Registration Dossier

Administrative data

skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
November 1997
1 (reliable without restriction)

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to guideline
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Version / remarks:
(adopted 17 July 1992)
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
(R)-1-Acetyl-3-(1-methyl-2-pyrrolidinyl methyl)-5-[2-(phenylsulphonyl)vinyl] -1H-indole
EC Number:
Cas Number:
Molecular formula:
C24 H26 N2 O3 S
(R)-1-Acetyl-3-(1-methyl-2-pyrrolidinyl methyl)-5-[2-(phenylsulphonyl)vinyl] -1H-indole
Test material form:
solid: bulk
Details on test material:
brown crystalline solid
Specific details on test material used for the study:
Brown Solid

Test animals

New Zealand White
Details on test animals or test system and environmental conditions:
At the start of the study the animals weighed 2.55 to 2.77 kg and were twelve to sixteen weeks old. After a minimum acclimatisation period of five days each animal was given a number unique within the study which was written with a black indelible marker-pen on the inner surface of the ear and on the cage label.
The animals were individually housed in suspended metal cages. Free access to mains drinking water and food was allowed throughout the study.
The animal room was maintained at a temperature of 17 to 19*C and relative humidity of 56 to 65%. The rate of air exchange was approximately fifteen changes per hour and the lighting was controlled by a time switch to give twelve hours continuous light and twelve hours darkness.

Test system

Type of coverage:
Preparation of test site:
Distilled water to moisten
Amount / concentration applied:
A quantity of 0.5g of the test material, moistened with 0.5 ml of distilled water, was introduced under a 2.5 cm x 2.5 cm cotton gauze patch and placed in position on the shorn skin. The patch was secured in position with a strip of surgical adhesive tape (approximate size 2.5 cm x 4.0 cm). To prevent the animals interferingwith the patches, the trunk of each rabbit was wrapped in an elasticated corset (TUBIGRIP) and the animals were returned to their cages for the duration of the exposure period.

Four hours after application the corset and patches were removed from each animal and any residual test material removed by gentle swabbing with cotton wool soaked in distilled water.
Duration of treatment / exposure:
4 hours
Observation period:
Approximately one hour following the removal of the patches and at 24, 48 and 72 hours following 4 hour exposure, the test sites were examined for evidence of primary irritation
Number of animals:
Details on study design:
The test system was chosen because the rabbit has been shown to be a suitable model for this type of study and is recommended in the test method. The resultsof the study are believed to be of value in predicting the likely skin irritancy potential of the test material to man.

Results and discussion

In vivo

Irritation parameter:
overall irritation score
animal: animal 1, 2 and 3
Time point:
24/48/72 h
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
The test material, UK-209,947, produced a primary irritation index of 0.0 and was classified as NON-IRRITANT to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.
Executive summary:

A study was performed to assess the irritancy potential of the test material to the skin of the New Zealand White rabbit. The method used followed the recommendations of the OECD Guidelines for Testing of Chemicals No. 404 "Acute Dermal Irritation/Corrosion" (adopted 17 July 1992) and Method B4 of Commission Directive 92/69/EEC (which constitutes Annex V of Council Directive 67/548/EEC). A single 4-hour, semi-occluded application of the test material to the intact skin of three rabbits produced very slight erythema at one treated skin site. All treated skin sites appeared normal at the 24-hour observation. The test material produced a primary irritation index of 0.0 and was classified as non- irritant to rabbit skin according to the Draize classification scheme. No corrosive effects were noted.