2-isopropyl-9H-thioxanthen-9-one

Direct observations: clinical cases, poisoning incidents and other

Administrative data

Endpoint:

direct observations: clinical cases, poisoning incidents and other

Remarks:

Skin irritation study in humans

Type of information:

experimental study

Adequacy of study:

supporting study

Study period:

August 1994

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1994

Report date:

1994

Materials and methods

Study type:

other: patch test

Endpoint addressed:

skin irritation / corrosion

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A 48-hour patch test was carried out on 10 volunteers at the Consumer Research Unit, Morningside, Edinburgh, field station of Inveresk Research International Limited. The irritation potential was evaluated following 2 consecutive 23h applications to skin with assessment of reactions 1h after each patch removal.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

2-isopropyl-9H-thioxanthen-9-one

EC Number:

226-827-9

EC Name:

2-isopropyl-9H-thioxanthen-9-one

Cas Number:

5495-84-1

Molecular formula:

C16H14OS

IUPAC Name:

2-isopropyl-9H-thioxanthen-9-one

Test material form:

solid: particulate/powder

Method

Type of population:

general

Subjects:

10 volunteers at the Consumer Research Unit, Morningside, Edinburgh, field station of Inveresk Research International Limited

Ethical approval:

not specified

Route of exposure:

dermal

Reason of exposure:

intentional

Exposure assessment:

measured

Details on exposure:

Test material was applied in approximatey 0.2 g amounts to 2 cm x 2 cm squares backed by Blenderm adhesive tape. The webril square was moistened with 0.3 ml of distilled water prior to application to the skin.
A patch strip contained 2 Webril squares and 2 patch strips comprised a patch scheme. The order of test meaterials applied to the patch scheme was randomised in 4 different ways to eliminate position and order bias.
Both patch strips were applied in parallel down the upper outer left arm of each volunteer. Approximately 23h after patch application the volunteers removed the patch scheme and washed off any excess test material with a water dampened tissue.

Examinations:

Reactions were assessed 1h later by a trainer assessor following a scoring system (scales of 0 to 8 for erythema and dryness). An identical patch scheme was then applied to the same area for a further period of 23h. Skin reactions were again assessed 1h after patch removal.

Medical treatment:

none

Results and discussion

Clinical signs:

none

Results of examinations:

no skin reaction was observed with ITX.
Mean Erythema score at 48h : 0
Mean Dryness score at 48h : 0.05

Applicant's summary and conclusion

Conclusions:

No skin irritation was observed after ITX exposure.

Executive summary:

A 48-hour patch test was carried out on 2 volunteers at the Consumer Research Unit, Morningside, Edinburgh, field station of Inveresk Research International Limited. The irritation potential was evaluated following 2 consecutive 23h applications to skin with assessment of reactions 1h after each patch removal.

No skin irritation was observed after ITX exposure.