), now the Personal Care Products Council (PCPC), which generally selects OECD-compliant protocols (or FDA protocols which are aligned with OECD guidelines) and requires execution of the study under GLP.
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Trihexyl O-acetylcitrate
- Cas Number:
- 24817-92-3
- Molecular formula:
- C26 H46 O8
- IUPAC Name:
- Trihexyl O-acetylcitrate
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Purity > 99% ATHC, Volatiles 1.4%.
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Female albino rabbits were divided equally into two groups (intact and abraded test sites, respectively). The mean body weight was 2.29 for one group (intact) and 2.81 kg (abraded sites) for the other group.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Skin in one group of animals is abraded, skin of the other group is intact. The test material is applied on gauze and covered with an occlusive dressing for 24 h.
- Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw (2 g/kg).
- No. of animals per sex per dose:
- 5 per sex per dose
- Control animals:
- not required
- Details on study design:
- The animals are observed after the application and at least once daily. The obsrvation period is 14 days. Animals are euthanised at 14 days, and necropsied are undertaken.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- not determinable due to absence of adverse toxic effects
- Mortality:
- No dealths occurred.
- Clinical signs:
- other: No clinical signs of systemic toxiicty.
- Gross pathology:
- No changes were observed in any of the animals tested.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was tested in an acute dermal toxicity study in 10 male/female rabbits at doses of 2000 mg/kg bw. Within the 14-day observation period, there were no deaths or clinical effects among the animals. The LD50 is > 2000 mg/kg bw. The substance does not meet the criteria for classification for acute oral toxicity according to Regulation EC No. 1272/2008.
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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