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Diss Factsheets
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EC number: 211-103-7 | CAS number: 629-70-9
- 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
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- December 1974
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets generally accepted scientific standards, well documented and acceptable for assessment.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 974
- Report date:
- 1974
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- not applicable
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- investigation took place prior to introduction of GLP
Test material
- Reference substance name:
- Hexadecyl acetate
- EC Number:
- 211-103-7
- EC Name:
- Hexadecyl acetate
- Cas Number:
- 629-70-9
- Molecular formula:
- C18H36O2
- IUPAC Name:
- hexadecyl acetate
- Details on test material:
- - Name of test material (as cited in study report): Acetulan
- Physical state: Cream coloured wax-like material
- Analytical purity: Declared by owner of study report to contain 90 % test item and to be equivalent to the substance described elsewhere in this dossier
- Lot/batch No.: 731
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: albino
- Details on test animals or test system and environmental conditions:
- - The investigation was conducted on six adult albino rabbits selected from healthy, acclimated, animals.
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- other: abraded
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Amount / concentration applied:
- 0.5 mL or 0.5 g
- Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- Six
- Details on study design:
- - The back of each animal was shaved free of hair.
- Intact skin was exposed on the left half of the shaved area.
- The right side of the shaved area was abraded.
- Test material (0.5 mL or 0.5 g) was introduced under a square patch of surgical gauze measuring 1 inch x 1 inch.
- Patches were removed after 24 hours and observations recorded.
- Further observations were made after 72 hours.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animals 1 to 6
- Time point:
- other: 24 h
- Score:
- 1.17
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animals 1 to 6
- Time point:
- other: 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animals 1 to 6
- Time point:
- other: 24 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animals 1 to 6
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: intact skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animals 1 to 6
- Time point:
- other: 24 h
- Score:
- 1.17
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- erythema score
- Basis:
- mean
- Remarks:
- animals 1 to 6
- Time point:
- other: 72 h
- Score:
- 1.33
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animals 1 to 6
- Time point:
- other: 24 h
- Score:
- 0.17
- Max. score:
- 4
- Reversibility:
- no data
- Remarks on result:
- other: abraded skin
- Irritation parameter:
- edema score
- Basis:
- mean
- Remarks:
- animals 1 to 6
- Time point:
- other: 72 h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: not applicable
- Remarks on result:
- other: abraded skin
- Irritant / corrosive response data:
- - Scoring of the effects produced by the test material is shown in Table 1 (attached).
- The test material produced erythema in all six animals with intact and abraded skin.
- The test material produced edema in one animal with abraded skin only.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- On the basis of the data presented, the test sample was considered to be a mild irritant to rabbit skin. Nevertheless, the scores for erythema and edema did not fall within the range requiring classification under the terms of Regulation (EC) No. 1272/2008 for 5 out of 6 animals over a period of 72 hours.
- Executive summary:
METHOD
Acute skin irritation was investigated in the rabbit using a mixture declared to contain 90 % of test item.
RESULTS
The test material produced erythema in all six animals with intact and abraded skin. However, the test material produced edema in one animal with abraded skin only.
CONCLUSION
On the basis of the data presented, the test sample was considered to be a mild irritant to rabbit skin. Nevertheless, the scores for erythema and edema did not fall within the range requiring classification under the terms of Regulation (EC) No. 1272/2008 for 5 out of 6 animals over a period of 72 hours.
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