Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 219-411-3 | CAS number: 2432-87-3
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- data from handbook or collection of data
- Justification for type of information:
- Data from peer reviewed journal
Data source
Reference
- Reference Type:
- publication
- Title:
- Final report of the Cosmetic Ingredient Review Expert Panel on the safety assessment of dicarboxylic acids, salts, and esters.
- Author:
- Fiume MM, Heldreth B, Eldreth H, Bergfeld WF, Belsito DV, Hill RA, Klaassen CD, Liebler D, Marks JG, Shank RC, Slaga TJ, Snyder PW, Andersen FA
- Year:
- 2 012
- Bibliographic source:
- International Journal of Toxicology, Vol 31, Issue 4_suppl, pp. 5S - 76S, 2012
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: As mentioned below
- Principles of method if other than guideline:
- Skin sensitization study of Diisopropyl sebacate was performed on human by patch test.
- GLP compliance:
- not specified
- Type of study:
- patch test
- Justification for non-LLNA method:
- No data available
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
- Test material form:
- liquid
- Details on test material:
- Name of test material (as cited in study report):Diisopropyl sebacate
Molecular formula : C16H30O4
Molecular weight: 286.411 g/mol
Substance type: Organic
Physical State: Liquid
Constituent 1
- Specific details on test material used for the study:
- Name of test material (as cited in study report):Diisopropyl sebacate
Molecular formula : C16H30O4
Molecular weight: 286.411 g/mol
Substance type: Organic
Physical State: Liquid
In vivo test system
Test animals
- Species:
- other: Human
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals and environmental conditions:
- No data available
Study design: in vivo (non-LLNA)
Induction
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
Challenge
- No.:
- #1
- Route:
- epicutaneous, occlusive
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- 100%
- No. of animals per dose:
- 107
- Details on study design:
- Details on study design
RANGE FINDING TESTS:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures:3
- Exposure period:24hr
- Test groups:107
- Control group: no data
- Site:2cm x2cm area of skin on right upper arm
- Frequency of applications: During weeks 1,2 and 3
- Duration:4 weeks
- Concentrations:100%
B. CHALLENGE EXPOSURE
- No. of exposures:1
- Day(s) of challenge: During 6 weeks
- Exposure period:24hr
- Test groups:105
- Control group: No data
- Site: No data
- Concentrations:100%
- Evaluation (hr after challenge):After 24 hr - Challenge controls:
- No data available
- Positive control substance(s):
- not specified
Study design: in vivo (LLNA)
- Statistics:
- No data available
Results and discussion
- Positive control results:
- No data available
In vivo (non-LLNA)
Results
- Reading:
- 1st reading
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 100%
- No. with + reactions:
- 0
- Total no. in group:
- 105
- Clinical observations:
- No skin sensitization reaction was noted
- Remarks on result:
- no indication of skin sensitisation
Applicant's summary and conclusion
- Interpretation of results:
- other: Not sensitizing
- Conclusions:
- The Diisopropyl sebacate (7491-02-3) was considered to be not sensitizing to humans.
- Executive summary:
In skin sensitization study, 107 volunteers were tested by patch test at a concentration of 100 % of Diisopropyl sebacate. In induction phase test material applied for 24hr on 2cm x2cm area of skin on right upper arm of each participant as patch.Three induction application given during 1to 4 weeks. After each induction application test site was examined immediately after removal of patch. No clinically significant effect observed during this phase.During week 6, challenge application given to 105 participants and observed for skin reaction. As No skin sensitization reaction was noted therefore, the Diisopropyl sebacate (7491-02-3) was considered to be not sensitizing to humans.
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.
