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Toxicological information

Skin sensitisation

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Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Remarks:
in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1976
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.

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
GLP compliance:
no
Type of study:
other: Modified Draize-Shelanski Repeat Insult Patch Test
Justification for non-LLNA method:
The Modified Draize-Shelanski Repeat Insult Patch Test was conducted in 1975.

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® A-268
- Physical state: Waxy solid
- Analytical purity: > 90%
- 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.: S-11700-79-A
- Expiration date of the lot/batch: See confidential details
- Stability under test conditions: Not provided
- Storage condition of test material: Not provided

In vivo test system

Test animals

Species:
human
Strain:
other: healthy adults
Sex:
male/female

Study design: in vivo (non-LLNA)

Induction
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
300mg of test item, 2.5% in petrolatum
Day(s)/duration:
10 alternate-day 24 hour periods
Adequacy of induction:
not specified
Challenge
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
300mg of test item 1% in petrolatum
Day(s)/duration:
1 day (24 hours)
Adequacy of challenge:
not specified
No. of animals per dose:
100
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 100
- Exposure period: 1 day (24 hours)
- Test groups: 1 test group of 100 healthy humans
- Control group: no control group
- Site: patch sites on the back or volar forearms
- Frequency of applications: 10 applications
- Duration: 10 days
- Concentrations: 300mg of test item 2.5% in petrolatum

B. CHALLENGE EXPOSURE
- No. of exposures: 100
- 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: 300mg of tet item 1% in petrolatum
- Evaluation (hr after challenge): 24 and 48 hours
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Key result
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:
0
Key result
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:
0
Key result
Reading:
other: 1st and 2nd reading
Group:
negative control
Remarks on result:
not measured/tested
Key result
Reading:
other: 1st and 2nd reading
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: EU
Conclusions:
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.
Executive summary:

A modified Draize-Shelanski Repeat Insult Patch Test was conducted with a 15 mm patch with 300 mg test material (2.5% test material with 90% act. ingr.) 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% test material with 90% act. ingr.) 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. There were no instances of irritation or sensitisation from this material on the Draize-Shelanski Test. It is unlikely that this material would present a danger of irritation or sensitisation in normal, intended use.