Androstane-3,17-diol, 2-(4-morpholinyl)-16-(1-pyrrolidinyl)-, (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:

31 August to 5 November 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:

(3aS,3bR,9aS,9bR,11aS)-9a,11a-dimethyl-8-(morpholin-4-yl)-2-(pyrrolidin-1-yl)-hexadecahydro-1H-cyclopenta[a]phenanthrene-1,7-diol

EC Number:

601-595-5

Cas Number:

119302-20-4

Molecular formula:

C27H46N2O3

IUPAC Name:

(3aS,3bR,9aS,9bR,11aS)-9a,11a-dimethyl-8-(morpholin-4-yl)-2-(pyrrolidin-1-yl)-hexadecahydro-1H-cyclopenta[a]phenanthrene-1,7-diol

Test material form:

other: Solid

Details on test material:

- Name of test material (as cited in study report): Pymordiol
- Physical state: Cream white solid
- Purity of test material: 96 wt%
- Lot/batch No.: DGM096K1A
- Expiration date of the lot/batch: 1 January 2001
- Stability under test conditions: Stable
- Storage condition of test material: At 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 Nederland, Someren, the Netherlands
- Age at study initiation: 6 weeks
- Weight at study initiation: Less than 3.5 kg
- Housing: Individually in cages with perforated floors.
- Diet: Approximately 100 g per day of standard laboratory rabbit diet (Charles River Breeding and Maintenance Diet for Rabbits, Altromin, Germany). Hay (BMI, Helmond, the Netherlands) was provided once a week.
- Water (e.g. ad libitum): Free-access to tap water.
- Acclimation period: 5 days

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

IN-LIFE DATES: From: To:

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

not required

Amount / concentration applied:

TEST MATERIAL
- 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 of single sex

Details on study design:

TEST SITE
- Area of exposure: Dorsal flank
- % coverage: 150 square centimetres
- Type of wrap if used: Metalline patch of 2x3 cm. Patch was mounted on Micropore tape, which was wrapped around the abdomen and secured with Coban elastic bandage.

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

SCORING SYSTEM: See table below

Results and discussion

In vivo

Results

Irritation parameter:

overall irritation score

Basis:

mean

Time point:

other: 72 hours

Score:

ca. 0

Max. score:

4

Irritant / corrosive response data:

No evidence of irritation after 4 hours of exposure to test substance was reported.

See tables No. 1 & 2 below for details on individual animals and animal means.

Other effects:

No staining of the treated skin by the test substance was observed. No symptoms of systemic toxicity were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Table 1: Individual Skin Irritation Scores

Animal No.	494		496		518
Time after exposure (hours)	Erythema	Oedema	Erythema	Oedema	Erythema	Oedema
1	0	0	0	0	0	0
24	0	0	0	0	0	0
48	0	0	0	0	0	0
72	0	0	0	0	0	0

Table 2: Mean Values of Skin Irritation Scores (24, 48 and 72 h after exposure):

Animal No.	Mean 24-72 hours
	Erythema	Oedema
494	0	0
496	0	0
518	0	0

Applicant's summary and conclusion

Interpretation of results:

not irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the current test conditions test substance is not considered to be irritating to the skin.