Dinaphtho[1,2,3-cd:3',2',1'-lm]perylene-5,10-dione, (9,10-dihydro-9,10-dioxo-1-anthracenyl)amino derivs.

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Study completion date: 01 April, 1985

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

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

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 45082/D
Batch No.: EN 35713.42
Stability: guaranteed by the sponsor until June, 1989
Description: solid
Test Article Received: 11 February, 1985

Test animals

Species:

rat

Strain:

other: Tif:RAIf(SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source:CIBA-GEIGY LTD. Tierfarm, 4334 Sisseln, Switzerland
- Weight at study initiation: 194 - 240 g
- Fasting period before study: Prior to dosing, the animals were fasted overnight.
- 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: approximately 15 air changes/h.
- Photoperiod: 12 hours light/day

IN LIFE Phase: Date of Administration: 26 February, 1985; Date of Completion: 12 March, 1985

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

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

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20 ml/kg bw

MAXIMUM DOSE VOLUME APPLIED: 5000 mg/kg bw

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5 males and 5 females

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: daily
- Body weight: on days 1, 7, and 14
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, mortality

Statistics:

From the body weights, the group means and their standard deviations were calculated.

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:

other: Dyspnoea, exophthalmos, ruffled fur, and curved body positions were seen, being common symptoms in acute tests. The animals recovered within 14 days.

Gross pathology:

No deviations from normal morphology were found.

Other findings:

None

Any other information on results incl. tables

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of FAT 45082/D in rats of both sexes observed over a period of 14 days is considered to be >5000 mg/kg bw.

Executive summary:

The acute oral toxicity of FAT 45082/D was evaluated in a study conducted according to OECD Guideline 401. A group of rats comprising of 5 males and 5 females were administered the test substance at 5000 mg/kg bw. No mortality occured. Dyspnoea, exophthalmos, ruffled fur, and curved body positions were seen, being common symptoms in acute tests. The animals recovered within 14 days. Normal body weight gain was noted. No gross organ changes were observed. Hence, the acute oral LD50 of FAT 45082/D in rats of both sexes observed over a period of 14 days is considered to be >5000 mg/kg bw.