Registration Dossier

Administrative data

Endpoint:
skin sensitisation: in vivo (non-LLNA)
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Study report which meets basic scientific principles (restriction: amount of applied substance not reported, no information on test substance)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Repeat insult patch test to determine if the test material is capable of irritating the skin of humans under controlled test conditions; and, if so, to classify the test material as a primary irritant, fatiguing agent, and/or sensitizer on the basis of visible clinical responses
GLP compliance:
no
Type of study:
patch test

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Purity test date: no data

In vivo test system

Test animals

Species:
human
Strain:
other: Test persons were selected from a local population (The study was performed by a company in Pennsylvania, U.S.A.)
Sex:
not specified
Details on test animals and environmental conditions:
The criteria for qualifying as test person were:
1. General well-being.
2. Absence of any skin disease which might be confused with skin reactions from the test material.
3. Willingness to cooperate.
4. Dependability and intelligence in following directions.
5. Reading, understanding, and signing an informed-consent contract, (In the case of minors, parental consent was obtained.)

Study design: in vivo (non-LLNA)

Inductionopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
20%
Challengeopen allclose all
Route:
epicutaneous, occlusive
Vehicle:
no data
Concentration / amount:
20%
No. of animals per dose:
200
Details on study design:
TYPE OF TEST(S) USED: repeated patch test (epicutaneous test)

ADMINISTRATION
The test material was applied as 20% dilution under occlusion to a skin size of 3*3 cm for a series of effective contact periods of two days' duration. On Monday, the test material was applied. The participants were instructed to contact the laboratory and inform the investigator immediately if any discomfort was felt at the patch site. On Wednesdays, the patches were removed, the contact sites examined, and the reactions, if any, were graded and recorded.
If no reactions occurred, the test material was re-applied immediately for another forty-eight-hour period. The participants were instructed to call the laboratory on Thursday if any discomfort was felt. On Friday, the covers were removed and the contact sites were again examined and graded. The contact sites were then rested until the following Monday. This cycle was repeated for three more weeks, so that a series of eight forty-eight-hour applications were completed.
On the second Monday following the removal of the last series of applications, the test material was applied to the same contact site. The covers were removed on Wednesday, thereby effecting a challenge contact period of forty-eight hours' duration. The contact sites were examined for visible changes which, if present, were graded and recorded. Sites were re-examined twenty-four and forty-eight hours later for delayed reactions.

EXAMINATIONS
- Grading/Scoring system:
0 = No reactions.
1+ = Slight erythema.
2+ = Marked erythema.
3+ = Marked erythema, edema, with or without a few vesicles.
4+ = Marked erythema, edema, with vesicles and oozing.
Challenge controls:
no
Positive control substance(s):
no

Results and discussion

In vivo (non-LLNA)

Resultsopen allclose all
Reading:
1st reading
Hours after challenge:
0
Group:
test group
Dose level:
20%
No. with + reactions:
0
Total no. in group:
200
Clinical observations:
no irritating reactions observed
Remarks on result:
other: Reading: 1st reading. . Hours after challenge: 0.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 200.0. Clinical observations: no irritating reactions observed .
Reading:
2nd reading
Hours after challenge:
24
Group:
test group
Dose level:
20%
No. with + reactions:
0
Total no. in group:
200
Remarks on result:
other: Reading: 2nd reading. . Hours after challenge: 24.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 200.0.
Reading:
other: 3rd reading
Hours after challenge:
48
Group:
test group
Dose level:
20%
No. with + reactions:
0
Total no. in group:
200
Remarks on result:
other: Reading: other: 3rd reading. . Hours after challenge: 48.0. Group: test group. Dose level: 20%. No with. + reactions: 0.0. Total no. in groups: 200.0.

Applicant's summary and conclusion