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EC number: 814-233-8 | CAS number: 444649-70-1
- 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:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From May 14, 2001 to May 18, 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2500 (Acute Dermal Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Neodecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
- Molecular formula:
- C16H28O5
- IUPAC Name:
- Neodecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
- Reference substance name:
- Neo undecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
- Molecular formula:
- C17H30O5
- IUPAC Name:
- Neo undecanoic acid, 1-ester with 1,2,3-propanetriol mono-2-propenoate
- Reference substance name:
- glycerol 1,3-dineodecanoate
- Molecular formula:
- C23H44O5
- IUPAC Name:
- glycerol 1,3-dineodecanoate
- Reference substance name:
- Sum of other constituents, each of them at <1%
- Molecular formula:
- Not available
- IUPAC Name:
- Sum of other constituents, each of them at <1%
- Test material form:
- liquid
Constituent 1
Constituent 2
Constituent 3
Constituent 4
- Specific details on test material used for the study:
- Batch no.: F016143 05
Appearance: Light-yellow, clear viscous liquid
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Remarks:
- females
- Details on test animals or test system and environmental conditions:
- Source: Charles River Wiga, D-97633
Acclimatization: 5 days
Body weight: 2.0-2.4 kg
Temperature: ca. 20.3°C, relative humidity : ca. 58.8% and light regimen: 12-hour light /12-hour dark cycle
Diet: laboratory food Altromin 2123, ad libitum
Water: tap water for human consumption, ad libitum
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- clipped
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- 0.5 mL
- Duration of treatment / exposure:
- 4 h
- Observation period:
- 1, 24, 48 and 72 h after patch removal
- Number of animals:
- 3
- Details on study design:
- - Hair was clipped on the dorsal areas of the trunks one day before the application of the test substance. The test sites were median on the dorsal thoracal region. 0.5 mL of the test substance was applied via a cellulose patch to a site of about 2.5 cm x 2.5 cm of the intact skin of each of 3 rabbits and covered by a semi-occlusive dressing.
- The skins were examinated for local alterations one day before the administration of the test substance (after clipping of the hair) and immediately before the administration. The treated areas and the surrounding untreated skin (control area) of the animals were examinated (using a cold light source KL 1500 electronic) for erythema/eschar and oedema as well as for other local alterations approximately 1, 24, 48 and 72h after patch removal. The animals were analysed once daily.
- Primary irritation index was calculated according to EPA: all scores for erythema and oedema for the 3 animals and the 4 reading times were added and divided by 12.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 0
- Max. score:
- 0
- Reversibility:
- other: no effects were seen
- Remarks:
- no effects were seen
- Remarks on result:
- no indication of irritation
- Irritant / corrosive response data:
- All exposed skin sites were normal at each examination term; neither erythema/eschar nor oedema were observed. The primary irritation index was 0.0. The test substance was considered not irritating to the skin.
- Other effects:
- No general toxic effects of the test substance were observed.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Remarks:
- does not need to be classified
- Conclusions:
- Under the study conditions, the test substance was considered not irritating to rabbit skin.
- Executive summary:
An in vivo study was conducted to determine the skin irritation potential of the test substance according to OECD Guideline 404, EU Method B.4 and EPA-Guideline OPPTS 870.2500, in compliance with GLP. Hair of 3 female rabbits (New-Zealand White) was clipped on the dorsal areas of the trunks one day before the application of the test substance. 0.5 mL of the test substance was applied via a cellulose patch to a site of about 2.5 cm x 2.5 cm of the intact skin of each of 3 rabbits and covered by a semi-occlusive dressing. The skins were examined for local alterations one day before the administration of the test substance (after clipping of the hair) and immediately before the administration. The treated areas and the surrounding untreated skin (control area) of the animals were examined for erythema/eschar and oedema as well as for other local alterations approximately 1, 24, 48 and 72h after patch removal. The animals were analysed once daily. Primary irritation index was calculated according to EPA: all scores for erythema and oedema for the 3 animals and the 4 reading times were added and divided by 12. No general toxic effects of the test substance were observed. All exposed skin sites were normal at each examination term; neither erythema/eschar nor oedema was observed. The primary irritation index was 0.0. Under the study conditions, the test substance was considered not irritating to the skin (Wolf, 2001).
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