Carbazole

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Basic data given: comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

Pre-guideline test, but the test method applied is similar to OECD test guideline 401.

GLP compliance:

no

Remarks:

pre-GLP test

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Carbazole

EC Number:

201-696-0

EC Name:

Carbazole

Cas Number:

86-74-8

Molecular formula:

C12H9N

IUPAC Name:

9H-carbazole

Details on test material:

- Name of test material (as cited in study report): Produkt 110 804 received from Rütgerswerke AG
- No further information on test material

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Schering AG, Berlin, Germany
- Age at study initiation: no data
- Weight at study initiation: males 100 - 105 g, females 90 - 100 g
- Fasting period before study: yes (ca. 16 h)
- Housing: 5 animals per cage, air-conditioned housing
- Diet: Ssniff pellets ad libitum
- Water: ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1 °C
- Humidity (%): no data
- Photoperiod (hrs dark / hrs light): 12 /12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration: Suspension of 40% test substance in 0.5 % carboxymethyl cellulose
- Amount of vehicle (if gavage): ~ 60 %

MAXIMUM DOSE VOLUME APPLIED: 4 mL

Doses:

single dose: 16,000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

> 16 000 mg/kg bw

Remarks on result:

other: limit dose

Mortality:

no mortality observed

Clinical signs:

other: unkempt hair coat, contorted posture, pallor of extremities, lacrimation, diarrhea, mid- to high-grade lethargy and ataxia

Gross pathology:

Mid-grade hyperemia of the lung and the liver

Other findings:

Potential target organs: lungs, liver

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

After oral administration of a single dose of 16000 mg carbazole/kg bw to male and female rats (5 each), no mortality was observed within the observation period of 14 days. Distinct clinical signs were obvious. Gross pathology revealed findings on lung and liver.