2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 17 JUL 1992 to 31 JUL 1992

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: Guideline study (EPA TSCA, 40 CFR 798)

Cross-reference

Reason / purpose:

reference to same study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1992

Report Date:

1992

Materials and methods

Test guideline

Qualifier:

according to

Guideline:

other: EPA TSCA, 40 CFR 798

Deviations:

no

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals and environmental conditions:

TEST ANIMALS
- Source: Ave Animals
- Age at study initiation: ~8 weeks
- Weight at study initiation: males: 257 - 278 g; females: 205 - 248 g
- Fasting period before study: 16 to 17 h
- Housing: in cages in groups of five by sex
- Diet: Fresh Purina Rat Chow (Diet #5012), ad libitum
- Water, ad libitum
- Acclimation period: at least one week

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

corn oil

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 0.5 g/mL (20 g of test article was added to corn oil for total volume of 40 mL)

MAXIMUM DOSE VOLUME APPLIED: 1 mL/100 g body weight for non-aqueous vehicles and 2 mL/100 g body weight for aqueous solutions

Doses:

5000 mg/kg bw

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations: 1, 2 and 4 hours post dose and once daily for 14 days toxicity and pharmacological effects, twice daily for 14 days for mortality
- Frequency of weighing: weekly
- Necropsy of survivors performed: yes

Statistics:

The LD50, 95% Confidence limits, dose response curve and slope were calculated, if possible, according to the method of Litchfield and Wilcoxon, 1949 or Horn, 1956.

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 occurred

Clinical signs:

- one animal had diarrhea 4 hours post appilcation
- in all animals the anogenital area was stained purple on days 1 and 2

Body weight:

- body weight development was not impaired

Gross pathology:

- all animals were sacrificed at the end
- only in one male animal there was a herniated liver protruding through the diaphragm
- in all other animals no macroscopically visible changes were found

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: other: CLP regulation

Conclusions:

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

Executive summary:

Acute oral toxicity of the test item was tested in male and female Wistar rats according to EPA TSCA, 40 CFR 798. The test was conducted administering the limit dose of 5000 mg/kg bw to 5 animals/sex. During the 14 days observation period no animals died and there were no toxicological relevant changes found in necropsy, thus leading to a median lethal dose (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.