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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

Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- 16 Sep - 25 Oct 2002
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Meets national standard methods with acceptable restrictions
Data source
Reference
- Reference Type:
- other: report on study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Marzulli and Maibach method
- Deviations:
- yes
- Remarks:
- no volume of the applied substance specified
- GLP compliance:
- not specified
- Remarks:
- GCP
Test material
- Reference substance name:
- Diisopropyl sebacate
- EC Number:
- 231-306-4
- EC Name:
- Diisopropyl sebacate
- Cas Number:
- 7491-02-3
- Molecular formula:
- C16H30O4
- IUPAC Name:
- diisopropyl sebacate
- Details on test material:
- - Name of test material (as cited in study report): only trade name given
- Analytical purity: 100%
- LOT: 02060013
Constituent 1
Method
- Type of population:
- general
- Subjects:
- - Number of subjects exposed: 55, however only 51 subjects were available at study termination.
- Sex: 13 male, 42 female
- Age: 18-69 years - Route of administration:
- dermal
- Details on study design:
- TYPE OF TEST(S) USED: other immunological tests: Marzulli and Maibach Method
ADMINISTRATION
- Type of application: For induction, occlusive exposure for 48 hours, three times a week for three weeks on the back was performed. After a two week recovery period, a challenge exposure was performed under an occlusive dressing for 48 h either on the same site as the induction or another site that had never had contact with the test substance.
- Description of patch: occlusive strip with Flexcon(TruMed Technologies Inc., Burnsville, Minnesota)
- Vehicle / solvent: no
- Concentrations: undiluted test substance (100%)
- Volume applied: no data
EXAMINATIONS
- Grading/Scoring system: see table 1
- Other: After each induction exposure, cutaneous reactions were evaluated directly as well as 24 and 48 h after patch removal.
Results and discussion
- Results of examinations:
- SYMPTOMS
- Frequency, level, duration of symptoms observed: No significant reaction attributable to sensitisation was observed in the 51 volunteers finishing the study.
NO. OF PERSONS WITH/OUT REACTIONS COMPARED TO STUDY POPULATION
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 51 (not all subjects finished study up to challenge)
- Number of subjects with irritating reactions: 0/53 (not all subjects continued study up to induction)
Any other information on results incl. tables
Table 2: Subjects with positive reactions at the study stages
Study stage |
Subjects with positive reactions/all subjects* |
Induction day 1 |
0/53 |
Induction day 2 |
0/53 |
Induction day 3 |
0/52 |
Induction day 4 |
0/51 |
Induction day 5 |
0/51 |
Induction day 6 |
0/51 |
Induction day 7 |
0/51 |
Induction day 8 |
0/51 |
Induction day 9 |
1/50** |
48h after challenge |
0/51 |
72h after challenge |
0/50 |
96h after challenge |
0/48 |
* The number of subjects changed during the study because of subjects that didn't continue the study or subjects that were not present at single observation days.
** None of the subjects showed any sensitisation to the test material and only one showed slight irritation (+) at day 9 of induction. The test material at 100% when applied to the human skin is not irritating and not sensitising.
Applicant's summary and conclusion
- Conclusions:
- In a study with human volunteers the test substance did not show a skin sensitisation potential.
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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