Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo study that was performed prior to current requirement for in vitro alternative testing
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: older study; not conducted in accordance with current GLP guidelines, incomplete data for study design
Qualifier:
no guideline followed
GLP compliance:
no
Type of study:
not specified
Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Route:
epicutaneous, open
Vehicle:
other: acetone/dioxane/guinea pig fat (7:2:1)
Route:
epicutaneous, open
Vehicle:
other: acetone/dioxane/guinea pig fat (7:2:1)
Details on study design:
The Kodak methods employed the topical application of the test material in a unique solvent designed to enhance penetration and dermal absorption to 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.
Positive control substance(s):
not specified
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.
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, the test material was dissolved in a solvent consisting of 70% acetone, 20% dioxane, and 10% guinea pig fat. The skin was also depilated prior to application to enhance contact and absorption. 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.

Justification for classification or non-classification