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Diss Factsheets
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EC number: 946-882-9 | 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
Sensitisation data (human)
Administrative data
- Endpoint:
- sensitisation data (humans)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2005
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Good clinical practices (GCP) statement
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 005
Materials and methods
- Type of sensitisation studied:
- skin
- Study type:
- study with volunteers
Test guideline
- Qualifier:
- no guideline followed
- Version / remarks:
- Methods is in the attached report
- Principles of method if other than guideline:
- To determine the irritation and/or sensitization potential of the test article after repeated application under semi-occlusive patch test conditions to the skin of human subjects
- GLP compliance:
- not specified
- Remarks:
- GCP: Good Clinical Practices
Test material
- Reference substance name:
- Fatty acids, C5-9, hexaesters with dipentaerythritol
- EC Number:
- 267-021-7
- EC Name:
- Fatty acids, C5-9, hexaesters with dipentaerythritol
- Cas Number:
- 67762-52-1
- Molecular formula:
- Not defined because UVCB
- IUPAC Name:
- Fatty acids, C5-9, hexaesters with dipentaerythritol
- Test material form:
- liquid: viscous
- Details on test material:
- Pale yellow liquid
Used as received
Constituent 1
Method
- Type of population:
- general
- Ethical approval:
- confirmed and informed consent free of coercion received
- Subjects:
- - Number of subjects exposed: 55
- Sex: male and female
- Age: between 18 and 70
- Race: no data
- Demographic information: no data
- Other:
Each subject was assigned a permanent CRL identification number. All subject signed an Informed Consent Form in compliance with 21 CFR Part 50: "Protection of Human Subjects" and a HIPAA Authorization Form in compliance with 45 CFR Part 160 and 164. All subject completed a Subject Profile/Medical History Form provided by Clinical Research Laboratories, Inc. prior to the study (Subject Demographics - Appendix I). Subject who met the following criteria were impaneled:
- Male and Female panelists between the ages of 18 and 70
- Subjects who have completed a Panelist Profile/Medical History
- Subjects who are in general good health as determined by a Panelist Profile/Medical History
- Subjects who do not exhibit any skin diseases that might be confused with a skin reaction from the test material
- Subjets who agree to avoid exposure of the test sites to the sun and to refrain from visits to tanning salons during the course of the study
- Subject willing to sign an Informed Consent Form in conformance with 21 CFR Part 50: "Protection of Human Subjects"
- Females who are not pregnant or lactating
- Subjects who demonstrate dependability and intelligence in following directions
- Subjects who are not currently using systemic or topical corticosteroids, anti-inflammatory drugs or antihistamines
- Subjects who do not exhibit skin disorder, sunburn, scars, excessive tatoos, etc. in the test area - Clinical history:
- The subjects did not exhibit any physical or dermatological condition that would have precluded application of the test article.
- Route of administration:
- dermal
- Details on study design:
- See test method in report attached
Results and discussion
- Results of examinations:
- This study was initiated with 56 subjects. One subject discontinued study participation for reasons unrelated to the test material. A total of 55 subjects completed the study.
Individual dermal scores recorded during the Induction and Challenge Phase appear in table 1 (report attached)
Based on the test population of 55 subjects and under the conditions of this study, the test material identified as Fatty acids, C5-9, hexaesters with dipentaerythritol did not demonstrate a potential for eliciting dermal irritation or sensitization
Applicant's summary and conclusion
- Conclusions:
- Based on the test population of 55 subjects and under the conditions of this study, the test material identified as Fatty acids, C5-9, hexaesters with dipentaerythritol did not demonstrate a potential for eliciting dermal irritation or sensitization
- Executive summary:
To determine the irritation and/or sensitization potential of the test article after repeated application under occlusive patch test conditions to the skin of human subjects (non-exclusive panel).
Fifty-six (56) subjects, 6 males and 50 females, ranging in age from 18 to 67 years were impaneled for this test.
The 9 Repeated Insult (semi-occlusive) Patch Test (9 RIPT) was conducted.
Based on the test population of 55 subjects and under the conditions of this study, the test material identified as Fatty acids, C5-9, hexaesters with dipentaerythritol did not demonstrate a potential for eliciting dermal irritation or sensitization
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.