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Toxicological information

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
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1989
Report Date:
1989

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 406 (Skin Sensitisation)
Deviations:
yes
Remarks:
challenge utilized Kodak foot pad method, which utilized a vehicle containing acetone+dioxane+guinea pig fat (7:2:1)
GLP compliance:
yes
Type of study:
guinea pig maximisation test
Justification for non-LLNA method:
The study was conducted prior to the introduction of the LLNA as a validated test method

Test material

Reference
Name:
Unnamed
Type:
Constituent

In vivo test system

Test animals

Species:
guinea pig
Strain:
Hartley
Sex:
male

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
other: acetone+dioxane+guinea pig fat (7:2:1)
Concentration / amount:
1% (induction); 10% (challenge)
Challengeopen allclose all
Route:
intradermal and epicutaneous
Vehicle:
other: acetone+dioxane+guinea pig fat (7:2:1)
Concentration / amount:
1% (induction); 10% (challenge)
No. of animals per dose:
10
Details on study design:
A 1% soluton of SAIB was prepared in Freund's Complete Adjuvant (FCA) and was applied topically to shaved skin of 10 guinea pigs, which was followed by an occlusive dressing. Ten control guinea pigs were treated similarly with FCA without SAIB.
Challenge controls:
vehicle controls
Positive control substance(s):
not specified

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
slight erythema in 5 of 10 animals
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: negative control. Dose level: 10%. No with. + reactions: 0.0. Total no. in groups: 10.0. Clinical observations: slight erythema in 5 of 10 animals.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
10%
No. with + reactions:
0
Total no. in group:
10
Clinical observations:
slight erythema in 6 of 10 animals
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. Clinical observations: slight erythema in 6 of 10 animals.
Key result
Reading:
other: not measured
Hours after challenge:
0
Group:
positive control
Dose level:
No positive group kept
No. with + reactions:
0
Total no. in group:
0
Clinical observations:
Not measured
Remarks on result:
not measured/tested
Remarks:
Not measured

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
The test article, sucrose diacetate hexaisobutyrate (SAIB) has a low potential to cause human skin sensitization
Executive summary:

Sucrose diacetate hexaisobutyrate (SAIB) was evaluated for its potential for dermal sensitization in guinea pigs, using the Kodak foot pad method. When a challenge concentration of 10% SAIB in the solvent vehicle was administered topically, alight erythema at the exposure site was notnd on five of ten irritation control animals and on six of ten animals previously induced with SAIB. No reaction was observed at challenge in any of the remaining animals in either group. Base on aimiliar reactions observed at challenge

between the group of animals previously induced with Freund' a adjuvant and the group of animals induced with the test article in

Freund's adjuvant, the test article was not considered a akin sensitizer. SAIB is considered to have a low potential to cause human skin sensitization.