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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: older study; not conducted in accordance with current GLP guidelines

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1984
Report Date:
1984

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
no
Type of study:
Buehler test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: acetone/dioxane/guinea pig fat (7:2:1)
Concentration / amount:
10% w/v in FCA
Challengeopen allclose all
Route:
intradermal
Vehicle:
other: acetone/dioxane/guinea pig fat (7:2:1)
Concentration / amount:
10% w/v in FCA
Details on study design:
The Kodak methods employed both a) topical application of the test material in a unique solvent designed to enhance penetration and dermal absorption and b) subcutaneous injection of the material into the foot pad of the test guinea pigs. The solvent that was used was prepared in the laboratory and consisted of 70% acetone, 20% dioxane, and 10% guinea pig fat. The skin was also depilated prior to application to enhance contact and absorption. To stimulate the immune system, Freund’s Complete Adjuvant was injected into the guinea pig footpad.
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Results
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
Based upon the results of this study, p-diisopropylbenzene is not a dermal sensitizer in guinea pigs
Executive summary:

In a Kodak standard dermal sensitization assay that is similar to the Buehler method, both topical and subcutaneous injections of test materials suspended or dissolved in agents known to stimulate the immune system. The Kodak method utilized ten guinea pigs that were treated by both a) topical application of the test material in a unique solvent designed to enhance penetration and dermal absorption and b) subcutaneous injection of the material into the foot pad of the test guinea pigs. The solvent that was used was prepared in the laboratory and consisted of 70% acetone, 20% dioxane, and 10% guinea pig fat. The skin was also depilated prior to application to enhance contact and absorption. To stimulate the immune system upon challenge, the test material was incorporated into Freund's Complete Adjuvant and was injected into the footpad of test animals. Following induction, animals were subjected to challenge with the test material that was evaluated 24 hours after exposure, wherein none of the test animals displayed evidence of dermal sensititization.