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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-366-1 | CAS number: 106-14-9
- 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro cytogenicity / chromosome aberration study in mammalian cells
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- No data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Secondary literature source with limited documentation, but used in the CIR report for the assessment of 12-hydrosystearic acid and meets generally accepted scientific principles, acceptable for assessment.
- Justification for data waiving:
- other:
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- review article or handbook
- Title:
- Amended final report on the safety assessessment of hydroxystearic acid (Reviewed by the Cosmetic Ingredient Review Expert Panel)
- Author:
- Cosmetic Ingredient Review (CIR) Panel
- Year:
- 1 999
- Bibliographic source:
- Int. J. of Toxicol., 18 (Suppl. 1): 1-10
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 473 (In Vitro Mammalian Chromosome Aberration Test)
- Principles of method if other than guideline:
- Not applicable.
- GLP compliance:
- not specified
- Type of assay:
- in vitro mammalian chromosome aberration test
Test material
- Reference substance name:
- 12-hydroxystearic acid
- EC Number:
- 203-366-1
- EC Name:
- 12-hydroxystearic acid
- Cas Number:
- 106-14-9
- Molecular formula:
- C18H36O3
- IUPAC Name:
- 12-hydroxyoctadecanoic acid
- Details on test material:
- - Name of test material (as cited in study report): 12-hydroxystearic acid
-Composition:
Hydroxystearic Acid, 94.9%;
Stearic Acid, 8%;
Palmitic Acid, 1%;
Triglyceride (castor oil), 5%; and
Tolyvinyl stearate <1%
Constituent 1
Method
- Target gene:
- Not applicable
Species / strain
- Species / strain / cell type:
- Chinese hamster Ovary (CHO)
- Details on mammalian cell type (if applicable):
- No data
- Additional strain / cell type characteristics:
- not specified
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor 1254-induced rat liver S-9
- Test concentrations with justification for top dose:
- In both initial and repeat tests doses ranged from 4 to 213 µg/mL in DMSO (vehicle) for 6, 18 and 42 h in the absence of S9 reaction mixture and for only 6 h in the presence of S9 mixture
- Vehicle / solvent:
- - Vehicle(s)/solvent(s) used: Dimethyl sulfoxide (DMSO)
Controlsopen allclose all
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- other: N-methyl-NP-nitro-N-nitrosoguanidine (MNNG)
- Remarks:
- 2 microgram/mL N-methyl-N'-nitro-N-nitrosoguanidine (MNNG), was used as the positive control for nonactivated cultures
- Untreated negative controls:
- yes
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- yes
- Positive controls:
- yes
- Positive control substance:
- benzo(a)pyrene
- Remarks:
- 30 microgram/mL Benzo(a)pyrene was used as positive control for activated cultures
- Evaluation criteria:
- No data
- Statistics:
- No data
Results and discussion
Test results
- Species / strain:
- Chinese hamster Ovary (CHO)
- Metabolic activation:
- with and without
- Genotoxicity:
- not determined
- Cytotoxicity / choice of top concentrations:
- no cytotoxicity
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative
Under the conditions of the study, the test substance did not induce a significant increase in chromosomal aberrations and was therefore considered to be negative in the CHO cytogenetic study. - Executive summary:
An in vitro cytogenetic study was conducted using Chinese hamster ovary (CHO) cells to determine the mutagenicity of the test substance.
In both initial and repeat tests doses ranged from 4 to 213 µg/mL in DMSO (vehicle) for 6, 18 and 42 h in the absence of S9 reaction mixture and for only 6 h in the presence of S9 mixture.
In the definitive assay, survival at the highest dose level scored was 52% in the non-activated 6 h treatment study; 48% in the non-activated 18 h treatment study; 44% in the non-activated 42 h treatment study and 82% in the S9 activated study.
The three highest doses with 200 scorable metaphase cells in the 6, 18 and 42 h treatment studies were selected for analysis. The test substance did not induce a statistically significant increase in structural or numerical chromosome aberrations in either the absence or presence of S9 activation, regardless of the treatment condition or harvest time.
Under the conditions of the study, the test substance did not induce a significant increase in chromosomal aberrations and was therefore considered to be negative in the CHO cytogenetic study.
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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