Sodium bis[2-[[5-(aminosulphonyl)-2-hydroxyphenyl]azo]-3-oxo-N-phenylbutyramidato(2-)]cobaltate(1-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from October 25 to November 30, 1979

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study conducted according to internationally accepted testing procedures.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1979

Report date:

1979

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

not specified

GLP compliance:

no

Remarks:

Pre GLP.

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Sodium bis[2-[[5-(aminosulphonyl)-2-hydroxyphenyl]azo]-3-oxo-N-phenylbutyramidato(2-)]cobaltate(1-)

EC Number:

276-701-2

EC Name:

Sodium bis[2-[[5-(aminosulphonyl)-2-hydroxyphenyl]azo]-3-oxo-N-phenylbutyramidato(2-)]cobaltate(1-)

Cas Number:

72496-88-9

Molecular formula:

C32H28CoN8NaO10S2

IUPAC Name:

monosodium bis[2-((E)-((Z)-3-oxido-1-oxo-1-(phenylamino)but-2-en-2-yl)diazenyl)-4-sulfamoylphenolate (2-)] cobaltate (1-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Test animals

Species:

rat

Strain:

other: RAIf (SPF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Tif
- Age at study initiation: 7 to 8 weeks old
- Weight at study initiation: males 206.5 g, females 182 g
- Fasting period before study: Animals fasted overnight
- Housing: 5 in Macrolon cages (type 3)
- Diet: ad libitum rat food NAFAG, Gossau SG
- Water: ad libitum
- Acclimation period: 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 °C
- Humidity (%): 55 ± 10 %
- Photoperiod: 10 hours of light during the day

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

other: carboxymethyl-cellulose 2 % (w/v) in dest. water

Details on oral exposure:

VEHICLE
- Concentration in vehicle:20 ml/kg bw

Doses:

5000, 7000, 8000, 10000 mg/kg

No. of animals per sex per dose:

5 x sex x doses

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing:Bodyweights were recorded immediately prior to dosing (control weights) and at 7 and 14 days
- Necropsy of survivors performed: yes

Statistics:

LD50 including 95 % confidence limits are calculated by the logit model.

Results and discussion

Effect levels

Effect levels 1

Sex:

male/female

Dose descriptor:

LD0

Effect level:

ca. 10 000 mg/kg bw

Based on:

test mat.

Effect levels 2

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed

Clinical signs:

other: Dhiarroea, Ruffled fur, Dyspnoea.

Gross pathology:

No substance related gross organ changes were seen

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The acute oral LD50 of test substance in rats of both sexes observed over a period of 14 days is greater than 10000 mg/kg bw.

Executive summary:

The acute oral LD50 of test substance in rats of both sexes observed over a period of 14 days is greater than 10000 mg/kg bw. The test material has therefore practically no acute toxicity to the rat by this route of administration.