9-ethylcarbazole

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: see 'Remark'

Remarks:

Test performed prior to the implementation of the current acknowledged testing and GLP guidelines . The test conduct however was in principle very similar to the OECD TG 401 as adopted in 1981. Important aspects (e.g. 14 day-postobservation time) were considered.

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:

yes

Remarks:

: no individual data included in report

GLP compliance:

no

Remarks:

pre-guideline study

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

9-ethylcarbazole

EC Number:

201-660-4

EC Name:

9-ethylcarbazole

Cas Number:

86-28-2

Molecular formula:

C14H13N

IUPAC Name:

9-ethyl-9H-carbazole

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Strain specifics: Wistar Han 78, SPF-Albino
- Source: Schering AG, Berlin
- Weight at study initiation: male 90 g - 105 g, female 90 g - 105 g on day 1 (treatment)
- Fasting period before study: approximately 16 hours before treatment
- Housing: in groups of five
- Diet: pellets (Ssniff) ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Photoperiod (hrs dark / hrs light): 12/12

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 % suspension in 0.5 % carboxymethyl cellulose

Doses:

5000 mg/kg body weight

No. of animals per sex per dose:

5 males
5 females

Control animals:

yes

Details on study design:

- 5 males and 5 females were used as control animals, 0.5 % carboxymethyl cellulose was administered
- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic examination

Statistics:

None

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Remarks on result:

other: no animals died within the 14 days observation period

Mortality:

no deaths

Clinical signs:

other: shaggy fur, crouch, diarrhea, lacrimation, tremor, slight lethargy and ataxia.

Gross pathology:

moderate hyperemia of lungs and liver, punctual hemorrhagic ablations of gastric mucosa

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: expert judgment

Conclusions:

Single application of 5000 mg test item per kg bw did not cause lethality in male and female rats during the 14 days observation period, resulting in a LD50 > 5000 mg/kg bw.

Executive summary:

Male and female rats were subjected to test acute oral toxicity. The test item was administered at the limit dose of 5000 mg/kg bw to 5 male and 5 female rats. During the 14 days observation period no animals died, thus leading to a LD50 > 5000 mg/kg bw.

Therefore, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008.