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Diss Factsheets
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EC number: 947-263-6 | CAS number: -
- 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 sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 13, 2016 to October 14, 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 guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- Buehler test
- Justification for non-LLNA method:
- A OECD, GLP compliant Buehler study on the test article was commissioned for R&D purposes. Therefore, in the interest of animal welfare it was considered scientifically unjustified to re-run the same study according to the LLNA method.
Test material
- Reference substance name:
- Reaction products of fatty acids, C16-18, C18 unsatd. with Amines, polyethylenepoly-, triethylenetetramine fraction and 3-(C9–C15, C12 rich, alk-1-enyl)dihydro-2,5-furandione
- EC Number:
- 947-263-6
- Cas Number:
- 68478-81-9
- Molecular formula:
- C36H68N4 - C76H136N4O6
- IUPAC Name:
- Reaction products of fatty acids, C16-18, C18 unsatd. with Amines, polyethylenepoly-, triethylenetetramine fraction and 3-(C9–C15, C12 rich, alk-1-enyl)dihydro-2,5-furandione
- Test material form:
- liquid: viscous
- Details on test material:
- - Appearance: Dark red-brown, thick vuscous liquid
- Storage: Ambient room temperature, in a closed container
1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- Dunkin-Hartley
- Sex:
- male
- Details on test animals and environmental conditions:
- Prior to use, all animals were acclimated for at least five days. Animals were individually housed in wire mesh suspension cages. The animals were maintained according to the recommendations contained in teh National Academy Press 2011: ' Guide for the Care and Use of Laboratory Animals' The animals were supplied Purina Guinea Pig Chow and tap water ad libitum during both acclimation and test periods.
ENVIRONMENTAL CONDITIONS:
Light/Dark Cycle : 12 hours light, 12 hour dark cycle
Temperature: 64 - 79 F
Relative Humidity: 30-70%
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- Weekly intervals for 3 weeks
- Adequacy of induction:
- other: The highest non-Irritating concentration
Challenge
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- Day(s)/duration:
- Once
- Adequacy of challenge:
- highest non-irritant concentration
- No. of animals per dose:
- 20
- Details on study design:
- the test substance was evaluated for sensitization potential by applying 0.4 mL at a 100% concentration directly inyo Hilltop Chambers and applying them to the clipped left shoulder of twentu albino guinea pigs in the follwing manner: the animals were held gently, and the chambers were applied as quickly as possible to the clipped left shoulder. The chambers were secured with Micropore tape and further secured with Kendall adhesive tape. Approximately 6 hours later, the tape and chambers were removed. Two additional induction doses were conducted follwoing the same procedure, at weekly intervals.
Two weeks after the final application the animals received a topical primary challenge ( 6 hurs contact) of the test substance at 100% concentration, on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application - Challenge controls:
- Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Six naive control animals received only the primary challemge dose, at a 100% concentration. The four remaining guinea pigs were designated for a re-challenge, if necessary
- Positive control substance(s):
- yes
- Remarks:
- 1-Chloro-2,4-Dinitrobenzene
Results and discussion
In vivo (non-LLNA)
Resultsopen allclose all
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 20
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 1
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Key result
- Reading:
- 2nd reading
- Hours after challenge:
- 48
- Group:
- negative control
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 6
- Remarks on result:
- no indication of skin sensitisation
- Group:
- positive control
- Remarks on result:
- not measured/tested
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The test substance is not considered to be a skin sensitizer based on the results of this study.
- Executive summary:
The test substance was evaluated for sensitization potential by applying 0.4 mL at a 100% concentration directly into Hilltop Chambers and applying them to the clipped left shoulder of twenty albino guinea pigs in the following manner: The animals were held gently, and the chambers were applied as quickly as possible to the clipped left shoulder. The chambers were secured with Micropore tape and further secured with Kendall adhesive tape. Approximatley six hours later, the tape and chambers were removed. Two additional induction doses were conducted following the same procedure, at weekly intervals.
Two weeks after the final applicaton the animals received a topical primary challenge dose ( 6 hours contact) of the test substance at 100% concentration, on a naive site located on the right shoulder. Animals were scored for irritation at 24 and 48 hours after initiation of the primary challenge application.
Ten guinea pigs served as a naive control group, and remained untreated through the induction phase. Six naive control animals received only the primary challenge dose, at a 100% concentration. The four remaining guinea pigs were designated for a re-challenge, if necessary.
Following primary challenge of the test substance, the incidence of grade 1 response or greater in the test group (2 of 20) was compared to that of the naive control group (1 of 6). The incidence and severity of these responses were not significantly greater than those produced by the naive control group indicating that sensitization had not been induced.
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