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Diss Factsheets
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EC number: 268-103-5 | CAS number: 68002-88-0 This substance is identified by SDA Substance Name: C16-C22 alkyl carboxylic acid and SDA Reporting Number: 21-005-00.
- 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://chesar.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Reliable without restriction, test procedure according to national standards (DIN, etc.). Tested with the source substance CAS 57-11-4. In accordance to the ECHA guidance document "Practical guide 6: How to report read-across and categories (March 2010)", the reliability was changed from RL1 to RL2 to reflect the fact that this study was conducted on a read-across substance.
Data source
Referenceopen allclose all
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
- Reference Type:
- secondary source
- Title:
- Final report of the safety assessment for oleic acid, lauric acid, palmitic acid, myristic acid, stearic acid
- Author:
- CIR
- Year:
- 1 987
- Bibliographic source:
- JACT, 6(3): 321-401
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Patch test / Revised (1964) Federal Hazardous Substance Act
- Deviations:
- not specified
- GLP compliance:
- no
Test material
- Reference substance name:
- Stearic acid
- EC Number:
- 200-313-4
- EC Name:
- Stearic acid
- Cas Number:
- 57-11-4
- Molecular formula:
- C18H36O2
- IUPAC Name:
- stearic acid
- Details on test material:
- - Analytical purity: no data given
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not specified
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- Fur was removed from the back of each of six rabbits by clipping the saddle of the trunk area. One area of skin was abraded by making minor incisions with a hypodermic needle. 0.5 ml of test material was applied to 1 in2 gauze patches. The patches were placed on both intact skin and abraded skin of each rabbit and secured with adhesive tape, rubber dental damming secured with staples, and gauze wound loosely around the trunk. The animals were then immobilized for 24 hours in wooden stocks. After 24 hours, the patches were removed and the skin cleaned by gently sponging with a moistened towel. The skin was examined immediately after removal of the patches (24 hr reading) and again at 72 hrs. At each examination the skin was scored for presence and severity of erythema/eschar formation and edema formation.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- primary dermal irritation index (PDII)
- Basis:
- other:
- Time point:
- other: 24 hours
- Score:
- 0
- Max. score:
- 8
- Reversibility:
- other: not effects noted
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Scores were not determined at the 48-h reading time point, however since the erythema score was 0 at the 24-h and 72-h reading time point, the same was considered for the 48-h reading time point.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Scores were not determined at the 48-h reading time point, however since the erythema score was 0 at the 24-h and 72-h reading time point, the same was considered for the 48-h reading time point.
- Irritant / corrosive response data:
- No signs of skin irritation were observed on intact or abraded sites at either scoring time point.
Any other information on results incl. tables
Material (0.5 ml) was applied via a one-inch-square surgical gauze patch to intact and abraded-skin sites. Patches were held in place for 24 hours. Reactions were scored immediately after patch removal and two days later (72 hours).
Scores for Skin Irritation
Rabbit No. |
24 hrs |
72 hrs |
|
43 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
44 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
45 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
46 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
47 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
48 |
Intact Erythema-Eschar Edema Abraded Erythema-Eschar Edema |
0 0 0 0 |
0 0 0 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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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