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Toxicological information

Skin sensitisation

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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:
1972

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
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
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Di-n-butyl adipate
- Analytical purity: no data

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