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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-757-7 | CAS number: 110-33-8
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across based on grouping of substances (category approach)
- Adequacy of study:
- weight of evidence
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only abstract available
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Di-(2-ethylhexyl) adipate
- Author:
- BUA
- Year:
- 1 996
- Bibliographic source:
- BUA report 196, S. Hirzel, Wissenschaftliche Verlagsgesellschaft Stuttgart
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- The Draize method was used to assess the skin sensitisation potential of Di-(2-ethylhexyl) adipate on 10 white males guinea pigs.
- GLP compliance:
- not specified
- Type of study:
- Draize test
- Justification for non-LLNA method:
- Study conducted in 1996
Test material
- Reference substance name:
- Bis(2-ethylhexyl) adipate
- EC Number:
- 203-090-1
- EC Name:
- Bis(2-ethylhexyl) adipate
- Cas Number:
- 103-23-1
- Molecular formula:
- C22H42O4
- IUPAC Name:
- bis(2-ethylhexyl) adipate
- Details on test material:
- - Name of test material: Di-(2-ethylhexyl) adipate
- Analytical purity: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- 0.1%
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- olive oil
- Concentration / amount:
- 0.1%
- No. of animals per dose:
- 10
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 10
- Exposure period: 3 weeks
- Site: dorsal flank
- Frequency of applications: 3 times a week
- Duration: 3 weeks
- Concentrations: 0.1% dilution of the test substance in olive oil was used for the intradermal induction
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Concentrations: 0.1% dilution of the test substance in olive oil was used for the intradermal challenge - Positive control substance(s):
- not specified
Results and discussion
In vivo (non-LLNA)
Results
- Remarks on result:
- no indication of skin sensitisation
Any other information on results incl. tables
The skin sensitization potential of 0.1% Di-(2-ethylhexyl) adipate in olive oil was determined in 10 white male guinea pigs. The test material was injected intracutaneously 3 times weekly until a total of 10 injections has been made. The first injection consisted of 0.05 mL of the test material, whereas the subsequent 9 injections consisted of 0.1 mL each. Two weeks following the tenth injection, a challenge injection was made using 0.05 mL of a 0.1% test solution. No skin sensitising potential was observed.
Applicant's summary and conclusion
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.
