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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
migrated information: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: see 'Remark'
Remarks:
Acceptable, well documented study report which meet sbasic scientific principles. Read-across to kaolin and bentonite: The amorphous glass phase of FeCr-slag consists of practically insoluble silicates, and therefore selection of kaolin and bentonite for read-across is justified.

Data source

Reference
Reference Type:
publication
Title:
Topical prevention of poison ivy/oak dermatitis.
Author:
Epstein, W.L.
Year:
1989
Bibliographic source:
Arch Dermatol 125, 499-501

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The potential of different substances as topical protectants against experimental poison ivy/oak dermatitis was tested in humans. The test substances were sprayed on the volar aspect of each forearm of the test persons, and was repeated within 10-14 days.
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Bentonite
EC Number:
215-108-5
EC Name:
Bentonite
Cas Number:
1302-78-9
IUPAC Name:
nitrilotriethane-2,1-diyl trinitrate
Constituent 2
Reference substance name:
kaolin
IUPAC Name:
kaolin
Details on test material:
No data available.

Test animals

Species:
human
Details on test animals or test system and environmental conditions:
28 healthy men and women volunteers, who reacted to 4.75 nmol or less of urushiol, were selected for the test.

Test system

Type of coverage:
open
Preparation of test site:
other: Test material was sprayed on forearm. After 4 h, open patch tests with urushiol were applied to the forearms.
Vehicle:
not specified
Controls:
yes
Amount / concentration applied:
No data
Observation period:
Up to 10-14 days
Number of animals:
28 humans
Details on study design:
The potential of different substances as topical protectants against experimental poison ivy/oak dermatitis was tested in humans. A spray of kaolin, bentonite or silicone-containing areosols was applied on the volar aspect of each forearm of the test persons and was repeated within 10-14 days.

Results and discussion

In vivo

Results
Irritation parameter:
other: no data
Basis:
other: no data
Time point:
other: 0-14 days
Score:
0
Remarks on result:
other: No signs of primary irritation were observed
Irritant / corrosive response data:
No signs of primary irritation were observed with any of the substaces.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: not specified
Conclusions:
Application of kaolin or bentonite on the forearm of humans did not cause any signs of irritation.
Executive summary:

The potential of different substances (for example kaolin and bentonite)

as topical protectants against experimental poison ivy/oak dermatitis was tested in humans. The test substances were sprayed on the volar aspect of each forearm of the test persons, and was repeated within 10-14 days. No signs of primary irritation were observed with any of the substaces. The compositions and concentrations of the sprays were not described.