Reaction mass of Sodium 2-(2 or 3-{[(chloroacetyl)amino]methyl}-4-{[4-(cyclohexylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}phenoxy)-5-methylbenzenesulfonate and Sodium 2-(3 or 2-{[(chloroacetyl)amino]methyl}-4-{[4-(cyclohexylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}phenoxy)-5-methylbenzenesulfonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Principles of method if other than guideline:

None

GLP compliance:

no

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Reaction mass of Sodium 2-(2 or 3-{[(chloroacetyl)amino]methyl}-4-{[4-(cyclohexylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}phenoxy)-5-methylbenzenesulfonate and Sodium 2-(3 or 2-{[(chloroacetyl)amino]methyl}-4-{[4-(cyclohexylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}phenoxy)-5-methylbenzenesulfonate

EC Number:

942-981-6

Molecular formula:

C36H33ClN3NaO7S

IUPAC Name:

Reaction mass of Sodium 2-(2 or 3-{[(chloroacetyl)amino]methyl}-4-{[4-(cyclohexylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}phenoxy)-5-methylbenzenesulfonate and Sodium 2-(3 or 2-{[(chloroacetyl)amino]methyl}-4-{[4-(cyclohexylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}phenoxy)-5-methylbenzenesulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

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: 6 weeks
- Weight at study initiation: 192 g (males), 143 g (females)
- Fasting period before study: 18 h
- Housing: Rats were caged singly
- Diet: Commercial pelleted diet (ad libitum)
- Water: Ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature: 21±2 °C.
- Photoperiod (hrs dark / hrs light): 12 h/12 h

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: deionised water

Details on oral exposure:

A 25 % w/v solution of the compound in deionised water was administered as a single dose by gavage to rats which had been fasted overnight, at a dose rate of 20 ml/kg (equivalent to 5 g/kg compound).
Ten rats (5 males and 5 females) were used for the study.

Doses:

5000 mg/kg/d

No. of animals per sex per dose:

5/sex/dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 d
- At the end of the observation period, surviving animals were killed by exsanguinations under other anaesthesia and an autopsy performed.
- Other examinations performed: Mortality, clinical symptoms

Statistics:

Not available

Results and discussion

Preliminary study:

Not available

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No death occurred during the study.

Clinical signs:

other: No clinical signs were observed during the study period.

Gross pathology:

No changes in organs or tissues were observed at autopsy.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of FAT 20077/A in rats is greater than 5000 mg/kg bw.

Executive summary:

A study was performed to determine the acute oral toxicity of FAT 20077/A, by treating male and female Sprague-Dawley rats at 5000 mg/kg bw and observed over a period of 14 days. A 25 % w/v solution of the compound in deionised water was administered as a single dose by gavage to rats which had been fasted for 18 hours, at a dose rate of 20 ml/kg (equivalent to 5000 mg/kg compound). No clinical symptoms were recorded and no deaths occurred during the 14 day observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.Hence, based on these findings, the acute oral LD50 of FAT 20077/A in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw.