Registration Dossier

Toxicological information

Skin sensitisation

Currently viewing:

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
read-across based on grouping of substances (category approach)
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, but differs from current methods.
Justification for type of information:
Data has been read across from a structurally similar substance in a category approach. See further discussion in the read across justification attached.
Cross-reference
Reason / purpose:
read-across: supporting information

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
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:
patch test
Justification for non-LLNA method:
Adequate results from in vivo studies are already available.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report):AEROSOL ® OT
- Physical state: white waxy solid
- Batch No.:
- Analytical purity: 100%


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)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.30 g of 2.5% AEROSOL ® OT dispersion in petrolatum (Induction)
0.30 g of 1% AEROSOL ® OT in petrolatum(Challenge)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
petrolatum
Concentration / amount:
0.30 g of 2.5% AEROSOL ® OT dispersion in petrolatum (Induction)
0.30 g of 1% AEROSOL ® OT in petrolatum(Challenge)
No. of animals per dose:
100 humans
Details on study design:
Modified Draize-Shelanski Repeat Insult Patch Test: Aproximately 300 mg of the test material was applied to 15 mm 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, 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.

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
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 24.0. Group: test group. Dose level: 300 mg. No with. + reactions: 0.0. Total no. in groups: 100.0. 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
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 300 mg. No with. + reactions: 0.0. Total no. in groups: 100.0. Clinical observations: none.

Applicant's summary and conclusion

Interpretation of results:
not sensitising
Remarks:
Migrated information
Conclusions:
Mild erythema was seen in 19 of 100 subjects after induction, however there were no instances of sensitization from this material on the Draize-Shelanski Test. It is unlikely that this material would present a danger of irritation or sensitization in normal, intended use.
Executive summary:

A15 mm patch of the test material was applied to patch sites on the back of volar forearms of 100 subjects for 10 alternate-day 24 hour periods under occlusion. Following a 7-day rest period, 15 mm challenge patches of the material 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 some subjects with mild erythema after induction, however there were no instances of sensitization from this material on the Draize-Shelanski Test. It is unlikely that this material would present a danger of irritation or sensitization in normal, intended use.