[1,1'-Bianthracene]-9,9',10,10'-tetrone, 4,4'-bis[[4,6-bis[[3-(diethylamino)propyl]amino]-1,3,5-triazin-2-yl]amino]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

January to March 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Well documented guideline study

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report date:

1992

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

not relevant

GLP compliance:

yes (incl. QA statement)

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

308 AQN

IUPAC Name:

308 AQN

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

At the start of the main study the males weighed 142 - 152g, and the females 143 - 157 g, and were approximately five to eight weeks old. After a minimum acclimatisation period of at least five days the animals were selected at random and given a unique number within the study by indelible ink marking on the tail and a number written on a cage card.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

arachis oil

Details on oral exposure:

All animals were dosed once only by gavage using a metal cannula attached to a graduated syringe. The volume administered to each animal was calculaed according to its fasted bodyweight at the time of dosing.

Doses:

Dose level: 2000 mg/kg
Concentration: 200 mg/ml
Dose volume: 10 ml/kg

No. of animals per sex per dose:

Male: 5
Female: 5

Control animals:

no

Details on study design:

Individual bodyweights were recorded prior to dosing on day 0 and on days 7 and 14.
At the end of the study the animals were killed by cervical dislocation and subjected to gross pathological examination. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained.

Results and discussion

Preliminary study:

Dose level: 2000 mg/kg
Concentration: 200 mg/ml
Dose volume: 10 ml/kg
Male: 1
Female: 1
There were no deaths. Diarrhoea was noted in the female 4 hours after dosing.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There were no deaths.

Clinical signs:

other: No signs of systemic toxicity were noted during the study.

Gross pathology:

Individual necropsy findings are given in table 4 of the report.
No abnormalties were noted at necropsy.

Other findings:

Diarrhoea was noted in the female 4 hours after dosing.

Any other information on results incl. tables

No deaths and no signs of sytemic toxicity were noted during the Study.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: OECD GHS

Conclusions:

The acute oral median lethal dose (LD50) of the test material, No. 308 AQN, in the Sprague-Dawley strain rat was found to be greater thant
2000 mg/kg bodyweight. No symbol and risk phrase are required according to EEC labeling regulations.

Executive summary:

The test item No. 308 AQN was tested according to OECD guideline No. 401 under GLP conditions to determine its oral toxicity.

The acute oral median lethal dose (LD50) of the test material, No. 308 AQN, in the Sprague-Dawley strain rat was found to be greater thant 2000 mg/kg bodyweight. No symbol and risk phrase are required according to EEC labeling regulations.