Registration Dossier

Diss Factsheets

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

Constituent 1
Chemical structure
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.