6,18-dihydrodinaphtho[2,3-i:2',3'-i']benzo[1,2-a:4,5-a']dicarbazole-5,7,12,17,19,24-hexone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study completion date: 28 March, 1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1984

Report date:

1984

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

6,18-dihydrodinaphtho[2,3-i:2',3'-i']benzo[1,2-a:4,5-a']dicarbazole-5,7,12,17,19,24-hexone

EC Number:

218-524-5

EC Name:

6,18-dihydrodinaphtho[2,3-i:2',3'-i']benzo[1,2-a:4,5-a']dicarbazole-5,7,12,17,19,24-hexone

Cas Number:

2172-33-0

Molecular formula:

C42H18N2O6

IUPAC Name:

6,18-dihydrodinaphtho[2,3-i:2',3'-i']benzo[1,2-a:4,5-a']dicarbazole-5,7,12,17,19,24-hexone

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Specific details on test material used for the study:

Code No. : FAT 46014/F
Batch No. : EN 94071.32
Stability: guaranteed by the sponsor until November 1988
Description: solid
Contents of active ingredient: 35.7 %
Test Article Received: December 6, 1983

Test animals

Species:

rat

Strain:

other: Tif. RAI (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Age at study initiation: 7-8 weeks
- Weight at study initiation: 179-215 g
- Housing:The animals were kept under conventional laboratory conditions. They were caged in groups of 5 in Macrolon cages type 4 with standardized soft wood bedding (Société Parisienne des sciures, Pantin).
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 55 ± 15
- Air changes (per hr): approximately 15 air changes/h
- Photoperiod (hrs dark / hrs light): 12 hours light/day

IN LIFE PHASE: From: 01 February, 1984; To: 15 February, 1984

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: Distilled water containing 0.5 % carboxymethylcellulose and 0.1 % polysorbate 80 (prepared by Pharmaceutical Division, Ciba-Geigy Ltd.).

Details on oral exposure:

- Amount of vehicle (if gavage): 20 ml/kg
The animals were allocated to the different dose groups by random selection.
Prior to dosing, the animals were fasted overnight.

Doses:

5000 mg/kg bw

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
- Necropsy of survivors performed: yes
- Other examinations performed: mortality, symptoms, body weight.

Statistics:

From the body weights, the group means and their standard deviations were calculated.
Where feasible, the LD50 including the 95% confidence limit were computed by the logit method (J. Berkson, J.Am. Stat. Ass. 39. 357-65, 1944).

Results and discussion

Preliminary study:

None

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed.

Clinical signs:

Dyspnoea, exophthalmos, ruffled fur and curved body position were seen, being common symptoms in acute tests. In addition, a transient diarrhea and tremor was observed. The surviving animals recovered within 10 days.

Body weight:

No effect on body weight gains was seen.

Gross pathology:

No gross lesions were found at necropsy.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Migrated information

Conclusions:

The acute oral LD50 of FAT 46014/F in rats of both sexes observed over a period of 14 days is 5000 mg/kg.

Executive summary:

The acute oral toxicity of FAT 46014/F was assessed in a study conducted according to OECD Guideline 401. In this study, a group of 5 male and 5 female rats were administered a dose of 5000 mg/kg bw. No mortality was seen. Dyspnoea, exophthalmos, ruffled fur and curved body position were seen, being common symptoms in acute tests. In addition, a transient diarrhea and tremor was observed. The surviving animals recovered within 10 days. No adverse effect on body weight gain was seen. No gross lesions were found at necropsy. Thus, based on the findings of the study, the LD50 of FAT 46014/F was determined to be >5000 mg/kg bw.