Registration Dossier
Registration Dossier
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EC number: 249-044-4 | CAS number: 28472-97-1
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only summary available
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 1 972
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 406 (Skin Sensitisation)
- Deviations:
- yes
- Remarks:
- Challenge exposure site not stated; only 5 animals tested; no positive control; lack of details on test substance;
- Principles of method if other than guideline:
- Combination of Bühler and GPMT elements.
- GLP compliance:
- no
- Type of study:
- intracutaneous test
Test material
- Reference substance name:
- Dibutyl adipate
- EC Number:
- 203-350-4
- EC Name:
- Dibutyl adipate
- Cas Number:
- 105-99-7
- Molecular formula:
- C14H26O4
- IUPAC Name:
- dibutyl adipate
- Details on test material:
- - Name of test material (as cited in study report): Di-n-butyl adipate
- Analytical purity: no data
Constituent 1
In vivo test system
Test animals
- Species:
- guinea pig
- Strain:
- other: Pirbright White W58
- Sex:
- male
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Weight at study initiation: Average 310 g
Study design: in vivo (non-LLNA)
Inductionopen allclose all
- Route:
- intradermal
- Vehicle:
- no data
- Concentration / amount:
- 25 % oil substance
Challengeopen allclose all
- Route:
- intradermal
- Vehicle:
- no data
- Concentration / amount:
- 25 % oil substance
- No. of animals per dose:
- 5
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
Administration of the 25 % oil substance preparation into the paravertebral shaved skin was carried out 10 times at intervals of 2 days, by intracutaneous injection. The volume applied was a constant 0.1 mL.
- No. of exposures: 10 injections
- Exposure period: 20 days
- Test groups: 5 male animals
- Control group: 5 control animals, vehicle only
- Site: paravertebral shaved skin
- Frequency of applications: every 2nd day
- Concentrations: 25 % oil substance
B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: A 14 day interval was left after the final application. Thereafter, the experimental animals were retreated at the same time as the controls, in the same way.
- Exposure period: single intradermal injection
- Test groups: 5
- Control group: 5
- Site: not reported
- Concentrations: 25 % oil substance
- Evaluation (hr after challenge): not reported - Positive control substance(s):
- no
Results and discussion
- Positive control results:
- No positive controls performed.
Any other information on results incl. tables
Treatment of the experimental animals led to a slight reddening of the injection point. This reaction subsided once more within 2 days. The body weights of the experimental animals increased continuously, and were comparable with the control body weights.
On re-treatment, there were no evident differences with regard to skin reaction between the experimental animals and the controls.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information
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