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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:
1977
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study was not performed under GLP, but according to state of the art methods of that period . The study was considered relevant, reliable and adequate.

Data source

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

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 Patch Test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid

In vivo test system

Test animals

Species:
human
Strain:
not specified
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:
Induction 2.5% in petrolatum, Challenge 1% in petrolatum
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
Induction 2.5% in petrolatum, Challenge 1% in petrolatum
No. of animals per dose:
100
Details on study design:
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 100
- Exposure period: ten alternate-day 24 hour periods
- Test groups: 100 subjects
- Control group: No
- Site: backs or volar forearms
- Frequency of applications: 10
- Duration: 10 x 24 hours in total
- Concentrations: 2.5% in petrolatum

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

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
24
Group:
test group
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.
Reading:
2nd reading
Hours after challenge:
48
Group:
test group
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.

Applicant's summary and conclusion

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

A 15 mm patch of the test item (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, 15mm challenge patches of the test item (1% 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, using the 0-4 scale. There were no instances of irritation or sensitisation from this test item on the Draize-Shelanski Patch Test. It is unlikely that this test item would present a danger of irritation or sensitisation in normal, intended use.