Sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-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:

1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Remarks:

Without GLP

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Report date:

1982

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

EC Number:

274-675-7

EC Name:

Sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Cas Number:

70571-81-2

Molecular formula:

C22H17N3O6S.Na

IUPAC Name:

sodium 4-[(3-acetamidophenyl)amino]-1-amino-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate

Test material form:

solid: particulate/powder

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Winkelmann, Borchen
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: males: 9 week, females: 14 weeks
- Weight at study initiation: males: 151 to 167 g; females: 156 to 177 g
- Fasting period before study: yes - 16 hours before to 4 hours after dosing
- Housing: groups of 5 rats/sex
- Diet (e.g. ad libitum): Altromin R 1324 ad lib
- Water (e.g. ad libitum): tap water ad lib
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5°C
- Humidity (%): 60 +/- 5%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12

IN-LIFE DATES: From: To: July/August 1982

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 250 mg/mL
- Amount of vehicle (if gavage): 20 mL/kg bw
- Justification for choice of vehicle: water soluble substance
- Lot/batch no. (if required): -
- Purity: -

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 and weighing: observations on treatment day: multiple times, thereafter twice daily on week days, once daily on week-ends
weighing: Day 1, 7, 14
- Necropsy of survivors performed: yes

Results and discussion

Effect levels

Effect levels 1

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

act. ingr.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD0

Effect level:

>= 5 000 mg/kg bw

Based on:

test mat.

Mortality:

none

Clinical signs:

other: none

Gross pathology:

no abnormalities

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

No deaths or adverse effects were observed in male and female rats at a dose level of 5000 mg/kg bw. Hence the LD0 and Ld50 is above 5000 mg/kg bw.