Disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulphonate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

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:

1974

Report date:

1974

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:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulphonate

EC Number:

274-499-0

EC Name:

Disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulphonate

Cas Number:

70247-70-0

Molecular formula:

C19H14BrCl2N5O8S2.2Na

IUPAC Name:

disodium 4-[4-({5-[(2-bromoacryloyl)amino]-2-sulfonatophenyl}diazenyl)-3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Test animals

Species:

rat

Strain:

other: Tif. RAI rats

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Age at study initiation: 6 to 7 weeks old
- Weight at study initiation: 160 to 180 g
-Fasting: one night before starting the treatment
- Housing: segregated and housed in Macrolon cages (Type 3)
- Diet: ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1
- Humidity (%): 50

Administration / exposure

Route of administration:

other: oral intubation

Vehicle:

polyethylene glycol

Remarks:

PEG 400

Details on oral exposure:

Concentration % of formulation: 30 %

Doses:

- 4640, 6000 and 7750 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
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: sedation, dyspnoea, curved position and ruffled fur

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 7 750 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was seen throughout the course of the study.

Clinical signs:

other: Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. All animals had recovered within 7 to 8 days.

Gross pathology:

No substance-related gross organ changes were seen.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral median lethal dose (LD50) of FAT 40061/A in rats of both sexes, observed over a period of 14 days is greater than 7750 mg/kg bw.

Executive summary:

The test was performed to determine the acute oral toxicity of FAT 40061/A using a method equivalent or similar to OECD Guideline 401 (Acute Oral Toxicity). Three groups of rats, each containing 5 males and 5 females, were administered the test item at 4640, 6000 and 7750 mg/kg bw. The rats used were of 6 -7 weeks of age and weighing 160 to 180 g. No animals died during the experiment. Within 2 hours after treatment the rats in all dosage groups showed sedation, dyspnoea, curved position and ruffled fur. These symptoms became more accentuated as the dose was increased. All animals had recovered within 7 to 8 days. No substance related gross organ changes were seen at the autopsy. In conclusion, the acute oral LD50 of FAT 40061/A in rats of both sexes, observed over a period of 14 days is greater than 7750 mg/kg bw.