Androstane-3,17-diol, 2-(4-morpholinyl)-16-(1-pyrrolidinyl)-, 17-acetate, (2.beta.,3.alpha.,5.alpha.,16.beta.,17.beta.)-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

17 - 20 August 1999

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1999

Report date:

1999

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

not specified

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

Deviations:

not specified

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Androstan-3,17-diol,2-(4-morpholinyl)-16-(1-pyrrolidinyl)-, 17-acetate (2α,3α,5α,16α,17β)-

EC Number:

601-596-0

Cas Number:

119302-24-8

Molecular formula:

C29H48N2O4

IUPAC Name:

Androstan-3,17-diol,2-(4-morpholinyl)-16-(1-pyrrolidinyl)-, 17-acetate (2α,3α,5α,16α,17β)-

Test material form:

other: Solid

Details on test material:

- Name of test material (as cited in study report): Pymorolac
- Physical state: Cream white solid
- Analytical purity: >/= 95%
- Lot/batch No.: DGN105K1A
- Expiration date of the lot/batch: 01 January 2001
- Stability under test conditions: Stable
- Storage condition of test material: Room temperature in the dark.

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Deutschland, Kisslegg, Germany
- Age at study initiation: 6 weeks old
- Weight at study initiation: Mean less than 3.5 kg
- Housing: Individually in cages with perforated floors
- Diet: 100 g/day of Standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany). Once/week hay was provided (BMI, HElmond, the Netherlands).
- Water (e.g. ad libitum): Free access to tap-water.
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21
- Humidity (%): 50%
- Air changes (per hr): 15/hr
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 1999-08-17 August To: 1999-08-20

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 grams

VEHICLE
- Amount(s) applied (volume or weight with unit): 0.5 grams

Duration of treatment / exposure:

4 Hours

Observation period:

72 Hours

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Flank
- coverage: 2x3 cm
- Type of wrap if used: Metalline patch mounted on Micropore tape and secured using Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): Water
- Time after start of exposure: 4 hrs

SCORING SYSTEM: See free text field below

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24 - 72 Hours

Score:

>= 0

Max. score:

4

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24 - 72 Hours

Score:

>= 0

Max. score:

4

Irritant / corrosive response data:

No skin irritation or corrosion was caused by the 4 hours of exposure to the test substance at 0.5 grams.

Other effects:

No symptoms of systemic toxicity were observed in the rabbits during the test period and no mortality was reported.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance when administered as supplied to rabbits, at a dosage of 0.5 grams does not cause irritation/corrosion to the animals.