Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 215-355-9 | CAS number: 1323-42-8
- 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)
Skin sensitisation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Remarks:
- sumamry
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- GLP compliance:
- not specified
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Test material form:
- solid
- Remarks:
- soft waxy solid or gel
- Details on test material:
- Melting point of 82 deg C; also reported as 75-77 deg C. Crystallizes from alcohol (ethanol). UV absorption maximum at 295 nm. Additional impurity reports: polyvinyl stearate, up to 2.0% (CASRN not reported, but may be 9003-95-6).
Constituent 1
impurity 1
- Specific details on test material used for the study:
- Purity 86%
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
Study design: in vivo (LLNA)
- Vehicle:
- dimethyl sulphoxide
- Concentration:
- 10, 25, 50%
- No. of animals per dose:
- 5
- Details on study design:
- Test material in DMSO was applied to the dorsal surface of each ear of the mice, daily for 3 days. On day 5, tritiated thymidine (3HTdR) was administered via the tail vein.
- Positive control substance(s):
- not specified
Results and discussion
In vivo (LLNA)
Results
- Key result
- Parameter:
- EC3
- Value:
- 16
- Remarks on result:
- other: positive
- Remarks:
- Sensitiser. value units are % TM in vehicle
Any other information on results incl. tables
None of the animals died, and there were no signs of toxicity. The EC3 value was calculated to be 16%. Hydroxystearic acid was considered a sensitiser.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1B (indication of skin sensitising potential) based on GHS criteria
- Conclusions:
- The test substance (12-HSA) was tested in an LLNA using tritiated thymidine in female CBA mice. The results were positive, and 12-hydroxystearic acid was considered a sensitiser. The EC3 value was calculated to be 16%. This summary data reflects the opinion of the CIR Expert Panel that the data are valid and informative, adding to a weight of evidence approach for the sensitisation potential of the test substance.
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.
![ECHA](/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/echa_logo.png)
Sebbene gran parte del materiale online fornito dall'ECHA sia accessibile nella tua lingua, alcuni contenuti di questa pagina sono disponibili solo in inglese. Maggiori informazioni sulla prassi dell'ECHA in materia di multilinguismo.
Benvenuti al sito dell'ECHA. Non tutte le funzionalità del presente sito sono fruibili con Internet Explorer 7 (e versioni precedenti). Aggiornare Internet Explorer a una versione più recente.
Questo sito web si avvale di cookie affinché possiate usufruire della migliore esperienza sui nostri siti web.
Per saperne di più su come utilizziamo i cookie.