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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
other information
Study period:
19 Feb 1990 - 23 Feb 1990
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1990
Report Date:
1990

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Principles of method if other than guideline:
An approprite quantity of each concentration (0.33 and 0.66 g/mL) of the test material was applied to a Johnson & Johnson 1.8 cm x 1.8 cm band aid clinical occlusive patch. A patch containing deionized distilled water was used as a control. The patches were applied to the designated test sites on the back of each subject (55 persons; age: 18 - 60 years). After the fourty-eight hour occlusive period, the patches were removed. The test sites were graded shortly after removal of the patches once the skin had equilibrated. Twenty-four hours after the patches were removed, each site was graded again. Because some reactions may appear even later, resuls were read again 48 hours after removal of the patch.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Abscents 55
- Related CAS number: 1318-02-1
- Lot/batch No.: Sample number 53-35; Lot 13979-29
- Storage condition of test material: at room temperature

Method

Type of population:
general
Controls:
internal controls (patch with deionized distilled water)
Route of administration:
dermal

Results and discussion

Results of examinations:
54 persons completed the entire study. There were no adverse reactions seen or reported during the study. Under the conditions of this study, no reactions were reported for the test material.

Applicant's summary and conclusion