Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate

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)

Deviations:

not specified

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

FAT 20033/L TE

IUPAC Name:

FAT 20033/L TE

Constituent 2

Reference substance name:

Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate

EC Number:

247-269-2

EC Name:

Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate

Cas Number:

25797-81-3

Molecular formula:

C24H23N3O8S2.Na

IUPAC Name:

sodium 1-amino-4-({3-[(2-hydroxyethyl)sulfamoyl]-4,5-dimethylphenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

powder / dark blue

Specific details on test material used for the study:

Teat material was blue powder.

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 - 7 weeks
- Weight at study initiation: 182 g for male and 136 g for female
- Fasting period before study: 18 h
- Diet: Oakes Special Diet with added Vit. E; ad libitum
- Water: ad libitum

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

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Deionised

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 25% w/v

MAXIMUM DOSE VOLUME APPLIED: 20 ml/kg bw

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
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, mortality, necropsy

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed.

Clinical signs:

other: No clinical signs observed.

Gross pathology:

At autopsy no changes in organs or tissues caused by the administration of the test compound were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The median lethal dose (LD50) of FAT 20033/C is >5000 mg/kg bw in male and female SD rats.

Executive summary:

An acute oral toxicity study was conducted using 5 Sprague Dawley rats/sex, which were gavaged with 5000 mg/kg bw of FAT 20033/C. Mortality and clinical signs were observed during 14 days. At the end of the observation period surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. No mortality or clinical signs were seen during the observation period. At autopsy no changes in organs or tissues caused by the administration of the test compound were seen. On the basis of the study results, the median lethal dose (LD50) for FAT 20033/C derived is >5000 mg/kg bw.