Androstan-17-ol, 2,3-epoxy-16-(1-pyrrolidinyl)-, (2.alpha.,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:

28 October 1997 - 31 October 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: The study was conducted according to OECD Guideline 404 and EU Method B.4 (Acute Dermal irritation/Corrosion) without deviations and GLP practices.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1998

Report date:

1998

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

(1S,2S,4R,6S,8S,11R,12S,14S,15R,16S)-2,16-dimethyl-14-(pyrrolidin-1-yl)-5-oxapentacyclo[9.7.0.0²,⁸.0⁴,⁶.0¹²,¹⁶]octadecan-15-ol

EC Number:

601-593-4

Cas Number:

119302-19-1

Molecular formula:

C23H37NO2

IUPAC Name:

(1S,2S,4R,6S,8S,11R,12S,14S,15R,16S)-2,16-dimethyl-14-(pyrrolidin-1-yl)-5-oxapentacyclo[9.7.0.0²,⁸.0⁴,⁶.0¹²,¹⁶]octadecan-15-ol

Test material form:

solid - liquid: suspension

Details on test material:

- Name of test material (as cited in study report): Epyrrol
- Substance type: pure active substance
- Physical state: Powder, off white in color
- Composition of test material, percentage of components: Main component= 75%, other= 18%, other= 7%
- Lot/batch No.: GL-1291 K1
- Expiration date of the lot/batch: 24 September 1998
- Stability under test conditions: Not indicated
- Storage condition of test material: Stable 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: Broekman Institute, Someren, The Neitherlands
- Age at study initiation: At least 6 weeks old
- Weight at study initiation: Less than 3.5 kg
- Housing: Individually housed in cages with perforated floors
- Diet (e.g. ad libitum): Standard laboratory rabbit diet (LKK-20, pelleted diameter 4mm, Hope Farms, Woerden, The Neitherlands), approximately 100 grams per day. Additionally, hay was provided once per week.
- Water (e.g. ad libitum): Free access to tap-water with decalcified water
- Acclimation period: At least 5 days before the start of treatment under laboratory conditions.

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

IN-LIFE DATES: From: Not documented in the study report To: Not documented in the study report

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

other: Adjacent areas of the untreated skin of each animal served as controls.

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): Water

Duration of treatment / exposure:

4 hours

Observation period:

Up to 72 hours after application (Observations were made 1, 24, 48 and 72 hours after exposure)

Number of animals:

Three animals of either sex

Details on study design:

TEST SITE
- Area of exposure: Skin of one flank/animal
- % coverage: % not specified in the study report, although an area of 150 square centimeters (10X15 cm2) was used for the exposure site
- Type of wrap if used: Scotchpak-non-woven patch of 2X3 cm mounted on Micropore tapeand secured with Coban elastic bandage.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): The dressing was removed and the remaining test substance was removed using a tissue moistened with tap-water and subsequently a dry tissue.
- Time after start of exposure: 4 hours

SCORING SYSTEM: Draize Scoring System

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24-72 h

Score:

0

Irritant / corrosive response data:

No irritation was caused by 4 hours of exposure to the test substance. There was no evidence of a corrosive effect on the skin.

Other effects:

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

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

No skin irritation was caused by 4 hours exposure to 0.5 grams of Epyrrol.