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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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- 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
- 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., USA.
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: 16 CFR 1500.41
- Version / remarks:
- U.S. Federal Hazardous Substances Act
- Principles of method if other than guideline:
- Similar to OECD 404 but occlusive exposure to the test material for 24 h. Observation period is 14 days.
- GLP compliance:
- not specified
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
Test animals
- Species:
- rabbit
- Strain:
- other: albino, likely New Zealand white
- Details on test animals or test system and environmental conditions:
- Mean body weight for one group was 2.29 kg (intact) and the other was 2.81 kg (abraded group)
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: intact skin and abraded in separate groups
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 2000 mg/kg bw
- Duration of treatment / exposure:
- 24 h
- Observation period:
- 14 d
- Number of animals:
- 10 total, 5 for intact skin exposure, 5 for abraded skin exposure.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal: 2/5
- Remarks:
- at abraded site
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 h
- Remarks on result:
- other: 1/2 with erythema persisted to day10; erythema was not related to test material application
- Irritation parameter:
- other: Desquamation
- Basis:
- other: 3/5
- Time point:
- other: day 5-6
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 5 days
- Remarks on result:
- other: very slight to slight desquamation
- Irritation parameter:
- other: desquamation
- Remarks:
- in Intact skin group
- Basis:
- other: 2/5
- Time point:
- 7 d
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 h
- Remarks on result:
- other: very slight to slight desquamation
- Irritant / corrosive response data:
- No erythema or edema effects were seen at intact skin sites. No edema was observed in any animal during the study.
Of the animals with abraded skin which displayed erythema, the extent was judged to be very mild (score 1 of 4). This resolved in one animal by day 3, but persisted to day 10 in the second. This was judeged by the study director to be unrelated to ATHC administration.
Desquamation, very slight to slight, was observed in five rabbits (three abraded skin, and two intact skin). The onset was day 5 or 6, and was cleared by day 10. At intact sites, desquamation was observed on day 6 or 7 only.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance was applied to the skin of rabbits in a very aggressive skin irritation protocol (US FHSA, 16 CFR 1500.41). The findings of no effects in intact skin does not meet the criteria for classification under the CLP regulation. The substance is not classified.
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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