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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
Study period:
1980 - 1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Literature paper reporting studies conducted on human volunteers; variety of potential allergens assessed. Only limited sensitisation effects were noted.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
1990
Report date:
1990

Materials and methods

Type of sensitisation studied:
skin
Study type:
study with volunteers
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Four patients who had experienced clinical reactions suggesting an allergic contact dermatitis associated with Band-Aid brand adhesive bandages were evaluated and patch-tested using Band-Aid adhesive components and a selection of plastics and glue allergens, including Tricresyl Phosphate. All chemicals were placed on Finn chambers and occluded for 48 hrs with Scanpor tape. Patch test reactions were evaluated at 2 days and 7 days. A reaction was read as allergic when it was raised or palpable or had vesicular surfaces that spead beyond the patch test or bandage site.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Tricresyl phosphate
IUPAC Name:
Tricresyl phosphate
Details on test material:
- Name of test material (as cited in study report): Tricresyl phosphate
- Molecular formula (if other than submission substance): not applicable
- Molecular weight (if other than submission substance): not applicable
- Smiles notation (if other than submission substance): not specified
- InChl (if other than submission substance): not specified
- Structural formula attached as image file (if other than submission substance): not applicable
- Substance type: not specified
- Physical state: not specified
- Analytical purity: not specified
- Impurities (identity and concentrations): not specified
- Composition of test material, percentage of components: not specified
- Isomers composition: not specified
- Purity test date: not specified
- Lot/batch No.: not specified
- Expiration date of the lot/batch: not specified
- Radiochemical purity (if radiolabelling): not applicable
- Specific activity (if radiolabelling): not applicable
- Locations of the label (if radiolabelling): not applicable
- Expiration date of radiochemical substance (if radiolabelling): not applicable
- Stability under test conditions: not specified
- Storage condition of test material: not specified
- Other:

Method

Type of population:
general
Ethical approval:
not specified
Subjects:
The four patients (two male, two female).
Clinical history:
The four patients (two male, two female) had experienced clinical reactions suggesting an allergic contact dermatitis associated with Band-Aid brand adhesive bandages. The extent of previous or additional patch-testing was determined by individual histories. Each patient had a positive allergic patch test reaction to the Band Aid Brand Sheer strip at 2 days with persistence for 7 days.
Controls:
None
Route of administration:
dermal
Details on study design:
Four patients who had experienced clinical reactions suggesting an allergic contact dermatitis associated with Band-Aid brand adhesive bandages were evaluated and patch-tested using Band-Aid adhesive components and a selection of plastics and glue allergens, including Tricresyl Phosphate. All chemicals were placed on Finn chambers and occluded for 48 hrs with Scanpor tape. Patch test reactions were evaluated at 2 days and 7 days. A reaction was read as allergic when it was raised or palpable or had vesicular surfaces that spead beyond the patch test or bandage site. Allergic reactions were read according to the criteria outlined by the North American Contact Dermatitis Group in the booklet distributed with the allerganes sold by Dermatology Services Inc.

Results and discussion

Results of examinations:
Of four patients with an allergic reaction to Band Aid brand sheer strips, one patient reacted to tricresyl phosphate, the plasticiser in the vinyl backing.

Between 1984 and 1988, 52 patients - 31 men and 21 women - were evaluated in the contact dermatitis clinic at the Oregon Health Sciences University for possible allergic contact dermatitis related to plastics. Each patient was patch tested with tricresyl phosphate in 1% petrolatum, with patches being evaluated at 2 and 7 days. There were 51 negative patch tests but one woman had an irritant reaction to tricresyl phosphate.

Applicant's summary and conclusion

Conclusions:
Of four patients with an allergic reaction to Band Aid brand sheer strips, one patient reacted to tricresyl phosphate, the plasticiser in the vinyl backing. However, evaluation of 52 patients - 31 men and 21 women in the contact dermatitis clinic at the Oregon Health Sciences University for possible allergic contact dermatitis related to plastics, where each patient was patch tested with tricresyl phosphate in 1% petrolatum, with patches being evaluated at 2 and 7 days. There were 51 negative patch tests but one woman had an irritant reaction to tricresyl phosphate.

Executive summary:

The study has shown that of four patients with a rare allergic reaction to Band Aid brand sheer strips, one patient reacted to tricresyl phosphate, the plasticiser in the vinyl backing. This gives a sensitisation rate of 25%; however the number of volunteers tested precludes the use of this data as being not statistically significant.  The negative sensitisation potential is also reinforced by the results reports on the 52 patients - 31 men and 21 women evaluated in the contact dermatitis clinic at the Oregon Health Sciences University for possible allergic contact dermatitis related to plastics. Each patient was patch tested with tricresyl phosphate in 1% petrolatum, with patches being evaluated at 2 and 7 days. There were 51 negative patch tests but one woman had an irritant reaction to tricresyl phosphate.

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