Estr-5(10)-en-17-one, 3,3-dimethoxy-

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Feb to Mar 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2000

Report date:

2000

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

17 January 1992

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3,3-Dimethoxyestr-5(10)-en-17-one

EC Number:

606-278-5

Cas Number:

19257-34-2

Molecular formula:

C20 H30 O3

IUPAC Name:

3,3-Dimethoxyestr-5(10)-en-17-one

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River, Kisslegg, Germany
- Weight at study initiation: males: 2.7-2.9 kg; females: 2.7-2.9 kg
- Housing: in conventional metal cages, individually
- Diet (e.g. ad libitum): pell. Altromin® K ; ad libitum
- Water (e.g. ad libitum): demineralized water; ad libitum
- Acclimation period: ≥ 14 days; during this period the animals were vaccinated against rabbit hemorrhagic disease (Arvilap®)

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-22
- Humidity (%): 54-62
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

physiological saline

Controls:

other: the untreated skin served as control

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

4 days

Number of animals:

2 males and 2 females

Details on study design:

TEST SITE
- Area of exposure: 2.5 x 2.5 cm
- % coverage: 6 cm² each
- Type of wrap if used: The sites (compound·treated and vehicle-treated) were covered with a piece of gauze (semiocclusive) fixed on the skin with Leukoflex ®.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After exposure the gauze was removed and the treated and untreated skin areas were wiped carefully with lukewarm tap water and paper towels.
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
The application sites were evaluated 1 , 24, 48 and 72 hours after end of exposure. Clinical observation was performed in each animal as long as findings occurred, at least until day 4 (72 hours after treatment). Body weight was recorded for the individual animal on the day of compound administration (day 1) and at the end of the observation period (day 4).

SCORING SYSTEM:
- Method of calculation: According to the system of evaluation recommended for EU.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1 - #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

animal: #1 - #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Other effects:

- Other adverse local effects: Slight to moderate reddening and scab formation were seen only outside of the administration sites in two out of four animals on day 4 of the test. These findings were not considered to be compound-related but due to shearing injuries.

Any other information on results incl. tables

No signs of local intolerance were observed after dermal administration of test item as a paste. The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.

Applicant's summary and conclusion

Conclusions:

A single dermal administration of the test substance (0.5 g applied as a paste) for 4 hours to male and female rabbits was tolerated without any local irritations. The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.

Executive summary:

In a primary dermal irritation study according to OECD TG 404 (adopted 12 May 1981), groups of young adult New Zealand White rabbits (2/sex) were dermally exposed to Dimethoxyketal in physiological saline for 4 hours at a dose 0.5g. Animals then were observed for 4 days. Irritation was scored by the method as recommended by the guideline.

The mean values of findings relevant for classification (reddening, scab formation and swelling of the skin) at the time-points 24, 48 and 72 hours after the end of administration were 0.
In this study, the test item is not a dermal irritant.