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Toxicological information

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:
September 1968
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: This study was not conducted according to a guideline, and not under GLP conditions as it is a human study. The study has a proper design and results are reported well.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1968
Report Date:
1968

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The test was performed on the skin of 50 human volunteers. The test material was applied to a predesignated site on the upper arm of each subject and covered with lintine gauze. The lintine, in turn, was covered with polypropylene, the edges of which were then affixed to the skin with tape to seal the contents completely. At the end of 24 hours, the patches were removed. The contact sites were examined and the observations were assigned scores. Following removal, the contact sites were left untreated and uncovered and allowed to rest. At the end of the rest period of 24 hours, they were re-examined and observations recorded. In total 15 applications, removals and rest periods were performed 3 times/week. After removal of the last (15th) application preceding the challenge, the sites were examined immediately and once daily for at least two days. The challenge was applied to the original contact site after 14 days of no contact with the test material. The challenge application was terminated after 24 hours. The sites were examined for immediate reactions which, if present, were graded and recorded. These sites were re-examined 24 and 48 hours later for delayed reactions.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Acceptable pre-guideline study that followed sound scientific principles.

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Santicizer 148
- Lot/batch No.: confidential

In vivo test system

Test animals

Species:
human
Strain:
other: not relevant
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:
unchanged (no vehicle)
Concentration / amount:
Unknown (applied as received)
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
unchanged (no vehicle)
Concentration / amount:
Unknown (applied as received)
No. of animals per dose:
50 human subjects (21 males and 29 females)
Details on study design:
RANGE FINDING TESTS: no data

MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: 15
- Exposure period: 24 hours
- Test groups: 50 human subjects (21 males and 29 females)
- Control group: no controls tested in this study
- Site: a predesignated site on the upper arm of each subject
- Frequency of applications: 15 applications, 3 times/week
- Duration: 5 weeks
- Concentrations: Unknown (applied as received)

B. CHALLENGE EXPOSURE
- No. of exposures: 1
- Day(s) of challenge: after 14 days of no contact with the test material
- Exposure period: 24 hours
- Test groups: 50 human subjects (21 males and 29 females)
- Control group: no controls tested in this study
- Site: the patches were applied to the same site as the initial patch: the predesignated site on the upper arm of each subject
- Concentrations: Unknown (applied as received)
- Evaluation (hr after challenge): 0, 24 and 48 hours after removal of the patch
Challenge controls:
No controls tested in this study.
Positive control substance(s):
no

Results and discussion

Positive control results:
No positive controls tested in this study.

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
other: all readings after induction
Group:
test group
Dose level:
no data (applied as received)
No. with + reactions:
0
Total no. in group:
50
Remarks on result:
other: Reading: other: all readings after induction. Group: test group. Dose level: no data (applied as received). No with. + reactions: 0.0. Total no. in groups: 50.0.
Reading:
other: all readings after challenge
Group:
test group
Dose level:
no data (applied as received)
No. with + reactions:
0
Total no. in group:
50
Remarks on result:
other: Reading: other: all readings after challenge. Group: test group. Dose level: no data (applied as received). No with. + reactions: 0.0. Total no. in groups: 50.0.

Applicant's summary and conclusion

Interpretation of results:
other: Not sensitising
Conclusions:
Under the conditions of this study, Santicizer 148 was found not to induce any positive reaction in human skin after challenge. Therefore, the substance does not need to be classified as a sensitiser based on the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.
Executive summary:

This Repeated Insult Patch test was performed on the skin of 50 human volunteers (21 males and 29 females). The test material was applied to a predesignated site on the upper arm of each subject and covered with lintine gauze. The lintine, in turn, was covered with polypropylene, the edges of which were then affixed to the skin with tape to seal the contents completely. At the end of 24 hours, the patches were removed. The contact sites were examined and the observations were assigned scores. Following removal, the contact sites were left untreated and uncovered and allowed to rest. At the end of the rest period of 24 hours, they were re-examined and observations recorded. In total 15 applications, removals and rest periods were performed 3 times/week. After removal of the last (15th) application preceding the challenge, the sites were examined immediately and once daily for at least two days. The challenge was applied to the original contact site after 14 days of no contact with the test material. The challenge application was terminated after 24 hours. The sites were examined for immediate reactions which, if present, were graded and recorded. These sites were re-examined 24 and 48 hours later for delayed reactions. Under the conditions of this study, Santicizer 148 was found not to induce any positive reaction in human skin after challenge. Therefore, the substance does not need to be classified as a sensitiser based on the criteria outlined in Annex I of 1272/2008/EC and Annex VI of 67/548/EEC.