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Diss Factsheets

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1954
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
he study was conducted prior to institution of Good Laboratory Practices. The study was conducted by an internal Eastman Kodak Company method, developed prior to established guidelines, but was in accord with acceptable scientific standard methods in use at the time the study was conducted. The results of this study are valid for classification insofar as the conditions of exposure are at least as stringent as modern guidelines.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1954
Report date:
1954

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
not specified
Principles of method if other than guideline:
Study conducted according to an intemal Eastman Kodak Company laboratory method, known as the drop-on method, not used elsewhere.
GLP compliance:
no
Type of study:
other: Guinea pig drop on method

Test material

Constituent 1
Chemical structure
Reference substance name:
Diisobutyl phthalate
EC Number:
201-553-2
EC Name:
Diisobutyl phthalate
Cas Number:
84-69-5
Molecular formula:
C16H22O4
IUPAC Name:
1,2-bis(2-methylpropyl) benzene-1,2-dicarboxylate
Details on test material:
Source: TEC
Purity: no data

In vivo test system

Test animals

Species:
guinea pig
Strain:
not specified
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, open
Vehicle:
other: All applications: 1:1:2 mixture of acetone:dioxane:corn oil
Concentration / amount:
0.1M
Challengeopen allclose all
Route:
epicutaneous, open
Vehicle:
other: All applications: 1:1:2 mixture of acetone:dioxane:corn oil
Concentration / amount:
0.1M
No. of animals per dose:
5
Details on study design:
Two groups of five guinea pigs were used to determine the dermal sensitization potential of the test substance using the Kodak Drop-On Method. The irritant potential of a 0.1 M solution of the test substance in a 1:1:3 mixture of Acetone: Dioxane: Corn Oil was determined 24 and 48 hours following application to the clipped back skin of five animals. An additional group of animals was treated with only the solvent mixture. A third group of animals was treated with a 0.1 M solution of a positive control substance, phenylhydrazine, in a mixture of Dioxane and Corn Oil. Animals were repeatedly treated topically for a period of two weeks. The degree of the response (erythema and edema) seen after the last application was compared to the readings seen after the first application to estimate potential for dermal sensitization following repeated exposure to the test material.
Positive control substance(s):
yes
Remarks:
phenylhydrazine

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No erythema or edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No erythema or edema.
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Dose level:
0%
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No erythema or edema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: negative control. Dose level: 0%. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No erythema or edema.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
0.1 M
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No erythema or edema
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 0.1 M. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No erythema or edema.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
0.1 M
No. with + reactions:
0
Total no. in group:
5
Clinical observations:
No erythema or edema
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 0.1 M. No with. + reactions: 0.0. Total no. in groups: 5.0. Clinical observations: No erythema or edema.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Diisobutyl phthalate is not considered to be a skin sensitizer using the Kodak Drop-on Method. Based on an absence of positive effects in this study, this material is not classifiable for Skin Sensitization according to UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) or EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.
Executive summary:

In a study with diisobutyl phthalate using the Kodak Drop-on Method, a group of five guinea pigs were treated with multiple topical applications of an 0.1 M solution of the test substance in acetone:dioxane:corn oil (1:1:2) over a two-week period. The final observations were compared to the initial observations to determine potential sensitization by the test material. A group of five control guinea pigs were treated with only the solvent mixture. Twenty four and forty-eight hours after the last application, the reactions in the control and test groups were similar. Based on the results of this study using the Kodak Drop-on Method, it was determined that diisobutyl phthalate was a not a dermal sensitizer.