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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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The test method is adequate and relevant, and was conducted according to standards at the time of conduct. The study is therefore considered adequate, relevant and reliable for classification.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Modified draize-Shelanski Patch Test
Deviations:
no
Principles of method if other than guideline:
Human predictive skin sensitisation tests have been in use the last 50 years. They have been used more widely in the United States than in Europe. Sensitisation potential has been investigated, and the development of animal sensitisation tests was partly based on comparison to human tests performed with the same chemicals. Further, human testing has the advantage that extrapolation of the test results from one species to another is avoided. There are a number of different human sensitisation tests available.(http://ec.europa.eu/health/scientific_committees/consumer_safety/opinions/sccnfp_opinions_97_04/sccp_out102_en.htm)
GLP compliance:
no
Type of study:
other: Modified Draize-Shelanski Patch test
Justification for non-LLNA method:
The Modified Draize-Shelanski Patch test was historically present for the registered substance and was considered most relevant and valid.

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium 1,2-diisobutoxycarbonylethanesulphonate
EC Number:
204-839-5
EC Name:
Sodium 1,2-diisobutoxycarbonylethanesulphonate
Cas Number:
127-39-9
Molecular formula:
C12H22O7S.Na
IUPAC Name:
sodium 1,4-diisobutoxy-1,4-dioxobutane-2-sulfonate
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Aerosol IB
- Physical state: Clear colorless liquid
- Analytical purity: 44-46 %
- Impurities (identity and concentrations): See confidential details
- Composition of test material, percentage of components: See confidential details
- Purity test date:Not provided
- Lot/batch No.: Not provided
- Expiration date of the lot/batch: Not provided
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided

In vivo test system

Test animals

Species:
human
Strain:
other: not applicable
Sex:
male/female
Details on test animals and environmental conditions:
Not applicable

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
Aerosol IB is an aqueous solution of sodium di-isobutyl sulfosuccinate.The sample used in the patch tests was 45 % real.
For use in the test, 2.5% and 1.0% by weight dispersions of Aerosol IB in petrolatum were prepared. Each induction application consisted of about 0.30g of the 2.5% petrolatum dispersion.
Each challenge application consisted about 0.30g of the 1.0% petrolatum dispersion.
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
Aerosol IB is an aqueous solution of sodium di-isobutyl sulfosuccinate.The sample used in the patch tests was 45 % real.
For use in the test, 2.5% and 1.0% by weight dispersions of Aerosol IB in petrolatum were prepared. Each induction application consisted of about 0.30g of the 2.5% petrolatum dispersion.
Each challenge application consisted about 0.30g of the 1.0% petrolatum dispersion.
No. of animals per dose:
100 humans
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- Exposure period: 10 alternate-day 24 hour period
- Test groups: 1 test group of 100 healthy humans
- Control group: no control group
- Site: patch sites on the back or volar forearms
- Duration: 10 days
- Concentrations: about 0.30g of the 2.5% petrolatum dispersion of Aerosol IB

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: After 7 days rest period
- Exposure period: 1 day (24 hours)
- Test groups: 1 test group of 100 healthy humans
- Control group: no control group
- Site: fresh patch sites on the back or volar forearms
- Concentrations: about 0.30g of the 1.0% petrolatum dispersion of Aerosol IB
- Evaluation (hr after challenge): 24 and 48 hours

Modified Draize-Shelanski Repeat Insult Patch Test: A 15 mm patch of the test material was applied to patch sites on the back or volar forearms of 100 subjects for ten alternate-day 24 hour period under occlusion. Following a seven-day rest period, 15mm challenge patches of the material were applied in the same manner to fresh sites on the back or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter, using the 0-4 scale.

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
test chemical
Dose level:
1% in petrolatum
No. with + reactions:
0
Total no. in group:
100
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 1% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 100.0.
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
test chemical
Dose level:
1% in petrolatum
No. with + reactions:
0
Total no. in group:
100
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 1% in petrolatum. No with. + reactions: 0.0. Total no. in groups: 100.0.
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
negative control
Remarks on result:
not measured/tested
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
negative control
Remarks on result:
not measured/tested
Key result
Reading:
1st reading
Hours after challenge:
24
Group:
positive control
Remarks on result:
not measured/tested
Key result
Reading:
2nd reading
Hours after challenge:
48
Group:
positive control
Remarks on result:
not measured/tested

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Criteria used for interpretation of results: expert judgment
Conclusions:
There were no instances of irritation or sensitization from this test item on the Draize-Shelanski Test.
It is unlikely that this test item would present a danger of irritation or sensitization in normal, intended use.
Executive summary:

A modified Draize-Shelanski Repeat Insult Patch Test with a 15 mm patch with 300 mg test item (2.5% test item containing 44 -46% act. ingr.in petrolatum) was applied to patch sites on the back or volar forearms of 100 subjects for ten alternate-day 24 hour period under occlusion. Following a seven-day rest period, 15 mm challenge patches (1.0 % test item containing 44 -46% act. ingr. in petrolatum) of the test item were applied in the same manner to fresh sites on the back or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter, using the 0-4 scale. There were no instances of irritation or sensitisation from this test item on the Draize-Shelanski Test. It is unlikely that this test item would present a danger of irritation or sensitisation in normal, intended use.