[No public or meaningful name is available]

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From December 12, 2007 to December 26, 2007

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

N-methyl-1-(trans-4-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclohexyl)methanesulfonamide

Cas Number:

1208319-26-9

Molecular formula:

C15H23N5O2S

IUPAC Name:

N-methyl-1-(trans-4-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclohexyl)methanesulfonamide

Specific details on test material used for the study:

Test material name in the study: PF-03394197-11
Lot Number: LCY33580119667

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Covance Research Products, Denver, Pennsylvania
- Age at study initiation: Approximately 4 months
- Weight at study initiation: Male: 2.78 and 2.95 kg
- Housing: Individual Stainless Steel Suspended Cages with deotized paper.
- Diet (e.g. ad libitum): Lab Diet® Certified Rabbit Diet # 5322, PMI Nutrition International, Inc. Animals were fasted on the day of arrival, and then food was increased in 25-g increments over
5 to 7 days until feeding was 125 g per day.
- Water (e.g. ad libitum): Automatic watering system, Ad libitum.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 61 to 72°F
- Humidity (%): 30 to 70%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): Fluorescent lighting was provided for approximately 12 hours per day.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

3 males

Details on study design:

TEST SITE
- Area of exposure: dorsal trunk of each animal
- % coverage:
- Type of wrap if used: The application site was wrapped with gauze bandaging and non-irritating, semi-occlusive tape.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the wrappings were removed and the residual test substance was removed. Any residual test substance was removed using tepid tap water and a WypAll®.
- Time after start of exposure: 4 hours

OBSERVATION TIME POINTS
(indicate if minutes, hours or days) The test site was scored for erythema/eschar and edema within 30 to 60 minutes and at 24, 48, and 72 hours following patch removal (postdose).

SCORING SYSTEM:
- Method of calculation: Draize scale for scoring skin irritation.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

0

Irritant / corrosive response data:

No erythema or edema was present at any time point in any animal.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Following a single dermal application for 4 hours, no erythema or edema was present at any time point in any animal, the test item is not irritating to rabbit skin. 

Executive summary:

The skin irritation study is performed according to OECD Guideline 404 under GLP. Following a single dermal application for 4 hours, no erythema or edema was present at any time point in any animal, the test item is not irritating to rabbit skin.