9,10-Anthracenedione, 1,4-bis[[3-[2-(2-hydroxyethoxy)ethoxy]propyl]amino]-

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

25 June 1987 to 9 July 1987

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1987

Report date:

1987

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Code of Federal Regulations, Volume 16, Part 1500.30

Deviations:

no

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Automatically generated during migration to IUCLID 6, no data available

IUPAC Name:

Automatically generated during migration to IUCLID 6, no data available

Test material form:

other: liquid (unspecified)

Details on test material:

- Appearance: Dark blue liquid
- Storage conditions: Room temperature

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: Young adult
- Weight at study initiation: 215.5 - 224.0 g (males); 219.5 - 245.7 g (females)
- Fasting period before study: Yes. Food was withheld for an overnight period just before test material administration.
- Housing: Animals were maintained in individual cages.
- Diet: ad libitum
- Water: ad libitum
- Acclimation period: at least 7 days

ENVIRONMENTAL CONDITIONS
Animals were housed in temperature-controlled and humidity-monitored quarters.

IN-LIFE DATES: From: 17 June 1987 To: 9 July 1987

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: distilled water

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg

Doses:

5000 mg/kg

No. of animals per sex per dose:

5 animals per sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Each animal was observed for signs of toxic and pharmacologic effects at 1, 2 and 4 hours after test material administration and once daily thereafter for 14 days. Mortality/moribundity were recorded twice daily. All animals were weighed just before test material administration, at Day 7, and at termination, or time of death.
- Necropsy of survivors performed: Yes. At termination, all the surviving animals were sacrificed and necropsied. Necropsies were also performed at time of death. Observations were recorded.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

Two female rats receiving the 5000 mg/kg dose had died by Day 2. All the remaining animals survived throughout the study.

Clinical signs:

other: A variety of clinical observations were noted in all the animals. These included soft faeces in two male and four female animals following test material administration and one female was urine stained; depression/slight depression was noted in one female

Gross pathology:

Observable gross pathology findings noted in four females involved the lungs, liver and spleen (discoloration) and the stomach and intestines (distended and abnormal contents). No gross pathology findings were observed in any of the males at time of necropsy.

Other findings:

The test material coloured the faeces and urine of the animals until Day 7.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the LD50 was estimated to be >5000 mg/kg bw in male and female rats.

Executive summary:

The acute oral toxicity potential of the test material was investigated in accordance with the standardised guideline from the Code of Federal Regulations, Volume 16, Part 1500.30.

The test material was administered in distilled water via gavage to 5 male and 5 female albino Sprague-Dawley rats at a limit dose of 5000 mg/kg bw.

Each animal was observed for signs of toxic and pharmacologic effects at 1, 2 and 4 hours after test material administration and once daily thereafter for 14 days. Mortality/moribundity were recorded twice daily. All animals were weighed just before test material administration, at Day 7, and at termination, or time of death. At termination, all the surviving animals were sacrificed and necropsied. Necropsies were also performed at time of death. Observations were recorded.

Two female rats receiving the 5000 mg/kg dose had died by Day 2. All the remaining animals survived throughout the study. Prior to death, the two females that did not survive lost weight, while the surviving animals gained weight. A variety of clinical observations were noted in all the animals. All the surviving animals returned to normal by Day 8 and remained normal to Day 14.

Observable gross pathology findings noted in four females involved the lungs, liver and spleen (discoloration) and the stomach and intestines (distended and abnormal contents). No gross pathology findings were observed in any of the males at time of necropsy.

Under the conditions of this study the LD50 was estimated to be >5000 mg/kg bw in male and female rats.