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Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1988
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1988
Report date:
1988

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
no
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
Test carried out in 1988 prior to LLNA being formally adopted by OECD

Test material

Constituent 1
Reference substance name:
Diisostearyl Malate
IUPAC Name:
Diisostearyl Malate
Test material form:
other: liquid

In vivo test system

Test animals

Species:
guinea pig
Strain:
Dunkin-Hartley
Sex:
not specified

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
intradermal
Vehicle:
propylene glycol
Concentration / amount:
Induction concentration: 5% in propylene glycol and freund's adjuvant
Challenge Concentration: 100%, 050% in petrolatum
Challengeopen allclose all
Route:
other: epicutaneous
Vehicle:
propylene glycol
Concentration / amount:
Induction concentration: 5% in propylene glycol and freund's adjuvant
Challenge Concentration: 100%, 050% in petrolatum
No. of animals per dose:
10 animals/dose
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- Duration: the assay are run by applying a minimally irritating dose of the test substance to the shaved flanks of Dunkin-hartley guinea pigs for approximately 3 weeks.
- Concentrations: 5% in propylene glycol and freund's adjuvant

B. CHALLENGE EXPOSURE
- Concentrations: undiluted and 50% in petrolatum
- Evaluation (hr after challenge): 24 hr and 48 hr
Challenge controls:
not included
Positive control substance(s):
not required

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
undiluted
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: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
undiluted
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: undiluted. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
50%
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: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
50%
No. with + reactions:
0
Total no. in group:
10
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 50%. No with. + reactions: 0.0. Total no. in groups: 10.0.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
The test substance does not appear to be a sensitizer in the Dunkin-Hartley guinea pig.
Executive summary:

Introduction

The ability of a chemical compound to induce an allergic contact dermatitis in the skin is determined by  using guinea-pigs as animal models. Assays in which guinea pigs are exposed to potential allergenic chemicals include the Magnusson-Kligman Maximization Assay, and the Buehler Assay which is used it because it more closely mimics human exposure.

Induction phase

The assays are run by applying a minimally irritating dose of the test compound (5% propylene glycol and freund's adjuvant) the to the shaved flanks of Dunkin-Hartley guinea pigs for approximately 3 weeks.

Challenge phase

About 1x week after the last application, the undiluted chemical or 50% in petrolatum is re-applied to the animals.

Scoring of erythema and edema (24 and 48 hours) is accomplished by adding up all the animals that responded in a group of ten and expressing it as a percentage (incidence) and determined the intensity of teach response on a scale of 0-4. 

Result

Scores of zero in all test animals were obtained at all time points examined. The test material does not appear to be a sensitizer in the guinea pig.