Registration Dossier

Administrative data

Description of key information

non-sensitizing in guinea pigs

Key value for chemical safety assessment

Skin sensitisation

Link to relevant study records
Reference
Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
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
Qualifier:
equivalent or similar to
Guideline:
EU Method B.6 (Skin Sensitisation)
GLP compliance:
no
Type of study:
Buehler test
Justification for non-LLNA method:
study performed in 1984, before the validation of the LLNA method
Species:
guinea pig
Strain:
Hartley
Sex:
not specified
Route:
epicutaneous, occlusive
Vehicle:
other: acetone/dioxane/guinea pig fat (7:2:1)
Concentration / amount:
10% w/v in FCA
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
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, 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.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

The sensitization potential of m-diisopropylbenzene was assessed in guinea pigs using a Buehler test design. Following 3 weekly applications of a 100% test substance, animals were challenged 2 weeks later by application of a 100% test substance. There were no signs of sensitization in any of the test animals. Consequently, the test substance was determined to be non-sensitizing in guinea pigs.

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

As DIPB is not a skin sensitiser, it is anticipated that it is not a respiratory sensitiser, as both are elicited at skin level. Furthermore DIPB have a low Vp.

Migrated from Short description of key information:

As DIPB is not a skin sensitiser, it is anticipated that it is not a respiratory sensitiser.

Justification for classification or non-classification

DIPB was negative at a dose of 100% applied to the guinea pig skin. Confirmed in 2 supporting studies with m-DIPB.

As DIPB is not a skin sensitiser, it is anticipated that it is not a respiratory sensitiser.