Estr-4-ene-3,17-dione

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

26 December 2019 - 16 April 2020

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

The additional test in skin irritation was performed based on the Guidance on Environmental Management Registration of New Chemical Substances (Order No. 12 of the MEE of the P.R. China). The in vivo test was the accepted method of the toxicological endpoint skin irritation/corrosion at the time for a New Chemical Substance Registration in China.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2020

Report date:

2020

Materials and methods

Test guideline

Test guideline 1

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

2015

Test guideline 2

Qualifier:

according to guideline

Guideline:

other: State Ministry of Environmental Protection of the People’s Republic of China. Guidelines of Chemical Testing (HJ/T 153-2004) Annex A 404 Acute Dermal Irritation/Corrosion Test.

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Estr-4-ene-3,17-dione

EC Number:

211-995-8

EC Name:

Estr-4-ene-3,17-dione

Cas Number:

734-32-7

Molecular formula:

C18H24O2

IUPAC Name:

estr-4-ene-3,17-dione

Test material form:

other: solid

Test animals

Species:

rabbit

Strain:

other: Japanese long-eared white rabbit

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Qingdao Kangda Biological Technology Co., Ltd.
- Weight at study initiation: 2.30-2.40 kg
- Housing: individually
- Diet (e.g. ad libitum): rabbit maintenance feed (batch no. 19101861) provided by Liaoning Changsheng Biotechnology Co., Ltd., ad libitum
- Water (e.g. ad libitum): drinking water, ad libitum
- Acclimation period: 19 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.03-23.70 °C
- Humidity (%): 40.71-67.80%
- Photoperiod (hrs dark / hrs light): 12/12

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: moistened with water

Controls:

other: untreeated left side of the spinal column on the back of teh animal served as control

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

4 h

Observation period:

72 h

Number of animals:

3

Details on study design:

TEST SITE
- Area of exposure: Two areas of skin on both sides of the midline below the shoulder blade were selected (approximately 2.5 cm x 2.5 cm)

REMOVAL OF TEST SUBSTANCE
- Washing (if done): ultra-pure water and absorbent cotton were used to wash the skin at the test area
- Time after start of exposure: 4 h

OBSERVATION TIME POINTS
Immediately after patch removal, 1, 24, 48, 72 h

SCORING SYSTEM:
- Method of calculation: Draize scale
Dermal Irritation Response Score
Skin response Score
Erythema and eschar formation
No erythema 0
Slight erythema (barely perceptible) 1
Clearly visible, easily defined erythema 2
Moderate to severe erythema 3
Severe erythema (purplish-red) to eschar formation 4
Oedema formation
No oedema 0
Slight oedema (barely perceptible) 1
Slight oedema (skin raised, clear outline) 2
Moderate oedema (skin raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm, extending beyond the area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

other: not applicable

Irritant / corrosive response data:

no abnormalities or skin reactions were observed immediately after the dressing was removed, and until 72 hours after the dressing was removed

Applicant's summary and conclusion

Conclusions:

Under the conditions of this test, based on observations seen and the assessment system adopted, mean dermal erythema/oedema scores at 24 hours,
48 hours, and 72 hours after the dressings were removed were 0/0, 0/0, and 0/0. Based on the GHS classification criteria for dermal irritation/corrosion, Norandrostendione did not meet the classification criteria.

Executive summary:

In a dermal irritation study equivalent to OECD Guideline 404 three male Japanese long-eared white rabbits were dermally exposed to Norandrostendione. 0.5 g of the test sample was administered to the clipped dorsal skin on the right side of each animal and the dorsal skin on the left side served as the control. Exposure time was four hours. The animals were observed clinically immediately after the dressing was removed and at one hour, 24 hours, 48 hours and 72 hours.
Skin response was observed immediately after the dressing was removed and at one hour, 24 hours, 48 hours and 72 hours, and was scored based on the skin irritation response scoring criteria.

In all three animals no abnormalities were observed immediately after the dressing was removed, and until 72 hours after the dressing was removed.

Under the conditions of this test, based on observations seen and the assessment system adopted, mean dermal erythema/oedema scores at 24 hours,
48 hours, and 72 hours after the dressings were removed were 0/0, 0/0, and 0/0. Based on the GHS classification criteria for dermal irritation/corrosion, Norandrostendione did not meet the classification criteria.