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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:
1968
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study with acceptable restrictions

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:
100 males and 100 female subjects were exposed twice (13 days rest period between treatment) for 48 hours on the upper arm using an occluded patch (impregnated paper). Skin reactions were scored at 0, 24 and 48 hours after removal of the patch to determine the sentising potential of the test substance.
GLP compliance:
no
Type of study:
patch test
Justification for non-LLNA method:
Human study available

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Santicizer 141
- Physical state: Liquid

In vivo test system

Test animals

Species:
human
Strain:
other: Not relevant
Sex:
male/female
Details on test animals and environmental conditions:
Not relevant, human study

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:
200 human subjects
Details on study design:
Not relevant, human study
Challenge controls:
Not relevant, human study
Positive control substance(s):
not required
Remarks:
human study

Results and discussion

Positive control results:
Not relevant, human study

In vivo (non-LLNA)

Resultsopen allclose all
Key result
Reading:
other: all readings after induction
Group:
test group
Dose level:
Not available
No. with + reactions:
30
Total no. in group:
200
Clinical observations:
Score of 1: 18 subjects, score of 2: 12 subjects
Remarks on result:
other: Reading:
Remarks:
Dose levels not available
Key result
Reading:
other: all readings after challenge
Group:
test group
Dose level:
Not available
No. with + reactions:
29
Total no. in group:
200
Clinical observations:
Score of 1: 18 subjects, score of 2: 11 subjects
Remarks on result:
other: Reading:
Remarks:
Dose levels not available

Any other information on results incl. tables

30 out of 200 subjects (20 female) showed positive skin reactions at 1 of the 3 readings after induction. At the challenge phase, 29 out of 200 subjects (again 20 female) showed a positive skin reaction at 1 of the 3 readings. Only 1 human subject showed an additional positive skin reaction at the challenge readings, while in 2 other subjects the reaction disappeared.

Due to the high level of skin reactions after the induction phase (comparable to that in de challenge phase), the substance can be considered rather irritating than sensitising.

The reactions on the skin cleared without incident within 10 days after removal of the patch.

Applicant's summary and conclusion

Interpretation of results:
ambiguous
Remarks:
Migrated information
Conclusions:
Under the conditions of this study, it was not possible to conclude on the sensitising potential of Santicizer 141, as the substance can be considered rather irritating than sensitising.
Executive summary:

100 males and 100 female subjects were exposed twice (15 days rest period) for 48 hours on the upper arm using an occluded patch (impregnated paper). Skin reactions were scored at 0, 24 and 48 hours after removal of the patch to determine the sensitising potential of the test substance.

30 out of 200 subjects showed positive skin reactions at 1 of the 3 readings after induction. At the challenge phase, 29 out of 200 subjects showed a positive skin reaction at 1 of the 3 readings. Only 1 human subject showed an additional positive skin reaction at the challenge readings, while in 2 other subjects the reaction disappeared.

Under the conditions of this study, it was not possible to conclude on the sensitising potential of Santicizer 141, as the substance can be considered rather irritating than sensitising.