13-β-ethyl-3-methoxygona-2,5(10)-dien-17-one

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

June to July 1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

24 February 1987

Deviations:

yes

Remarks:

- 3 instead of 5 animals/sex used

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Gona-2,5(10)-dien-17-one, 13-ethyl-3-methoxy

IUPAC Name:

Gona-2,5(10)-dien-17-one, 13-ethyl-3-methoxy

Constituent 2

Reference substance name:

13-β-ethyl-3-methoxygona-2,5(10)-dien-17-one

EC Number:

219-034-4

EC Name:

13-β-ethyl-3-methoxygona-2,5(10)-dien-17-one

Cas Number:

2322-77-2

Molecular formula:

C20 H28 O2

IUPAC Name:

3-Methoxy-18-methyl-2,5(10)-estradien-17-on

Test material form:

semi-solid (amorphous): gel

Remarks:

migrated information: paste

Test animals

Species:

rat

Strain:

other: Han: WIST (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Schering AG
- Weight at study initiation: 106-118 g (males) and 95-111 g (females)
- Fasting period before study: ca. 19 hours
- Housing: 1 animal/cage
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20-22°C
- Humidity (%): 54-64%
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: 900 mg NaCl ad 100 ml bidist. water

Details on dermal exposure:

Amount of drug substance: 190-236 mg + 0.3 ml vehicle

Duration of exposure:

24 hours

Doses:

2000 mg/kg bw

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: day 1, 7 and 14
- Necropsy of survivors performed: yes

Statistics:

none (limit dose)

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died during the course of the study.

Clinical signs:

other: No compound related clinical findings.

Gross pathology:

Autopsy revealed no compound related findings.

Applicant's summary and conclusion

Conclusions:

A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight.

Executive summary:

In an acute dermal toxicity study similar to OECD TG 402 (adopted 24 February 1987), groups of young adult Wistar rats (3/sex) were dermally exposed to D-ET-Dienon in physiological saline for 24 hours at a dose 2000 mg/kg bw. Animals then were observed for 14 days.

 

Dermal LD50 Combined = > 2000 mg/kg bw

 

No mortality occurred during the limit test.

The test item is of low Toxicity based on the combined LD50 value of > 2000 mg/kg bw.

 

There were no treatment related clinical signs, necropsy findings or changes in body weight.