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EC number: 244-971-0 | CAS number: 22413-03-2
- 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:
- weight of evidence
- Study period:
- 07 Sep - 24 Nov 2016
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- Report date:
- 2016
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 2002
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Version / remarks:
- adopted 2015
- Deviations:
- no
- GLP compliance:
- no
- Remarks:
- The study was conducted to meet the requirement of a regulation (Japan) other than Regulation (EC) No. 1907/2006 and therefore not conducted according to GLP.
Test material
- Reference substance name:
- Docosyl stearate
- EC Number:
- 244-971-0
- EC Name:
- Docosyl stearate
- Cas Number:
- 22413-03-2
- Molecular formula:
- C40H80O2
- IUPAC Name:
- docosyl octadecanoate
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: Japanese White rabbits (Jla:JW)
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: JLA, INC.
- Age at study initiation: 18 weeks
- Weight at study initiation: 2.94 - 3.38 kg
- Housing: The animals were individually housed in aluminium cages (W 560 x D 550 x H 410 mm) and given a plastic chain (polyethylene) as the environmental enrichment.
- Diet: RC4 pelleted diet (Oriental Yeast Co., Ltd., Lot No. 160518 and 160613), ad libitum
- Water: Tap water, ad libitum
- Acclimation period: Yes, 14 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 24
- Humidity (%): 42 - 66
- Air changes (per hr): 11 - 14
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 07 Sep 2016 To: 24 Nov 2016
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- water
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied: 0.5 g
VEHICLE
- Amount(s) applied: 0.5 mL - Duration of treatment / exposure:
- Initial test: 3 min, 1 and 4 h
Confirmatory test: 4 h - Observation period:
- 1, 24, 48 and 72 h
- Number of animals:
- 3
- Details on study design:
- TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- Type of wrap: At the 3-min and 1-h exposure duration, the applied lint patch was covered with a tape [Tegaderm (3M Health Care)]. At the 4-h exposure duration, the applied lint patches (control and test substance) were covered with an elastic bandage [3M Coban Self-Adherent Wrap (3M Health Care)] and fixed with polyethylene film tape [KEEPPORE A (Nichiban Co., Ltd.)].
REMOVAL OF TEST SUBSTANCE
- Washing: The application sites were wiped with absorbent cotton soaked with water for injection [Lot No. 5J84 (Otsuka Pharmaceutical Factory, Inc.)].
- Time after start of exposure: 3 min, and 1 and 4 h, respectively
OBSERVATION TIME POINTS
1, 24, 48 and 72 h
SCORING SYSTEM:
- Method of calculation: Draize scoring system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Remarks:
- 4 h of exposure
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Remarks:
- 1 h of exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- erythema score
- Remarks:
- 3 min of exposure
- Basis:
- animal #1
- Time point:
- other: 1 and 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Test was discontinued since no signs of skin icorrosion (full thickness necrosis) were observed.
- Irritation parameter:
- edema score
- Remarks:
- 4 h of exposure
- Basis:
- mean
- Remarks:
- of all 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Remarks:
- 1 h of exposure
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Irritation parameter:
- edema score
- Remarks:
- 3 min of exposure
- Basis:
- animal #1
- Time point:
- other: 1 and 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: Test was discontinued since no signs of skin icorrosion (full thickness necrosis) were observed.
- Irritant / corrosive response data:
- There were no skin corrosive or irritating reactions on any application site of the test substance (sites for 3-min, 1-h or 4-h exposure) of any animal at any observation point.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required 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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