Sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Nov 1976

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:

1976

Report date:

1976

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:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)

EC Number:

266-577-8

EC Name:

Sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)

Cas Number:

67109-27-7

Molecular formula:

C32H24Cl2CrN10O8S2.Na

IUPAC Name:

sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

Name of the test substance as cited in the report: FAT 20028/B
Physical state: A dark red 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: 5 to 6 weeks
- Weight at study initiation: 162 (M) to 136 g (F).
- Diet: ad libitum (Dakes special Diet with added Vit. E)
- Water: ad libitum


ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 +/- 2 °C
- Photoperiod (hrs dark / hrs light): 12 hours darkness and 12 hours artificial light in each 24 hour period.
- Rats were cages singly.

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

water

Remarks:

Tap water

Details on oral exposure:

DOSAGE PREPARATION :
A 25 % w/v solution of the compound in tap water was administered as a single dose by gavage to rats which had been fasted for 18 h, at a rate of 20 ml/kg. (equivalent to 5 g/kg. of compound).

Doses:

- 5000 mg/kg

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

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occurred during the 14 day observation period.

Clinical signs:

other: 24 h after administration the faeces were stained by the compound.

Gross pathology:

Autopsy: No changes in organs or tissues caused by the administration of the test substance were seen.

Other findings:

24 h after administration the faeces were stained by the compound.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The acute oral LD50 of FAT 20028/B in rats of both sex is greater than 5,000 mg/kg.

Executive summary:

An acute oral toxicity study was carried out with FAT 20028/B in rats. Five rats per sex were used for this experiment. FAT 20028/B was used at 5000 mg/kg dose levels. All animals were observed over a period of 14 days. Mortality, body weights and clinical signs were recoded. At the end of the observation period, all animals were killed to be autopsied and gross pathology was carried out. No deaths occurred during the 14 day observation period. At autopsy, no substance related gross organ changes were seen. In conclusion, acute oral median lethal dose (LD₅₀) of FAT 20028/B in rats of both sex is greater than 5,000 mg/kg.