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Toxicological information

Sensitisation data (human)

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Administrative data

Endpoint:
sensitisation data (humans)
Type of information:
experimental study
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Well reported non-guideline study.

Data source

Referenceopen allclose all

Reference Type:
study report
Title:
Unnamed
Year:
1984
Reference Type:
review article or handbook
Title:
Unnamed
Year:
1992
Report Date:
1992

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
according to
Guideline:
other: HRIPT by modified Shelanski procedure

Test material

Reference
Name:
Unnamed
Type:
Constituent

Method

Type of population:
general
Route of administration:
dermal
Details on study design:
1st application: Induction undiluted occlusive epicutaneous
2nd application: Challenge undiluted occlusive epicutaneous

Results and discussion

Results of examinations:
Symptoms:
- Frequency, level, duration of symptoms observed:
Signs of irritation during induction: minimal erythema: 5/209 on single occasion; 4/209 on 2 occasions

No. of persons with/out reactions compared to study population:
- Number of subjects with positive reactions: 0
- Number of subjects with negative reactions: 209
- Number of subjects with equivocal reactions: 0
- Number of subjects with irritating reactions: 5

Any other information on results incl. tables

From an original panel of 212 volunteers 209 completed the study. During the induction period minimal irritation was observed on one/two occasions in 9/209 subjects. In 5 of these individuals irritation was observed only once during the 12 applications. In the remaining 4 volunteers irritation was observed twice. All individuals concerned showed minimal erythema only. There was no dermal reaction to challenge.

Applicant's summary and conclusion

Conclusions:
TBEP was not sensitizing in this test.
Executive summary:

TBEP was tested in a human repeated insult patch test (HRIPT) using the modified Shelanski procedure. Of the 209 volunteers subjected to a three week induction period 47 were male and 162 female. A site on the back of each individual was identified as the intact contact site. Approximately 0.2ml of TBEP, as supplied, was placed on a webril pad of the bandage and the patch then applied to the designated site. A series of 12 applications of 24-h duration was conducted at the rate of 4 applications per week during the 3-week induction period. During the 4th week a series of four challenge applications on virgin sites was completed. All reactions were scored on a scale of 0 to 4.

During the induction period minimal irritation was observed on one/two occasions in 9/209 subjects. In 5 of these individuals irritation was observed only once during the 12 applications. In the remaining 4 volunteers irritation was observed twice. All individuals concerned showed minimal erythema only. There was no dermal reaction to challenge. It was concluded that TBEP did not induce sensitization in this test procedure.