1,4-bis(butylamino)anthraquinone

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1971

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Early study, no GLP, short report.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1971

Report date:

1971

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre-dates GLP regulation

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

1,4-bis(butylamino)anthraquinone

EC Number:

241-379-4

EC Name:

1,4-bis(butylamino)anthraquinone

Cas Number:

17354-14-2

Molecular formula:

C22H26N2O2

IUPAC Name:

1,4-bis(butylamino)anthraquinone

Details on test material:

technically pure

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: SPF-Zucht: Firma Gassner, Ottobrunn, Deutschland
- Age at study initiation: no data
- Weight at study initiation: male: ca 215 g; female: ca. 155 g
- Fasting period before study: no data

- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS : no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

CMC (carboxymethyl cellulose)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 2 or 16 % (w/v; suspension)
- Amount of vehicle (if gavage): max. ca. 8,6 mL
- Justification for choice of vehicle: the test material is insoluble in all possible vehicles
- Lot/batch no. (if required): no data


MAXIMUM DOSE VOLUME APPLIED: ca. 8,6 mL

Doses:

200 - 1600 - 3200 - 6400 mg/kg bw

No. of animals per sex per dose:

10

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: no data
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs,

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 6 400 mg/kg bw

Based on:

test mat.

Mortality:

One male rat died about 7 days after treatment. The animal showed pneumonia during necropsy. The death was not considered as a consequence of treatment. Surviving animals also showed signs of pneumonia at necropsy.

Clinical signs:

other: Dyspnea and apathy were observed for 2 to 5 days.

Gross pathology:

The deceased animal showed pneumonia during necropsy. Surviving animals also showed signs of pneumonia at necropsy.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The lethal dose of the test material was above the maximum tested dose of 6400 mg/kg bw after single, oral gavage in the rat.

Executive summary:

The acute oral toxicity of the test material was determined in Sprague-Dawley rats. The test material was suspended in an aqueous suspension of carboxymethyl-cellulose at 2 % (low dose) or 16 % (w/v; other doses). Doses employed were 200, 1600, 3200 and 6400 mg/kg applied orally by gavage.

The aproximate mean lethal dose (AID 50) was above 6400 rng/kg bw.