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Diss Factsheets
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EC number: 249-044-4 | CAS number: 28472-97-1
- 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:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Comparable to Guideline Study with acceptable restrictions.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 976
- Report date:
- 1976
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- 24 hours exposure instead of 4 hours, occlusive instead of semi-occlusive dressing, skin examinations only at 24 and 72 hours, not at 48 hours after patch removal. Lack of details on test substance and test animals.
- Principles of method if other than guideline:
- Federal Hazardous Substances Labeling Act (FHSA)
- GLP compliance:
- no
Test material
- Reference substance name:
- Dibutyl sebacate
- EC Number:
- 203-672-5
- EC Name:
- Dibutyl sebacate
- Cas Number:
- 109-43-3
- Molecular formula:
- C18H34O4
- IUPAC Name:
- dibutyl sebacate
- Details on test material:
- - Name of test material (as cited in study report): Di-Butyl Sebacate
-Analytical purity: No data
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Details on test animals or test system and environmental conditions:
- No data
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- other: clipped back skin
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 mL
- Concentration (if solution): Unchanged test substance - Duration of treatment / exposure:
- 24 hours
- Observation period:
- 72 hours
- Number of animals:
- 6
- Details on study design:
- TEST SITE
- Area of exposure: back skin
- % coverage: 2.5 cm x 2.5 cm
- Type of wrap if used:
The patches consisted of two layers of light gauze cut in squares (2.5 cm x 2.5 cm). The patches were secured to the area by thin bands of adhesive tape. The material to be tested (0.5 mL) was introduced beneath the patch. The entire trunks of the animals were then wrapped in clear plastic trunk bands. The trunk bands helped to hold the patches in position an retarded evaporation of volatile substances during the 24 h exposure.
The animals were immobilized in a special holder during the 24 h exposure period.
SCORING SYSTEM: Draize system
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: average 24 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: 24 hours exposure of intact skin under occlusive coonditions.
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: average 24 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: 24 hours exposure of intact skin under occlusive coonditions.
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: average 24 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: 24 hours exposure of intact skin under occlusive coonditions.
- Irritation parameter:
- erythema score
- Basis:
- animal #4
- Time point:
- other: average 24 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: 24 hours exposure of intact skin under occlusive coonditions.
- Irritation parameter:
- erythema score
- Basis:
- animal #5
- Time point:
- other: average 24 and 72h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72h
- Remarks on result:
- other: 24 hours exposure of intact skin under occlusive coonditions.
- Irritation parameter:
- erythema score
- Basis:
- animal #6
- Time point:
- other: average 24 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: 24 hours exposure of intact skin under occlusive coonditions.
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- other: average 24 and 72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- other: no effects
- Remarks on result:
- other: 24 hours exposure of intact skin under occlusive conditions.
Any other information on results incl. tables
The test substance was not skin irritating, as no edema and only light erythema in 1 out of 6 animals occured which was fully reversible within 72 hours, although the testing was performed according to FHSA, and therefore under more critical conditions than those required for OECD Guideline 404.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
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