Registration Dossier
Registration Dossier
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EC number: 203-090-1 | CAS number: 103-23-1
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
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- German Chemical Society Advisory Committee on Existing Chemicals of Environmental Relevance. Di-(2-ethylhexyl)adipate.
- Author:
- BUA
- Year:
- 1 996
- Bibliographic source:
- BUA Report 196. S. Hirzel Wissenschaftliche Verlagsgesellschaft, Stuttgart, 1996.
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 967
- Report date:
- 1967
Materials and methods
- Principles of method if other than guideline:
- Draize test
- GLP compliance:
- not specified
- Type of study:
- intracutaneous test
- Justification for non-LLNA method:
- Study performed prior to implementation of the LLNA
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:
- no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- not specified
- Sex:
- male
- Details on test animals and environmental conditions:
- no data
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:
- DEHA was further tested for sensitisation in a Draize test with 10 male guinea pigs.
On the first day, 0.05 ml of a 0.1% DEHA solution was dosed intracutaneously in shaved back or side skin. Afterwards, 0.1 ml of a 0.1% DEHA solution was dosed every other day for a period of 3 weeks (10 injections in total). Olive oil was used as a carrier.
Two weeks after the last injection the animals were challenged intradermally with 0.05 ml of the 0.1% DEHA solution. - Challenge controls:
- no data
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other:
- Hours after challenge:
- 24
- Group:
- test chemical
- Dose level:
- 0.1%
- No. with + reactions:
- 0
- Total no. in group:
- 10
- Remarks on result:
- other: Reading: other:. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Any other information on results incl. tables
Observations were made 24 h after each injection as to area, height, and color of reaction. The challenge injection reaction was compared with an average of-the scores taken after the original 10 doses. The area and height of the retest area was smaller and lower than the average induction reactions. Thus no sensitizing potential could be deduced.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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