3-oxo-4-azaandrost-5-ene-17β-carboxylic acid

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1995-10-09 - 1995-10-31

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Study performed the OECD 420 fix dose method and Method B1 Annex V of 67/548/EEC

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

3-oxo-4-azaandrost-5-ene-17β-carboxylic acid

EC Number:

407-830-6

EC Name:

3-oxo-4-azaandrost-5-ene-17β-carboxylic acid

Cas Number:

103335-54-2

Molecular formula:

Hill formula: C19H27NO3 CAS formula: C19H27NO3

IUPAC Name:

4a,6a-dimethyl-2-oxo-1H,2H,3H,4H,4aH,4bH,5H,6H,6aH,7H,8H,9H,9aH,9bH,10H-indeno[5,4-f]quinoline-7-carboxylic acid

Details on test material:

- Name of test material (as cited in study report): GR91287X
- Molecular formula (if other than submission substance): C19-H27-N-O3
- Molecular weight (if other than submission substance): 317.43
- Analytical purity: >95%
- Lot/batch No.: CO-0099
- Storage condition of test material: room temp in dark

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River (UK) Ltd
- Age at study initiation: 7 - 8 weeks
- Weight at study initiation: 188 -218g (males), 178-180g (females)
- Housing: 5 animals in solid floored polyporpylene cages with woodflakes
- Diet (e.g. ad libitum): Rat and Mouse expanded diet No.1, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-24°C
- Humidity (%): 50 - 55
- Air changes (per hr): 15
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: 09.10.1995 To: 31.10.1995

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 200 mg/ml

Doses:

Limit dose: 2000 mg/kg

No. of animals per sex per dose:

5 males 5 females

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: at least daily
- Frequency of weighing: Day 0, 1, 2, 3, 7, 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Preliminary study:

2 males and 2 females 500mg/kg (50mg/ml)
2 males and 2 females 2000mg/kg (200mg/ml)

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died during the 14 day observation period.

Clinical signs:

other: Hunched posture was noted in all animals. Decreased respiratory rate was also noted in nine animals. All animals recovered one day ofter dosing.

Gross pathology:

No abnormlities were detected.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The LD50 (rat oral) of GR91287X is greater than 2000 mg/kg bw.

Executive summary:

The LD50 (rat oral) of GR91287X is greater than 2000 mg/kg bw. The experiment was performed as limit test with a concentration of 2000 mg/kg bw. No animal died during the 14 day observation period. No abnormalities were detected regarding body weight development or gross pathology. Hunched posture was noted in all animals. Decreased respiratory rate was also noted in nine animals. All animals recovered one day ofter dosing. The LD50 was determined to be greater than 2000 mg/kg bw.