Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]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:

July 7, 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1976

Report date:

1976

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

no

Remarks:

pre GLP

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

EC Number:

267-224-0

EC Name:

Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate

Cas Number:

67827-60-5

Molecular formula:

C31H26N3O6S.Na

IUPAC Name:

sodium 1-amino-4-({3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl}amino)-9,10-dioxo-9,10-dihydroanthracene-2-sulfonate

Test material form:

not specified

Test animals

Species:

rat

Strain:

other: TIF RAIF

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: the mean initial body weight of the groups ranged from 80 to 110 grams
- Diet: standard diet of pellets - No. 890, Nafag Gossau SG. Fasted overnight before treatment
- Water: ad libitum
- Acclimation period: minimum 5 days
- Housing: During the treatment and observation period the animals were housed in groups of 5 in Macrolon cages.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±1°C
- Humidity (%): 55*5 %
- Photoperiod (hrs dark / hrs light): 14 hours light cycle day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: sesame oil

Details on oral exposure:

Concentrations of substance in vehicle:
- 10 % (1000mg/kg)
- 30 % (3000mg/kg)
- 20 % (8000mg/kg)
- 25 % (10000mg/kg)
- 25 % (15000mg/kg)

Doses:

1000, 3000, 5000, 8000, 10000, 15000 (mg/kg)

No. of animals per sex per dose:

5 per sex per dose

Control animals:

no

Details on study design:

Physical condition and rate of death were monitored throughout the whole observation period.
Post observation period = 15 days

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 8 850 mg/kg bw

Based on:

test mat.

95% CL:

> 7 960 - < 9 900

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

ca. 5 664 mg/kg bw

Based on:

act. ingr.

Mortality:

1000, 3000 mg/Kg bw: no death occurs
8000 mg/Kg bw: 1 female died in a day
10000 mg/Kg bw: 4 male and 5 female died in a day
15000 mg/Kg bw: all animals died in a day

Clinical signs:

other: 1000 mg/Kg bw: none 3000 mg/Kg bw: diarrhea, after 24 hours no symptoms 8000 mg/Kg bw: ditto, reduction in spontaneous motility, ataxia, ventricumbency, muscular hypotonia, hypoventilation. After 2 days no symptoms 10000 mg/Kg bw: ditto 15000 mg/Kg bw: di

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50 = 8850 mg/Kg bw

Executive summary:

Method:

Similar to OECD guideline 401.

 

Observations:

At a concentrations of 8000 mg/Kg a death occured after a day. At 10000 mg/Kg bw nine animals death after a day and at 15000 mg/Kg bw ten animals death after a day.

All animals died in respiratory failure.

 

Results:

LD50 = 8850 mg/Kg bw (LD50 = 5664 mg/kg bw based on active ingredient).