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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1976
Report Date:
1976

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Modified Draize-Shelanski Repeat Insult 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 Repeat Insult Patch Test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
- Name of test material (as cited in study report): Aerosol® TR , Sodium Bis-tridecyl Sulfosuccinate
- Physical state: Waxy solid
- Analytical purity : 96-98%
- Impurities (identity and concentrations): Not provided
- Composition of test material, percentage of components: See confidential details
- Purity test date: Not provided
- Lot/batch No.: S-11700-75-B
- 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
Sex:
male/female
Details on test animals and environmental conditions:
Not applicable

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
2.5% Induction (of Aerosol TR in petrolatum)
Challenge
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
1% Challenge(of Aerosol TR in petrolatum)
No. of animals per dose:
100 humans
Details on study design:
RANGE FINDING TESTS: Not provided

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 100
- Exposure period: 24 hour periods under occlusion
- Test groups: 1
- Control group: no
- Site: backs or volar forearms of 100 subjects
- Frequency of applications: 10 alternate-day
- Duration:24 h
- Concentrations: approximately 300 mg of the test material was applied of 2.5% of the test material
in petrolatum

B. CHALLENGE EXPOSURE
- No. of exposures: 100
- Day(s) of challenge: 1
- Exposure period: 24 hours
- Test groups: 100 humans
- Control group: no
- Site: fresh sites on the backs or volar forearms of 100 subjects
- Concentrations: 1% of the test material in petrolatum
- Evaluation (hr after challenge):24 and 48 hours

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
Dose level:
300 mg
No. with + reactions:
0
Total no. in group:
100
Clinical observations:
none
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
Dose level:
300 mg
No. with + reactions:
0
Total no. in group:
100
Clinical observations:
none

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Criteria used for interpretation of results: EU
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:

Approximately 300 mg of the test item, containing 96 -98% active ingredient (2.5% in petrolatum) was applied to patch sites on the backs or volar forearms of 100 subjects for ten alternate-day 24 hour periods under occlusion. Following a seven-day rest period, challenge patches of the test item (1.0% in petrolatum) were applied in the same manner to fresh sites on the backs or volar forearms of all 100 subjects for 24 hours. Challenge sites were read on removal of the patch and 24 hours thereafter.There were no instances of irritation or sensitization from this material on the Draize-Shelanski Test. It is unlikely that this test item would present a danger of irritation or sensitization in normal, intended use.